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Xhepa G, Inzerillo A, Constantinescu I, Faerber P, Gleyzolle A, Biondetti P, Del Grande F, Xhepa E, Mortellaro S, Carrafiello G, Pellegrino G, Ricoeur A. Limus Devices for the Treatment of SFA: Latest Outcomes and Future Perspectives. J Clin Med 2025; 14:3594. [PMID: 40429588 PMCID: PMC12112002 DOI: 10.3390/jcm14103594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2025] [Revised: 05/15/2025] [Accepted: 05/18/2025] [Indexed: 05/29/2025] Open
Abstract
Globally, cardiovascular disease is a leading cause of disability and early death, affecting 422.7 million people and causing 17.9 million deaths (31% of global deaths) in 2015. Peripheral arterial disease, previously overlooked compared to coronary artery disease, is now recognised as a major contributor to cardiovascular morbidity and mortality, with distinct characteristics. After noninvasive methods, the femoropopliteal segment is frequently treated with revascularisation, which is recommended for claudication and chronic limb-threatening ischemia (CLTI). Challenges such as mechanical stresses, chronic occlusions, extensive plaque, and calcification affect procedural success and vessel patency. Innovations were needed to address these issues, and vascular drug delivery devices have become integral to endovascular treatment. We review the current literature concerning a diverse range of these devices in clinical use and their role in managing symptomatic patients.
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Affiliation(s)
- Genti Xhepa
- Istituto di Imaging della Svizzera Italiana (IIMSI), Ente Ospedaliero Cantonale (EOC), 6900 Lugano, Switzerland; (G.X.); (F.D.G.)
- Interventional Radiology Unit, University Hospital of Geneva (HUG), 1205 Geneva, Switzerland; (I.C.); (P.F.); (A.G.); (A.R.)
| | - Agostino Inzerillo
- AOUP Paolo Giaccone, Biomedicine, Neuroscience and Advanced Diagnostic Department (BiND), University of Palermo, 90127 Palermo, Italy;
| | - Ilinca Constantinescu
- Interventional Radiology Unit, University Hospital of Geneva (HUG), 1205 Geneva, Switzerland; (I.C.); (P.F.); (A.G.); (A.R.)
| | - Pierre Faerber
- Interventional Radiology Unit, University Hospital of Geneva (HUG), 1205 Geneva, Switzerland; (I.C.); (P.F.); (A.G.); (A.R.)
| | - Adrien Gleyzolle
- Interventional Radiology Unit, University Hospital of Geneva (HUG), 1205 Geneva, Switzerland; (I.C.); (P.F.); (A.G.); (A.R.)
| | - Pierpaolo Biondetti
- Department of Radiology, Foundation IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, 20122 Milan, Italy; (P.B.); (G.C.)
| | - Filippo Del Grande
- Istituto di Imaging della Svizzera Italiana (IIMSI), Ente Ospedaliero Cantonale (EOC), 6900 Lugano, Switzerland; (G.X.); (F.D.G.)
- Facoltà di Scienze Biomediche, Campus Est, Università Della Svizzera Italiana (USI), 6900 Lugano, Switzerland
| | - Edon Xhepa
- Postgraduate School in Radiodiagnostics, University of Milan, 20122 Milan, Italy; (S.M.); (G.P.)
| | - Simone Mortellaro
- Postgraduate School in Radiodiagnostics, University of Milan, 20122 Milan, Italy; (S.M.); (G.P.)
| | - Gianpaolo Carrafiello
- Department of Radiology, Foundation IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, 20122 Milan, Italy; (P.B.); (G.C.)
- Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy
| | - Giuseppe Pellegrino
- Postgraduate School in Radiodiagnostics, University of Milan, 20122 Milan, Italy; (S.M.); (G.P.)
| | - Alexis Ricoeur
- Interventional Radiology Unit, University Hospital of Geneva (HUG), 1205 Geneva, Switzerland; (I.C.); (P.F.); (A.G.); (A.R.)
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Migita S, Kitano D, Li Y, Koyama Y, Shimodai-Yamada S, Okumura Y, Hirayama A, Hao H. Intravascular Imaging and Pathological Features of Drug-Coated Balloon Angioplasty in Atherosclerotic Porcine Peripheral Arteries. J Atheroscler Thromb 2025:65558. [PMID: 40383637 DOI: 10.5551/jat.65558] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/20/2025] Open
Abstract
AIMS The safety and efficacy of drug-coated balloon angioplasty (DCBA), compared to plain old balloon angioplasty (POBA) for peripheral artery in-stent restenosis (ISR), have been examined in clinical trials. However, little is known about the pathological response after DCBA for ISR. We compared the intravascular imaging findings and tissue responses of in-stent neointima in iliac arteries after DCBA and POBA using atherosclerotic porcine peripheral arteries. METHODS Bare metal stents (BMSs) were implanted in the iliac arteries of microminipigs fed high-cholesterol chow. Four weeks after BMS implantation, stented regions were assessed by optical coherence tomography (OCT), followed by either DCBA or POBA. The adherence of the drugs delivered was observed by OCT and angioscopy, performed immediately after DCBA, and then confirmed with scanning electron microscopy. Four weeks after balloon angioplasty, the stented regions were investigated by OCT followed by pathological examination. RESULTS Neointimal volume after DCBA was significantly reduced, while that after POBA showed minimal change. Histological assessments revealed decreases in cell number and the α-smooth muscle actin (SMA)-positive area, while the aniline blue-positive area and the alcian blue-positive area in the neointima was increased, after DCBA as compared to after POBA. CONCLUSIONS The neointima after DCBA in the BMS-implanted region showed fewer smooth muscle cells and more mature extracellular matrix than that after POBA. These results confirmed the clinical benefits of DCBA with ISR for lower extremity arterial disease.
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Affiliation(s)
- Suguru Migita
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Daisuke Kitano
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Yuxin Li
- Division of Cell Regeneration and Transplantation, Department of Functional Morphology, Nihon University School of Medicine
| | - Yutaka Koyama
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Sayaka Shimodai-Yamada
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
| | - Yasuo Okumura
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | | | - Hiroyuki Hao
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
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Tannu M, Jones WS, Swaminathan RV, Rymer JA, Gutierrez JA. Femoropopliteal Endovascular Intervention: A Review of the Current Landscape. Circ Cardiovasc Interv 2025; 18:e014024. [PMID: 40276857 DOI: 10.1161/circinterventions.124.014024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Revised: 02/18/2025] [Accepted: 03/17/2025] [Indexed: 04/26/2025]
Abstract
Superficial femoral artery disease poses significant challenges in patients with peripheral artery disease due to its unique anatomic and physiological characteristics. While conservative measures remain the initial approach for chronic, stable symptoms, endovascular therapies have gained prominence due to their minimally invasive nature, expedited recovery times, and preservation of future treatment options when performed correctly. Options for endovascular interventions include balloon angioplasty (percutaneous transluminal angioplasty [standard], drug-coated balloon), stenting (bare metal, drug-eluting, covered stents), with or without adjunct therapy (atherectomy or intravascular lithotripsy). Randomized controlled trials have demonstrated superior outcomes with drug-coated balloons and drug-eluting stents over bare metal stents or percutaneous transluminal angioplasty alone, particularly in long, heavily calcified lesions. However, challenges such as in-stent restenosis, stent fracture, and in-stent thrombosis persist, driving ongoing innovation in device technology and drug formulations on devices. Emerging therapies such as bioresorbable scaffolds and percutaneous bypass devices offer promising alternatives. Further research is needed to refine treatment strategies, minimize risks, and optimize outcomes.
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Affiliation(s)
- Manasi Tannu
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - W Schuyler Jones
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - Rajesh V Swaminathan
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Durham VA Medical Center, Durham, NC (R.V.S., J.A.G.)
| | - Jennifer A Rymer
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - J Antonio Gutierrez
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Durham VA Medical Center, Durham, NC (R.V.S., J.A.G.)
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Conte MS, Aulivola B, Barshes NR, Bertges DJ, Corriere MA, Murad MH, Powell RJ, Reed AB, Robinson WP, Simons JP. Society for Vascular Surgery Clinical Practice Guideline on the management of intermittent claudication: Focused update. J Vasc Surg 2025:S0741-5214(25)01003-1. [PMID: 40316185 DOI: 10.1016/j.jvs.2025.04.041] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2025] [Accepted: 04/24/2025] [Indexed: 05/04/2025]
Abstract
Intermittent claudication (IC) is the most common symptom of peripheral artery disease, which is a growing public health burden in the United States and globally. Patients with IC present with a broad spectrum of risk factors, comorbid conditions, range of disability, and treatment goals. Informed shared decision-making hinges on a comprehensive evaluation of these factors, patient education, and knowledge of the latest available evidence. In 2015, the Society for Vascular Surgery published a clinical practice guideline on the management of asymptomatic peripheral artery disease and IC. An expert writing group was commissioned to provide a focused update to this guideline on the management of IC. Based on the available evidence from published research conducted since the prior guideline, six specific key questions were formulated spanning the areas of antithrombotic management, exercise therapy, and revascularization for IC. A systematic review and evidence synthesis of each question was conducted by a dedicated methodology team. The GRADE approach was employed to describe the strength of each recommendation and level of certainty of evidence. The review identified major gaps in evidence particularly in the arena of comparative effectiveness for interventions (exercise, revascularization) across defined clinical subgroups and employing meaningful patient-centered outcomes. Twelve recommendations, among which are two best practice statements, are provided in this focused update. They address the use of dual pathway antithrombotic strategies, the role and type of exercise therapy, endovascular interventions for femoropopliteal and infrapopliteal disease, and the identification of specific risk factors that should be incorporated into shared decision-making around revascularization. A comprehensive and individualized approach to the management of patients with IC, relying first on education, risk factor control, optimal medical therapy, and exercise, is emphasized. A rubric for decision-making that includes a thorough assessment of risk, benefits, degree of impairment, and treatment durability, is considered fundamental to a patient-centered approach in IC. Significant unmet research needs in this field are also enumerated.
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Affiliation(s)
- Michael S Conte
- Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
| | - Bernadette Aulivola
- Division of Vascular Surgery and Endovascular Therapy, Loyola University Chicago Stritch School of Medicine, Maywood, IL
| | - Neal R Barshes
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX
| | - Daniel J Bertges
- Division of Vascular Surgery and Endovascular Therapy, University of Vermont Medical Center, Burlington, VT
| | - Matthew A Corriere
- Division of Vascular Surgery and Diseases, The Ohio State University Wexner Medical Center, Columbus, OH
| | - M Hassan Murad
- Mayo Clinic Evidence-based Practice Center, Rochester, MN
| | - Richard J Powell
- Geisel School of Medicine, Dartmouth-Hitchcock Medical Center, Hanover, NH
| | - Amy B Reed
- Medical University of South Carolina, Tidelands Health, Vascular Surgery, Murrells Inlet, SC
| | - William P Robinson
- Division of Vascular Surgery, Southern Illinois University School of Medicine, Springfield, IL
| | - Jessica P Simons
- Division of Vascular and Endovascular Surgery, University of Massachusetts Chan Medical School, Worcester, MA
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Saadi S, Nayfeh T, Rajjoub R, Hasan B, Firwana M, Jawaid T, Hazem W, Shah S, Alsawaf Y, Seisa MO, Prokop LJ, Conte MS, Murad MH. A systematic review supporting the Society for Vascular Surgery guideline update on the management of intermittent claudication. J Vasc Surg 2025:S0741-5214(25)01002-X. [PMID: 40316186 DOI: 10.1016/j.jvs.2024.12.135] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2024] [Revised: 12/12/2024] [Accepted: 12/22/2024] [Indexed: 05/04/2025]
Abstract
OBJECTIVE This systematic review and meta-analysis evaluates the current evidence on the management of intermittent claudication (IC), a prevalent manifestation of peripheral arterial disease (PAD). METHODS We conducted comprehensive searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus. We addressed six questions developed by a guideline committee from the Society for Vascular Surgery, addressing pharmacological treatments, exercise regimens, endovascular interventions, and predictors of major adverse cardiovascular, limb-related events, and mortality. RESULTS The search resulted in 5333 citations, from which we included 73 studies (46 randomized trials). In patients with PAD and IC who had one or more high-risk comorbidities, low-dose rivaroxaban and aspirin were associated with lower risk of major adverse limb events and major adverse cardiovascular events than aspirin alone. In patients who have undergone surgical or endovascular interventions for PAD, the addition of low-dose rivaroxaban to aspirin may improve limb outcomes. Of note, rivaroxaban trials excluded patients at high risk of bleeding. Single antiplatelet agents showed no significant efficacy differences head-to-head in ambulatory patients with IC and had a lower bleeding risk compared with combination therapy or anticoagulation. Home exercise programs were feasible and may be an alternative to supervised exercise in ambulatory patients with IC and in those who had revascularization. Several comorbidities increased the risk of adverse outcomes after revascularization for IC, such as advanced age, diabetes, coronary artery disease, chronic obstructive pulmonary disease, previous interventions, congestive heart failure, infrapopliteal artery involvement, and longer lesion lengths. In patients with IC undergoing endovascular intervention for superficial femoral artery disease, plain balloon angioplasty was associated with worse outcomes than drug elution or stent implantation for intermediate or longer lesions (ie, >5 cm). CONCLUSIONS This systematic review summarizes the current evidence base for the management of IC, offering insights into the relative benefits and risks of various therapeutic strategies. The findings underscore the need for individualized patient care, considering both the potential benefits and risks associated with different interventions.
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Affiliation(s)
- Samer Saadi
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.
| | - Tarek Nayfeh
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Rami Rajjoub
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Bashar Hasan
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Mohammed Firwana
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Tabinda Jawaid
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Walid Hazem
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Sahrish Shah
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Yahya Alsawaf
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Mohamed O Seisa
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | | | - Michael S Conte
- The Division of Vascular and Endovascular Surgery, University of California San Francisco, San Francisco, CA
| | - M Hassan Murad
- Evidence-Based Practice Center, Mayo Clinic, Rochester, MN; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
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Gostev AA, Osipova OO, Cheban AV, Saaya SB, Rubtsun AA, Ignatenko PV, Karpenko AA, Gouëffic Y. Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial. J Endovasc Ther 2025; 32:192-198. [PMID: 37128865 DOI: 10.1177/15266028231170125] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/03/2023]
Abstract
PURPOSE The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. MATERIALS AND METHODS The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. RESULTS Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. CONCLUSION Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. CLINICAL IMPACT Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.
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Affiliation(s)
- Alexander A Gostev
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Olesia O Osipova
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Alexey V Cheban
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Shoraan B Saaya
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Artem A Rubtsun
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Pavel V Ignatenko
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Andrey A Karpenko
- Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation
| | - Yann Gouëffic
- Laboratoire de Physiopathologie de la Résorption Osseuse, Inserm-UN UMR-957, Nantes, France
- Service de Chirurgie Vasculaire et Endovasculaire, Groupe Hospitalier Paris Saint Joseph, Paris, France
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Schwartz AW, Shah Y, Huang H, Nathan A, Fanaroff AC, Giri JS, Parikh SA, Lansky AJ, Shah T. Comparison of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2025; 4:102432. [PMID: 40061407 PMCID: PMC11887560 DOI: 10.1016/j.jscai.2024.102432] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 05/30/2024] [Revised: 09/24/2024] [Accepted: 10/08/2024] [Indexed: 05/02/2025]
Abstract
Background To understand the relative safety and efficacy of endovascular treatment modalities used for superficial femoral artery (SFA) disease, we performed a network meta-analysis to compare outcomes between percutaneous transluminal angioplasty (PTA), atherectomy (A), bare metal stent (BMS), brachytherapy/radiotherapy, covered stent graft (CSG), cutting balloon angioplasty (CBA), drug-coated balloon (DCB), drug-eluting stent (DES), and intravascular lithotripsy (L). Methods We performed a systematic literature search of PubMed from January 2000 to January 2023 to identify randomized trials comparing endovascular interventions for the treatment of SFA disease. The primary end points were technical success and 12-month primary patency. Results In total, 57 studies (9089 patients) were included. The mean age of the included patients was 68.4 years, 41.4% had diabetes, 18.3% had critical limb ischemia, and 81.3% had de novo lesions. A mean of 1.2 lesions were treated per patient. Technical success was superior for CSG, BMS, and A+DCB compared with PTA, while A+DCB and CSG were superior to DCB. All interventions except brachytherapy alone had superior primary patency compared with PTA. There were no significant differences in 12-month mortality or major amputation. All interventions except L+DCB, PTA+A, and CBA were superior to PTA regarding target lesion revascularization, while only DCB, DES, and BMS were better than PTA at improving Rutherford classification. Conclusions In SFA disease, PTA alone is mostly inferior to other endovascular techniques. This comparison of other endovascular techniques will be valuable for endovascular device selection in the treatment of SFA disease.
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Affiliation(s)
- Andrew W. Schwartz
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Yousuf Shah
- Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York
| | - Haocheng Huang
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Ashwin Nathan
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Alexander C. Fanaroff
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Jay S. Giri
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Sahil A. Parikh
- Division of Cardiology, Columbia University Irving Medical Center, New York, New York
| | - Alexandra J. Lansky
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Tayyab Shah
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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Warren BE, Tan KT, Rajan DK, Witheford M, Crawford S, Jaberi A, Mafeld S. Moving away from metal: Step toward the future with bioresorbable vascular scaffolds and novel antiproliferative agents. JVS Vasc Sci 2024; 6:100277. [PMID: 39906027 PMCID: PMC11791325 DOI: 10.1016/j.jvssci.2024.100277] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2024] [Accepted: 12/14/2024] [Indexed: 02/06/2025] Open
Abstract
Background Peripheral arterial disease (PAD) is a common source of morbidity and mortality globally and is expected to raise increase in prevalence. Many endovascular techniques exist to manage PAD; however, there remains room for improvement, especially as it relates to below-the-knee vessels. Recent evidence and devices are leading to a resurgence of interest in bioresorbable vascular scaffolds and the -limus family of antiproliferative drugs in the PAD treatment space. Methods This nonsystematic review examines emerging technology for treatment of PAD with a specific focus on below-the-knee vessels and bioresorbable vascular scaffolds. Additional emerging and early technology such as novel delivery platforms are also briefly discussed with directions of future research highlighted. Results Bioresorbable vascular scaffold biomechanics and history are highlighted. Foundational knowledge of antiproliferative agents and evolving agents in peripheral vascular disease are also described. Conclusions Bioresorbable vascular scaffolds are an additional endovascular tool for the treatment of peripheral vascular disease. The integration with an antiproliferative agent may result in improved patency and performance; however, there is a paucity of data in the literature at present.
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Affiliation(s)
- Blair E. Warren
- Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, Toronto, Ontario, Canada
| | - Kong-Teng Tan
- Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, Toronto, Ontario, Canada
| | - Dheeraj K. Rajan
- Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, Toronto, Ontario, Canada
| | - Miranda Witheford
- Division of Vascular Surgery, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada
| | - Sean Crawford
- Division of Vascular Surgery, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada
| | - Arash Jaberi
- Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, Toronto, Ontario, Canada
| | - Sebastian Mafeld
- Department of Medical Imaging, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
- Division of Vascular and Interventional Radiology, Joint Department of Medical Imaging, University Health Network, Toronto, Ontario, Canada
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Gouëffic Y, Brodmann M, Deloose K, Dubosq-Lebaz M, Nordanstig J. Drug-eluting devices for lower limb peripheral arterial disease. EUROINTERVENTION 2024; 20:e1136-e1153. [PMID: 39279515 PMCID: PMC11423351 DOI: 10.4244/eij-d-23-01080] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Accepted: 06/06/2024] [Indexed: 09/18/2024]
Abstract
Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.
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Affiliation(s)
- Yann Gouëffic
- Service de chirurgie vasculaire et endovasculaire, Groupe Hospitalier Paris St Joseph, Paris, France
| | | | - Koen Deloose
- Department of Vascular Surgery, AZ Sint-Blasius Hospital Dendermonde, Dendermonde, Belgium
| | - Maxime Dubosq-Lebaz
- Vascular & endovascular surgery, Aortic Centre, Institut Coeur Poumon, CHU de Lille, Lille, France
| | - Joakim Nordanstig
- Institute of Medicine, Department of Molecular and Clinical Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
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10
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Bellissard A, Kuntz S, Lejay A, Chakfé N. Systematic Review of Femoral Artery Stent Fractures. EJVES Vasc Forum 2024; 62:48-56. [PMID: 39328303 PMCID: PMC11426108 DOI: 10.1016/j.ejvsvf.2024.08.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2023] [Revised: 07/29/2024] [Accepted: 08/13/2024] [Indexed: 09/28/2024] Open
Abstract
Objective Primary stenting for long femoropopliteal (FP) lesions remains controversial because of the high risk of stent fracture (SF). This study aimed to summarise current knowledge on SF from randomised control trials about FP stenting. Methods A systematic review of the Medline database was performed by a combined strategy of MeSH terms: femoral artery, popliteal artery, stenting, and stent fracture. SF was classified according to a standard classification: 1 = single strut fracture; 2 = ≥ two struts fracture; 3 = type 2 with deformation; 4 = multiple struts fracture with acquired transection; 5, type 4 with gap in the stent body. Results The literature search identified 25 publications including covered stents (CSs; n = 3), drug eluting stents (DESs; n = 8), bare metal stents (BMS; n = 17), and bioabsorbable stents (n = 1). Data were extracted from 4 047 patients; mean age ± standard deviation was 68.9 ± 3.0 years and 69% were male. The median lesion length was 87.6 mm (interquartile range [IQR] 70.0, 149) with a median chronic total occlusion proportion of 36.8% (IQR 29.0, 56.5). In 208 patients treated with CS, SF rates ranged from none to 2.6% at 36 months with no clinical correlation. In 1 106 patients treated with DES, SF rates were relatively low in large cohorts, ranging from 0% at 12 months to 1.9% at 60 months. In smaller cohorts (under 100 patients per group), they ranged from 12.5% at six months to 46.7% at 12 months, with no clinical repercussion. In 1 610 patients treated with BMS, SF rates ranged from 2% to 32.7% at 12 months and from 2.9% to 48.9% at 24 months, with no clinical repercussion. Conclusion SF rates in large cohorts were low in CF and DES, and quite common in BMS, although none of them had clinical consequences. However, longer follow up and detailed, accurate reports are needed to assess eventual real clinical outcomes.
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Affiliation(s)
- Arielle Bellissard
- Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France
- GEPROMED, Bâtiment d’Anesthésiologie, Strasbourg, France
| | - Salomé Kuntz
- Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France
- GEPROMED, Bâtiment d’Anesthésiologie, Strasbourg, France
| | - Anne Lejay
- Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France
- GEPROMED, Bâtiment d’Anesthésiologie, Strasbourg, France
| | - Nabil Chakfé
- Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France
- GEPROMED, Bâtiment d’Anesthésiologie, Strasbourg, France
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11
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Tonpe S, Warbhe H, Banode P, Gaddam N. Current Advances in Diagnostic and Treatment Approaches for Subclavian Steal Syndrome: A Case Report and Review of the Literature. Cureus 2024; 16:e65925. [PMID: 39229428 PMCID: PMC11370707 DOI: 10.7759/cureus.65925] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2024] [Accepted: 07/31/2024] [Indexed: 09/05/2024] Open
Abstract
With newly created therapy devices and cutting-edge diagnostic techniques, we successfully diagnosed and treated subclavian steal syndrome in this case report. This case report is complemented by a literature review that examines the current state of knowledge about diagnostic and treatment options. The patient reported pain and numbness in his left upper arm when raising his arm above his head. On clinical examination, he had good left radial and ulnar pulses while in a sitting position; however, he had absent left ulnar pulses when he raised his hand above his head. Angiography revealed retrograde perfusion of the left vertebral artery and nearly complete occlusion of the ostium of the left subclavian artery. The patient underwent angioplasty and stenting. Immediately after the procedure, the patient reported a reduction in the pain and numbness in his left upper limb by 50%, which completely disappeared at his routine follow-up after one month. The patient was completely asymptomatic during follow-up and had no signs of neurological deficit.
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Affiliation(s)
- Sudhanshu Tonpe
- Department of Interventional Radiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Himandri Warbhe
- Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Pankaj Banode
- Department of Interventional Radiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Nikhita Gaddam
- Department of Radiology, Government Medical College, Nirmal, Nirmal, IND
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12
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Ding Y, Warlick L, Chen M, Taddese E, Collins C, Fu R, Duan C, Wang X, Ware H, Sun C, Ameer G. 3D-printed, citrate-based bioresorbable vascular scaffolds for coronary artery angioplasty. Bioact Mater 2024; 38:195-206. [PMID: 38756202 PMCID: PMC11096684 DOI: 10.1016/j.bioactmat.2024.04.030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2024] [Revised: 04/25/2024] [Accepted: 04/27/2024] [Indexed: 05/18/2024] Open
Abstract
Fully bioresorbable vascular scaffolds (BVSs) aim to overcome the limitations of metallic drug-eluting stents (DESs). However, polymer-based BVSs, such as Abbott's Absorb, the only US FDA-approved BVS, have had limited use due to increased strut thickness (157 μm for Absorb), exacerbated tissue inflammation, and increased risk of major cardiac events leading to inferior clinical performance when compared to metallic DESs. Herein we report the development of a drug-eluting BVS (DE-BVS) through the innovative use of a photopolymerizable, citrate-based biomaterial and a high-precision additive manufacturing process. BVS with a clinically relevant strut thickness of 62 μm can be produced in a high-throughput manner, i.e. one BVS per minute, and controlled release of the anti-restenosis drug everolimus can be achieved by engineering the structure of polymer coatings to fabricate drug-eluting BVS. We achieved the successful deployment of BVSs and DE-BVSs in swine coronary arteries using a custom-built balloon catheter and BVS delivery system and confirmed BVS safety and efficacy regarding maintenance of vessel patency for 28 days, observing an inflammation profile for BVS and DE-BVS that was comparable to the commercial XIENCE™ DES (Abbott Vascular).
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Affiliation(s)
- Yonghui Ding
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Liam Warlick
- Department of Materials Science and Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Mian Chen
- Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Eden Taddese
- Department of Materials Science and Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Caralyn Collins
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Mechanical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Rao Fu
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Mechanical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Chongwen Duan
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Xinlong Wang
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Henry Ware
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Mechanical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Cheng Sun
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Mechanical Engineering, Northwestern University, Evanston, IL 60208, USA
| | - Guillermo Ameer
- Centre for Advanced Regenerative Engineering (CARE), Northwestern University, Evanston, IL 60208, USA
- Department of Biomedical Engineering, Northwestern University, Evanston, IL 60208, USA
- Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA
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13
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Jiang X, Ju S, Liu H, Chen B, Jiang J, Shi Y, Ma T, Lin C, Fang G, Guo D, Xu X, Fu W, Dong Z. Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery. Ann Vasc Surg 2024; 104:196-204. [PMID: 38492729 DOI: 10.1016/j.avsg.2023.12.091] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2023] [Revised: 12/14/2023] [Accepted: 12/18/2023] [Indexed: 03/18/2024]
Abstract
BACKGROUND The treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. METHODS From June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications, and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class. RESULTS A total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions, while 41 (67.2%) patients had chronic total occlusions. The mean length of these lesions was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. CONCLUSIONS ELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.
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Affiliation(s)
- Xiaolang Jiang
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Shuai Ju
- Center for Vascular Surgery and Wound Care, Jinshan Hospital, Fudan University, Shanghai, China
| | - Hao Liu
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Bin Chen
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Junhao Jiang
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Yun Shi
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Tao Ma
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Changpo Lin
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Gang Fang
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Daqiao Guo
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Xin Xu
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China
| | - Weiguo Fu
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
| | - Zhihui Dong
- Institute of Vascular Surgery, Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China; Center for Vascular Surgery and Wound Care, Jinshan Hospital, Fudan University, Shanghai, China.
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14
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Loureiro L, Pinelo A, Veterano C, Rocha H, Castro J, Machado R. Navigating complexity: The Supera's triumph in femoropopliteal lesions. Vascular 2024:17085381241246321. [PMID: 38588331 DOI: 10.1177/17085381241246321] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/10/2024]
Abstract
INTRODUCTION The femoropopliteal sector endovascular treatment is particularly challenging due to its high tortuosity and torsional forces. Better results are still needed to ensure the long-term patency of stenting in this area. The Supera stent appears to change this paradigm. METHODS This single-center retrospective cohort study aims to evaluate the efficacy and safety of femoropopliteal stenting with Supera in a real-world population. Seventy-nine patients were treated between January 2015 and December 2020, and the results are reported with a median follow-up of 28 months. RESULTS Indications for revascularization were chronic limb-threatening ischemia with tissue loss (73.6%) or ischemic rest pain (17.7%) and claudication (7.6%). Thirty-six patients (45.6%) were classified as GLASS stage III according to the Global Limb Anatomic Staging System, with 65.8% and 30.4% in grades 3 and 4 of femoropopliteal and infrapopliteal sectors, respectively. The 36-month primary, primary-assisted, and secondary patency rates were 68.6%, 72.0%, and 79.0%, respectively, with an amputation-free survival rate of 86.6%. There was no significant difference between primary patency rates in GLASS stages I-II compared with GLASS stage III (36-month primary patency rates of 72% vs 63% respectively, p = 0.342) nor in amputation-free survival (88% vs 84%, p = 0.877). After adjusting for potential confounders, only the stent conformation significantly affected the primary patency rates, with a higher hazard of reintervention for the elongated (HR = 3.179; p = 0.36; CI 1.081-9.347) and the compressed (HR = 3.014; p = 0.42; CI 1.039-8.746) forms. CONCLUSIONS The 36-month patency of the Supera stents in our real-world cohort was similar to other reported series. The GLASS stage did not interfere with the stent patency, proving it is a good choice even in the most adverse anatomy patients. Only the non-nominal stent conformation affected the primary patency rates in our patients.
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Affiliation(s)
- Luis Loureiro
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
| | - Andreia Pinelo
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
| | - Carlos Veterano
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
| | - Henrique Rocha
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
| | - João Castro
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
| | - Rui Machado
- Angiology and Vascular Surgery Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
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15
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Chen K, Xu L, Liu X. Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysis. J Thromb Thrombolysis 2024; 57:520-530. [PMID: 38281227 DOI: 10.1007/s11239-023-02932-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 11/27/2023] [Indexed: 01/30/2024]
Abstract
Drug-eluting stents (DESs) have become the first-line treatment for symptomatic peripheral arterial disease (PAD). Currently, there are many types of DESs on the market. The same type of DESs has different concentrations, and various drugs in them show uneven efficacy. The selection of DESs remains controversial. This study was aimed at comparing the long-term real-world outcomes of different DESs in the treatment of peripheral arterial occlusive disease (PAOD). The databases including Cochrane Library, Embase, and PubMed were searched with a time frame until March 25, 2023. The primary patency (PP) and target lesion revascularization (TLR) at 6 months were used as the primary endpoints. A total of 32 studies (5467 patients) were eligible. At the six-month follow-up, DES-Evero 1 ug/mm2 ranked first in terms of PP, with a significant difference from BMSs (RR [95% CI] = 1.6). DES-Siro 0.9 ug/mm2, DES-Siro 1.4 ug/mm2, DES-Siro 1.95 ug/mm2, DES-PTX 0.167 ug/mm2, DES-PTX 1 ug/mm2 and covered stents (CSs) showed significantly better PPs than BMSs. In terms of TLR, DES-Siro 0.9 ug/mm2 (0.31) ranked first, and DES-Evero 1 ug/mm2 ranked last. Among the treatment modalities for PAD, different DESs showed overall encouraging results in improving PP and TLR compared with BMSs. DES-Evero 1 ug/mm2 showed the best PP, but it had the highest reintervention rate at 6 months. Sirolimus-eluting stents were not always more effective with higher concentrations of sirolimus. Among various DESs, sirolimus-eluting stents and everolimus-eluting stents were superior to paclitaxel-eluting stents.
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Affiliation(s)
- Keqin Chen
- Department of Vascular Surgery, The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University (The First Hospital of Changsha), 311 Yingpan Road, Changsha City, 410005, Hunan Province, China.
| | - Lei Xu
- Public Health Clinical Center, Xiangtan Central Hospital, Xiangtan, China
| | - Xiehong Liu
- Hunan Provincial Key Laboratory of Emergency and Critical Care Metabonomics, Institute of Emergency Medicine, The First Affiliated Hospital of Hunan Normal University (Hunan Provincial People's Hospital), Changsha, China
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Zywicka EM, McNally E, Elliott L, Twine CP, Mouton R, Hinchliffe RJ. Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review. Eur J Vasc Endovasc Surg 2024; 67:155-164. [PMID: 37678660 DOI: 10.1016/j.ejvs.2023.08.066] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2023] [Revised: 08/04/2023] [Accepted: 08/31/2023] [Indexed: 09/09/2023]
Abstract
OBJECTIVE Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD). DATA SOURCES AND REVIEW METHODS A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials. RESULTS After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored. CONCLUSION The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214.
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Affiliation(s)
- Ewa M Zywicka
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
| | | | - Lucy Elliott
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK
| | - Christopher P Twine
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/TwineVasc
| | - Ronelle Mouton
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/RonelleMouton
| | - Robert J Hinchliffe
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/robhinchliffe1
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17
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Al-Nowfal A, Ahmed I. Novel Endovascular Technologies in Femoropopliteal Disease. MASTERING ENDOVASCULAR TECHNIQUES 2024:193-208. [DOI: 10.1007/978-3-031-42735-0_20] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
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18
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Fransson T, Gottsäter A, Abdulrasak M, Malina M, Resch T. Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia. Vasc Endovascular Surg 2023; 57:706-716. [PMID: 37085152 DOI: 10.1177/15385744231171746] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/23/2023]
Abstract
OBJECTIVE Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. METHODS Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. RESULTS A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. CONCLUSIONS This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.
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Affiliation(s)
- Torbjörn Fransson
- Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö, Sweden
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
| | - Anders Gottsäter
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
- Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden
| | - Mohammad Abdulrasak
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
- Department of Internal Medicine, Section of Gastroenterology, Skåne University Hospital, Malmö, Sweden
| | - Martin Malina
- West London Vascular and Interventional Centre, Northwick Park University Hospital, Harrow, UK
| | - Timothy Resch
- Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Li M, Tu H, Yan Y, Guo Z, Zhu H, Niu J, Yin M. Meta-analysis of outcomes from drug-eluting stent implantation in femoropopliteal arteries. PLoS One 2023; 18:e0291466. [PMID: 37733656 PMCID: PMC10513203 DOI: 10.1371/journal.pone.0291466] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2023] [Accepted: 08/25/2023] [Indexed: 09/23/2023] Open
Abstract
OBJECTIVE In recent years, studies of drug-eluting stent (DES) for femoropopliteal artery diseases (FPADs) have been gradually published. To explore whether this type of stent is superior to the traditional bare metal stent (BMS), we performed this study. METHODS A systematic search for randomized controlled trials (RCTs) in Excerpta Medica Database (Embase), PubMed, Web of Science (WOS), and Cochrane Library was performed on November 29, 2022. We innovatively adopted the hazard ratio (HR), the most appropriate indicator, as a measure of the outcomes that fall under the category of time-to-event data. The HRs was extracted directly or indirectly. Then, the meta-analyses using random effects model were performed. The bias risks of included papers were assessed by the Cochrane Risk of Bias 2.0 tool. This study was registered on the PROSPER platform (CRD42023391944) and not funded. RESULTS Seven RCTs involving 1,889 participants were found. After pooled analyses, we obtained results without propensity on each of the following 3 outcomes of interest: in-stent restenosis (ISR) -free survival, primary patency (PP) survival, and target lesion revascularization (TLR) -free survival (P >0.05, respectively). Because the results of pooled analyses of the other two outcomes of interest (all-cause death free survival and clinical benefit survival) had high heterogeneity both, they were not accepted by us. CONCLUSION For FPADs, the DES has not yet demonstrated superiority or inferiority to BMS, in the ability to maintain PP, avoid ISR and TLR.
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Affiliation(s)
- Mingxuan Li
- Beijing Fengtai You’anmen Hospital, Beijing, China
| | - Haixia Tu
- Beijing Fengtai You’anmen Hospital, Beijing, China
| | - Yu Yan
- Beijing Fengtai You’anmen Hospital, Beijing, China
| | - Zhen Guo
- Beijing Fengtai You’anmen Hospital, Beijing, China
| | - Haitao Zhu
- Beijing Fengtai You’anmen Hospital, Beijing, China
| | | | - Mengchen Yin
- Beijing Fengtai You’anmen Hospital, Beijing, China
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20
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5273-5287. [PMID: 37621588 PMCID: PMC10445070 DOI: 10.12998/wjcc.v11.i22.5273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/04/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio. AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs. METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model. RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively]. CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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21
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5267-5281. [DOI: 10.12998/wjcc.v11.i22.5267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/03/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.
AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.
METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model.
RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively].
CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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22
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Salamaga S, Stępak H, Żołyński M, Kaczmarek J, Błaszyk M, Stanišić MG, Krasiński Z. Three-Year Real-World Outcomes of Interwoven Nitinol Supera Stent Implantation in Long and Complex Femoropopliteal Lesions. J Clin Med 2023; 12:4869. [PMID: 37510984 PMCID: PMC10381725 DOI: 10.3390/jcm12144869] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2023] [Revised: 07/20/2023] [Accepted: 07/21/2023] [Indexed: 07/30/2023] Open
Abstract
BACKGROUND Peripheral artery disease (PAD) remains a major issue in modern societies and affects more than 200 million people around the world. Endovascular methods have been evaluated to be safe and effective in limb salvage. The Supera is able to withstand increased compression, biomechanical stress and to have higher radial force. The objective of this study is to evaluate performance, durability and 3-year patency of Supera stent implantation in severe femoropopliteal disease. METHODS A retrospective real-world analysis was performed with consideration of 77 patients that had a Supera stent implanted with femoropopliteal atherosclerotic disease at a single center. Among the 77 individuals, 92 Supera stents were implanted. Analysis of patients' demographics, lesions characteristics, reintervention rates and patency rates was performed. RESULTS The median follow-up was 33 months and ranged from 0 to 84 months. Chronic limb-threatening ischemia was observed among 43 patients. Mean lesion length was 152.8 ± 94.6 mm. Chronic total occlusions were observed in a majority of lesions. Overall, primary patency rates at 6, 12, 24 and 36 months were 85.0%, 73.6%, 59.2% and 53.2%, respectively. CONCLUSIONS The Supera stent is effective in the management of long and complex lesions. The results of patency rates were evaluated to be worse among lesions extending to the popliteal artery.
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Affiliation(s)
- Szymon Salamaga
- Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Długa Street, 61-848 Poznan, Poland
| | - Hubert Stępak
- Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Długa Street, 61-848 Poznan, Poland
| | - Mikołaj Żołyński
- Department of Cardiology-Intensive Therapy, Poznan University of Medical Sciences, Ul. Przybyszewskiego 49, 60-355 Poznan, Poland
| | - Jagoda Kaczmarek
- Faculty of Medicine, Poznan University of Medical Sciences, 1/2 Długa Street, 61-848 Poznan, Poland
| | - Maciej Błaszyk
- Department of Radiology, Poznan University of Medical Sciences, 1/2 Długa Street, 61-848 Poznan, Poland
| | - Michał-Goran Stanišić
- Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Długa Street, 61-848 Poznan, Poland
| | - Zbigniew Krasiński
- Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Długa Street, 61-848 Poznan, Poland
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Berti F, Brambilla A, Pennati G, Petrini L. Relevant Choices Affecting the Fatigue Analysis of Ni-Ti Endovascular Devices. MATERIALS (BASEL, SWITZERLAND) 2023; 16:3178. [PMID: 37110014 PMCID: PMC10146368 DOI: 10.3390/ma16083178] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 03/13/2023] [Revised: 04/07/2023] [Accepted: 04/15/2023] [Indexed: 06/19/2023]
Abstract
Ni-Ti alloys are widely used for biomedical applications due to their superelastic properties, which are especially convenient for endovascular devices that require minimally invasive insertion and durable effects, such as peripheral/carotid stents and valve frames. After crimping and deployment, stents undergo millions of cyclic loads imposed by heart/neck/leg movements, causing fatigue failure and device fracture that can lead to possibly severe consequences for the patient. Standard regulations require experimental testing for the preclinical assessment of such devices, which can be coupled with numerical modeling to reduce the time and costs of such campaigns and to obtain more information regarding the local state of stress and strain in the device. In this frame, this review aimed to enlighten the relevant choices that can affect the outcome of the fatigue analysis of Ni-Ti devices, both from experimental and numerical perspectives.
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Affiliation(s)
- Francesca Berti
- Department of Chemistry, Materials and Chemical Engineering “G. Natta” (LaBS), Politecnico di Milano, 20133 Milan, Italy; (F.B.); (G.P.)
| | - Alma Brambilla
- Department of Civil and Environmental Engineering, Politecnico di Milano, 20133 Milan, Italy;
| | - Giancarlo Pennati
- Department of Chemistry, Materials and Chemical Engineering “G. Natta” (LaBS), Politecnico di Milano, 20133 Milan, Italy; (F.B.); (G.P.)
| | - Lorenza Petrini
- Department of Civil and Environmental Engineering, Politecnico di Milano, 20133 Milan, Italy;
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24
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Lin LH, Ho KL, Jian YM, Chiang KH, Hsiao HM. Effects of Tapered-Strut Design on Fatigue Life Enhancement of Peripheral Stents. Bioengineering (Basel) 2023; 10:bioengineering10040443. [PMID: 37106630 PMCID: PMC10136194 DOI: 10.3390/bioengineering10040443] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2023] [Revised: 03/20/2023] [Accepted: 03/29/2023] [Indexed: 04/05/2023] Open
Abstract
Peripheral stent could fracture from cyclic loadings as a result of our blood pressures or daily activities. Fatigue performance has therefore become a key issue for peripheral stent design. A simple yet powerful tapered-strut design concept for fatigue life enhancement was investigated. This concept is to move the stress concentration away from the crown and re-distribute the stresses along the strut by narrowing the strut geometry. Finite element analysis was performed to evaluate the stent fatigue performance under various conditions consistent with the current clinical practice. Thirty stent prototypes were manufactured in-house by laser with a series of post-laser treatments, followed by the validation of bench fatigue tests for proof of concept. FEA simulation results show that the fatigue safety factor of the 40% tapered-strut design increased by 4.2 times that of a standard counterpart, which was validated by bench tests with 6.6-times and 5.9-times fatigue enhancement at room temperature and body temperature, respectively. Bench fatigue test results agreed very well with the increasing trend predicted by FEA simulation. The effects of the tapered-strut design were significant and could be considered as an option for fatigue optimization of future stent designs.
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Affiliation(s)
- Li-Han Lin
- Department of Mechanical Engineering, National Taiwan University, Taipei City 106, Taiwan
| | - Kuang-Lei Ho
- Department of Mechanical Engineering, National Taiwan University, Taipei City 106, Taiwan
| | - Yu-Min Jian
- Department of Mechanical Engineering, National Taiwan University, Taipei City 106, Taiwan
| | - Kuang-Hsing Chiang
- Division of Cardiology and Cardiovascular Research Center, Department of Internal Medicine, Taipei Medical University Hospital, Taipei City 110, Taiwan
| | - Hao-Ming Hsiao
- Department of Mechanical Engineering, National Taiwan University, Taipei City 106, Taiwan
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25
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Fong KY, Xin L, Ng J, Loh SEK, Ng JJ, Choong AMTL. A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial disease. J Vasc Surg 2023; 77:1264-1273.e3. [PMID: 36183989 DOI: 10.1016/j.jvs.2022.09.022] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2022] [Revised: 08/29/2022] [Accepted: 09/19/2022] [Indexed: 10/14/2022]
Abstract
OBJECTIVE We performed a systematic review and meta-analysis to analyze the efficacy and safety of sirolimus-eluting stents (SESs) in the treatment of below-the-knee (BTK) arterial disease. METHODS An electronic literature search was conducted from inception to July 24, 2021. Retrospective, prospective, and randomized studies that had used SESs to treat BTK arterial disease and had reported the primary patency, technical success, target lesion revascularization, and/or mortality were included. Meta-analyses of the proportions were conducted to derive pooled summary statistics of the outcomes. Where Kaplan-Meier curves were provided for primary patency, a meta-analysis of the individual patient data was conducted via a graphic reconstruction tool to estimate primary patency at various follow-up points. For studies comparing SESs and bare metal stents (BMSs), a two-stage meta-analysis was performed to compare the 6-month primary patency of SESs vs BMSs. RESULTS Ten studies across 13 publications, including 995 patients, were retrieved for analysis. In the meta-analysis of proportions, across six studies (n = 339 patients), the pooled 6-month primary patency was 87.3% (95% confidence interval [CI], 81.6%-92.1%). Across seven studies (n = 283 patients), the pooled 6-month mortality was 5.4% (95% CI, 1.4%-11.2%). An individual patient data analysis of three studies (n = 282 patients) yielded a primary patency rate of 95.2% (95% CI, 92.7%-97.8%), 82.8% (95% CI, 78.3%-87.6%), 79.8% (95% CI, 75.0%-85.0%), and 79.8% (95% CI, 75.0%-85.0%) at 6, 12, 18, and 24 months, respectively. The 12-month target lesion revascularization rate across four studies (n = 324 patients) was 9.6% (95% CI, 6.4%-13.4%). In the two-stage meta-analysis of 6-month primary patency across three studies (n = 168 patients), the use of SESs was significantly favored over BMSs (risk ratio, 1.28; 95% CI, 1.12-1.46; P < .001). CONCLUSIONS The overall evidence suggests that the use of SESs appears to be safe and offers favorable outcomes for BTK arterial disease compared with BMSs.
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Affiliation(s)
- Khi Yung Fong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Liu Xin
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Magdalen College, University of Oxford, Oxford, UK
| | - Josiah Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Stanley E K Loh
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Diagnostic Imaging, National University Health System, Singapore
| | - Jun Jie Ng
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore
| | - Andrew M T L Choong
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore; Cardiovascular Research Institute, National University of Singapore, Singapore.
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Sharma N, Finn MT, Parikh SA, Granada J. The Ranger drug-coated balloon: advances in drug-coated technology for treatment of femoropopliteal segment arterial disease. Future Cardiol 2023; 19:127-135. [PMID: 37334764 DOI: 10.2217/fca-2022-0072] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/20/2023] Open
Abstract
Paclitaxel drug-coated balloons (DCBs) have been shown to improve patency and lower revascularization rates compared with plain old balloon angioplasty. DCBs continue to evolve by improving balloon-coating techniques that minimize the quantity of particles washed off into the bloodstream while maximizing drug retention and vascular-healing profile. Against this backdrop, it is clear that the future of antiproliferatives for the superficial femoral artery will focus on enhancements in device coating materials that will improve the efficiency of drug delivery. The Ranger DCB system recently gained US FDA approval for use. This review discusses the background of DCBs and how the Ranger DCB builds on these previous platforms based on experimental and clinical data.
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Affiliation(s)
- Navneet Sharma
- Columbia University Medical Center, New York, NY 10032, USA
| | - Matthew T Finn
- Columbia University Medical Center, New York, NY 10032, USA
- Cardiovascular Institute of the South, Houma, LA 70360, USA
| | - Sahil A Parikh
- Columbia University Medical Center, New York, NY 10032, USA
- Cardiovascular Research Foundation-Skirball Center for Innovation, Orangeburg, NY 10962, USA
| | - Juan Granada
- Columbia University Medical Center, New York, NY 10032, USA
- Cardiovascular Research Foundation-Skirball Center for Innovation, Orangeburg, NY 10962, USA
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27
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Jang BS, Kim E, Gwak MA, Park SA, Park WH. Fabrication and application of drug eluting stent for peripheral artery disease. KOREAN J CHEM ENG 2023. [DOI: 10.1007/s11814-022-1286-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/18/2023]
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28
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He R, Zhao L, Silberschmidt VV. Effect of balloon pre-dilation on performance of self-expandable nitinol stent in femoropopliteal artery. Biomech Model Mechanobiol 2023; 22:189-205. [PMID: 36282361 PMCID: PMC9957922 DOI: 10.1007/s10237-022-01641-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2022] [Accepted: 09/19/2022] [Indexed: 11/24/2022]
Abstract
Balloon pre-dilation is usually performed before implantation of a nitinol stent in a femoropopliteal artery in a case of severe blockage or calcified plaque. However, its effect on performance of the nitinol stent in a diseased femoropopliteal artery has not been studied yet. This study compares the outcomes of stenting with pre-dilation and without it by modelling the entire processes of stent deployment. Fatigue deformation of the implanted stent is also modelled under diastolic-systolic blood pressure, repetitive bending, torsion, axial compression and their combination. Reduced level of stress in the stent occurs after stenting with pre-dilation, but causing the increased damage in the media layer, i.e. the middle layer of the arterial wall. Generally, pre-dilation increases the risk of nitinol stent's fatigue failure. Additionally, the development of in-stent restenosis is predicted based on the stenting-induced tissue damage in the media layer, and no severe mechanical irritation is induced to the media layer by pre-dilation, stent deployment or fatigue loading.
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Affiliation(s)
- Ran He
- Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Loughborough University, Epinal Way, Loughborough, LE11 3TU, UK.
| | - Liguo Zhao
- Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Loughborough University, Epinal Way, Loughborough, LE11 3TU UK ,College of Energy and Power Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, 210016 People’s Republic of China
| | - Vadim V. Silberschmidt
- Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Loughborough University, Epinal Way, Loughborough, LE11 3TU UK
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29
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Ali I, Arslan B, Beasley R, Bechara C, Berens P, Chandra V, Chohan O, Cote C, Dadrass F, Dhand S, Dua A, Elmasri F, Fischer B, Hallak AO, Han DK, Heaney C, Herman K, Jaffer U, Jessula S, Kayssi A, Keefe N, Khurana N, Kohi M, Korff RA, Krishnan P, Kumar A, Laurich C, Lookstein RA, Madassery S, Maringo A, Martin J, Mathews SJ, McCon RP, Mehta A, Melton JG, Miranda J, Mize A, Baker MM, Mustapha JA, Nagi M, N’Dandu Z, Osman M, Parsons BP, Posham R, Raja A, Riaz R, Richard M, Rundback JH, Saab FA, Salazar G, Schiro BJ, Secemsky E, Sommerset J, Tabriz DM, Taylor J, Thomas A, Tummala S, Tummala V, Uddin OM, Van Den Berg J, Watts M, Wiechmann BN, Ysa A. Arterial Revascularization. LIMB PRESERVATION FOR THE VASCULAR SPECIALIST 2023:77-249. [DOI: 10.1007/978-3-031-36480-8_6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
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30
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Mosarla RC, Armstrong E, Bitton-Faiwiszewski Y, Schneider PA, Secemsky EA. State-of-the-Art Endovascular Therapies for the Femoropopliteal Segment: Are We There Yet? JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2022; 1. [PMID: 36268042 PMCID: PMC9581461 DOI: 10.1016/j.jscai.2022.100439] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 12/02/2022]
Abstract
Peripheral arterial disease is an increasingly prevalent condition with significant associated morbidity, mortality, and health care expenditure. Endovascular interventions are appropriate for most patients with either ongoing symptoms of intermittent claudication despite lifestyle and medical optimization or chronic limb-threatening ischemia. The femoropopliteal segment is the most common arterial culprit responsible for claudication and the most commonly revascularized segment. Endovascular approaches to revascularization of the femoropopliteal segment are advancing with an evolving landscape of techniques for arterial access, device-based therapies, vessel preparation, and intraprocedural imaging. These advances have been marked by debate and controversy, notably related to the safety of paclitaxel-based devices and necessity of atherectomy. In this review, we provide a critical overview of the current evidence, practice patterns, emerging evidence, and technological advances for endovascular intervention of the femoropopliteal arterial segment.
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Affiliation(s)
| | - Ehrin Armstrong
- Adventist Heart and Vascular Institute, St Helena, California
| | | | | | - Eric A. Secemsky
- Harvard Medical School, Boston, Massachusetts
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- Corresponding author: (E.A. Secemsky)
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Abstract
Endovascular revascularization strategies have advanced tremendously over the years and are now often considered first line for treatment of peripheral arterial disease. Drug-eluting stents (DESs) have been developed as one of the tools to overcome the limitations of elastic recoil and neointimal hyperplasia observed with balloon angioplasty and bare metal stents. While these stents have been extremely successful in coronary revascularization, they have not translated as effectively to the peripheral arteries which differ in their unique mechanical environments and differences in vessel and lesion composition. DESs, through their embedded pharmaceutical agent, seek to inhibit vascular smooth muscle cell (VSMC) proliferation and migration. Paclitaxel, sirolimus, and its derivatives (-limus family) achieve VSMC inhibition through unique mechanisms. Several clinical trials have been performed to evaluate the use of DES in the femoropopliteal and infrapopliteal territory and have demonstrated overall decrease in revascularization rates and improved clinical outcomes.
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Affiliation(s)
- Chetan Velagapudi
- Department of Vascular and Interventional Radiology, Rush University Medical Center, Chicago, Illinois
| | - Sreekumar Madassery
- Department of Vascular and Interventional Radiology, Rush University Medical Center, Chicago, Illinois
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Jiang X, Fan L, Chen B, Jiang J, Liu J, Qiao G, Ju S, Shi Y, Ma T, Lin C, Fang G, Guo D, Xu X, Dong Z, Fu W. Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial. BMC Cardiovasc Disord 2022; 22:317. [PMID: 35842583 PMCID: PMC9287897 DOI: 10.1186/s12872-022-02751-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2022] [Accepted: 07/07/2022] [Indexed: 11/16/2022] Open
Abstract
Background The efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized. Methods ELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD. Discussion ELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years. Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx.
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Affiliation(s)
- Xiaolang Jiang
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Longhua Fan
- Department of Vascular Surgery, Qingpu Branch of Zhongshan Hospital, Fudan University, 1158 East Gongyuan Road, Shanghai, 201715, China
| | - Bin Chen
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Junhao Jiang
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Jianjun Liu
- Department of Vascular Surgery, Qingpu Branch of Zhongshan Hospital, Fudan University, 1158 East Gongyuan Road, Shanghai, 201715, China
| | - Guanyu Qiao
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Shuai Ju
- Department of Vascular and Wound Treatment Center, Jinshan Hospital, Fudan University, Shanghai, 200540, China
| | - Yun Shi
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Tao Ma
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Changpo Lin
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Gang Fang
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Daqiao Guo
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Xin Xu
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
| | - Zhihui Dong
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
| | - Weiguo Fu
- Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China
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Low J, Shih T, Lu E, Derubertis BG, Baril DT. Midterm Results of the Supera Stent for the Treatment of Femoropopliteal Occlusive Disease. Ann Vasc Surg 2022; 86:177-183. [PMID: 35779806 DOI: 10.1016/j.avsg.2022.05.031] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2021] [Revised: 04/20/2022] [Accepted: 05/18/2022] [Indexed: 11/19/2022]
Abstract
BACKGROUND The Supera (Abbott Vascular, Santa Clara, CA) stent is an interwoven nitinol, shape-memory stent with high strength and flexibility characteristics which are purported to increase resistance to kinking and compression. The purpose of this study was to review single-center outcomes of the use of this stent in the femoropopliteal segment. METHODS We performed a single-center, retrospective analysis of patients who underwent Supera stent placement for femoropopliteal occlusive disease from 2016-2019. Data was collected on patient demographics and procedural details. Follow-up imaging data, including duplex imaging and ankle-brachial indices, and clinical data were abstracted from encounter notes. RESULTS Sixty-two patients with 72 unique Supera stent placements were identified. Mean age was 76 and 69% were male. 56% of patients had severe calcification and 11% had moderate calcification. 48% of lesions were Trans-Atlantic Inter-Society Consensus Document C or D lesions. Primary patency rates at 12, 24, and 36 months were 85%, 82%, and 75%, respectively. Primary patency was not affected significantly by lesion length, degree of calcification, number of outflow vessels, concomitant interventions, or stent size. CONCLUSIONS These results demonstrate sustained primary patency with the Supera stent over a 3-year interval in treatment of patients with femoropopliteal occlusive disease, including in the setting of severely calcified vessels.
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Affiliation(s)
- Josiah Low
- David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA
| | - Terri Shih
- David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA
| | - Eileen Lu
- Department of General Surgery, Cedars-Sinai Medical Center, Los Angeles, CA
| | - Brian G Derubertis
- Division of Vascular Surgery, Weill Cornell Medical College, New York, NY
| | - Donald T Baril
- Division of Vascular Surgery, Cedars-Sinai Medical Center, Los Angeles, CA.
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Gostev AA, Osipova OS, Saaya SB, Bugurov SV, Cheban AV, Rabtsun AA, Ignatenko PV, Karpenko AA. Bypass Versus Interwoven Nitinol Stents for Long Femoro-Popliteal Occlusions: A Propensity Matched Analysis. Cardiovasc Intervent Radiol 2022; 45:929-938. [PMID: 35581472 DOI: 10.1007/s00270-022-03134-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2021] [Accepted: 03/23/2022] [Indexed: 01/22/2023]
Abstract
PURPOSE To compare femoro-popliteal bypass and interwoven nitinol stenting for long occlusions of the femoro-popliteal segment. MATERIALS AND METHODS Single center retrospective propensity matching analysis of the symptomatic patients with long occlusion of the femoro-popliteal segment (> 20 cm), who underwent stenting with interwoven nitinol stent or femoro-popliteal bypass from 2012 to 2020. PRIMARY ENDPOINTS primary patency, primary-assisted patency, secondary patency. Secondary endpoints: major adverse cardiovascular events, major adverse limb events, primary sustained clinical improvement, survival. RESULTS A total of 437 patients were enrolled: 294 in the bypass group and 143 in the endovascular therapy (EVT) group. After propensity score matching, 264 and 113 patients remained in the groups, respectively. A median occlusion length was 250 mm. One-year and two-year primary and secondary patency rates were comparable in both groups (two-year primary patency: 68.5% for bypass vs. 68.9% for EVT, p = 1.00). In the "above the knee" subgroup analysis, two-year secondary patency was higher in the EVT group than in the bypass group (90.9% vs. 77.5%, p = 0.048). In "below-the-knee" subgroup analysis, primary and primary assisted patency were statistically significantly higher in the EVT group than in artificial bypass subgroup (66.7% vs. 42.4%, p = .046 and 76.7% vs. 45.5%, p = .011, respectively). However, compared to autovenous bypass, the EVT group showed lower primary patency rates, although the differences are not significant. CONCLUSION A nonselective endovascular strategy can allow for regular successful treatment of femoro-popliteal lesions longer than 25 cm.
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Affiliation(s)
- Alexander A Gostev
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055.
| | - Olesya S Osipova
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Shoraan B Saaya
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Savr V Bugurov
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Alexey V Cheban
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Artem A Rabtsun
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Pavel V Ignatenko
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
| | - Andrey A Karpenko
- Department of Vascular Pathology and Hybrid Technologies, Meshalkin National Medical Research Center of the Ministry of Healthcare of the Russian Federation, Novosibirsk Area, Rechkunovskaya 15'th st., Novosibirsk, Russia, 630055
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Bernini M, Colombo M, Dunlop C, Hellmuth R, Chiastra C, Ronan W, Vaughan TJ. Oversizing of self-expanding nitinol vascular stents – A biomechanical investigation in the superficial femoral artery. J Mech Behav Biomed Mater 2022; 132:105259. [DOI: 10.1016/j.jmbbm.2022.105259] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2021] [Revised: 04/20/2022] [Accepted: 04/29/2022] [Indexed: 10/18/2022]
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Zhao S, Li L, Cui K. Network Analysis of Endovascular Treatment Strategies for Femoropopliteal Arterial Occlusive Disease. J Endovasc Ther 2022:15266028221090434. [PMID: 35392691 DOI: 10.1177/15266028221090434] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
PURPOSE Endovascular treatment of femoropopliteal arterial diseases remains controversial. We conducted a Bayesian network meta-analysis of randomized controlled trials aiming to investigate the efficacy differences between paclitaxel- or sirolimus-eluting stents, covered stents, drug-coated balloons, bare metal stents, and percutaneous transluminal angioplasty. METHOD MEDLINE, Embase, Ovid, and other relevant online material were searched up to October 21, 2020. Primary endpoints were primary patency and target lesion revascularization at 6, 12, and more than 24 months. RESULTS Thirty-eight eligible trials included 6026 patients. In terms of primary patency, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (80.6), 12 (78.4), and more than 24 months (96.5) of follow-ups. In terms of target lesion revascularization, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (90.3), 12 (71.3), and more than 24 months (82.1) of follow-ups. Covered stents and bare metal stents had higher ranks in target lesion revascularization than those in primary patency. Sirolimus stents had a higher rank than paclitaxel stents. CONCLUSION Drug eluting stents showed encouraging results in primary patency rates and freedom from target lesion revascularization at all phases of follow-up for femoropopliteal arterial diseases. Sirolimus stents appear to be more effective in femoropopliteal segment than paclitaxel stent.
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Affiliation(s)
- Shenyu Zhao
- Department of Cardiovascular Medicine, West China Hospital of Sichuan University, Chengdu, China
| | - Lingzhi Li
- Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China
| | - Kaijun Cui
- Department of Cardiovascular Medicine, West China Hospital of Sichuan University, Chengdu, China
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Steiner S, Honton B, Langhoff R, Chiesa R, Kahlberg A, Thieme M, Zeller T, Garot P, Commeau P, Cremonesi A, Marone EM, Sauguet A, Scheinert D. 2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study. JACC Cardiovasc Interv 2022; 15:618-626. [PMID: 35219622 DOI: 10.1016/j.jcin.2021.12.034] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2021] [Revised: 12/14/2021] [Accepted: 12/21/2021] [Indexed: 01/22/2023]
Abstract
OBJECTIVES The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. BACKGROUND DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. METHODS Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. RESULTS At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. CONCLUSIONS The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).
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Affiliation(s)
- Sabine Steiner
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany; Helmholtz Institute for Metabolic, Obesity and Vascular Research, Helmholtz Zentrum München at the University of Leipzig and University Hospital Leipzig, Leipzig, Germany
| | | | - Ralf Langhoff
- Department of Angiology, Center for Internal Medicine I, Campus Clinic Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg an der Havel, Germany
| | - Roberto Chiesa
- Department of Vascular Surgery, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy
| | - Andrea Kahlberg
- Department of Vascular Surgery, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy
| | | | - Thomas Zeller
- Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
| | - Philippe Garot
- Institut Cardio-vasculaire Paris Sud, Hôpital Privé Claude Galien, Ramsay-Générale de santé, Quincy-sous-Sénart, France
| | | | - Alberto Cremonesi
- Cardiovascular Department, Humanitas Gavazzeni Hospital, Bergamo, Italy
| | - Enrico Maria Marone
- Vascular Surgery, Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy; Department of Vascular Surgery, Policlinico di Monza Group, Monza and Ivrea, Ollioules, Italy
| | | | - Dierk Scheinert
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.
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Influence of Lamina Vastoadductoria Dissection on the Outcomes of Femoral Artery Extensive Lesion Stenting: A Pilot Randomised Investigation. J Biomech 2022; 136:111053. [DOI: 10.1016/j.jbiomech.2022.111053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2021] [Revised: 12/20/2021] [Accepted: 03/15/2022] [Indexed: 11/17/2022]
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Bontinis V, Antonopoulos CN, Bontinis A, Koutsoumpelis A, Giannopoulos A, Ktenidis K. A systematic review and meta-analysis of Supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease. THE JOURNAL OF CARDIOVASCULAR SURGERY 2022; 63:137-145. [PMID: 35005877 DOI: 10.23736/s0021-9509.22.12129-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
INTRODUCTION Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. EVIDENCE ACQUISITION We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. EVIDENCE SYNTHESIS Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. CONCLUSIONS This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.
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Affiliation(s)
- Vangelis Bontinis
- Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece -
| | - Constantine N Antonopoulos
- Department of Vascular Surgery, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece
| | - Alkis Bontinis
- Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece
| | - Andreas Koutsoumpelis
- Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece
| | - Argirios Giannopoulos
- Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece
| | - Kiriakos Ktenidis
- Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece
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Silveira FT, Razuk Filho Á, Saad PF, Saad KR, Telles GJP, Ravizzini PIC, Caffaro RA, Castelli Júnior V. Stent fractures in the superficial femoral artery: predisposing factors and their implications. J Vasc Bras 2022; 21:e20200014. [PMID: 36187216 PMCID: PMC9499724 DOI: 10.1590/1677-5449.202000142] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2020] [Accepted: 09/23/2020] [Indexed: 11/22/2022] Open
Abstract
Abstract Background Fractures in stents implanted in the superficial femoral artery (SFA) are recognized complications of endovascular management of this arterial territory. Objectives The objective of this study was to determine the prevalence of fractures in stents implanted in the SFA and to identify predisposing factors for these fractures together with their impact on the patency of these devices. Methods The study included 39 patients (65.7±9.0 years) who previously underwent angioplasty for delivery of 56 stents into the SFA. During follow-up, which ranged from 7 to 46 months, variables were collected on the characteristics of the lesions treated and characteristics of the stents implanted. Two examiners independently analyzed digital radiographs for the presence of stent fractures and the patency of the devices. Results We found a 10.7% prevalence of fracture of implanted stents. Implantation of multiple stents was identified as a significant predisposing factor for fractures. We observed a marked tendency for fractures in female patients and in lesions treated with longer stents (> 150 mm). Stenosis exceeding 50% and occlusions were significantly more frequent in fractured stents. Conclusions This study suggests that implants longer than 150 mm and multiple stents are associated with higher device fracture rates. In cases with stent fractures, stenoses exceeding 50% and occlusions were significantly more frequent.
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Affiliation(s)
| | | | - Paulo Fernandes Saad
- Universidade Federal de São Paulo, Brasil; Universidade Federal do Vale do São Francisco, Brasil
| | - Karen Ruggeri Saad
- Universidade Federal de São Paulo, Brasil; Universidade Federal do Vale do São Francisco, Brasil
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Wolosker N, Silva MFAD, Portugal MFC, Stabellini N, Zerati AE, Szlejf C, Amaro Junior E, Teivelis MP. Epidemiological analysis of lower limb revascularization for peripheral arterial disease over 12 years on the public healthcare system in Brazil. J Vasc Bras 2022; 21:e20210215. [PMID: 36187218 PMCID: PMC9477476 DOI: 10.1590/1677-5449.202102152] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2021] [Accepted: 06/29/2022] [Indexed: 11/21/2022] Open
Abstract
Abstract Background Worldwide, peripheral arterial disease (PAD) is a disorder with high morbidity, affecting more than 200 million people. Objectives Our objective was to analyze surgical treatment for PAD provided on the Brazilian Public Healthcare System over 12 years using publicly available data. Methods The study was conducted with analysis of data available on the Brazilian Health Ministry’s database platform, assessing distributions of procedures and techniques over the years and their associated mortality and costs. Results A total of 129,424 procedures were analyzed (performed either for claudication or critical ischemia, proportion unknown). The vast majority of procedures were endovascular (65.49%) and this disproportion exhibited a rising trend (p<0.001). There were 3,306 in-hospital deaths (mortality of 2.55%), with lower mortality in the endovascular group (1.2% vs. 5.0%, p=0.008). The overall governmental expenditure on these procedures was U$ 238,010,096.51, and endovascular procedures were on average significantly more expensive than open surgery (U$ 1,932.27 vs. U$ 1,517.32; p=0.016). Conclusions Lower limb revascularizations were performed on the Brazilian Public Healthcare System with gradually increasing frequency from 2008 to 2019. Endovascular procedures were vastly more common and were associated with lower in-hospital mortality rates, but higher procedure costs.
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Affiliation(s)
- Nelson Wolosker
- Faculdade Israelita de Ciências da Saúde Albert Einstein, Brasil; Universidade de São Paulo, Brasil
| | | | | | | | | | | | - Edson Amaro Junior
- Universidade de São Paulo, Brasil; Hospital Israelita Albert Einstein, Brasil
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Marques L, Hopf-Jensen S, Preiss M, Mueller-Huelsbeck S. An Update on Drug-eluting Technology in Peripheral Arteries to Treat Peripheral Arterial Disease. Heart Int 2021; 15:73-78. [PMID: 36277826 PMCID: PMC9524588 DOI: 10.17925/hi.2021.15.2.73] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2021] [Accepted: 06/03/2021] [Indexed: 05/30/2025] Open
Abstract
For the treatment of peripheral arterial disease, drug-eluting technology is a widely accepted therapeutic option, with significant reduction in intimal hyperplasia and, consequently, use of target lesion revascularization. Nevertheless, the reputation of such devices was damaged after a meta-analysis, published in December 2018, showed increased mortality in patients receiving paclitaxel-eluting devices. Although subsequent studies have failed to establish such correlation, the use of paclitaxel-eluting devices remains heavily restricted. As such, other options and drugs have been developed, for instance sirolimus. In this article we present the available data on drug-eluting technology.
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Affiliation(s)
- Leonardo Marques
- Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Flensburg, Germany
| | - Silke Hopf-Jensen
- Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Flensburg, Germany
| | - Michael Preiss
- Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Flensburg, Germany
| | - Stefan Mueller-Huelsbeck
- Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg, Flensburg, Germany
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Sheorain VS, Parakh R, Grover T, Sahu T, Aher A. Supera Stent Implantation with Ultrasound Guidance for Complex Ostial Lesions of Superficial Femoral Artery by Retrograde Approach: The SUGAR Technique. JOURNAL OF CLINICAL INTERVENTIONAL RADIOLOGY ISVIR 2021. [DOI: 10.1055/s-0041-1728976] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022] Open
Abstract
Abstract
Purpose The aim of this study was to describe a modified technique for accurate deployment of the Supera stent under ultrasound (US) guidance for complex lesions involving superficial femoral artery (SFA) ostium without jailing profunda femoral artery (PFA) by retrograde approach.
Technique Retrograde pedal access was initially taken in all the cases. The stenotic or occlusive femoropopliteal lesions involving the SFA ostium were crossed retrogradely and additional contralateral common femoral artery (CFA) access was taken only if we failed to cross the lesion. In addition to fluoroscopy, extravascular US guidance was freely used whenever required throughout the procedure. After desired predilatation of the SFA lesion, US guidance (gray scale and color Doppler) was used to start deployment of the proximal few centimeters of Supera stent ensuring that the landing of first crown was exactly from the SFA ostium not extending into CFA or jailing the PFA ostium. The rest of the stent was deployed under fluoroscopic guidance. Retrograde pedal access site hemostasis was achieved by manual compression. The Supera stent implantation with Ultrasound Guidance for complex ostial lesions of superficial femoral Artery by Retrograde approach (SUGAR) technique was applied successfully in 35 patients (mean age 58.1 ± 4.4 years; 24 males) with critical limb ischemia via the distal pedal approach. No access site or remote complications were observed.
Conclusion The SUGAR technique has superior advantage of utilizing a simple tool like extravascular US in addition to fluoroscopy for retrograde Supera stent deployment by allowing very precise landing at SFA ostium, bypassing the need for multiple oblique projections, unwanted radiation exposure, and extra contrast dye overload.
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Affiliation(s)
- Virender Singh Sheorain
- Department of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Gurgaon, Haryana, India
| | - Rajiv Parakh
- Department of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Gurgaon, Haryana, India
| | - Tarun Grover
- Department of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Gurgaon, Haryana, India
| | - Tapish Sahu
- Department of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Gurgaon, Haryana, India
| | - Ashutosh Aher
- Department of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity, Gurgaon, Haryana, India
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Catheter based interventions for lower extremity peripheral artery disease. Prog Cardiovasc Dis 2021; 69:62-72. [PMID: 34813857 DOI: 10.1016/j.pcad.2021.11.008] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2021] [Accepted: 11/14/2021] [Indexed: 01/27/2023]
Abstract
The field of peripheral arterial intervention has exploded over the past 20 years. Current knowledge includes a growing evidence base for treatment as well as a myriad of new interventional approaches to complex disease. This review seeks to outline the current state of the art for interventional approaches to lower extremity peripheral arterial disease.
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Zhou Y, Wang J, He H, Li Q, Li M, Li X, Shu C. Comparative effectiveness of endovascular treatment modalities for de novo femoropopliteal lesions in intermittent claudication: A network meta-analysis of randomized controlled trials. Int J Cardiol 2021; 343:122-130. [PMID: 34461162 DOI: 10.1016/j.ijcard.2021.08.038] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/19/2021] [Revised: 08/01/2021] [Accepted: 08/23/2021] [Indexed: 12/12/2022]
Abstract
PURPOSE To evaluate the most effective endovascular treatment modalities for de novo femoropopliteal lesions in intermittent claudication (IC) in terms of technical success, primary patency, target lesion revascularization (TLR) and all-cause mortality through network meta-analysis of randomized controlled trials. METHODS Medical databases were searched on December 3, 2020. 16 studies (3265 patients) and 7 treatments were selected. Outcomes were technical success, primary patency, TLR and mortality at 6 and/or 12 months. RESULTS Regarding 6-month primary patency, drug-eluting stents (DES) was better than balloon angioplasty (BA; odds ratio [OR], 23.27; 95% confidence interval [CI], 12.57-43.06), drug-coated balloons (DCB; OR, 5.63; 95% CI, 2.26-14.03) and directional atherectomy (DA; OR, 31.52; 95% CI, 7.81-127.28), and bare nitinol stents (BNS) was better than BA (OR, 17.91; 95% CI, 7.22-44.48), DCB (OR, 4.33; 95% CI, 1.40-13.45) and DA (OR, 24.27; 95% CI, 5.16-114.11). Regarding 12-month primary patency, DES was better than BA (OR, 10.05; 95% CI, 4.56-22.16), DCB (OR, 3.70; 95% CI, 1.54-8.89) and DA (OR, 29.54; 95% CI, 7.26-120.26). DCB and combination of balloon and atherectomy were the most effective treatment regarding 12-month TLR and technical success (residual stenosis <30%), respectively. DES, BNS and DA with DCB (DA-DCB) were included in the best cluster in the clustered ranking plot combining 12-month primary patency and TLR. CONCLUSIONS Balloon and atherectomy may confer advantages over other treatments for technical success; DCB may for TLR. Stent technologies confer substantial advantages regarding primary patency. Stent technologies and DA-DCB should be given priority in treating femoropopliteal lesions in IC.
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Affiliation(s)
- Yang Zhou
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Junwei Wang
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Hao He
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Quanming Li
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Ming Li
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Xin Li
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Chang Shu
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.
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AbuRahma AF, Beasley M, AbuRahma ZT, Davis M, Adams E, Dean LS, Shapiro J, Scott G, Davis E. Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience. J Endovasc Ther 2021; 29:350-360. [PMID: 34622706 DOI: 10.1177/15266028211049339] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
BACKGROUND Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. PATIENT POPULATIONS/METHODS A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. RESULTS Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A-C lesions. Mean follow-up was 18.4 months (1-76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A-C vs 59% and 59% for D lesions, p=0.001). CONCLUSION Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A-C lesions but inferior/unsatisfactory for TASC D lesions.
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Affiliation(s)
- Ali F AbuRahma
- Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA
| | - Matthew Beasley
- Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA
| | - Zachary T AbuRahma
- Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA
| | - Meghan Davis
- Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA
| | - Elliot Adams
- Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA
| | - L Scott Dean
- CAMC Institute for Academic Medicine, Charleston, WV, USA
| | | | | | - Elaine Davis
- CAMC Institute for Academic Medicine, Charleston, WV, USA
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Guzzardi G, Spinazzola A, Cangiano G, Natrella M, Paladini A, Porta C, Boccalon L, Negroni D, Leati G, Laganà D, Guglielmi R, Carriero A. Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study. J Public Health Res 2021; 11. [PMID: 34595901 PMCID: PMC8847959 DOI: 10.4081/jphr.2021.2360] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2021] [Accepted: 06/10/2021] [Indexed: 11/25/2022] Open
Abstract
Background: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), most of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature. Design and methods: In this study we enrolled only patients who satisfied the inclusion criteria: i) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; ii) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow- up at 12-24 and 36 months to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value. Results: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled). Conclusions: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease.
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