1
|
Ibrahim MS, Seresht HB, Kum CH, Cho JH, Jin G, An SH, Ye S, Kim S, Wagner WR, Chun Y. Novel laser-textured grooves extended to the sidewall edges of CoCr surfaces for rapid and selective endothelialization following coronary artery stenting. Biomaterials 2025; 321:123299. [PMID: 40188719 DOI: 10.1016/j.biomaterials.2025.123299] [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: 12/19/2024] [Revised: 03/03/2025] [Accepted: 03/27/2025] [Indexed: 05/04/2025]
Abstract
The long-term performance of coronary stents is often compromised by delayed endothelialization and late thrombosis, particularly in drug-eluting stents (DES) that impair vascular healing. To address these challenges, we report a novel micro-hierarchical surface modification that integrates sidewall edge structuring into grid patterns on cobalt-chromium (CoCr) stents, enhancing endothelial cell (EC) interactions without compromising mechanical integrity. Laser fabrication was used to create microgrooves (5-30 μm) with extended sidewall edges, designed to promote rapid EC adhesion and proliferation. Comprehensive in vitro evaluations, including EC viability, adhesion, and platelet aggregation assays, demonstrated that stents with grid pattern and sidewall edge structuring on an already fabricated stent enhanced EC viability approximately six-fold compared to the non-patterned controls, reaching 2276 ± 220 cells/ml by day three of culture. The sidewall edges provided possible promising stable anchoring sites and gateway channels, improving EC attachment and selective alignment, while also substantially reducing platelet deposition in grooved regions. To ensure these surface modifications did not affect mechanical performance, comprehensive three-point bending and radial compression tests were conducted. No significant differences were observed compared to coronary stents, confirming that the micro-hierarchical texture with sidewall edges maintains essential mechanical properties. Together, these findings highlight the potential of sidewall edge-integrated grid patterns to accelerate endothelialization and reduce thrombogenic risks, offering a promising strategy for improving the design and long-term performance of next-generation coronary stents.
Collapse
Affiliation(s)
- Mohamed S Ibrahim
- Department of Industrial Engineering, University of Pittsburgh, Pittsburgh, PA, USA
| | | | | | - Jae Hwa Cho
- OSSTEMCARDIO Co. Ltd., Seoul, Republic of Korea
| | - Gyuhyun Jin
- OSSTEMCARDIO Co. Ltd., Seoul, Republic of Korea
| | - Sang Hyun An
- Daegu-Gyeongbuk Medical Innovation Foundation Laboratory Animal Center, Daegu, Republic of Korea
| | - Sangho Ye
- Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA
| | - Seungil Kim
- Department of Agricultural & Biological Engineering, Mississippi State University, Mississippi, MS, USA
| | - William R Wagner
- McGowan Center for Regenerative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA; Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA; Department of Chemical and Petroleum Engineering, University of Pittsburgh, Pittsburgh, PA, USA
| | - Youngjae Chun
- Department of Industrial Engineering, University of Pittsburgh, Pittsburgh, PA, USA; McGowan Center for Regenerative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.
| |
Collapse
|
2
|
Park HM, Kim CL, Kong D, Heo SH, Park HJ. Innovations in Vascular Repair from Mechanical Intervention to Regenerative Therapies. Tissue Eng Regen Med 2025; 22:551-567. [PMID: 39921820 PMCID: PMC12122965 DOI: 10.1007/s13770-024-00700-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2024] [Revised: 12/19/2024] [Accepted: 12/31/2024] [Indexed: 02/10/2025] Open
Abstract
BACKGROUND Vascular diseases, including atherosclerosis and thrombosis, are leading causes of morbidity and mortality worldwide, often resulting in vessel stenosis that impairs blood flow and leads to severe clinical outcomes. Traditional mechanical interventions, such as balloon angioplasty and bare-metal stents, provided initial solutions but were limited by restenosis and thrombosis. The advent of drug-eluting stents improved short-term outcomes by inhibiting vascular smooth muscle cell proliferation, however, they faced challenges including delayed reendothelialization and late-stage thrombosis. METHODS This review highlights the progression from mechanical to biological interventions in treating vascular stenosis and underscores the need for integrated approaches that combine mechanical precision with regenerative therapies. RESULTS To address long-term complications, bioresorbable stents were developed to provide temporary scaffolding that gradually dissolves, yet they still encounter challenges with mechanical integrity and optimal degradation rates. Consequently, emerging therapies now focus on biological approaches, such as gene therapy, extracellular vesicle treatments, and cell therapies, that aim to promote vascular repair at the cellular level. These strategies offer the potential for true vascular regeneration by enhancing endothelialization, modulating immune responses, and stimulating angiogenesis. CONCLUSION Integrating mechanical precision with regenerative biological therapies offers a promising future for treating vascular stenosis. A comprehensive approach combining these modalities could achieve sustainable vascular health.
Collapse
Affiliation(s)
- Hye-Min Park
- Department of Molecular Science and Technology, Ajou University, Suwon, 16499, Republic of Korea
| | - Chae-Lin Kim
- Department of Molecular Science and Technology, Ajou University, Suwon, 16499, Republic of Korea
| | - Dasom Kong
- Department of Molecular Science and Technology, Ajou University, Suwon, 16499, Republic of Korea
| | - Seon-Hee Heo
- Department of Surgery, Yonsei University College of Medicine, Seoul, 03722, Republic of Korea.
| | - Hyun-Ji Park
- Department of Molecular Science and Technology, Ajou University, Suwon, 16499, Republic of Korea.
- Advanced College of Bio-Convergence Engineering, Ajou University, Suwon, 16499, Republic of Korea.
| |
Collapse
|
3
|
Wu X, Liu Z, Huang H, Wu M, Huang H, Wang L. Intravascular ultrasound assessment of stent edge restenosis mechanisms and treatment outcomes following percutaneous coronary intervention. Sci Rep 2025; 15:16298. [PMID: 40348838 PMCID: PMC12065881 DOI: 10.1038/s41598-025-01381-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2025] [Accepted: 05/06/2025] [Indexed: 05/14/2025] Open
Abstract
This study aimed to elucidate the biological or mechanical causes of stent edge restenosis (SER) via intravascular ultrasound (IVUS). A retrospective assessment was conducted on 126 SER lesions that underwent IVUS prior to revascularization. The primary mechanisms of SER were categorized. (1) neointimal hyperplasia (NIH); (2) neoatherosclerosis; (3) uncovered lesion; (4) stent underexpansion; or (5) a protruding calcified nodule (CN). The predominant biological or mechanical causes of SER were NIH in 42.9% (n = 54) of lesions, neoatherosclerosis in 32.5% (n = 41), uncovered lesion in 14.3% (n = 18), stent underexpansion in 7.9% (n = 10), and protruding CN in 2.4% (n = 3). The 2-year device-oriented clinical endpoints (DoCE) incidence was 7.1% (n = 9). The group with biological causes treated via drug-coated balloons (DCB) exhibited a comparable DoCE rate (9.5%) to those with biological causes treated with drug-eluting stents (DES) and mechanical causes managed with or without restenting (6.0%, HR 2.78, 95% CI: 0.91-9.21; p = 0.161). The majority of the analyzed SERs were attributed to biological causes, including NIH, neoatherosclerosis, and uncovered lesions. The 2-year DoCE rate within patients receiving DCB for mechanically or biologically induced SER was similar to that observed in patients receiving new DES.
Collapse
Affiliation(s)
- Xi Wu
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China
| | - Zhe Liu
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China
| | - Haobo Huang
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China
| | - Mingxing Wu
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China
| | - He Huang
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China
| | - Lei Wang
- Department of Cardiology, Xiangtan Central Hospital (the affiliated hospital of Hunan University), Xiangtan, 411100, Hunan, People's Republic of China.
| |
Collapse
|
4
|
Witzig T, Puricel S, Witzig A, Meier P, Arroyo D, Togni M, Cook S. Durable versus biodegradable polymer drug-eluting stents in all-comers. Open Heart 2025; 12:e003104. [PMID: 40032607 PMCID: PMC11877205 DOI: 10.1136/openhrt-2024-003104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/04/2024] [Accepted: 02/06/2025] [Indexed: 03/05/2025] Open
Abstract
BACKGROUND Drug-eluting stents (DESs) have become the gold standard of coronary angioplasty since their inception in 2002. Biodegradable polymer DESs (BP-DESs) have been postulated to be superior to durable polymer DESs (DP-DESs) due to their more biocompatible polymer. To date, no study has shown the superiority of one type of polymer compared with the other. We aimed to compare outcomes between a broad range of second-generation DP-DES and BP-DES in an all-comer population. METHODS We analysed data from 2824 patients who underwent percutaneous coronary intervention (PCI) with BP-DES or DP-DES in the Cardio-FR database. Of these, 2079 (1286 DP-DES and 793 BP-DES) met the inclusion and exclusion criteria and completed a 2-year follow-up: The primary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, non-fatal target vessel myocardial infarction and target lesion revascularisation. RESULTS Mean age was 67 years, with 75% male. Despite the DP-DES group exhibiting significantly higher rates of risk factors, such as arterial hypertension (63.1% vs 57.5%, p=0.010), a greater average number of stents implanted per patient (1.72±0.92 vs 1.63±0.84, p=0.040), more acute coronary syndrome (ACS) (55.1% vs 50.2%, p=0.031) and a higher rate of post-dilatation (42.2% vs 35.2%, p<0.001), the rate of acute stent thrombosis (ST) was significantly lower than in the BP-DES group (HR 0.240, 95% CI 0.075 to 0.766; p=0.016). This difference remained significant even after adjusting for covariates using a Cox proportional hazards model and performing a win ratio analysis (4.09, 95% CI 1.28 to 13.09; p=0.018). Despite this increased rate of acute ST, there was no difference in DOCE (12.1% vs 14.5%, OR 1.218, 95% CI 0.926 to 1.600; p=0.158) between the two groups up to 2 years. CONCLUSION Clinical follow-up up to 2 years shows similar outcomes between BP-DES and DP-DES. The rate of acute ST is higher in patients with BP-DES.
Collapse
Affiliation(s)
- Thierry Witzig
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Serban Puricel
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Alain Witzig
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Pascal Meier
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Diego Arroyo
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Mario Togni
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| | - Stéphane Cook
- Cardiology, University & Hospital Fribourg, Fribourg, Switzerland
| |
Collapse
|
5
|
O'Callaghan D, Coughlan JJ, Giacoppo D, Colleran R, Byrne RA. Off TARGET Effects in Stent Comparison Trials: Looking Beyond the Primary Endpoint Analysis. J Am Coll Cardiol 2025; 85:575-577. [PMID: 39772371 DOI: 10.1016/j.jacc.2024.11.021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2024] [Accepted: 11/07/2024] [Indexed: 02/14/2025]
Affiliation(s)
- Daniel O'Callaghan
- Department of Cardiology and Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland
| | - J J Coughlan
- Department of Cardiology and Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Daniele Giacoppo
- Department of Cardiology and Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland
| | - Roisin Colleran
- Department of Cardiology and Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Robert A Byrne
- Department of Cardiology and Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
| |
Collapse
|
6
|
Sartore L, Gitto M, Oliva A, Kakizaki R, Mehran R, Räber L, Spirito A. Recent Advances in the Treatment of Coronary In-Stent Restenosis. Rev Cardiovasc Med 2024; 25:433. [PMID: 39742224 PMCID: PMC11683712 DOI: 10.31083/j.rcm2512433] [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: 06/22/2024] [Revised: 08/10/2024] [Accepted: 08/20/2024] [Indexed: 01/03/2025] Open
Abstract
In-stent restenosis (ISR) remains the predominant cause of stent failure and the most common indication for repeat revascularization. Despite technological advances in stent design, ISR continues to pose significant challenges, contributing to increased morbidity and mortality among patients undergoing percutaneous coronary interventions. In the last decade, intravascular imaging has emerged as an important method for identifying the mechanisms behind ISR and guiding its treatment. Treatment options for ISR have expanded to include balloon angioplasty, cutting or scoring balloons, intravascular lithotripsy, atheroablative devices, drug-eluting stents, drug-coated balloons, surgical revascularization, and intravascular brachytherapy. The aim of the current review is to describe the classification and mechanisms of ISR, provide a comprehensive and updated overview of the evidence supporting different treatment strategies, suggest a management algorithm, and present insights into future developments in the field.
Collapse
Affiliation(s)
- Luca Sartore
- Department of Cardiology, Bern University Hospital, Inselspital, CH-3010 Bern, Switzerland
| | - Mauro Gitto
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | - Angelo Oliva
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | - Ryota Kakizaki
- Department of Cardiology, Bern University Hospital, Inselspital, CH-3010 Bern, Switzerland
| | - Roxana Mehran
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | - Lorenz Räber
- Department of Cardiology, Bern University Hospital, Inselspital, CH-3010 Bern, Switzerland
| | - Alessandro Spirito
- Department of Cardiology, Bern University Hospital, Inselspital, CH-3010 Bern, Switzerland
| |
Collapse
|
7
|
Sim DS, Cho KH, Hyun DY, Park DS, Park JK, Byeon DH, Jo WI, Kim SW, Ahn JH, Lee SH, Kim MC, Hong YJ, Kim JH, Ahn Y, Jeong MH. First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film. J Korean Med Sci 2024; 39:e234. [PMID: 39189711 PMCID: PMC11347186 DOI: 10.3346/jkms.2024.39.e234] [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] [Received: 10/11/2023] [Accepted: 06/27/2024] [Indexed: 08/28/2024] Open
Abstract
BACKGROUND In patients with coronary artery disease treated with permanent polymer-coated drug-eluting stents (DES), the persistent presence of a less biocompatible polymer might delay arterial healing. Thin strut polymer-free DES have the potential to improve clinical outcomes and reduce the duration of dual antiplatelet therapy (DAPT). The purpose of this first-in-human study was to assess the safety and effectiveness of a novel polymer-free DES in patients with de novo coronary lesions. The TIGERevolutioN® stent (CG Bio Co., Ltd., Seoul, Korea) consists of a cobalt chromium platform with a strut thickness of 70 μm and a surface treated with titanium dioxide onto which everolimus-eluting stent (EES) is applied abluminally (6 µg/mm of stent length) without utilization of a polymer. METHODS A total of 20 patients were enrolled, with de novo coronary lesions (stable or unstable angina) and > 50% diameter stenosis in a vessel 2.25 to 4.00 mm in diameter and ≤ 40 mm in length for angiographic, optical coherence tomography (OCT), and clinical assessment at 8 months. All patients received DAPT after stent implantation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at 8 months. RESULTS Twenty patients with 20 lesions were treated with TIGERevolutioN®. At 8 months, in-stent LLL was 0.7 ± 0.4 mm. On OCT, percent area stenosis was 29.2 ± 9.4% and stent strut coverage was complete in all lesions. No adverse cardiovascular event occurred at 8 months. CONCLUSION The new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up. TRIAL REGISTRATION Trial Registration: Clinical Research Information Service Identifier: KCT0005699.
Collapse
Affiliation(s)
- Doo Sun Sim
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
| | - Kyung Hoon Cho
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Dae Young Hyun
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Dae Sung Park
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
| | | | | | | | - Sang-Wook Kim
- Heart and Brain Hospital, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
| | - Joon Ho Ahn
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Seung Hun Lee
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Min Chul Kim
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Young Joon Hong
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
| | - Ju Han Kim
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
| | - Youngkeun Ahn
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
| | - Myung Ho Jeong
- Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
- Korea Cardiovascular Stent Institute, Jangseong, Korea
- Gwangju Veterans Hospital, Gwangju, Korea.
| |
Collapse
|
8
|
Rehman A, Ahmed IE, Nouman A, Irfan R, Rehman Q, Syed ARS, Zakir SJ, Mehdi S, Khosa MM, Kumar S, Khatri M, Samiullah FNU, Mohamad T, Varrassi G. Comparison of long-term clinical outcomes of bioabsorbable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis. Egypt Heart J 2024; 76:91. [PMID: 38985375 PMCID: PMC11236827 DOI: 10.1186/s43044-024-00522-1] [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: 04/07/2024] [Accepted: 07/03/2024] [Indexed: 07/11/2024] Open
Abstract
BACKGROUND One million individuals in the USA die from acute myocardial infarction (MI), which currently affects 3 million people globally. The available data about the early and late outcomes of both biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents exhibit inconsistency. We performed a meta-analysis comparing the safety and efficacy of BP-DES with DP-DES. METHODS PubMed, Google Scholar, EMBASE, Cochrane, Ovid Medline, and Clinical Trials.gov databases were used to find out studies comparing BP-DES to DP-DES. All the analyses used the random-effects model. RESULTS A total of 18 studies were incorporated in this meta-analysis that involved 28,874 patients, out of which 11,997 received the BP Stent, and the rest of 16,578 received the DP stent. Thorough analyses revealed that the risk of all-cause death was significantly higher in the BP-DES group (5.4% vs 2.7%) (RR 1.22, p 0.02) for two years or less than two-year follow-up. For studies with more than two years of follow-up, all-cause death was 9.07% (599/6603) in BP-DES and 9.47% (531/5602) in the DP-DES group but failed to achieve statistically significant levels (RR 0.97, p 0.58). CONCLUSIONS The study revealed no clinically significant (P value was > 0.05) differences in all-cause death, cardiac death, target lesion revascularization (TLR), late stent thrombosis, device-oriented composite endpoint/target lesion failure (DOCE/TLF), myocardial infarction (MI), target vessel MI, target vessel revascularization (TVR), target vessel infarction (TVI) between BP-DES and DP-DES for more than two years of follow-up. Additionally, all-cause death was only outcomes which found to have a statistically significant difference for less than two years of follow-up, while remaining were statistically non-significant.
Collapse
Affiliation(s)
- Abdur Rehman
- Department of Medicine, Shaikh Zayed Hospital, Lahore, Pakistan
| | | | - Ahmed Nouman
- Department of Medicine, Shaikh Zayed Hospital, Lahore, Pakistan
| | - Rabia Irfan
- Federal Medical and Dental College, Rawalpindi, Pakistan
| | - Qareeha Rehman
- Federal Medical and Dental College, Rawalpindi, Pakistan
| | | | | | - Samar Mehdi
- Department of Medicine, Shaikh Zayed Hospital, Lahore, Pakistan
| | | | - Satesh Kumar
- Department of Medicine, Shaheed Mohtarma Benazir Bhutto Medical College, Lyari, Karachi, Pakistan.
| | - Mahima Khatri
- Dow University of Health Science (Medicine), Karachi, Pakistan
| | - F N U Samiullah
- Department of Medicine, Shaheed Mohtarma Benazir Bhutto Medical College, Lyari, Karachi, Pakistan
| | | | | |
Collapse
|
9
|
Tanaka T, Kawai K, Ellis CR, Srivastava M, Kawakami R, Konishi T, Shiraki T, Sekimoto T, Virmani R, Finn AV. Challenges and advances in device-related thrombus in left atrial appendage occlusion. Future Cardiol 2024; 20:343-358. [PMID: 38948932 PMCID: PMC11457600 DOI: 10.1080/14796678.2024.2363063] [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: 01/03/2024] [Accepted: 05/29/2024] [Indexed: 07/02/2024] Open
Abstract
Oral anticoagulation therapy (OAC) is a mainstay for mitigating stroke and other embolic events in patients with atrial fibrillation (AF). Despite the demonstrated efficacy of OAC in reducing events, many patients are unable to tolerate OAC due to bleeding risks. Left atrial appendage occlusion (LAAO) devices were developed as implantable technologies to moderate stroke risk in patients with intolerance to OAC. Despite clinical data supporting near-comparable protection against thromboembolic events with OAC, device-related thrombus formation has emerged as a critical complication following LAAO that remains a potential limitation to the safety and efficacy of LAAO. Improved biocompatibility of LAAO devices with fluoropolymers, a well-established stent-coating technology used to reduce thrombus formation and promote endothelialization, may optimize outcomes after LAAO.
Collapse
Affiliation(s)
| | - Kenji Kawai
- CVPath Institute, Gaithersburg, MD20878, USA
| | | | - Mukta Srivastava
- University of Maryland, School of Medicine, Baltimore, MD21201, USA
| | | | | | | | | | | | - Aloke V Finn
- CVPath Institute, Gaithersburg, MD20878, USA
- University of Maryland, School of Medicine, Baltimore, MD21201, USA
| |
Collapse
|
10
|
Zhang F, Wang W, Zhu Y, Mao Y, Wang T, Gao P. Coronary stent implantation links to the occurrence of eosinophilia and interstitial pneumonia: a case report and systematic review. BMC Pulm Med 2024; 24:281. [PMID: 38886703 PMCID: PMC11184702 DOI: 10.1186/s12890-024-03101-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2023] [Accepted: 06/13/2024] [Indexed: 06/20/2024] Open
Abstract
BACKGROUND Rapamycin has been extensively utilized for coating coronary artery stents to reduce the occurrence of restenosis, yet there has been limited research on the potential harms of rapamycin-eluting stents. Herein, We report a case of eosinophilia and interstitial pneumonia caused by a cobalt-based alloy stent eluted with rapamycin. CASE PRESENTATION The patient was admitted due to fever, cough, and expectoration symptoms. Previously, the patient had undergone a procedure of percutaneous coronary stent implantation in our hospital's cardiology department, which led to a gradual rise in blood eosinophil count. This time, the eosinophil count was higher than the previous admission. A chest CT scan revealed multiple flocculent density increases in both lungs and bronchiectasis. The rapamycin-eluting stents may have caused eosinophilia and interstitial pneumonia, which improved after administering corticosteroids. A systematic review of relevant literature was conducted to summarize the characteristics of interstitial pneumonia caused by drug-eluting stents. CONCLUSION Paclitaxel, everolimus, zotarolimus, and rapamycin are the types of drugs that can lead to drug-eluting stents, and because of the rarity of their onset, clinical doctors must be precise and prompt in diagnosing suspected cases to avoid misdiagnosis and delayed treatment.
Collapse
Affiliation(s)
- Fuyun Zhang
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China
| | - Wei Wang
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China
| | - Yingwei Zhu
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China
| | - Yimin Mao
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China
| | - Tongsheng Wang
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China.
| | - Pengfei Gao
- Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, Henan, China.
| |
Collapse
|
11
|
Cortese B, Sanchez-Jimenez E, Lazar L. Coronary stent failure: role of a blended approach with drug-coated balloons for complex lesions. Minerva Cardiol Angiol 2024; 72:266-280. [PMID: 36939731 DOI: 10.23736/s2724-5683.22.06172-5] [Citation(s) in RCA: 6] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/21/2023]
Abstract
The management of coronary artery disease by means of percutaneous approach have been focused initially to overcome the recoil and acute occlusion after vessel ballooning; therefore, to develop and improve metallic stent platforms, and later drug-eluting technologies. Contemporarily, the necessity emerged to optimize interventional procedures using functional physiologic tests and intravascular imaging guidance, but still stent failures, especially in the complex lesion setting, continue to be not negligible. This comprehensive review is focused on the technology of drug-coated balloons as a tool to treat coronary artery disease without the need for metal implantation but still eluting antirestenotic drugs such as paclitaxel or sirolimus. We delve into these technologies, the drugs, the technical aspects of the deployment and the most updated evidence also proposing a dedicated interventional algorithm. There is solid data to support the use of drug-coated balloons in patients with in-stent restenosis and de-novo small coronary artery disease but also new evidence with promising results from recent studies indicate the feasibility of this approach in complex coronary interventions, bifurcation lesions and larger coronary vessels. In this state-of-the-art review, we also propose a blended approach based on the combination of drug-eluting stents and drug-coated balloons, keeping in mind the necessity to reduce the total stent length in order to reduce the long-term risk of complications.
Collapse
Affiliation(s)
- Bernardo Cortese
- Fondazione Ricerca e Innovazione Cardiovascolare, Milan, Italy -
| | | | - Leontin Lazar
- Fondazione Ricerca e Innovazione Cardiovascolare, Milan, Italy
| |
Collapse
|
12
|
Shafiabadi Hassani N, Ogliari LC, Vieira de Oliveira Salerno PR, Pereira GTR, Ribeiro MH, Palma Dallan LA. In-Stent Restenosis Overview: From Intravascular Imaging to Optimal Percutaneous Coronary Intervention Management. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:549. [PMID: 38674195 PMCID: PMC11051745 DOI: 10.3390/medicina60040549] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/12/2024] [Revised: 03/13/2024] [Accepted: 03/18/2024] [Indexed: 04/28/2024]
Abstract
Despite ongoing progress in stent technology and deployment techniques, in-stent restenosis (ISR) still remains a major issue following percutaneous coronary intervention (PCI) and accounts for 10.6% of all interventions in the United States. With the continuous rise in ISR risk factors such as obesity and diabetes, along with an increase in the treatment of complex lesions with high-risk percutaneous coronary intervention (CHIP), a substantial growth in ISR burden is expected. This review aims to provide insight into the mechanisms, classification, and management of ISR, with a focus on exploring innovative approaches to tackle this complication comprehensively, along with a special section addressing the approach to complex calcified lesions.
Collapse
Affiliation(s)
- Neda Shafiabadi Hassani
- Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA; (N.S.H.); (P.R.V.d.O.S.); (G.T.R.P.)
- Intravascular Imaging Core Laboratory, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA
| | - Lucas Carlini Ogliari
- SOS Cardio Hospital and Imperial Hospital de Caridade, Florianópolis 88020-210, SC, Brazil; (L.C.O.); (M.H.R.)
| | - Pedro Rafael Vieira de Oliveira Salerno
- Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA; (N.S.H.); (P.R.V.d.O.S.); (G.T.R.P.)
- Intravascular Imaging Core Laboratory, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA
| | - Gabriel Tensol Rodrigues Pereira
- Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA; (N.S.H.); (P.R.V.d.O.S.); (G.T.R.P.)
- Intravascular Imaging Core Laboratory, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA
| | - Marcelo Harada Ribeiro
- SOS Cardio Hospital and Imperial Hospital de Caridade, Florianópolis 88020-210, SC, Brazil; (L.C.O.); (M.H.R.)
| | - Luis Augusto Palma Dallan
- Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA; (N.S.H.); (P.R.V.d.O.S.); (G.T.R.P.)
| |
Collapse
|
13
|
Lungu CN, Creteanu A, Mehedinti MC. Endovascular Drug Delivery. Life (Basel) 2024; 14:451. [PMID: 38672722 PMCID: PMC11051410 DOI: 10.3390/life14040451] [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: 02/06/2024] [Revised: 03/12/2024] [Accepted: 03/25/2024] [Indexed: 04/28/2024] Open
Abstract
Drug-eluting stents (DES) and balloons revolutionize atherosclerosis treatment by targeting hyperplastic tissue responses through effective local drug delivery strategies. This review examines approved and emerging endovascular devices, discussing drug release mechanisms and their impacts on arterial drug distribution. It emphasizes the crucial role of drug delivery in modern cardiovascular care and highlights how device technologies influence vascular behavior based on lesion morphology. The future holds promise for lesion-specific treatments, particularly in the superficial femoral artery, with recent CE-marked devices showing encouraging results. Exciting strategies and new patents focus on local drug delivery to prevent restenosis, shaping the future of interventional outcomes. In summary, as we navigate the ever-evolving landscape of cardiovascular intervention, it becomes increasingly evident that the future lies in tailoring treatments to the specific characteristics of each lesion. By leveraging cutting-edge technologies and harnessing the potential of localized drug delivery, we stand poised to usher in a new era of precision medicine in vascular intervention.
Collapse
Affiliation(s)
- Claudiu N. Lungu
- Department of Functional and Morphological Science, Faculty of Medicine and Pharmacy, Dunarea de Jos University, 800010 Galati, Romania;
| | - Andreea Creteanu
- Department of Pharmaceutical Technology, University of Medicine and Pharmacy Grigore T Popa, 700115 Iași, Romania
| | - Mihaela C. Mehedinti
- Department of Functional and Morphological Science, Faculty of Medicine and Pharmacy, Dunarea de Jos University, 800010 Galati, Romania;
| |
Collapse
|
14
|
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.
Collapse
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
| |
Collapse
|
15
|
Klein LW, Nathan S, Maehara A, Messenger J, Mintz GS, Ali ZA, Rymer J, Sandoval Y, Al-Azizi K, Mehran R, Rao SV, Lotfi A. SCAI Expert Consensus Statement on Management of In-Stent Restenosis and Stent Thrombosis. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2023; 2:100971. [PMID: 39131655 PMCID: PMC11308135 DOI: 10.1016/j.jscai.2023.100971] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 08/13/2024]
Abstract
Stent failure remains the major drawback to the use of coronary stents as a revascularization strategy. Recent advances in imaging have substantially improved our understanding of the mechanisms underlying these occurrences, which have in common numerous clinical risk factors and mechanical elements at the time of stent implantation. In-stent restenosis remains a common clinical problem despite numerous improvements in-stent design and polymer coatings over the past 2 decades. It generates significant health care cost and is associated with an increased risk of death and rehospitalization. Stent thrombosis causes abrupt closure of the stented artery and therefore carries a high risk of myocardial infarction and death. This Society for Cardiovascular Angiography & Interventions (SCAI) Expert Consensus Statement suggests updated practical algorithmic approaches to in-stent restenosis and stent thrombosis. A pragmatic outline of assessment and management of patients presenting with stent failure is presented. A new SCAI classification that is time-sensitive with mechanistic implications of in-stent restenosis is proposed. Emphasis is placed on frequent use of intracoronary imaging and assessment of timing to determine the precise etiology because that information is crucial to guide selection of the best treatment option. SCAI recommends image-guided coronary stenting at the time of initial implantation to minimize the occurrence of stent failure. When in-stent restenosis and stent thrombosis are encountered, imaging should be strongly considered to optimize the subsequent approach.
Collapse
Affiliation(s)
- Lloyd W. Klein
- Division of Cardiology, University of California, San Francisco, San Francisco, California
| | - Sandeep Nathan
- Section of Cardiology, Department of Medicine, University of Chicago, Chicago, Illinois
| | - Akiko Maehara
- Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University College of Physicians and Surgeons, New York, New York
| | - John Messenger
- Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado
| | - Gary S. Mintz
- Clinical Trials Center, Cardiovascular Research Foundation, New York, New York
| | - Ziad A. Ali
- DeMatteis Cardiovascular Institute, St. Francis Hospital & Heart Center, Roslyn, New York
| | - Jennifer Rymer
- Division of Cardiology, Duke University School of Medicine, Durham, North Carolina
| | - Yader Sandoval
- Allina Health Minneapolis Heart Institute, Minneapolis, Minnesota
| | - Karim Al-Azizi
- Department of Interventional Cardiology, Baylor Scott & White Health – The Heart Hospital, Plano, Texas
| | - Roxana Mehran
- Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, New York, New York
| | - Sunil V. Rao
- Division of Cardiology, NYU Langone Health System, New York, New York
| | - Amir Lotfi
- Division of Cardiology, University of Massachusetts Chan Medical School – Baystate, Springfield, Massachusetts
| |
Collapse
|
16
|
Park DS, Jeong MH, Jin YJ, Na MH, Sim DS, Kim M, Cho KH, Hyun DY, Oh S, Kim JH, Lim KS, Park JK, Kim HK, Hong YJ, Kim JH, Ahn Y, Kim JH. Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model. Tissue Eng Regen Med 2023; 20:239-249. [PMID: 36881249 PMCID: PMC10070568 DOI: 10.1007/s13770-023-00518-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2022] [Revised: 12/23/2022] [Accepted: 01/03/2023] [Indexed: 03/08/2023] Open
Abstract
BACKGROUND Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. METHODS The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-to-artery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. RESULTS Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 μm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. CONCLUSION BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.
Collapse
Affiliation(s)
- Dae Sung Park
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- The Research Institute of Medical Sciences, Chonnam National University, Gwangju, 61469, Republic of Korea
| | - Myung Ho Jeong
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea.
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea.
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea.
| | - Yu Jeong Jin
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
| | - Mi Hyang Na
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
| | - Doo Sun Sim
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Munki Kim
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
| | - Kyung Hoon Cho
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Dae Young Hyun
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Seok Oh
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Jeong Ha Kim
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
| | - Kyung Seob Lim
- The Futuristic Animal Research Center, The Korean Research Institute of Bioscience and Biotechnology, Ochang, 28116, Republic of Korea
| | | | - Han Ki Kim
- CGBio Co. Ltd., Seoul, Republic of Korea
| | - Young Joon Hong
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Ju Han Kim
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Youngkeun Ahn
- The Korean Cardiovascular Stent Research Institute, Jangsung, 57248, Republic of Korea
- The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju, 61469, Republic of Korea
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| | - Jeong Hun Kim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, 61469, Republic of Korea
| |
Collapse
|
17
|
Schwartz BL, Pithadia DJ, Chen JK. Hypersensitivity to Implanted Metal Devices. CURRENT DERMATOLOGY REPORTS 2023. [DOI: 10.1007/s13671-023-00381-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
|
18
|
Panduranga P, Mohammed A. The Outcome of Ultrathin-Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in Coronary Artery Disease Patients - A Feasibility Study. Heart Views 2023; 24:1-5. [PMID: 37124429 PMCID: PMC10144419 DOI: 10.4103/heartviews.heartviews_46_22] [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: 05/20/2022] [Accepted: 01/17/2023] [Indexed: 02/24/2023] Open
Abstract
Background Drug-eluting coronary stents with ultrathin struts and biodegradable polymers have been shown to reduce inflammation, neointimal proliferation, and thrombus formation, leading to less early and late complications in patients with coronary artery disease as compared to thinner strut and durable polymer second-generation stents. In Oman, currently, second-generation stents are used for all patients. Objective The purpose of this feasibility study was to evaluate the clinical safety and performance of ultrathin-strut (60 μm) biodegradable polymer-coated sirolimus-eluting stents in an all-comers patient population. Methods This was a prospective, observational, single-center, and single-arm investigator-initiated study from August 2018 to August 2019. Inclusion criteria: 18 years of age, patients with symptomatic coronary artery disease indicated for percutaneous coronary intervention, and stenting of at least one coronary lesion. All patients were followed clinically or telephonically at 12 months after the index procedure. Results A total of 88 patients were recruited in the study, but 10 patients were lost to follow-up and hence excluded from the analysis. The overall mean age was 63 ± 13 years and 78% were males. The main comorbid conditions were hypertension (58%), diabetes mellitus (49%), and hyperlipidemia (26%). Fifty-three percent presented with unstable angina or non-ST elevation myocardial infarction (MI), 10% with ST elevation MI, recent MI 16%, 18% with stable angina, and 1.3% in cardiogenic shock. The mean left ventricular ejection fraction of the cohort was 46 ± 14%. Angiographically, Type A lesions were seen in 25%, Type B in 32%, and Type C in 42%. Left anterior descending stenting was done in 44%, right coronary artery in 32%, left circumflex artery in 14%, left main in 5%, and graft stenting in 4%. Device success was 96%. Procedural success was seen in 97% of patients. At 1-year follow-up, 93% were asymptomatic; overall device-oriented clinical events were 6.8% including cardiac death in 2.7%, target-vessel MI in 2.7%, and target-lesion revascularization in 1.3% which all occurred in uncontrolled diabetic patients. Conclusions At index admission and 1 year, ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent study showed low device-related adverse clinical events which are comparable to published data for the second-generation stents. This feasibility study shows that these stents can be used in all types of stent-indicated patients with added advantages of biodegradable polymer and ultrathin struts. In addition, measures to prevent, diagnose, and control diabetes need to be taken in Oman as this cohort of patients develop ST after stenting.
Collapse
Affiliation(s)
- Prashanth Panduranga
- Department of Cardiology, National Heart Center, Royal Hospital, Muscat, Sultanate of Oman
| | - Azzam Mohammed
- Department of Cardiology, National Heart Center, Royal Hospital, Muscat, Sultanate of Oman
| |
Collapse
|
19
|
Wang R, Lu J, Yin J, Chen H, Liu H, Xu F, Zang T, Xu R, Li C, Wu Y, Wu Q, Fei X, Zhu M, Shen L, Ge J. A TEMPOL and rapamycin loaded nanofiber-covered stent favors endothelialization and mitigates neointimal hyperplasia and local inflammation. Bioact Mater 2023; 19:666-677. [PMID: 35600979 PMCID: PMC9114161 DOI: 10.1016/j.bioactmat.2022.04.033] [Citation(s) in RCA: 26] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2022] [Revised: 04/12/2022] [Accepted: 04/28/2022] [Indexed: 10/26/2022] Open
|
20
|
Lamothe PA, Berkowitz DM, Schimmel ME. A Case of Nitinol Airway Stent Placement in a Patient With Known Nickel Skin Sensitivity With No Local or Systemic Reactions After 6 Months of Follow-up. J Bronchology Interv Pulmonol 2023; 30:83-85. [PMID: 35838198 DOI: 10.1097/lbr.0000000000000847] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Affiliation(s)
- Pedro A Lamothe
- Interventional Pulmonology, Division of Pulmonary, Allergy and Critical Care Medicine Emory University School of Medicine, Atlanta, GA
| | | | | |
Collapse
|
21
|
Donisan T, Madanat L, Balanescu DV, Mertens A, Dixon S. Drug-Eluting Stent Restenosis: Modern Approach to a Classic Challenge. Curr Cardiol Rev 2023; 19:e030123212355. [PMID: 36597603 PMCID: PMC10280993 DOI: 10.2174/1573403x19666230103154638] [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: 04/13/2022] [Revised: 11/19/2022] [Accepted: 11/21/2022] [Indexed: 01/05/2023] Open
Abstract
In-stent restenosis (ISR) is a recognized complication following percutaneous coronary intervention in which the luminal diameter is narrowed through neointimal hyperplasia and vessel remodeling. Although rates of ISR have decreased in most recent years owing to newer generation drug-eluting stents, thinner struts, and better intravascular imaging modalities, ISR remains a prevalent dilemma that proves to be challenging to manage. Several factors have been proposed to contribute to ISR formation, including mechanical stent characteristics, technical factors during the coronary intervention, and biological aspects of drug-eluting stents. Presentation of ISR can range from asymptomatic to late myocardial infarction and could be difficult to differentiate from acute thrombus formation. No definite guidelines are present on the management of ISR. In this review, we will discuss the mechanisms underlying ISR and provide insight into patient-related and procedural risk factors contributing to ISR, in addition to highlighting common treatment approaches utilized in the management of ISR.
Collapse
Affiliation(s)
- Teodora Donisan
- Department of Internal Medicine, Beaumont Hospital, Royal Oak, MI, 48073, USA
| | - Luai Madanat
- Department of Internal Medicine, Beaumont Hospital, Royal Oak, MI, 48073, USA
| | - Dinu V. Balanescu
- Department of Internal Medicine, Beaumont Hospital, Royal Oak, MI, 48073, USA
| | - Amy Mertens
- Department of Cardiovascular Medicine, Beaumont Hospital, Royal Oak, MI, 48073, USA
| | - Simon Dixon
- Department of Cardiovascular Medicine, Beaumont Hospital, Royal Oak, MI, 48073, USA
| |
Collapse
|
22
|
Matsuura Y, Moribayashi K, Kaikita K. Optimal Antithrombotic Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Focused Review on High Bleeding Risk. J Atheroscler Thromb 2022; 29:1409-1420. [PMID: 35934784 PMCID: PMC9529379 DOI: 10.5551/jat.rv17066] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Accepted: 06/08/2022] [Indexed: 11/11/2022] Open
Abstract
Dual antiplatelet therapy (DAPT) is a therapeutic cornerstone to prevent stent thrombosis following percutaneous coronary intervention (PCI) for coronary artery disease (CAD). However, the longer the DAPT duration, the higher the incidence of bleeding and mortality. Since the advent of second-generation drug-eluting stents (DES), the continuous evolution of DES has reduced the thrombotic risk and allowed for a shorter DAPT duration. On the other hand, concerns on the elevated risk of bleeding during antithrombotic therapy have been further raised due to the growing number of elderly CAD patients with multiple comorbidities. The consequent debate topic over post-PCI antithrombotic therapy has shifted from simply reducing thrombotic risk to safely minimizing bleeding risk. Due to the significant impact of bleeding on clinical outcomes, including prognosis, current guidelines on antithrombotic therapy for CAD prioritize stratification of patients at a high bleeding risk (HBR) as the top consideration in determining post-PCI antithrombotic therapy. Achieving optimal antithrombotic therapy for each patient undergoing PCI requires a better understanding of the clinical variables constituting the balance of bleeding and thrombotic risk. This review highlights relevant evidence required to optimize antithrombotic therapy for HBR patients undergoing PCI.
Collapse
Affiliation(s)
- Yunosuke Matsuura
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
| | - Kohei Moribayashi
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
| | - Koichi Kaikita
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
| |
Collapse
|
23
|
Chen Z, Matsumura M, Mintz GS, Noguchi M, Fujimura T, Usui E, Seike F, Hu X, Jin G, Li C, Salem H, Fall KN, Shlofmitz E, Kirtane AJ, Cao JJ, Moses JW, Ali ZA, Jeremias A, Shlofmitz RA, Maehara A. Prevalence and Impact of Neoatherosclerosis on Clinical Outcomes After Percutaneous Treatment of Second-Generation Drug-Eluting Stent Restenosis. Circ Cardiovasc Interv 2022; 15:e011693. [PMID: 36126137 DOI: 10.1161/circinterventions.121.011693] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Clinical and morphological factors associated with lipidic versus calcified neoatherosclerosis within second-generation drug-eluting stents and the impact of lipidic versus calcified neoatherosclerosis on long-term outcomes after repeat intervention have not been well studied. METHODS A total of 512 patients undergoing optical coherence tomography before percutaneous coronary intervention for second-generation drug-eluting stents in-stent restenosis were included. Neoatherosclerosis was defined as lipidic or calcified neointimal hyperplasia in ≥3 consecutive frames or ruptured lipidic neointimal hyperplasia. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, or clinically driven target lesion revascularization). RESULTS The overall prevalence of neoatherosclerosis was 28.5% (146/512): 56.8% lipidic, 30.8% calcified, and 12.3% both lipidic and calcific. The prevalence increased as a function of time from stent implantation: 20% at 1 to 3 years, 30% at 3 to 7 years, and 75% >7 years. Renal insufficiency, poor lipid profile, and time from stent implantation were associated with lipidic neoatherosclerosis, whereas severe renal insufficiency, female sex, and time from stent implantation were associated with calcified neoatherosclerosis. Multivariable Cox regression revealed that female sex and lipidic neoatherosclerosis were associated with more target lesion failure, whereas stent age and final minimum lumen diameter after reintervention were related to lower target lesion failure. Calcified neoatherosclerosis was not related to adverse events after reintervention for in-stent restenosis given a large enough minimum lumen diameter was achieved. CONCLUSIONS Lipidic but not calcified neoatherosclerosis was associated with poor subsequent outcomes after repeat revascularization if optimal stent expansion was achieved in lesions with calcified neoatherosclerosis.
Collapse
Affiliation(s)
- Zhaoyang Chen
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.).,Department of Cardiology, Union Hospital, Fujian Medical University, China (Z.C.)
| | - Mitsuaki Matsumura
- Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Gary S Mintz
- Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Masahiko Noguchi
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Tatsuhiro Fujimura
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Eisuke Usui
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Fumiyasu Seike
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Xun Hu
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Ge Jin
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Chenguang Li
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Hanan Salem
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Khady N Fall
- Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Evan Shlofmitz
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.)
| | - Ajay J Kirtane
- Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - J Jane Cao
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.)
| | - Jeffrey W Moses
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Ziad A Ali
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Allen Jeremias
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Richard A Shlofmitz
- Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| | - Akiko Maehara
- St. Francis Hospital, Roslyn, NY (Z.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., E.S., J.J.C.' J.W.M., Z.A.A., A.J., A.M.).,Division of Cardiology, New York-Presbyterian Hospital/Columbia University Irving Medical Center (X.C., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., A.J.K., J.W.M., Z.A.A., A.M.).,Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.C., M.M., G.S.M., M.N., T.F., E.U., F.S., X.H., G.J., C.L., H.S., K.N.F., A.J.K., J.W.M., Z.A.A., A.J., R.A.S., A.M.)
| |
Collapse
|
24
|
Thondapu V, Dayawansa NH, Claessen B, Dangas GD, Barlis P. Durable Polymer Everolimus Eluting Stents. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch31] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022] Open
|
25
|
Milewski M, Ng CKJ, Gąsior P, Lian SS, Qian SX, Lu S, Foin N, Kedhi E, Wojakowski W, Ang HY. Polymer Coating Integrity, Thrombogenicity and Computational Fluid Dynamics Analysis of Provisional Stenting Technique in the Left Main Bifurcation Setting: Insights from an In-Vitro Model. Polymers (Basel) 2022; 14:polym14091715. [PMID: 35566886 PMCID: PMC9099851 DOI: 10.3390/polym14091715] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2022] [Revised: 04/19/2022] [Accepted: 04/20/2022] [Indexed: 02/04/2023] Open
Abstract
Currently, the provisional stenting technique is the gold standard in revascularization of lesions located in the left main (LM) bifurcation. The benefit of the routine kissing balloon technique (KBI) in bifurcation lesions is still debated, particularly following the single stent treatment. We compared the latest-generation drug-eluting stent (DES) with no side branch (SB) dilatation “keep it open” technique (KIO) vs. KBI technique vs. bifurcation dedicated drug-eluting stent (BD-DES) implantation. In vitro testing was performed under a static condition in bifurcation silicone vessel models. All the devices were implanted in accordance with the manufacturers’ recommendations. As a result, computational fluid dynamics (CFD) analysis demonstrated a statistically higher area of high shear rate in the KIO group when compared to KBI. Likewise, the maximal shear rate was higher in number in the KIO group. Floating strut count based on the OCT imaging was significantly higher in KIO than in KBI and BD-DES. Furthermore, according to OTC analysis, the thrombus area was numerically higher in both KIO and KBI than in the BD-DES. Scanning electron microscopy (SEM) analysis shows the highest degree of strut coating damage in the KBI group. This model demonstrated significant differences in CFD analysis at SB ostia with and without KBI optimization in the LM setting. The adoption of KBI was related to a meaningful reduction of flow disturbances in conventional DES and achieved results similar to BD-DES.
Collapse
Affiliation(s)
- Marek Milewski
- Division of Cardiology and Structural Heart Diseases, Medical University of Silesia in Katowice, 40-635 Katowice, Poland; (M.M.); (P.G.); (E.K.); (W.W.)
| | - Chen Koon Jaryl Ng
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609, Singapore; (C.K.J.N.); (S.L.); (N.F.)
| | - Pawel Gąsior
- Division of Cardiology and Structural Heart Diseases, Medical University of Silesia in Katowice, 40-635 Katowice, Poland; (M.M.); (P.G.); (E.K.); (W.W.)
| | - Shaoliang Shawn Lian
- Department of Biomedical Engineering, National University of Singapore, Singapore 119077, Singapore;
| | - Su Xiao Qian
- Division of Chemical and Biomolecular Engineering, Nanyang Technological University, Singapore 637459, Singapore;
| | - Shengjie Lu
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609, Singapore; (C.K.J.N.); (S.L.); (N.F.)
| | - Nicolas Foin
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609, Singapore; (C.K.J.N.); (S.L.); (N.F.)
- Duke-NUS Medical School, Singapore 169857, Singapore
| | - Elvin Kedhi
- Division of Cardiology and Structural Heart Diseases, Medical University of Silesia in Katowice, 40-635 Katowice, Poland; (M.M.); (P.G.); (E.K.); (W.W.)
- Erasmus Hospital, Université libre de Bruxelles (ULB), 1070 Brussels, Belgium
| | - Wojciech Wojakowski
- Division of Cardiology and Structural Heart Diseases, Medical University of Silesia in Katowice, 40-635 Katowice, Poland; (M.M.); (P.G.); (E.K.); (W.W.)
| | - Hui Ying Ang
- National Heart Research Institute Singapore, National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609, Singapore; (C.K.J.N.); (S.L.); (N.F.)
- Department of Biomedical Engineering, National University of Singapore, Singapore 119077, Singapore;
- Duke-NUS Medical School, Singapore 169857, Singapore
- Correspondence: ; Tel.: +65-6704-2343; Fax: +65-6704-2210
| |
Collapse
|
26
|
Chong B, Goh RSJ, Kong G, Sim FRE, Ng CH, Teo XYV, Quek JX, Lim O, Chin YH, Chan SP, Chan MY, Tan HC, Chew NWS, Loh PH. Comparison of biodegradable and newer generation durable polymer drug-eluting stents with short-term dual antiplatelet therapy: a systematic review and Bayesian network meta-analysis of randomized trials comprising of 43,875 patients. J Thromb Thrombolysis 2022; 53:671-682. [PMID: 34981305 DOI: 10.1007/s11239-021-02628-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/27/2021] [Indexed: 12/17/2022]
Abstract
Newer generation durable polymer drug-eluting stents (DP-DES) and biodegradable polymer DES (BP-DES) have similar efficacy with dual-antiplatelet therapy (DAPT) duration of > 6 months. However, this difference in outcomes have not been well studied in shorter DAPT regime. This study compares the safety and efficacy profiles of DP-DES and BP-DES based on short-term (1-3 months), intermediate-term (4-6 months) and standard DAPT (6-12 months) durations. A search was conducted on Embase and Medline for Randomized Controlled Trials (RCTs) comparing stent types, and DAPT durations. Primary endpoints include cardiac death, myocardial infarction (MI), definite stent thrombosis, stroke, target vessel revascularization (TVR) and major bleeding. Network analysis was conducted to summarize the evidence. A total of 15 RCTs involving 43,875 patients were included. DP-DES was associated with significantly lower major bleeding rates compared to BP-DES (RR 0.44, Crl 0.22-0.83) in short-term DAPT. Among DP-DES patients, short-term DAPT was associated with lower major bleeding risk compared to standard DAPT (RR 0.47, CrI 0.32-0.69). This favorable bleeding profile with short DAPT was not found in BP-DES patients. Cardiac death, MI, definite stent thrombosis, stroke and TVR rates were similar across the various DAPT durations and stent types. Our preliminary findings demonstrated comparable efficacy and safety outcomes between BP-DES and newer generation BP-DES across various DAPT durations. In patients requiring short DAPT, DP-DES had more favourable major bleeding profile compared to BP-DES, without compromising anti-thrombotic efficacy.
Collapse
Affiliation(s)
- Bryan Chong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Rachel Sze Jen Goh
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Gwyneth Kong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Faith Ruo En Sim
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Chen Han Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Xin Yi Vanessa Teo
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Jing Xuan Quek
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Oliver Lim
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Yip Han Chin
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Siew-Pang Chan
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- Department of Cardiology, National University Heart Centre, National University Health System, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore
| | - Mark Y Chan
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- Department of Cardiology, National University Heart Centre, National University Health System, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore
| | - Huay-Cheem Tan
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- Department of Cardiology, National University Heart Centre, National University Health System, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore
| | - Nicholas W S Chew
- Department of Cardiology, National University Heart Centre, National University Health System, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.
| | - Poay Huan Loh
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- Department of Cardiology, National University Heart Centre, National University Health System, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore
| |
Collapse
|
27
|
van Hemert ND, Voskuil M, Rozemeijer R, Stein M, Frambach P, Pereira B, Rittersma SZ, Kraaijeveld AO, Leenders GEH, Timmers L, van der Harst P, Agostoni P, Stella PR. 3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis. JACC Cardiovasc Interv 2021; 14:2477-2486. [PMID: 34794654 DOI: 10.1016/j.jcin.2021.08.078] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Revised: 07/16/2021] [Accepted: 08/24/2021] [Indexed: 11/30/2022]
Abstract
OBJECTIVES The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population. BACKGROUND PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy. METHODS In this physician-initiated, multicenter, randomized, all-comers trial, patients undergoing percutaneous coronary intervention with implantation of DES were enrolled. Patients were stratified for diabetes and troponin status and randomized to implantation of a permanent-polymer zotarolimus-eluting stent (PP-ZES) or a PF-AES. Dual-antiplatelet therapy duration was 12 months in troponin-positive patients and 1 month in troponin-negative patients. A noninferiority analysis was conducted to compare the 2 arms regarding target lesion failure (TLF) between 1 and 3 years. RESULTS A total of 1,491 patients were randomized and treated. In this landmark analysis, between 1- and 3-year follow-up, TLF occurred in 35 patients (4.9%) in the PP-ZES arm and 37 PF-AES patients (5.1%). Clinical noninferiority of the PF-AES was confirmed, with a risk difference of 0.2% (upper limit 1-sided 95% CI: 2.2%; Pnoninferiority = 0.0031). CONCLUSIONS ReCre8 (Randomized "All-Comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent) is the first randomized, multicenter trial with a head-to-head comparison of PP-ZES compared with PF-AES to investigate clinical outcomes of these new-generation DES in an all-comers population with long-term follow-up. On the basis of the present results, PF-AES are clinically noninferior to PP-ZES regarding TLF between 1 and 3 years. (Randomized "All-Comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent; NCT02328898).
Collapse
Affiliation(s)
- Nicole D van Hemert
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Michiel Voskuil
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Rik Rozemeijer
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Mèra Stein
- Department of Cardiology, Zuyderland Medical Center, Heerlen, the Netherlands
| | - Peter Frambach
- National Institute of Cardiac Surgery and Interventional Cardiology, Luxembourg, Luxembourg
| | - Bruno Pereira
- National Institute of Cardiac Surgery and Interventional Cardiology, Luxembourg, Luxembourg
| | - Saskia Z Rittersma
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Adriaan O Kraaijeveld
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Geert E H Leenders
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | - Leo Timmers
- Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
| | - Pim van der Harst
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
| | | | - Pieter R Stella
- Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.
| | | |
Collapse
|
28
|
Shim JW, Kim SS, Kim HK, Bae IH, Park DS, Park JK, Kim JU, Kim HB, Lee MY, Kim JS, Kim JH, Koo BS, Jeong KJ, Kim SU, Kim MC, Sim DS, Hong YJ, Ahn Y, Lim KS, Jeong MH. Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film-Coated Coronary Stent Loaded With Mycophenolic Acid. Front Bioeng Biotechnol 2021; 9:650408. [PMID: 34778222 PMCID: PMC8585759 DOI: 10.3389/fbioe.2021.650408] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2021] [Accepted: 10/15/2021] [Indexed: 01/12/2023] Open
Abstract
Background: Titanium is commonly used in blood-exposed medical devices because it has superior blood compatibility. Mycophenolic acid inhibits the proliferation of vascular smooth muscle cells. This study examined the effect of a non-polymer TiO2 thin film–coated stent with mycophenolic acid in a porcine coronary overstretch restenosis model. Methods: Thirty coronary arteries in 15 pigs were randomized into three groups in which the coronary arteries were treated with a TiO2 film–coated stent with mycophenolic acid (NTM, n = 10), everolimus-eluting stent with biodegradable polymer (EES, n = 10), or TiO2 film–coated stent (NT, n = 10). A histopathologic analysis was performed 28 days after the stenting. Results: There were no significant intergroup differences in injury score, internal elastic lamina area, or inflammation score. Percent area stenosis was significantly smaller in the NTM and EES groups than in the NT group (36.1 ± 13.63% vs. 31.6 ± 7.74% vs. 45.5 ± 18.96%, respectively, p = 0.0003). Fibrin score was greater in the EES group than in the NTM and NT groups [2.0 (range, 2.0–2.0) vs. 1.0 (range, 1.0–1.75) vs. 1.0 (range, 1.0–1.0), respectively, p < 0.0001]. The in-stent occlusion rate measured by micro-computed tomography demonstrated similar percent area stenosis rates on histology analysis (36.1 ± 15.10% in NTM vs. 31.6 ± 8.89% in EES vs. 45.5 ± 17.26% in NT, p < 0.05). Conclusion: The NTM more effectively reduced neointima proliferation than the NT. Moreover, the inhibitory effect of NTM on smooth muscle cell proliferation was not inferior to that of the polymer-based EES with lower fibrin deposition in this porcine coronary restenosis model.
Collapse
Affiliation(s)
- Jae Won Shim
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Sung Soo Kim
- Division of Cardiology, Chosun University Hospital, Gwangju, South Korea
| | - Hyun Kuk Kim
- Division of Cardiology, Chosun University Hospital, Gwangju, South Korea
| | - In Ho Bae
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Dae Sung Park
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea.,Research Institute of Medical Sciences, Chonnam National University, Gwangju, South Korea
| | | | - Jae Un Kim
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Han Byul Kim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Min Young Lee
- College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, South Korea
| | - Joong Sun Kim
- College of Veterinary Medicine, Chonnam National University, Gwangju, South Korea
| | - Jung Ha Kim
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Bon-Sang Koo
- Futuristic Animal Resource and Research Center, National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Chungbuk, South Korea
| | - Kang-Jin Jeong
- Futuristic Animal Resource and Research Center, National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Chungbuk, South Korea
| | - Sun-Uk Kim
- Futuristic Animal Resource and Research Center, National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Chungbuk, South Korea
| | - Min Chul Kim
- Futuristic Animal Resource and Research Center, National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Chungbuk, South Korea
| | - Doo Sun Sim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Young Joon Hong
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Youngkeun Ahn
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| | - Kyung Seob Lim
- Futuristic Animal Resource and Research Center, National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Chungbuk, South Korea
| | - Myung Ho Jeong
- Korea Cardiovascular Stent Research Institute, Jangsung, South Korea.,Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, South Korea
| |
Collapse
|
29
|
Cho KH, Jeong MH, Park DS, Kim M, Kim J, Park JK, Han X, Hyun DY, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model. J Korean Med Sci 2021; 36:e259. [PMID: 34664799 PMCID: PMC8524232 DOI: 10.3346/jkms.2021.36.e259] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2021] [Accepted: 08/22/2021] [Indexed: 01/11/2023] Open
Abstract
BACKGROUND Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION®) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine®) in a porcine coronary restenosis model. METHODS Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION® stent and XIENCE Alpine® stent groups. The stents were implanted in the coronary artery at a 1.1-1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. RESULTS Quantitative coronary analysis showed no significant differences in the pre-procedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION® stent group (0 vs. 0.07 ± 0.11, P = 0.180). CONCLUSION Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION® stent exhibited efficacy and safety comparable with the XIENCE Alpine® stent, supporting the need for further clinical studies on the TIGEREVOLUTION® stent.
Collapse
Affiliation(s)
- Kyung Hoon Cho
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Myung Ho Jeong
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea.
| | - Dae Sung Park
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Moonki Kim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - JungHa Kim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | | | - Xiongyi Han
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Dae Young Hyun
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Min Chul Kim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea
| | - Doo Sun Sim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea
| | - Young Joon Hong
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea
| | - Ju Han Kim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea
| | - Youngkeun Ahn
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Hwasun, Korea
| |
Collapse
|
30
|
Chioncel V, Andrei CL, Brezeanu R, Sinescu C, Avram A, Tatu AL. Some Perspectives on Hypersensitivity to Coronary Stents. Int J Gen Med 2021; 14:4327-4336. [PMID: 34408475 PMCID: PMC8364397 DOI: 10.2147/ijgm.s326679] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2021] [Accepted: 07/22/2021] [Indexed: 11/23/2022] Open
Abstract
The development of coronary stents has represented a revolution in the treatment of coronary heart disease. Beyond their many advantages, stents also have their limitations and complications. Allergic reactions to coronary stents are more common than acknowledged. These stented patients are exposed to foreign substances inserted in direct contact with the coronary intima. Hypersensitivity to stent components and drugs prescribed after stent insertion together with any environmental exposure seem to contribute to these adverse reactions. Patients can present to the hospital with a wide range of symptoms and multiple complications, the most important ones being instent restenosis and stent thrombosis. Although not very common (and not always easy to identify), allergic reactions after coronary or peripheral stents should be taken into account. Careful selection of patients (for elective stent implantation) depending on the propensity to allergies, although hard to achieve, represents a key factor in reducing the number of these complications.
Collapse
Affiliation(s)
- Valentin Chioncel
- Department of Cardio-Thoracic Pathology, Faculty of Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, 050474, Romania
| | - Catalina Liliana Andrei
- Department of Cardio-Thoracic Pathology, Faculty of Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, 050474, Romania
| | - Radu Brezeanu
- Department of Cardio-Thoracic Pathology, Faculty of Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, 050474, Romania
| | - Crina Sinescu
- Department of Cardio-Thoracic Pathology, Faculty of Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, 050474, Romania
| | - Anamaria Avram
- Department of Cardio-Thoracic Pathology, Faculty of Medicine, "Carol Davila" University of Medicine and Pharmacy, Bucharest, 050474, Romania
| | - Alin Laurentiu Tatu
- Medical and Pharmaceutical Research Unit/Competitive, Interdisciplinary Research Integrated Platform "Dunărea de Jos", ReForm-UDJG, Research Centre in the Field of Medical and Pharmaceutical Sciences, Faculty of Medicine and Pharmacy, Clinical Medical Department, "Dunărea de Jos" University of Galati, Galati, 800010, Romania
| |
Collapse
|
31
|
Marlevi D, Edelman ER. Vascular Lesion-Specific Drug Delivery Systems: JACC State-of-the-Art Review. J Am Coll Cardiol 2021; 77:2413-2431. [PMID: 33985687 PMCID: PMC8238531 DOI: 10.1016/j.jacc.2021.03.307] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2021] [Revised: 03/08/2021] [Accepted: 03/21/2021] [Indexed: 01/15/2023]
Abstract
Drug delivery is central to modern cardiovascular care, where drug-eluting stents, bioresorbable scaffolds, and drug-coated balloons all aim to restore perfusion while inhibiting exuberant healing. The promise and enthusiasm of these devices has in some cases exceeded demonstration of efficacy and even understanding of driving mechanisms. The authors review the means of drug delivery in each device, outlining how the technologies affect vascular behavior. They focus on how drug retention and response are governed by lesion morphology: lipid displacing drug-specific binding sites, calcium inhibiting diffusion, blocking thrombi or promoting luminal washout, and vascular healing steering hyperplastic developments. In this regard, the authors outline the fundamental impact of vascular structure on drug delivery and review the development of contemporary and future devices for coronary and peripheral intervention. They look toward a future where incorporating information on lesion distribution is central to therapeutic success and envision a transition toward lesion-specific treatment for improved interventional outcomes.
Collapse
Affiliation(s)
- David Marlevi
- Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
| | - Elazer R Edelman
- Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
| |
Collapse
|
32
|
Seo KW, Yang HM, Yoon J, Kim HS, Chang K, Lim HS, Choi BJ, Choi SY, Yoon MH, Lee SH, Ahn SG, Youn YJ, Lee JW, Koo BK, Park KW, Yang HM, Han JK, Chung WS, Park HJ, Hwang BH, Choo EH, Oh GC, Tahk SJ. Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer. Medicine (Baltimore) 2021; 100:e25765. [PMID: 34106607 PMCID: PMC8133141 DOI: 10.1097/md.0000000000025765] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2020] [Revised: 04/05/2021] [Accepted: 04/09/2021] [Indexed: 11/26/2022] Open
Abstract
This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.
Collapse
Affiliation(s)
- Kyoung-Woo Seo
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - Hyoung-Mo Yang
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - Junghan Yoon
- Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju
| | - Hyo-Soo Kim
- Department of Internal Medicine, Seoul National University College of Medicine
| | - Kiyuk Chang
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hong-Seok Lim
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - Byoung-Joo Choi
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - So-Yeon Choi
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - Myeong-Ho Yoon
- Department of Cardiology, Ajou University School of Medicine, Suwon
| | - Seung-Hwan Lee
- Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju
| | - Sung Gyun Ahn
- Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju
| | - Young Jin Youn
- Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju
| | - Jun-Won Lee
- Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju
| | - Bon-Kwon Koo
- Department of Internal Medicine, Seoul National University College of Medicine
| | - Kyung Woo Park
- Department of Internal Medicine, Seoul National University College of Medicine
| | - Han-Mo Yang
- Department of Internal Medicine, Seoul National University College of Medicine
| | - Jung-Kyu Han
- Department of Internal Medicine, Seoul National University College of Medicine
| | - Wook-Sung Chung
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hun-Jun Park
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Byung-Hee Hwang
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Eun-Ho Choo
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Gyu-Chul Oh
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Seung-Jea Tahk
- Department of Cardiology, Ajou University School of Medicine, Suwon
| |
Collapse
|
33
|
Spione F, Brugaletta S. Second generation drug-eluting stents: a focus on safety and efficacy of current devices. Expert Rev Cardiovasc Ther 2021; 19:107-127. [PMID: 33417509 DOI: 10.1080/14779072.2021.1874352] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
Introduction: Percutaneous coronary intervention (PCI) represents the most frequent procedure performed in medicine. Second generation drug eluting stents (DES) have been developed to reduce the rates of late and very late complications of first generation DES.Areas covered: To improve long-term efficacy and safety of patients undergoing PCI, second generation DES have been developed with novel stent platforms, biocompatible durable and biodegradable polymers and newer antiproliferative agents. In this review we provide an overview of second generation DES and their clinical trials, discussing safety and effectiveness of these devices, and outlining clinical indication for use.Expert commentary: Numerous clinical trials have demonstrated the safety and efficacy of second generation DES over the last decade. These devices represent the gold standard treatment in stable and acute coronary syndromes.
Collapse
Affiliation(s)
- Francesco Spione
- Division of University Cardiology, Cardiothoracic Department, Policlinico University Hospital, Bari, Italy
| | - Salvatore Brugaletta
- Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
| |
Collapse
|
34
|
Inflammation as a determinant of healing response after coronary stent implantation. Int J Cardiovasc Imaging 2021; 37:791-801. [PMID: 33479786 PMCID: PMC7969567 DOI: 10.1007/s10554-020-02073-3] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2020] [Accepted: 10/13/2020] [Indexed: 12/25/2022]
Abstract
Cardiovascular disease remains the leading cause of death and morbidity worldwide. Inflammation plays an important role in the development of atherosclerosis and is associated with adverse clinical outcomes in patients after percutaneous coronary interventions. Data on stent elements that lead to excessive inflammatory response, proper identification of high-risk patients, prevention and treatment targeting residual inflammatory risk are limited. This review aims to present the role of inflammation in the context of evolving stent technologies and appraise the potential imaging modalities in detection of inflammatory response and anti-inflammatory therapies.
Collapse
|
35
|
Sakamoto A, Sato Y, Kawakami R, Cornelissen A, Mori M, Kawai K, Fernandez R, Fuller D, Gadhoke N, Guo L, Romero ME, Kolodgie FD, Virmani R, Finn AV. Risk prediction of in-stent restenosis among patients with coronary drug-eluting stents: current clinical approaches and challenges. Expert Rev Cardiovasc Ther 2021; 19:801-816. [PMID: 33470872 DOI: 10.1080/14779072.2021.1856657] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Introduction: In-stent restenosis (ISR) has been one of the biggest limitations to the success of percutaneous coronary intervention for the treatment of coronary artery disease (CAD). The introduction of drug-eluting stent (DES) was a revolution in the treatment of CAD because these devices drastically reduced ISR to very low levels (<5%). Subsequently, newer generation DES treatments have overcome the drawbacks of first-generation DES, i.e. delayed endothelialization, and late stent thrombosis. However, the issue of late ISR, including neoatherosclerosis after DES implantation especially in high-risk patients and complex lesions, still exists as a challenge to be overcome.Areas covered: We discuss the mechanisms of ISR development including neoatherosclerosis, past and current clinical status of ISR, and methods to predict and overcome this issue from pathological and clinical points of view.Expert opinion: The initial drawbacks of first-generation DES, such as delayed endothelial healing and subsequent risk of late stent thrombosis, have been improved upon by the current generation DES. To achieve better long-term clinical outcomes, further titration of drug-release and polymer degradation profile, strut thickness as well as material innovation are needed.
Collapse
Affiliation(s)
| | - Yu Sato
- CVPath Institute, Gaithersburg, MD, United States
| | | | | | | | - Kenji Kawai
- CVPath Institute, Gaithersburg, MD, United States
| | | | | | - Neel Gadhoke
- CVPath Institute, Gaithersburg, MD, United States
| | - Liang Guo
- CVPath Institute, Gaithersburg, MD, United States
| | | | | | - Renu Virmani
- CVPath Institute, Gaithersburg, MD, United States
| | - Aloke V Finn
- CVPath Institute, Gaithersburg, MD, United States.,School of Medicine, University of Maryland, Baltimore, MD, United States
| |
Collapse
|
36
|
Vascular Wall Reactions to Coronary Stents-Clinical Implications for Stent Failure. Life (Basel) 2021; 11:life11010063. [PMID: 33477361 PMCID: PMC7829777 DOI: 10.3390/life11010063] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2020] [Revised: 01/14/2021] [Accepted: 01/15/2021] [Indexed: 12/21/2022] Open
Abstract
Coronary stents belong to the most commonly implanted devices worldwide. A number of different types of stent exist, with very different mechanical and biochemical characteristics that influence their interactions with vascular tissues. Inappropriate inflammatory reactions are the major cause of the two major complications that follow implantation of stents in a percentage as high as 5-20%. It is therefore important to understand these reactions and how different they are among different generations of stents.
Collapse
|
37
|
Nezami FR, Athanasiou LS, Edelman ER. Endovascular drug-delivery and drug-elution systems. BIOMECHANICS OF CORONARY ATHEROSCLEROTIC PLAQUE 2021:595-631. [DOI: 10.1016/b978-0-12-817195-0.00028-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
|
38
|
Coronary Stents and Metal Allergy. Contact Dermatitis 2021. [DOI: 10.1007/978-3-030-36335-2_81] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
|
39
|
Aoki J, Tanabe K. Mechanisms of drug-eluting stent restenosis. Cardiovasc Interv Ther 2020; 36:23-29. [PMID: 33222019 DOI: 10.1007/s12928-020-00734-7] [Citation(s) in RCA: 59] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2020] [Accepted: 11/06/2020] [Indexed: 01/03/2023]
Abstract
Drug-eluting stents (DES) were developed to overcome in-stent restenosis (ISR), which has long been considered the main complication limiting the long-term efficacy of coronary stenting. New-generation DES which composed of advanced stent design with and without specific biocompatible polymer contributes a reduction of the incidence of ISR to rate ranging from 5 to 10%. The precise reasons of DES restenosis are still controversial and not fully understood. Angiographic and coronary images at the index procedure, systemic status of patients, medications, and intracoronary imaging at ISR site are all considered to find the possible mechanisms of DES restenosis. Multiple biological, genetic, mechanical, and technical factors might intricately contribute to DES restenosis. Biological and genetic factors of ISR are not able to be sufficiently modified by the current medical approaches. Tailored treatments avoiding mechanical and technical factors of ISR are required to reduce DES restenosis. Elucidation of DES restenosis leads to further improvement in the current DES system and finds the optimal approach to treat DES restenosis. The possible mechanisms of DES restenosis are discussed in this review.
Collapse
Affiliation(s)
- Jiro Aoki
- Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan.
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan
| |
Collapse
|
40
|
Lansky A, Grubman D, Scheller B. Paclitaxel-coated balloons: a safe alternative to drug-eluting stents for coronary in-stent restenosis. Eur Heart J 2020; 41:3729-3731. [PMID: 31702784 DOI: 10.1093/eurheartj/ehz731] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2025] Open
Abstract
Abstract
Collapse
Affiliation(s)
- Alexandra Lansky
- Section of Cardiology, Yale University School of Medicine, New Haven, CT, USA
| | - Daniel Grubman
- Section of Cardiology, Yale University School of Medicine, New Haven, CT, USA
| | - Bruno Scheller
- Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany
| |
Collapse
|
41
|
Satish M, Gunasekar P, Asensio JA, Agrawal DK. Vitamin D attenuates HMGB1-mediated neointimal hyperplasia after percutaneous coronary intervention in swine. Mol Cell Biochem 2020; 474:219-228. [PMID: 32737774 DOI: 10.1007/s11010-020-03847-y] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2020] [Accepted: 07/20/2020] [Indexed: 12/15/2022]
Abstract
Intracoronary stenting is a common procedure in patients with coronary artery disease (CAD). Stent deployment stretches and denudes the endothelial layer, promoting a local inflammatory response, resulting in neointimal hyperplasia. Vitamin D deficiency associates with CAD. In this study, we examined the association of vitamin D status with high mobility group box 1 (HMGB1)-mediated pathways (HMGB1, receptor for advanced glycation end products [RAGE], and Toll-like receptor-2 and -4 [TLR2 and TLR4]) in neointimal hyperplasia in atherosclerotic swine following bare metal stenting. Yucatan microswine fed with a high-cholesterol diet were stratified to receive vitamin D-deficient (VD-DEF), vitamin D-sufficient (VD-SUF), and vitamin D-supplemented (VD-SUP) diet. After 6 months, PTCA (percutaneous transluminal balloon angioplasty) followed by bare metal stent implantation was performed in the left anterior descending (LAD) artery of each swine. Four months following coronary intervention, angiogram and optical coherence tomography (OCT) were performed and swine euthanized. Histology and immunohistochemistry were performed in excised LAD to evaluate the expression of HMGB1, RAGE, TLR2, and TLR4. OCT analysis revealed the greatest in-stent restenosis area in the LAD of VD-DEF compared to VD-SUF or VD-SUP swine. The protein expression of HMGB1, RAGE, TLR2, and TLR4 was significantly higher in the LAD of VD-DEF compared to VD-SUF or VD-SUP swine. Vitamin D deficiency was associated with both increased in-stent restenosis and increased HMGB1-mediated inflammation noted in coronary arteries following intravascular stenting. Inversely, vitamin D supplementation was associated with both a decrease in this inflammatory profile and in neointimal hyperplasia, warranting further investigation for vitamin D as a potential adjunct therapy following coronary intervention.
Collapse
Affiliation(s)
- Mohan Satish
- Department of Clinical & Translational Science, Creighton University School of Medicine, 2500 California Plaza, Omaha, NE, 68178, USA
| | - Palanikumar Gunasekar
- Department of Clinical & Translational Science, Creighton University School of Medicine, 2500 California Plaza, Omaha, NE, 68178, USA
| | - Juan A Asensio
- Department of Clinical & Translational Science, Creighton University School of Medicine, 2500 California Plaza, Omaha, NE, 68178, USA
| | - Devendra K Agrawal
- Department of Translational Research, Western University of Health Sciences, 309 E. Second Street, Pomona, CA, 91766, USA.
| |
Collapse
|
42
|
Ford MK, Cohn JR. Clopidogrel Hypersensitivity: Pathogenesis, Presentation and Diagnosis. Curr Vasc Pharmacol 2020; 17:110-112. [PMID: 30381080 DOI: 10.2174/1570161116666181031143628] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2018] [Revised: 10/10/2018] [Accepted: 10/15/2018] [Indexed: 11/22/2022]
Abstract
This paper provides an overview of the pathogenesis, presentation and diagnosis of clopidogrel hypersensitivity. The majority of clopidogrel hypersensitivity cases are due to a T cell mediated Gell and Coombs Type IV reaction. History, histology, and patch testing have shown consistency with a T cell mediated mechanism. Clopidogrel reactions most commonly present as a mild delayed maculopapular erythematous rash 5 to 10 days after introduction of the drug, and do not always require discontinuation of the drug. Severe cutaneous, systemic, and immediate adverse reactions to clopidogrel are rare. For the diagnosis of clopidogrel hypersensitivity, drug causality can be determined using patch testing, or for mild reactions, recurrence of symptoms after drug reintroduction, although neither are required for diagnosis.
Collapse
Affiliation(s)
- Megan K Ford
- Jane and Leonard Korman Respiratory Institute, Division of Pulmonary, Allergy & Critical Care Medicine, Allergy & Immunology Section, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 19107, United States
| | - John R Cohn
- Jane and Leonard Korman Respiratory Institute, Division of Pulmonary, Allergy & Critical Care Medicine, Allergy & Immunology Section, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 19107, United States
| |
Collapse
|
43
|
Kikura M, Suzuki Y, Nishino J, Uraoka M. Allergic Acute Coronary Artery Stent Thrombosis After the Administration of Sugammadex in a Patient Undergoing General Anesthesia: A Case Report. A A Pract 2020; 13:133-136. [PMID: 30985320 DOI: 10.1213/xaa.0000000000001015] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
In addition to cutaneous, gastrointestinal, hemodynamic, and respiratory symptoms, allergic reactions can induce an acute coronary syndrome in normal or atheromatous coronary arteries and can cause coronary stent thrombosis. Here, we report a case of coronary stent thrombosis due to allergic acute coronary syndrome during anaphylaxis induced by sugammadex in a female patient undergoing general anesthesia. She was emergently treated with percutaneous transluminal coronary balloon angioplasty with catecholamine, vasodilator, and intraaortic balloon support. Knowledge of perioperative allergy-triggered acute coronary syndrome is crucial for prompt and appropriate treatment.
Collapse
Affiliation(s)
- Mutsuhito Kikura
- From the Department of Anesthesiology, Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety, Hamamatsu, Japan
| | - Yuji Suzuki
- Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine, Hamamatsu, Japan
| | - Junko Nishino
- From the Department of Anesthesiology, Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety, Hamamatsu, Japan
| | - Masahiro Uraoka
- From the Department of Anesthesiology, Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety, Hamamatsu, Japan
| |
Collapse
|
44
|
Anderson JM, Schoen FJ, Ziats NP. In Vivo Assessment of Tissue Compatibility. Biomater Sci 2020. [DOI: 10.1016/b978-0-12-816137-1.00058-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
|
45
|
Coronary Stents and Metal Allergy. Contact Dermatitis 2020. [DOI: 10.1007/978-3-319-72451-5_81-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
|
46
|
Akhlaghi S, Rabbani S, Alavi S, Alinaghi A, Radfar F, Dadashzadeh S, Haeri A. Green formulation of curcumin loaded lipid-based nanoparticles as a novel carrier for inhibition of post-angioplasty restenosis. MATERIALS SCIENCE & ENGINEERING. C, MATERIALS FOR BIOLOGICAL APPLICATIONS 2019; 105:110037. [DOI: 10.1016/j.msec.2019.110037] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2019] [Revised: 07/08/2019] [Accepted: 07/30/2019] [Indexed: 01/01/2023]
|
47
|
Layer-by-layer biofabrication of coronary covered stents with clickable elastin-like recombinamers. Eur Polym J 2019. [DOI: 10.1016/j.eurpolymj.2019.109334] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
|
48
|
Abstract
Inflammation is an important player both for the initiation and progression of coronary artery disease and for coronary plaque instability. Moreover, inflammation contributes to stent thrombosis and in-stent restenosis after percutaneous coronary intervention. In the past several decades, most studies evaluated the involvement of cellular effectors of classic inflammatory responses, such as monocytes/macrophages, neutrophils, and T cells. Yet, besides classic inflammation, mounting evidence derived from both experimental and clinical studies suggests an important, often unrecognized, role for effector cells of allergic inflammation in both the pathogenesis of coronary artery disease and adverse events following stent implantation. In this review, we discuss the role of effector cells of allergic inflammation in the setting of coronary artery disease progression and instability, and in the occurrence of adverse events following stent implantation, as well. Moreover, we discuss possible therapeutic approaches targeting different specific pathways of allergic inflammatory activation.
Collapse
Affiliation(s)
- Giampaolo Niccoli
- Giampaolo Niccoli and Filippo Crea: Dipartimento di Scienze Cardiovascolari eToraciche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia (G.N., F.C.).,Università Cattolica del Sacro Cuore, Roma, Italia (G.N., F.C.)
| | - Rocco A Montone
- Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy (R.A.M.)
| | - Vito Sabato
- Immunology-Allergology-Rheumatology, University of Antwerp and Antwerp University Hospital, Belgium (V.S.)
| | - Filippo Crea
- Giampaolo Niccoli and Filippo Crea: Dipartimento di Scienze Cardiovascolari eToraciche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia (G.N., F.C.).,Università Cattolica del Sacro Cuore, Roma, Italia (G.N., F.C.)
| |
Collapse
|
49
|
Jambunathan R, Basavanna D, Vani P, Neuss M, Janbandhu P. One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India. World J Cardiol 2019; 11:200-208. [PMID: 31523398 PMCID: PMC6715581 DOI: 10.4330/wjc.v11.i8.200] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/03/2019] [Revised: 06/18/2019] [Accepted: 07/17/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice.
AIM To investigate 1-year clinical outcomes of Neohexa DES in real practice.
METHODS Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure.
RESULTS A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively.
CONCLUSION The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.
Collapse
Affiliation(s)
| | - Dinesh Basavanna
- Cauvery Heart and Multispecialty Hospital, Mysore, Karnataka 570011, India
- Department of Cardiology Mysore Medical College and Research Institute, Mysore, Karnataka 570001, India
| | - Preeti Vani
- Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India
| | - Malte Neuss
- Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India
- Manemed Research and Development, Roeckumstr, Bonn 53123, Germany
| | - Prashant Janbandhu
- Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India
| |
Collapse
|
50
|
Lv L, Ye W, Song P, Chen Y, Yang J, Zhang C, Chen X, Luo F. Relationship between ALDH2 genotype and in-stent restenosis in Chinese Han patients after percutaneous coronary intervention. BMC Cardiovasc Disord 2019; 19:176. [PMID: 31345174 PMCID: PMC6659264 DOI: 10.1186/s12872-019-1161-9] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2018] [Accepted: 07/15/2019] [Indexed: 01/14/2023] Open
Abstract
BACKGROUND It is well known that the genotype of ALDH2 is associated with coronary artery disease (CAD), and in-stent restenosis (ISR) is a primary complication of percutaneous coronary intervention (PCI), a primary recommended treatment for CAD. The aim of this study was to identify the relationship between aldehyde dehydrogenase 2 (ALDH2) genotype and in-stent restenosis (ISR). METHODS This study recruited 531 patients who were undergoing PCI at two Chinese hospitals from 2015 to 2017 and 183 were diagnosed with ISR after PCI during the one-year follow-up period. We used polymerase chain restriction fragment length polymorphism (PCR-RFLP) and sequencing to determine ALDH2 polymorphisms. RESULTS Among all 531 patients (mean age = 59.4 ± 9.8; 65.9% male), 68.7% carried the wild-type genotype, 28.4% were heterozygous for the mutation, and 2.8% were homozygous for the mutation. Multiple logistical regression analyses indicated no correlation between ALDH2 genotype and the occurrence of restenosis after PCI (OR = 1.448, 95% CI: 0.965-2.168, p = 0.073), though a significant association was observed for patients with diabetes (OR = 4.053, 95% CI: 1.668-10.449, p = 0.003). CONCLUSION In this study, we found that carrying an ALDH2*2 allele had no notable relationship with ISR one year after PCI but that it did have a significant association with complications in diabetic patients. Further studies with larger sample sizes will be necessary to reveal a consensus.
Collapse
Affiliation(s)
- Lizhi Lv
- Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, Changsha, Hunan 410008 People’s Republic of China
| | - Weijie Ye
- Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, 410008 People’s Republic of China
| | - Peiyuan Song
- Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, 410008 People’s Republic of China
| | - Yubin Chen
- Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, Changsha, Hunan 410008 People’s Republic of China
| | - Jing Yang
- Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052 Henan People’s Republic of China
| | - Congmin Zhang
- Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052 Henan People’s Republic of China
| | - Xiaoping Chen
- Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, 410008 People’s Republic of China
| | - Fanyan Luo
- Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, Changsha, Hunan 410008 People’s Republic of China
| |
Collapse
|