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Yong BSJ, Ling RR, Li R, Poh JW, Tan CS, Ho SWL, Rochwerg B, Arya R, Ramanathan K, Fan BE. Pharmacotherapy for Venous Thromboprophylaxis following Total Hip or Knee Arthroplasty: A Systematic Review and Network Meta-analysis. Semin Thromb Hemost 2025; 51:290-300. [PMID: 38950598 DOI: 10.1055/s-0044-1787996] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/03/2024]
Abstract
The optimal pharmacological prophylaxis for venous thromboembolism (VTE) after hip or knee arthroplasty is uncertain. We conducted a systematic review and network meta-analysis to compare the efficacy and safety of various medications. We searched multiple databases for randomized clinical trials (RCTs) comparing medications (including factor Xa inhibitors, factor IIa inhibitor, warfarin, unfractionated heparin [UFH], low-molecular-weight heparin [LMWH], aspirin, pentasaccharide) for VTE prophylaxis post-arthroplasty. Outcomes included any postoperative VTE identified with screening, major bleeding, and death. We used LMWH as the main comparator for analysis and performed trial sequential analysis (TSA) for each pairwise comparison. Certainty of evidence was assessed using GRADE (Grading of Recommendations, Assessments, Developments and Evaluations). We analyzed 70 RCTs (55,841 participants). Factor Xa inhibitors decreased postoperative VTE significantly compared with LMWH (odds ratio [OR]: 0.55, 95% confidence interval [CI]: 0.44-0.68, high certainty). Pentasaccharides probably reduce VTE (OR: 0.61, 95% CI: 0.36-1.02, moderate certainty), while the factor IIa inhibitor dabigatran may reduce VTE (OR: 0.75, 95% CI: 0.40-1.42, low certainty). UFH probably increases VTE compared with LMWH (OR: 1.31, 95% CI: 0.91-1.89, moderate certainty), and other agents like warfarin, aspirin, placebo, and usual care without thromboprophylaxis increase VTE (high certainty). Factor Xa inhibitors may not significantly affect major bleeding compared with LMWH (OR: 1.06, 95% CI: 0.81-1.39, low certainty). No medications had a notable effect on mortality compared with LMWH (very low certainty). TSA suggests sufficient evidence for the benefit of factor Xa inhibitors over LMWH for VTE prevention. Compared with LMWH and aspirin, factor Xa inhibitors are associated with reduced VTE after hip or knee arthroplasty, without an increase in bleeding and likely no impact on mortality.
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Affiliation(s)
- Bryan Song Jun Yong
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Ryan Ruiyang Ling
- Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore
| | - Ruiqi Li
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Jane Wenjin Poh
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Chuen Seng Tan
- Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore
| | - Sean Wei Loong Ho
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore
- Department of Orthopaedic Surgery, Tan Tock Seng Hospital, Singapore, Singapore
| | - Bram Rochwerg
- Division of Critical Care, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Roopen Arya
- Department of Haematological Medicine, King's Thrombosis Centre, King's College Hospital Foundation NHS Trust, London, United Kingdom
| | - Kollengode Ramanathan
- Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore
- Cardiothoracic Intensive Care Unit, National University Heart Centre, National University Hospital, Singapore, Singapore
| | - Bingwen Eugene Fan
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore
- Department of Haematology, Tan Tock Seng Hospital, Singapore, Singapore
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Tomić N, Anđić V, Ćurlik D, Čeko J, Tanović Avdić A, Mehić M, Šukalo A, Glamočlija U. Therapy adherence, safety and efficacy of rivaroxaban in prevention of venous thromboembolism in patients with hip or knee endoprosthesis. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY : ORTHOPEDIE TRAUMATOLOGIE 2024; 34:1435-1440. [PMID: 38233567 DOI: 10.1007/s00590-023-03786-6] [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: 07/28/2023] [Accepted: 11/15/2023] [Indexed: 01/19/2024]
Abstract
PURPOSE Rivaroxaban is a potent, selective direct inhibitor of factor Xa. The aim of this study was to evaluate the therapy adherence, safety and efficacy of rivaroxaban therapy in reducing the risk of venous thromboembolism in patients undergoing elective hip or knee replacement. METHODS The prospective, post-marketing clinical trial was conducted on adult patients after knee or hip endoprosthesis. Data were collected at the baseline and three control visits (five days, a month and three months after the baseline). Morisky Medication Adherence Scale (MMAS-8) was used for evaluation of therapy adherence. RESULTS The study included 60 patients who received rivaroxaban therapy in a dose of 10 mg once a day. A low adherence to the drug was observed in 15% patients. All patients had an average MMAS-8 score in the range of high adherence 0.65 ± 0.90. Symptomatic venous thromboembolism was observed in two patients with numerous risk factors. No major bleeding was recorded during entire follow-up period. During the five-day postoperative in-hospital follow-up, signs of wound complications were recorded in 8 (13.3%) patients, and 4 (6.7%) of them underwent surgical revision of the wound. CONCLUSION Generally, there was high adherence to rivaroxaban therapy, but low adherence was present in 15% of patients. Rivaroxaban showed good safety and efficacy. However, high proportion of wound complications and patients needing surgical revision of the wound should be further evaluated through larger studies.
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Affiliation(s)
- Nemanja Tomić
- University Clinical Center of the Republic of Srpska, Dvanaest beba bb, 78 000, Banja Luka, Bosnia and Herzegovina
| | - Vladimir Anđić
- University Clinical Center of the Republic of Srpska, Dvanaest beba bb, 78 000, Banja Luka, Bosnia and Herzegovina
| | - Dejan Ćurlik
- University Clinical Center of the Republic of Srpska, Dvanaest beba bb, 78 000, Banja Luka, Bosnia and Herzegovina
| | - Jovica Čeko
- University Clinical Center of the Republic of Srpska, Dvanaest beba bb, 78 000, Banja Luka, Bosnia and Herzegovina
| | | | - Meliha Mehić
- Bosnalijek d.d., Jukićeva 53, 71 000, Sarajevo, Bosnia and Herzegovina
| | - Aziz Šukalo
- Bosnalijek d.d., Jukićeva 53, 71 000, Sarajevo, Bosnia and Herzegovina
| | - Una Glamočlija
- Bosnalijek d.d., Jukićeva 53, 71 000, Sarajevo, Bosnia and Herzegovina.
- Department of Pharmaceutical Biochemistry and Laboratory Diagnostics, University of Sarajevo, Faculty of Pharmacy, Zmaja of Bosne 8, 71 000, Sarajevo, Bosnia and Herzegovina.
- School of Medicine, University of Mostar, Bijeli brijeg b.b., 88 000, Mostar, Bosnia and Herzegovina.
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Chu C, Mu W, Wahafu T, Zou C, Xu B, Cao L. Efficacy and safety of postoperative single-dose anticoagulant treatment in preventing venous thromboembolism after revision hip arthroplasty: a retrospective cohort study. INTERNATIONAL ORTHOPAEDICS 2023; 47:2709-2716. [PMID: 37491609 DOI: 10.1007/s00264-023-05893-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/29/2023] [Accepted: 07/04/2023] [Indexed: 07/27/2023]
Abstract
PURPOSE The purpose of the study is to determine the efficacy and safety of postoperative single-dose anticoagulant treatment in preventing venous thromboembolism (VTE) after revision THA, in comparison with a multiple-dose chemoprophylaxis protocol. METHODS We retrospectively compared 295 patients undergoing revision THA who received multiple-dose chemoprophylaxis protocol (40 mg low-molecular-weight heparin once and oral rivaroxaban for 10 days) or single-dose chemoprophylaxis protocol (40 mg low-molecular-weight heparin once) for VTE. The patients in both groups performed active lower limb exercises. Each group was further stratified into subgroups based on the aetiology of revision. The incidence of VTE, wound complications within three months, hidden blood loss (HBL), transfusion rate, and surgical drainage duration were recorded. RESULTS The incidence rates of VTE (P = 0.870) did not differ between the two prophylaxis protocols. However, significant differences were observed in wound complications within three months (P = 0.002), HBL (P = 0.015), transfusion rate (P = 0.028). Surgical drainage duration was also shorter in the single-dose chemoprophylaxis group (P = 0.0023). In the subgroup analysis, the use of single-dose chemoprophylaxis protocol cannot significantly reduce HBL and transfusion rate after septic revision THA. The use of multiple-dose chemoprophylaxis protocol (OR = 2.89, P = 0.002) and high BMI (OR = 1.09, P = 0.037) were independent risk factors of wound complications. CONCLUSIONS Single-dose chemoprophylaxis protocol effectively and safely prevented VTE after revision THA compared with multiple-dose chemoprophylaxis protocol. The effect in reducing HBL and postoperative transfusion rate was limited in septic revision.
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Affiliation(s)
- Chenghan Chu
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
| | - Wenbo Mu
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
- College of Pharmacy, Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
| | - Tuerhongjiang Wahafu
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
| | - Chen Zou
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
| | - Boyong Xu
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China
| | - Li Cao
- Department of Orthopaedics, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, Xinjiang, China.
- Ministry of Education, Key Laboratory of High Incidence Disease Research in Xinjiang(Xinjiang Medical University, Urumqi, 830054, Xinjiang, China.
- Xinjiang Clinical Research Center for Orthopedics, Urumqi, 830054, Xinjiang, China.
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Za P, Papalia GF, Franceschetti E, Rizzello G, Adravanti P, Papalia R. Aspirin is a safe and effective thromboembolic prophylaxis after total knee arthroplasty: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc 2023; 31:4407-4421. [PMID: 37449989 DOI: 10.1007/s00167-023-07500-1] [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: 12/24/2022] [Accepted: 07/03/2023] [Indexed: 07/18/2023]
Abstract
PURPOSE Patients undergoing total knee arthroplasty (TKA) are at high risk for thromboembolic events compared to non-surgical patients. Both anticoagulants and antiplatelet agents are used as antithrombotic prophylaxis in TKA. The aim of this review is to understand the role of aspirin in the prevention of thromboembolic events and to compare its efficacy and safety with the main anticoagulants used in antithromboembolic prophylaxis in TKA. METHODS A systematic review and meta-analysis was performed according to the PRISMA guidelines. An electronic systematic search was conducted using PubMed, Scopus, and the Cochrane Central Registry to evaluate studies that compared aspirin with other anticoagulants, in terms of deep venous thrombosis and pulmonary embolism after TKA. The meta-analysis compared the rate of complications between aspirin and other anticoagulants. RESULTS Thirteen studies were included in the systematic review for a total of 163,983 patients, and 10 studies were included in the meta-analysis. The meta-analysis demonstrated no statistically significant differences between aspirin and other anticoagulants in terms of the rate of deep venous thrombosis (OR 0.93, 95% CI 0.81-1.08, p = 0.35) and pulmonary embolism (OR 0.89, 95% CI 0.56-1.41, p = 0.61). CONCLUSION Aspirin is safe, effective, and not inferior to other main anticoagulants in preventing thromboembolic events following TKA.
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Affiliation(s)
- Pierangelo Za
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Giuseppe Francesco Papalia
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy.
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
| | - Edoardo Franceschetti
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Giacomo Rizzello
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Paolo Adravanti
- Department of Orthopaedic and Trauma Surgery, Casa di Cura Città of Parma, 43123, Parma, Italy
| | - Rocco Papalia
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
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Tsai SW, Chang WL, Pai FY, Chou TFA, Chen CF, Wu PK, Chen WM. Combination of enoxaparin and low-dose aspirin for thromboprophylaxis in selective patients after primary total joint arthroplasty in a Taiwanese population. J Chin Med Assoc 2023; 86:923-929. [PMID: 37563769 DOI: 10.1097/jcma.0000000000000978] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/12/2023] Open
Abstract
BACKGROUND The incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty (TJA) procedures are lower in Asian populations than in Caucasian populations. Therefore, the need for thromboprophylaxis in Asian patients undergoing TJA remains inconclusive. The aim of this study was to validate the clinical outcomes of thromboprophylaxis in selective TJA patients in a Taiwanese population. METHODS We retrospectively reviewed records of patients who underwent TJA procedures performed by a single-surgeon between January 2010 through December 2019. Patients received thromboprophylaxis with a combination of enoxaparin and low-dose aspirin if they fulfilled any of the following criteria: 1) body mass index >30 (kg/m 2 ), 2) presence of varicose veins, 3) history of DVT or PE, or 4) simultaneous bilateral TJA procedure. We assessed the incidence of DVT and PE, 90-day postoperative complications, length of stay, in-hospital mortality, 30-day and 90-day readmission, and 1-year reoperation. RESULTS Of the 7511 patients included in this study, 2295 (30.6%) patients received thromboprophylaxis. For patients who received thromboprophylaxis(N = 2295), the incidence of DVT and PE were 0.44% and 0%, respectively. For patients who did not receive thromboprophylaxis (N = 5216), the incidence of DVT and PE was 0.46% and 0.04%, respectively. The overall rates of 90-day postoperative complications (2.3%), 30-day (1.8%) and 90-day readmission (2.3%), and 1-year reoperation (1.1%) were low. CONCLUSION Providing thromboprophylaxis for selective TJA patients within the Taiwanese population was effective, as indicated by the low incidence of DVT and PE. Complications, such as surgical site infection, should be carefully weighed and managed.
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Affiliation(s)
- Shang-Wen Tsai
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Wei-Lin Chang
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Fu-Yuan Pai
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Te-Feng Arthur Chou
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Cheng-Fong Chen
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Po-Kuei Wu
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Wei-Ming Chen
- Department of Orthopaedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC
- Department of Orthopaedics, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
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Hsiao PM, Liao SC, Chen IJ, Chou YC, Hsu YH, Wang SM, Yu YH. Incidence of deep vein thrombosis and symptomatic pulmonary embolism in Taiwanese patients with pelvic and/or acetabular fractures: a retrospective study. Sci Rep 2023; 13:16352. [PMID: 37770539 PMCID: PMC10539495 DOI: 10.1038/s41598-023-43449-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2023] [Accepted: 09/24/2023] [Indexed: 09/30/2023] Open
Abstract
Venous thromboembolism (VTE) is common in patients with trauma, and thromboprophylaxis has been advocated. However, conflicting results regarding VTE rates in the Asian population following orthopaedic procedures have been presented. We aimed to investigate the VTE incidence in Taiwanese patients with pelvic and/or acetabular fractures and identify the associated risk factors. We included 402 patients who underwent surgery for pelvic and/or acetabular fractures. All patients received mechanical thromboprophylaxis with graduated compression stockings. Duplex scanning was performed postoperatively or during follow-up when signs or symptoms of deep vein thrombosis (DVT) developed. Variables with a significance level of ≤ 0.1 in the univariate analyses were introduced into the multivariate logistic regression analysis to identify DVT risk factors. The overall DVT and symptomatic pulmonary embolism (PE) rate was 3.48% (14/402 patients). Among patients with DVT, 46.1% were asymptomatic. Patients with VTE were significantly older than those without. Multivariate logistic regression analysis revealed that age was a VTE risk factor. The incidence of DVT and symptomatic PE in our cohort was low. Advanced age was a risk factor for VTE. These findings could help clinicians develop appropriate prevention and treatment strategies for VTE in Taiwanese patients with pelvic and/or acetabular fractures.
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Affiliation(s)
- Po-Meng Hsiao
- Department of Orthopaedics, New Taipei Municipal TuCheng Hospital, No. 6, Sec. 2, Jincheng Rd., Tucheng Dist., New Taipei City, 236, Taiwan
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - Shu-Chen Liao
- Department of Orthopaedics, New Taipei Municipal TuCheng Hospital, No. 6, Sec. 2, Jincheng Rd., Tucheng Dist., New Taipei City, 236, Taiwan
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - I-Jung Chen
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - Ying-Chao Chou
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - Yung-Heng Hsu
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - Shu-Mei Wang
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan
- Department of Pediatric Orthopedics, Chang Gung Memorial Hospital, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan
| | - Yi-Hsun Yu
- Chang Gung University, No. 259, Wenhua 1St Rd., Guishan Dist., Taoyuan City, 33302, Taiwan.
- Department of Orthopedic Surgery, Musculoskeletal Research Center, Chang Gung Memorial Hospital, Linkou Branch, No. 5, Fu-Hsin St. Kweishan, 33302, Taoyuan, Taiwan.
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The Role of Anti-Factor Xa Activity in the Management of Ecchymosis in Patients Receiving Rivaroxaban after Total Knee Arthroplasty. J Clin Med 2023; 12:jcm12031161. [PMID: 36769808 PMCID: PMC9917433 DOI: 10.3390/jcm12031161] [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: 12/23/2022] [Revised: 01/30/2023] [Accepted: 01/31/2023] [Indexed: 02/05/2023] Open
Abstract
This study aims to evaluate the efficacy of anti-factor Xa activity (aFXa) in predicting ecchymosis after total knee arthroplasty (TKA). One hundred and two unilateral primary TKA patients were recruited consecutively in this prospective observational study. Participants received rivaroxaban (10 mg p.o. qd) from postoperative day 1 (POD1) to POD35 and were divided into a non-ecchymosis group (group A) and an ecchymosis group (group B). AFXa was assessed as the primary outcome on POD1 and POD3. Prothrombin time (PT), activated partial thromboplastin time (APTT) and thromboelastography (TEG) were recorded both preoperatively and postoperatively (on POD1 and POD3). Other outcomes, including venous thromboembolism (VTE), blood loss and wound complications were also collected and compared. As a result, 27.5% of the participants (n = 28) were allocated into group B. Demographic data were comparable between the two groups. The aFXa levels in group B were significantly higher than those in group A on POD1 and POD3, and the aFXa level was assessed as an independent risk factor for ecchymosis. The cut-off value of aFXa was determined to be 121.38 ng/mL at maximal Youden index, associated with area under the receiver operating characteristics curve of 0.67. Group B experienced significantly more blood loss and wound complications than group A. No statistical difference was detected regarding PT, APTT and TEG parameters. AFXa is a promising parameter to predict ecchymosis after TKA. Patients with aFXa > 121.38 ng/mL should be considered as high-risk population for postoperative ecchymosis and may require intense monitoring or dosage modification of anticoagulants.
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Pellegrini VD, Eikelboom JW, Evarts CM, Franklin PD, Garvin KL, Goldhaber SZ, Iorio R, Lambourne CA, Magaziner J, Magder L. Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol. BMJ Open 2022; 12:e060000. [PMID: 35260464 PMCID: PMC8905949 DOI: 10.1136/bmjopen-2021-060000] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2021] [Accepted: 02/01/2022] [Indexed: 01/02/2023] Open
Abstract
INTRODUCTION More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%-0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications. METHODS AND ANALYSIS Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board. ETHICS AND DISSEMINATION The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants. TRIAL REGISTRATION NCT02810704.
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Affiliation(s)
| | | | - C McCollister Evarts
- Orthopaedics and Physical Medicine, Penn State College of Medicine, Hershey, Pennsylvania, USA
| | - Patricia D Franklin
- Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Kevin L Garvin
- Orthopaedics and Physical Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA
| | | | - Richard Iorio
- Orthopaedics, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Carol Ann Lambourne
- Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
| | - Jay Magaziner
- Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA
| | - Laurence Magder
- Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA
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Bai CW, Ruan RX, Pan S, Huang CR, Zhang XC, Pang Y, Zheng X, Guo KJ. Application of thromboelastography in comparing coagulation difference of rivaroxaban and enoxaparin for thromboprophylaxis after total hip arthroplasty. J Orthop Surg (Hong Kong) 2021; 29:23094990211042674. [PMID: 34550034 DOI: 10.1177/23094990211042674] [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: 11/15/2022] Open
Abstract
Purpose: The purpose of this study was to compare the coagulation difference in patients with either rivaroxaban or enoxaparin as thromboprophylaxis after total hip arthroplasty (THA) regarding thromboelastography (TEG) and routine coagulation tests. Patients and methods: Two hundred and twenty-eight patients undergoing primary THA were recruited in this study. They were divided into two groups according to a computer-generated random sequence. Patients in the rivaroxaban group received 10 mg of rivaroxaban orally once daily. Patients in the enoxaparin group received 4000 AxaIU (0.4 mL) of enoxaparin subcutaneously once daily. Rivaroxaban and enoxaparin were started 6-8 h after surgery. The administration of the anticoagulant prophylaxis was lasted for a minimum of 14 days. TEG and routine coagulation tests were performed on the day before the operation and 1 day and 7 days after the operation. Results: No difference was observed in the incidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) between the two groups. There was no significant difference with regard to prothrombin time (PT), activated partial thromboplastin time (PTT), international normalized ratio (INR), and thrombin time (TT) between the two groups. However, while considering TEG, R time of the rivaroxaban group was significantly higher than that of the enoxaparin group (p = 0.003), whereas the maximum amplitude (MA) (p = 0.036) value and coagulation index (CI) (p = 0.002) value were significantly lower than those of the enoxaparin group. Conclusion: With regard to TEG analysis, there was coagulation difference in patients with rivaroxaban and those with enoxaparin as thromboprophylaxis after THA. Under recommended dose of rivaroxaban and enoxaparin, patients undergoing THA were in hypercoagulability on 7days postoperative.
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Affiliation(s)
- Chao-Wen Bai
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.,Department of Orthopaedic Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China
| | - Ru-Xin Ruan
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
| | - Sheng Pan
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
| | - Chao-Ran Huang
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
| | - Xing-Chen Zhang
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
| | - Yong Pang
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
| | - Xin Zheng
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.,Department of Orthopaedic Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou China
| | - Kai-Jin Guo
- Department of Orthopaedic Surgery, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
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12
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Wang M, Xie J, Zheng H, Wang S, Zhou R, Li W, Xue E, Wang X, Jiang J, Wu T, Zhan S. Wound complications and bleeding with new oral anticoagulants in patients undergoing total joint arthroplasty: A systematic review and meta-analysis of randomized controlled trials. Br J Clin Pharmacol 2021; 88:500-513. [PMID: 34322914 DOI: 10.1111/bcp.15005] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2021] [Revised: 06/18/2021] [Accepted: 07/15/2021] [Indexed: 02/05/2023] Open
Abstract
AIMS The results of associations between new oral anticoagulants (NOACs) and wound complications after total joint arthroplasty remain inconsistent. We conducted a systematic review and meta-analysis of randomized controlled trials to make comparisons with low molecular weight heparins (LMWH) on the clinical outcomes of total wound complications, together with other efficacy and safety endpoints to further evaluate the safety and efficacy of NOACs. METHODS This meta-analysis was conducted based on a published protocol (PROSPERO: CRD42019140841). We searched for available articles in PubMed, Embase and Cochrane Library through Jun 62 021. Random-effects meta-analyses, including subgroup analyses, were conducted to estimate the pooled relative risk (RR) and 95% confidence interval (CI) for specific doses of NOACs. RESULTS We retrieved 1683 studies, of which 20 were eligible for inclusion. We found that apixaban was associated with a lower incidence of total wound complications compared with LMWH (RR = 0.81; 95% CI: 0.65-1.00), while dabigatran and rivaroxaban did not increase the risk of total wound complications. In addition, apixaban was associated with a reduction in the risk of major/clinically relevant nonmajor bleeding events compared to LMWH (RR = 0.80, 95% CI: 0.65-0.99), while rivaroxaban increased the risk for major/clinically relevant nonmajor bleeding events (RR = 1.23, 95% CI: 1.02-1.50). Moreover, all 4 NOACs were associated with lower incidences of major venous thromboembolism compared with LMWH. CONCLUSION A lower risk of wound complications was detected for apixaban, while dabigatran and rivaroxaban did not increase the risk when compared with LMWH. The efficacy of 4 NOACs was broadly similar.
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Affiliation(s)
- Mengying Wang
- School of Public Health, Peking University, Beijing, China
| | - Jinwei Xie
- Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China
| | - Hongchen Zheng
- School of Public Health, Peking University, Beijing, China
| | - Siyue Wang
- School of Public Health, Peking University, Beijing, China
| | - Ren Zhou
- School of Public Health, Peking University, Beijing, China
| | - Wenyong Li
- School of Public Health, Peking University, Beijing, China
| | - Enci Xue
- School of Public Health, Peking University, Beijing, China
| | - Xueheng Wang
- School of Public Health, Peking University, Beijing, China
| | - Jin Jiang
- School of Public Health, Peking University, Beijing, China
| | - Tao Wu
- School of Public Health, Peking University, Beijing, China.,Institute of Reproductive and Child Health/Key Laboratory of Reproductive Health, National Health Commission of the People's Republic of China, China
| | - Siyan Zhan
- School of Public Health, Peking University, Beijing, China
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13
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Heidemann J, Tanislav C, Kostev K. (Absence of) Association Between Non-Vitamin K Antagonist Oral Anticoagulant Therapy and Urinary Tract Infection in Patients With Atrial Fibrillation. J Cardiovasc Pharmacol 2021; 77:830-834. [PMID: 34016840 DOI: 10.1097/fjc.0000000000001020] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2021] [Accepted: 02/13/2021] [Indexed: 12/26/2022]
Abstract
ABSTRACT The aim of the present study is to identify a potential association of urinary tract infections (UTI) in a large population of patients receiving oral anticoagulation therapy treated in general practices in Germany. This study contains patients diagnosed with atrial fibrillation who received at least one prescription of either non-vitamin K antagonist oral anticoagulation (NOAC) or vitamin K antagonists (VKA) within January 2015 and December 2018. The incidence of UTI was examined cumulatively on the basis of Kaplan-Meier methods and was complemented by incidence rates measured in cases per 1000 patient years. Sex-stratified Cox regressions were conducted to examine possible associations in specific sex groups. The study comprised 26,934 patients receiving NOAC therapy and 8121 patients treated with VKA agents. Within a period of 5 years, slightly more NOAC than VKA users were diagnosed with UTI (20.3% vs. 19.3%), whereas the incidence rate was slightly higher in patients receiving NOAC therapy than in those under VKA treatment (50.8 cases vs. 50.5 cases in 1000 patient years). There was no significant association between direct oral anticoagulants versus vitamin K antagonists and infections of the urinary tract. Our study did not identify any significant association between therapy with direct oral anticoagulants versus vitamin K anticoagulants and UTI in patients diagnosed with atrial fibrillation in general practices in Germany. Because current findings regarding the risk of UTI in patients receiving oral anticoagulation therapy remain limited and contradictory, further investigations including a broad patient population are necessary to determine patients at risk for UTI and reconcile conflicting evidence.
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Affiliation(s)
| | - Christian Tanislav
- Department of Geriatrics and Neurology, Diakonie Hospital Jung Stilling Siegen, Germany
| | - Karel Kostev
- Epidemiology, IQVIA, Frankfurt am Main, Germany ; and
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14
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Comparable efficacy of 100 mg aspirin twice daily and rivaroxaban for venous thromboembolism prophylaxis following primary total hip arthroplasty: a randomized controlled trial. Chin Med J (Engl) 2021; 134:164-172. [PMID: 33410616 PMCID: PMC7817327 DOI: 10.1097/cm9.0000000000001305] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Abstract
Background: Aspirin has demonstrated safety and efficacy for venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA); however, inconsistent dose regimens have been reported in the literature. This study aimed to evaluate and compare the safety and efficacy of 100 mg aspirin twice daily with rivaroxaban in VTE prophylaxis following THA. Methods: Patients undergoing elective unilateral primary THA between January 2019 and January 2020 were prospectively enrolled in the study and randomly allocated to receive 5 weeks of VTE prophylaxis with either oral enteric-coated aspirin (100 mg twice daily) or rivaroxaban (10 mg once daily). Medication safety and efficacy were comprehensively evaluated through symptomatic VTE incidence, deep vein thrombosis (DVT) on Doppler ultrasonography, total blood loss (TBL), laboratory bloodwork, Harris hip score (HHS), post-operative recovery, and the incidence of other complications. Results: We included 70 patients in this study; 34 and 36 were allocated to receive aspirin and rivaroxaban prophylaxis, respectively. No cases of symptomatic VTE occurred in this study. The DVT rate on Doppler ultrasonography in the aspirin group was not significantly different from that in the rivaroxaban group (8.8% vs. 8.3%, χ2 = 0.01, P = 0.91), confirming the non-inferiority of aspirin for DVT prophylaxis (χ2 = 2.29, P = 0.01). The calculated TBL in the aspirin group (944.9 mL [658.5–1137.8 mL]) was similar to that in the rivaroxaban group (978.3 mL [747.4–1740.6mL]) (χ2 = 1.55, P = 0.12). However, there were no significant inter-group differences in HHS at post-operative day (POD) 30 (Aspirin: 81.0 [78.8–83.0], Rivaroxaban: 81.0 [79.3–83.0], χ2 = 0.43, P = 0.67) and POD 90 (Aspirin: 90.0 [89.0–92.0], Rivaroxaban: 91.5 [88.3–92.8], χ2 = 0.77, P = 0.44), the incidence of bleeding events (2.9% vs. 8.3%, χ2 = 0.96, P = 0.33), or gastrointestinal complications (2.9% vs. 5.6%, χ2 = 1.13, P = 0.29). Conclusion: In terms of safety and efficacy, the prophylactic use of 100 mg aspirin twice daily was not statistically different from that of rivaroxaban in preventing VTE and reducing the risk of blood loss following elective primary THA. This supports the use of aspirin chemoprophylaxis following THA as a less expensive and more widely available option for future THAs. Trial Registration: Chictr.org, ChiCTR18000202894; http://www.chictr.org.cn/showproj.aspx?proj=33284
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15
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Xu J, Kanagaratnam A, Cao JY, Chaggar GS, Bruce W. A comparison of aspirin against rivaroxaban for venous thromboembolism prophylaxis after hip or knee arthroplasty: A meta-analysis. J Orthop Surg (Hong Kong) 2020; 28:2309499019896024. [PMID: 31908175 DOI: 10.1177/2309499019896024] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Abstract
PURPOSE Total knee arthroplasty (TKA) and total hip arthroplasty (THA) patients are at an elevated risk of post-operative venous thromboembolism (VTE). Newer thromboprophylactic agents such as rivaroxaban are increasingly used and effective in preventing thromboembolic events but may worsen bleeding risk. Recent studies have suggested that the more cost-effective aspirin may also be effective in preventing VTE. This systematic review and meta-analysis aimed to compare the efficacy of aspirin against rivaroxaban for the prevention of VTE following TKA and THA. METHODS Electronic searches were performed using five databases from their date of inception to August 2018. Relevant studies were identified, with data extracted and meta-analyzed from the studies. RESULTS Five studies were included, which consisted of 2257 in the aspirin group and 2337 in the rivaroxaban group. There were no differences between aspirin and rivaroxaban for either VTE (p = 0.48) or its components deep vein thrombosis (p = 0.44) and pulmonary embolism (p = 0.98). Also, there were no differences between groups for either major bleeding (p = 0.17), any bleeding (p = 0.62), readmissions (p = 0.37) or wound complications (p = 0.17). CONCLUSION Aspirin was not significantly different to rivaroxaban for prevention of VTE or adverse events after TKA or THA. However, this study was limited by the significant heterogeneity of the included studies. More large randomized studies are needed to add to this body of evidence.
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Affiliation(s)
- Joshua Xu
- Sydney Medical School, University of Sydney, Camperdown, NSW, Australia
| | - Aran Kanagaratnam
- Sydney Medical School, University of Sydney, Camperdown, NSW, Australia
| | - Jacob Y Cao
- Sydney Medical School, University of Sydney, Camperdown, NSW, Australia.,Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
| | | | - Warwick Bruce
- Sydney Medical School, University of Sydney, Camperdown, NSW, Australia.,Sydney Olympic Park Hip and Knee Clinic, Sydney Olympic Park, NSW, Australia.,Department of Orthopaedics, Concord Repatriation General Hospital, Concord, NSW, Australia
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16
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Le G, Yang C, Zhang M, Xi L, Luo H, Tang J, Zhao J. Efficacy and safety of aspirin and rivaroxaban for venous thromboembolism prophylaxis after total hip or knee arthroplasty: A protocol for meta-analysis. Medicine (Baltimore) 2020; 99:e23055. [PMID: 33285683 PMCID: PMC7717737 DOI: 10.1097/md.0000000000023055] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2020] [Revised: 09/04/2020] [Accepted: 10/06/2020] [Indexed: 12/28/2022] Open
Abstract
BACKGROUND The purpose of this meta-analysis is to compare the efficacy and safety of aspirin and rivaroxaban in the prevention of venous thromboembolism (VTE) following either total knee arthroplasty or total hip arthroplasty. METHODS A comprehensive literature search of several electronic databases (PubMed, Embase, and Web of Science) was conducted to identify relevant studies. Outcomes of interest included VTE rate, deep vein thrombosis (DVT) rate, pulmonary embolism rate, major bleeding events, mortality rate, blood transfusion, and wound complication. Risk ratio (RR) with 95% confidence intervals (95%CIs) were calculated using a fixed-effects model or random-effects model. RESULTS A total of 8 studies with 97,677 patients met the inclusion criteria and were included in this meta-analysis. Compared with rivaroxaban, aspirin had a significantly higher incidence of DVT (RR = 1.48, 95%CI: 1.27, 1.72; P < .001), and decreased risk of blood transfusion (RR = 0.94, 95%CI: 0.93, 0.94; P < .001). However, there were no significant differences between the 2 drugs in terms of total VTE rate (RR = 1.39%, 95%CI: 0.94, 2.05; P = .101), pulmonary embolism rate (RR = 1.64, 95%CI: 0.92, 2.92; P = .094), mortality rate (RR = 1.13, 95%CI: 0.15, 8.27; P = .907), major bleeding (RR = 1.00, 95%CI: 0.44, 2.27; P = .995), and wound complication rate (RR = 0.37, 95%CI: 0.07, 1.87; P = .229). CONCLUSION Our results suggested that aspirin and rivaroxaban offered similar effect in the prevention of VTE after total knee arthroplasty or total hip arthroplasty. However, rivaroxaban seemed to have better effect than aspirin in reducing the risk of DVT, and aspirin was safer than rivaroxaban in decreasing the blood transfusion rate.
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Affiliation(s)
- Guoping Le
- Division of Traumatic Surgery, First Affiliated Hospital of Guangxi Medical University, Nanning
| | - Chengzhi Yang
- Department of Orthopedics, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China
| | - Ming Zhang
- Department of Orthopedics, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China
| | - Licheng Xi
- Department of Orthopedics, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China
| | - Hanwen Luo
- Department of Orthopedics, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China
| | - Jingli Tang
- Department of Orthopedics, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi, China
| | - Jinmin Zhao
- Division of Traumatic Surgery, First Affiliated Hospital of Guangxi Medical University, Nanning
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17
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Hood B, Springer B, Odum S, Curtin BM. No difference in patient compliance between full-strength versus low-dose aspirin for VTE prophylaxis following total hip and total knee replacement. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY 2020; 31:779-783. [PMID: 33211234 DOI: 10.1007/s00590-020-02833-w] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/22/2020] [Accepted: 11/10/2020] [Indexed: 11/24/2022]
Abstract
INTRODUCTION The utilization of aspirin for VTE prophylaxis following TJA has increased due to updated clinical practice guidelines. Aspirin is the only approved VTE prophylaxis medication that does not require a prescription, but adherence and tolerance remain unknown. We hypothesized decreased patient compliance utilizing full-strength 325 mg aspirin twice daily following TJA when compared to low-dose 81 mg twice daily. We also investigated the reasons why patients may elect to stop the medication earlier than 28 days. METHODS A consecutive series of patients undergoing primary total hip or knee arthroplasty utilizing 325 or 81 mg of EC aspirin twice daily for 4 weeks were surveyed to determine compliance with use and any adverse events related to the medication. Fisher's exact test was used to determine statistical significance. RESULTS 404 patients were enrolled with 199 patients prescribed the 325 mg regimen. Fifty-two patients who were prescribed 325 mg missed a dose versus 51 patients who were prescribed 81 mg (p = 0.082). No significant difference in the frequency of missed doses (missing < 5 doses, 5-10 doses, > 10 doses) between the treatment regimens (p = 0.78, 0.39 and 0.83, respectively). Most commonly cited reason for stopping aspirin in both treatment groups was gastrointestinal issues (10.5% and 7%, respectively). DISCUSSION AND CONCLUSIONS By surveying patients on their use of aspirin we find no difference in adherence between full-strength and low-dose treatment regimens. Additionally, we have a better understanding of the reasons for noncompliance as GI upset was a relatively common complaint with both doses.
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Affiliation(s)
- Brandon Hood
- OrthoCarolina Hip and Knee Center, 2001 Vail Avenue, Ste 200A, Charlotte, NC, 28207, USA
| | - Bryan Springer
- OrthoCarolina Hip and Knee Center, 2001 Vail Avenue, Ste 200A, Charlotte, NC, 28207, USA
| | - Susan Odum
- Odum OrthoCarolina Research Institute, 2001 Vail Avenue, Charlotte, NC, 28207, USA
| | - Brian M Curtin
- OrthoCarolina Hip and Knee Center, 2001 Vail Avenue, Ste 200A, Charlotte, NC, 28207, USA.
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18
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Highcock AJ, As-Sultany M, Finley R, Donnachie NJ. A Prospective Cohort Comparative Study of Rivaroxaban, Dabigatran, and Apixaban Oral Thromboprophylaxis in 2431 Hip and Knee Arthroplasty Patients: Primary Efficacy Outcomes and Safety Profile. J Arthroplasty 2020; 35:3093-3098. [PMID: 32674939 DOI: 10.1016/j.arth.2020.06.032] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2020] [Revised: 05/30/2020] [Accepted: 06/14/2020] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Direct oral anticoagulants (DOACs) have promised superior efficacy to low molecular weight heparins in the prevention of venous thromboembolism (VTE) in total hip and knee arthroplasty. However, there are concerns about raised associated bleeding and wound problems with these agents. This study aims to evaluate and compare the efficacy and safety of the 3 DOAC drugs: rivaroxaban, dabigatran and apixaban. METHODS The primary outcome measures were rate of symptomatic VTE and major bleeding. Secondary outcome measures were wound healing problems and requirement for return to theater. A total of 2431 patients received one of the DOAC drugs as thromboprophylaxis following total hip arthroplasty (35 days) or total knee arthroplasty (14 days) between 2011 and 2015. Binary variables were compared between the 3 groups by using the chi-squared test or Fisher's exact test. Relative risks of selected primary and secondary end points were also calculated for the prespecified pairwise comparison. RESULTS The overall symptomatic VTE rate was 2%. Rivaroxaban had a statistically significant superior efficacy for overall VTE prevention (0.8% vs 2.6%) compared with dabigatran (P < .01) and apixaban (P < .01), and deep vein thrombosis prevention (0.3% vs 2.2%) over dabigatran (P < .01). The overall rate of major bleeding was 1.2% with no significant difference observed between the 3 studied drugs. CONCLUSION All 3 drugs had symptomatic VTE rates comparable with low molecular weight heparin from the published literature. Rivaroxaban appears to have superior efficacy in VTE prevention over apixaban and dabigatran. No statistical difference was observed for major bleeding with any of the 3 agents.
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Affiliation(s)
- Alan J Highcock
- Wirral University Teaching Hospital NHS Foundation Trust, Trauma & Orthopedic Department, Wirral, United Kingdom
| | - Mohammed As-Sultany
- Wirral University Teaching Hospital NHS Foundation Trust, Trauma & Orthopedic Department, Wirral, United Kingdom; Mersey Deanery, Liverpool, United Kingdom
| | - Rosemary Finley
- Wirral University Teaching Hospital NHS Foundation Trust, Trauma & Orthopedic Department, Wirral, United Kingdom
| | - Nigel J Donnachie
- Wirral University Teaching Hospital NHS Foundation Trust, Trauma & Orthopedic Department, Wirral, United Kingdom
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19
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Nandi S, Sommerville L, Nellenbach K, Mihalko E, Erb M, Freytes DO, Hoffman M, Monroe D, Brown AC. Platelet-like particles improve fibrin network properties in a hemophilic model of provisional matrix structural defects. J Colloid Interface Sci 2020; 577:406-418. [PMID: 32502667 PMCID: PMC7415593 DOI: 10.1016/j.jcis.2020.05.088] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2020] [Revised: 05/20/2020] [Accepted: 05/22/2020] [Indexed: 12/27/2022]
Abstract
Following injury, a fibrin-rich provisional matrix is formed to stem blood loss and provide a scaffold for infiltrating cells, which rebuild the damaged tissue. Defects in fibrin network formation contribute to impaired healing outcomes, as evidenced in hemophilia. Platelet-fibrin interactions greatly influence fibrin network structure via clot contraction, which increases fibrin density over time. Previously developed hemostatic platelet-like particles (PLPs) are capable of mimicking platelet functions including binding to fibrin fibers, augmenting clotting, and inducing clot retraction. In this study, we aimed to apply PLPs within a plasma-based in vitro hemophilia B model of deficient fibrin network structure to determine the ability of PLPs to improve fibrin structure and wound healing responses within hemophilia-like abnormal fibrin network formation. PLP impact on structurally deficient clot networks was assessed via confocal microscopy, a micropost deflection model, atomic force microscopy and an in vitro wound healing model of early cell migration within a provisional fibrin matrix. PLPs improved clot network density, force generation, and stiffness, and promoted fibroblast migration within an in vitro model of early wound healing under hemophilic conditions, indicating that PLPs could provide a biomimetic platform for improving wound healing events in disease conditions that cause deficient fibrin network formation.
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Affiliation(s)
- Seema Nandi
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States; Comparative Medicine Institute, North Carolina State University, Raleigh, NC, United States
| | | | - Kimberly Nellenbach
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States; Comparative Medicine Institute, North Carolina State University, Raleigh, NC, United States
| | - Emily Mihalko
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States; Comparative Medicine Institute, North Carolina State University, Raleigh, NC, United States
| | - Mary Erb
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States
| | - Donald O Freytes
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States; Comparative Medicine Institute, North Carolina State University, Raleigh, NC, United States
| | - Maureane Hoffman
- Department of Pathology, Duke University, Durham, NC, United States
| | - Dougald Monroe
- Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
| | - Ashley C Brown
- Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh, NC, United States; Comparative Medicine Institute, North Carolina State University, Raleigh, NC, United States.
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20
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Deng ZF, Zhang ZJ, Sheng PY, Fu M, Xu DL, He AS, Liao WM, Kang Y. Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid. Medicine (Baltimore) 2020; 99:e22028. [PMID: 32899057 PMCID: PMC7478743 DOI: 10.1097/md.0000000000022028] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Comparison of different anticoagulants in blood management and complications with tranexamic acid (TXA) in total hip arthroplasty (THA) is unclear. Our aim was to compare the efficacy and safety among receiving nadroparin calcium, enoxaparin sodium or rivaroxaban after TXA in THA.150 patients undergoing primary unilateral THA were received 15 mg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban (Group C) randomly during hospitalization. The primary outcome was hidden blood loss (HBL). Other outcomes such as the maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications were also compared.There were no statistically significant differences in HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications among 3 groups. LOS was significantly higher for patients in Group B than Group A (P = .026). Neither deep venous thrombosis (DVT) nor pulmonary embolism (PE) occurred in any group.There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.
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21
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Gonzalez Della Valle A, Shanaghan KA, Nguyen J, Liu J, Memtsoudis S, Sharrock NE, Salvati EA. Multimodal prophylaxis in patients with a history of venous thromboembolism undergoing primary elective hip arthroplasty. Bone Joint J 2020; 102-B:71-77. [DOI: 10.1302/0301-620x.102b7.bjj-2019-1559.r1] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
Aims We studied the safety and efficacy of multimodal thromboprophylaxis in patients with a history of venous thromboembolism (VTE) who undergo total hip arthroplasty (THA) within the first 120 postoperative days, and the mortality during the first year. Multimodal prophylaxis includes discontinuation of procoagulant medications, VTE risk stratification, regional anaesthesia, an intravenous bolus of unfractionated heparin prior to femoral preparation, rapid mobilization, the use of pneumatic compression devices, and chemoprophylaxis tailored to the patient’s risk of VTE. Methods Between 2004 to 2018, 257 patients with a proven history of VTE underwent 277 primary elective THA procedures by two surgeons at a single institution. The patients had a history of deep vein thrombosis (DVT) (186, 67%), pulmonary embolism (PE) (43, 15.5%), or both (48, 17.5%). Chemoprophylaxis included aspirin (38 patients), anticoagulation (215 patients), or a combination of aspirin and anticoagulation (24 patients). A total of 50 patients (18%) had a vena cava filter in situ at the time of surgery. Patients were followed for 120 days to record complications, and for one year to record mortality. Results Postoperative VTE was diagnosed in seven patients (2.5%): DVT in five, and PE with and without DVT in one patient each. After hospitalization, three patients required readmiss-ion for evacuation of a haematoma, one for wound drainage, and one for monitoring of an elevated international normalized ratio (INR). Seven patients died (2.5%). One patient died five months postoperatively of a PE during open thrombectomy. She had discontinued anticoagulation. One patient died of a haemorrhagic stroke while receiving Coumadin. PE or bleeding was not suspected in the remaining five fatalities. Conclusion Multimodal prophylaxis is safe and effective in patients with a history of VTE. Postoperative anticoagulation should be prudent as very few patients developed VTE (2.5%) or died of suspected or confirmed PE. Mortality during the first year was mostly unrelated to either VTE or bleeding. Cite this article: Bone Joint J 2020;102-B(7 Supple B):71–77.
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Affiliation(s)
- Alejandro Gonzalez Della Valle
- Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Kate A. Shanaghan
- Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Joseph Nguyen
- Department of Biomechanics, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Jiabin Liu
- Department of Anesthesiology, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Stavros Memtsoudis
- Department of Anesthesiology, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Nigel E. Sharrock
- Department of Anesthesiology, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
| | - Eduardo A. Salvati
- Department of Orthopaedic Surgery, Hospital for Special Surgery, Weill Cornell Medical College of Cornell University, New York, New York, USA
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22
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Ní Cheallaigh S, Fleming A, Dahly D, Kehoe E, O'Byrne JM, McGrath B, O'Connell C, Sahm LJ. Aspirin compared to enoxaparin or rivaroxaban for thromboprophylaxis following hip and knee replacement. Int J Clin Pharm 2020; 42:853-860. [PMID: 32328957 DOI: 10.1007/s11096-020-01032-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2019] [Accepted: 04/08/2020] [Indexed: 11/29/2022]
Abstract
Background The risk of venous thromboembolism following major orthopaedic surgery is among the highest for all surgical specialties. Our hospital guidelines for thromboprophylaxis following elective primary total hip or knee replacement are based on American College of Chest Physicians guidance. The most recent change to local guidelines was the introduction of the extended aspirin regimen as standard thromboprophylaxis. Objective To establish the appropriateness of this regimen by comparing venous thromboembolism rates in patients receiving extended aspirin to previous regimens. Setting The largest dedicated orthopaedic hospital in Ireland. Methods This was a retrospective cohort study. Data were collected from patient record software. All eligible patients undergoing primary total hip or knee replacement between 1st January 2010 and 30th June 2016 were included. Main outcome measure Venous thromboembolism up to 6 months post-operatively. Results Of the 6548 participants (55.3% female, mean age 65.4 years (± 11.8 years, 55.8% underwent total hip replacement), venous thromboembolism occurred in 65 (0.99%). Venous thromboembolism rate in both the inpatient enoxaparin group (n = 961) and extended aspirin group (n = 3460) was 1.04% and was 0.66% in the modified rivaroxaban group (n = 1212). Non-inferiority analysis showed the extended aspirin regimen to be equivalent to the modified rivaroxaban regimen. History of venous thromboembolism was the only significant demographic risk factor for post-operative venous thromboembolism (0.87% vs. 3.54%, p = 0.0002). Conclusion In daily clinical practice, extended aspirin regimen is at least as effective as modified rivaroxaban for preventing clinically important venous thromboembolism among patients undergoing hip or knee arthroplasty who are discharged from the hospital without complications. Aspirin can be considered a safe and effective agent in the prevention of venous thromboembolism after total hip or total knee replacement.
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Affiliation(s)
| | - Aoife Fleming
- Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland
| | - Darren Dahly
- HRB Clinical Research Facility Cork, School of Public Health, University College Cork, Cork, Ireland
| | - Eimear Kehoe
- Pharmacy Department, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - John M O'Byrne
- RCSI Department of Orthopaedic Surgery, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Brid McGrath
- Department of Anaesthetics, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Charles O'Connell
- Pharmacy Department, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Laura J Sahm
- Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland.
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23
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Dombrowski M, Murawski CD, Yasui Y, Chen AF, Ewalefo SO, Fourman MS, Kennedy JG, Hogan MV. Medical comorbidities increase the rate of surgical site infection in primary Achilles tendon repair. Knee Surg Sports Traumatol Arthrosc 2019; 27:2840-2851. [PMID: 30663002 DOI: 10.1007/s00167-018-5295-6] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2018] [Accepted: 11/13/2018] [Indexed: 10/27/2022]
Abstract
PURPOSE To assess the effects of medical comorbidities on the incidence of surgical site infection following primary Achilles tendon repair. A secondary aim was to assess the effects of specific medical comorbidities on the cost and extent of healthcare utilization related to surgical site infection following primary Achilles tendon repair. METHODS 24,269 patients undergoing primary Achilles tendon repair between 2005 and 2012 were examined. Current Procedural Terminology codes for primary Achilles tendon repair, and incision and drainage were used to search for and compile patient data from the United Healthcare Orthopedic and Medicare databases. Primary outcome measures regarding surgical site infection following primary Achilles tendon repair included the rate of occurrence, cost, and duration of treatment. RESULTS Patients with one or more preexisting medical comorbidities at the time of surgery had an increased rate of surgical site infection compared to those without. Diabetes and vascular complications were associated with the highest surgical site infection rates. The rate of surgical incision and drainage was higher in patients with cardiac arrhythmias and uncomplicated hypertension. The presence of a medical comorbidity significantly increased the cost and duration of surgical site infection treatment. CONCLUSIONS Medical comorbidities can complicate the postoperative course for patients undergoing Achilles tendon repair, which increases the cost of care and duration of treatment. A better understanding of the relationship between each medical comorbidity and surgical site infections following Achilles tendon repair may be ascertained with additional prospective studies, thus, allowing for a more accurate evaluation and stratification of surgical candidates to improve patient outcomes. LEVEL OF EVIDENCE Retrospective cohort study, Level III.
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Affiliation(s)
- Malcolm Dombrowski
- Foot and Ankle Injury Research [F.A.I.R.] group, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, 3471 Fifth Ave., Pittsburgh, PA, 15213, USA
| | - Christopher D Murawski
- Foot and Ankle Injury Research [F.A.I.R.] group, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, 3471 Fifth Ave., Pittsburgh, PA, 15213, USA
| | - Youichi Yasui
- Department of Orthopaedic Surgery, Teikyo University School of Medicine, Tokyo, Japan
- Department of Foot and Ankle Surgery, Hospital for Special Surgery, New York, NY, USA
| | - Antonia F Chen
- Department of Orthopaedic Surgery, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA
| | - Samuel O Ewalefo
- Foot and Ankle Injury Research [F.A.I.R.] group, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, 3471 Fifth Ave., Pittsburgh, PA, 15213, USA
| | - Mitchell S Fourman
- Foot and Ankle Injury Research [F.A.I.R.] group, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, 3471 Fifth Ave., Pittsburgh, PA, 15213, USA
| | - John G Kennedy
- Department of Foot and Ankle Surgery, Hospital for Special Surgery, New York, NY, USA
| | - MaCalus V Hogan
- Foot and Ankle Injury Research [F.A.I.R.] group, Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, 3471 Fifth Ave., Pittsburgh, PA, 15213, USA.
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Changing Patterns of Anticoagulation After Total Hip Arthroplasty in the United States: Frequency of Deep Vein Thrombosis, Pulmonary Embolism, and Complications With Rivaroxaban and Warfarin. J Arthroplasty 2019; 34:1793-1801. [PMID: 31005440 DOI: 10.1016/j.arth.2019.03.057] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2019] [Revised: 03/22/2019] [Accepted: 03/25/2019] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND This study evaluated the trends in anticoagulation use after total hip arthroplasty (THA), and the effectiveness and safety of rivaroxaban compared to warfarin. METHODS This retrospective database analysis used healthcare claims from the Truven Health MarketScan database (2010-2015). Patients undergoing elective THA were followed for use of anticoagulants after surgery. Logistic regression models were used to compare differences in deep vein thrombosis (DVT), pulmonary embolism (PE), and adverse events, within 90 days after THA, among warfarin and rivaroxaban users. Inverse probability treatment weighting was used to account for selection bias. RESULTS There were 12,876 users of warfarin and 10,892 users of rivaroxaban in commercially insured (CI) patients, and 7416 warfarin users and 4739 rivaroxaban users in Medicare supplement (MS) patients. Warfarin use decreased over time in both insurance cohorts, whereas rivaroxaban use increased from 2011 to 2015. Warfarin users were significantly more likely to experience both DVT (CI: odds ratio [OR] 2.63, 95% confidence interval 1.97-3.50; MS: OR 1.78, 95% confidence interval 1.38-2.29) and PE (CI: OR 2.60, 95% confidence interval 2.04-3.31; MS: OR 2.09, 95% confidence interval 1.66-2.65). There was no significant difference in rates of bleeding between the 2 agents, but warfarin users had higher odds of periprosthetic joint infection in both cohorts (CI: OR 1.57, 95% confidence interval 1.16-2.13; MS: OR 1.79, 95% confidence interval 1.14-2.81). CONCLUSION There has been an increase in prophylaxis with rivaroxaban, and a decrease in warfarin use after elective THA over 4 years. Warfarin users were more likely to experience DVT and PE than rivaroxaban, and bleeding risks were similar.
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25
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Postoperative Thromboprophylaxis With New Oral Anticoagulants is Superior to LMWH in Hip Arthroplasty Surgery: Findings from the Swedish Registry. Clin Orthop Relat Res 2019; 477:1335-1343. [PMID: 31136431 PMCID: PMC6554117 DOI: 10.1097/corr.0000000000000714] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
BACKGROUND Although the use of thromboprophylaxis is well established, there is no consensus on the preferred thromboprophylaxis regimen after THA; large, population-based studies offer an opportunity to examine this problem in a robust way that can complement results from randomized trials. QUESTIONS/PURPOSES Using data from a large national registry, we asked: (1) Is there any difference between low-molecular weight heparin (LMWH) and new oral anticoagulants in preventing symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), after THA? (2) Are there any differences in safety parameters, such as bleeding, reoperations and mortality, between LMWH and new oral anticoagulants? METHODS Between 2008 and 2012, 78,066 THAs were performed in Sweden. This study evaluated 32,663 (42%) of them, selected through the merger of several national registries. These patients underwent unilateral THA due to primary osteoarthritis. They had not experienced any venous thromboembolic events 5 years before the index operation and were not prescribed potent antithrombotic agents, of any type, in the 6 months before the index operation. Additionally, their postoperative thromboprophylaxis was confirmed in a national registry by purchase of prescribed medications. We divided the cohort into two groups: those patients who received new oral anticoagulants (5752, 18%) and those who received LMWH (26,881, 82%) as postoperative thromboprophylaxis. Our primary endpoints were the frequencies of symptomatic DVT and symptomatic PE within 3 months of surgery. Our secondary comparison was a between-group comparison of bleeding (by way of diagnostic coding), reoperation, and mortality within 3 months of surgery. Odds ratios (OR) are presented with 95% confidence intervals (CIs) as pooled results for the two groups after adjustment for duration of thromboprophylaxis (short or extended for at least 28 days), year of the index operation, Elixhauser comorbidity index, sex, age and previous treatment with platelet aggregation inhibitors. RESULTS The risk of symptomatic DVT was lower in the group that received new oral anticoagulants than the group that received LMWH (0.3% versus 0.6%, OR, 0.47; 95% CI, 0.27-0.76; p = 0.026). The risk of symptomatic PE was lower in the group that received new oral anticoagulants than the group that received LMWH (0.1% versus 0.4%, OR, 0.36; 95% CI, 0.16-0.69; p = 0.005). There was no difference in the risk of bleeding (by way of diagnostic coding) (OR, 1.03; 95% CI, 0.82-1.28; p = 0.688), reoperation (OR, 1.02; 95% CI, 0.71-1.44; p = 0.860) or mortality (OR, 0.83; 95% CI, 0.31-1.88; p = 0.883) between groups. CONCLUSIONS New oral anticoagulants were associated with a lower risk of symptomatic DVT and symptomatic PE in this large, registry study, and we observed no differences in the risk of bleeding, reoperation, or death between the groups. Although we were able to control for a number of potential confounding variables, we cannot ascertain the indications that drove the prescription decisions in this setting, and there were important between-group differences in terms of duration of thromboprophylaxis (new oral anticoagulants generally were used for a longer period of time after surgery). Future studies, preferably large randomized trials with pragmatic inclusion criteria, to analyze symptomatic DVT, symptomatic PE and death are needed to confirm or refute our findings. LEVEL OF EVIDENCE Level III, therapeutic study.
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26
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Muhamed I, Sproul EP, Ligler FS, Brown AC. Fibrin Nanoparticles Coupled with Keratinocyte Growth Factor Enhance the Dermal Wound-Healing Rate. ACS APPLIED MATERIALS & INTERFACES 2019; 11:3771-3780. [PMID: 30604611 DOI: 10.1021/acsami.8b21056] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/09/2023]
Abstract
Expediting the wound-healing process is critical for patients chronically ill from nonhealing wounds and diseases such as hemophilia or diabetes or who have suffered trauma including easily infected open wounds. FDA-approved external tissue sealants include the topical application of fibrin gels, which can be 500 times denser than natural fibrin clots. With lower clot porosity and higher polymerization rates than physiologically formed fibrin clots, the commercial gels quickly stop blood loss but impede the later clot degradation kinetics and thus retard tissue-healing rates. The fibrin nanoparticles (FBNs) described here are constructed from physiologically relevant fibrin concentrations that support new tissue and dermal wound scaffold formation when coupled with growth factors. The FBNs, synthesized in a microfluidic droplet generator, support cell adhesion and traction generation, and when coupled to keratinocyte growth factor (KGF), support cell migration and in vivo wound healing. The FBN-KGF particles enhance cell migration in vitro greater than FBN alone or free KGF and also improve healing outcomes in a murine full thickness injury model compared to saline, bulk fibrin sealant, free KGF, or bulk fibrin mixed with KGF treatments. Furthermore, FBN can be potentially administered with other tissue-healing factors and inflammatory mediators to improve wound-healing outcomes.
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Affiliation(s)
- Ismaeel Muhamed
- Joint Department of Biomedical Engineering , North Carolina State University and University of North Carolina at Chapel Hill , Raleigh 27695 , North Carolina , United States
- Comparative Medicine Institute , North Carolina State University , Raleigh 27695 , North Carolina , United States
| | - Erin P Sproul
- Joint Department of Biomedical Engineering , North Carolina State University and University of North Carolina at Chapel Hill , Raleigh 27695 , North Carolina , United States
- Comparative Medicine Institute , North Carolina State University , Raleigh 27695 , North Carolina , United States
| | - Frances S Ligler
- Joint Department of Biomedical Engineering , North Carolina State University and University of North Carolina at Chapel Hill , Raleigh 27695 , North Carolina , United States
- Comparative Medicine Institute , North Carolina State University , Raleigh 27695 , North Carolina , United States
| | - Ashley C Brown
- Joint Department of Biomedical Engineering , North Carolina State University and University of North Carolina at Chapel Hill , Raleigh 27695 , North Carolina , United States
- Comparative Medicine Institute , North Carolina State University , Raleigh 27695 , North Carolina , United States
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27
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Low-molecular-weight heparin followed by rivaroxaban or not for the prevention of deep venous thromboembolism after total knee arthroplasty. Blood Coagul Fibrinolysis 2019; 30:29-33. [DOI: 10.1097/mbc.0000000000000786] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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28
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Wang J, Zhu HL, Shi ZJ, Zhang Y. The Application of Thromboelastography in Understanding and Management of Ecchymosis After Total Knee Arthroplasty. J Arthroplasty 2018; 33:3754-3758. [PMID: 30219266 DOI: 10.1016/j.arth.2018.08.024] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2018] [Revised: 08/05/2018] [Accepted: 08/21/2018] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Ecchymosis is a common complication after total knee arthroplasty (TKA). However, only a few studies have been conducted to determine the coagulation status of these patients. Using thromboelastography (TEG), a new technique recording the viscoelastic changes of a whole-blood sample, this study was performed to understand the ecchymosis-related coagulation status and its risk factors. METHODS Seventy-five patients receiving unilateral TKA were recruited in this observational study. Oral rivaroxaban was applied as prophylaxis treatment after surgery. TEG was performed 1 day before surgery and 4 days after surgery. Total blood loss and hidden blood loss were recorded and calculated. Univariate and multivariate analyses were conducted to determine risk factors. RESULTS Twenty-five patients (33.3%) developed ecchymosis within 2-3 days after TKA. Compared with the baseline before TKA, the α-angle (P = .032) and calculated coagulation index (CI; P = .012) were increased in non-ecchymosis group, whereas in the ecchymosis group, there was no significant difference regarding any variable of postoperative TEG evaluation. The ecchymosis group exhibited more hidden blood loss (P = .007) and total blood loss (P = .011). Value change of CI (OR = 0.666, 95% confidence interval = [0.496, 0.895], P = .007) and hidden blood loss (OR = 1.008, 95% confidence interval = [1.002, 1.013], P = .004) were recognized as the independent risk factors for postoperative ecchymosis. CONCLUSION In TEG evaluation, the value change of CI and hidden blood loss are independent risk factors of ecchymosis. In view of the relative hypocoagulation status, it is reasonable to stop anticoagulation therapy in patients with excessive ecchymosis. Personalized anticoagulation therapy may be helpful for managing ecchymosis after TKA.
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Affiliation(s)
- Jian Wang
- Department of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
| | - Hai-Lun Zhu
- Orthopaedic Center, Shenzhen Hospital, Southern Medical University, Guangzhou, Guangdong, China
| | - Zhan-Jun Shi
- Department of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
| | - Yang Zhang
- Department of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
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29
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Bozhkova SA, Kasimova AR, Nakopia VB, Kornilov NN. DO WE KNOW ALL ABOUT PREVENTION OF VENOUS THROMBOEMBOLISM AFTER MAJOR ORTHOPEDIC SURGERY? TRAUMATOLOGY AND ORTHOPEDICS OF RUSSIA 2018. [DOI: 10.21823/2311-2905-2018-24-1-129-143] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/01/2022]
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30
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Colleoni JL, Ribeiro FN, Mos PAC, Reis JP, Oliveira HRD, Miura BK. Profilaxia do tromboembolismo venoso após artroplastia total de joelho: aspirina vs. rivaroxabana. Rev Bras Ortop 2018. [DOI: 10.1016/j.rbo.2016.12.004] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022] Open
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31
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Colleoni JL, Ribeiro FN, Mos PAC, Reis JP, Oliveira HRD, Miura BK. Venous thromboembolism prophylaxis after total knee arthroplasty (TKA): aspirin vs. rivaroxaban. Rev Bras Ortop 2017; 53:22-27. [PMID: 29367902 PMCID: PMC5771791 DOI: 10.1016/j.rboe.2017.11.007] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2016] [Accepted: 12/15/2016] [Indexed: 01/25/2023] Open
Abstract
Objectives To compare the efficacy and safety of aspirin and rivaroxaban in preventing venous thromboembolism (VTE) after total knee arthroplasty (TKA). Methods Thirty-two patients with osteoarthritis of the knee and knee arthroplasty indication were selected. The operated patients were randomized into two groups (A and B). Group A received 300 mg of acetylsalicylic acid (aspirin) and Group B received 10 mg of rivaroxaban daily for 14 days. Follow-up was performed weekly for four weeks and evaluated the presence of signs and symptoms of DVT, the healing of the surgical wound, and possible local complications such as hematoma, and superficial or deep infection that required surgical approach. Results It was verified that there were no differences between groups (rivaroxaban and aspirin) regarding gender, age, and (p > 0.05). After using the general linear model (GLM) test, it was found that there was a decrease in Hb and Ht levels, preoperatively and at one, three, seven, and 14 days (Hb: p = 1.334 × 10-30; Ht: p = 1.362 × 10-28). However, they did not differ as to the type of medication (Hb: p = 0.152; Ht: p = 0.661). There were no identifiable differences in local complications, systemic complications, deep vein thrombosis (DVT), readmission to hospital, reoperation, or death (p > 0.05) between groups (rivaroxaban and aspirin). Conclusions Both aspirin and rivaroxaban can be considered useful among drugs available VTE the prevention after TKA.
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Affiliation(s)
- Jose Luiz Colleoni
- Hospital Mario Covas, Faculdade de Medicina do ABC, Santo André, SP, Brazil
| | | | | | - João Paulo Reis
- Hospital Mario Covas, Faculdade de Medicina do ABC, Santo André, SP, Brazil
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32
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Xie J, Hu Q, Ma J, Huang Q, Pei F. Multiple boluses of intravenous tranexamic acid to reduce hidden blood loss and the inflammatory response following enhanced-recovery primary total hip arthroplasty: a randomised clinical trial. Bone Joint J 2017; 99-B:1442-1449. [PMID: 29092982 DOI: 10.1302/0301-620x.99b11.bjj-2017-0488.r1] [Citation(s) in RCA: 77] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2017] [Accepted: 07/25/2017] [Indexed: 11/05/2022]
Abstract
AIMS The aim of this study was to examine the efficacy and safety of multiple boluses of intravenous (IV) tranexamic acid (TXA) on the hidden blood loss (HBL) and inflammatory response following primary total hip arthroplasty (THA). PATIENTS AND METHODS A total of 150 patients were allocated randomly to receive a single bolus of 20 mg/kg IV TXA before the incision (group A), a single bolus followed by a second bolus of 1 g IV-TXA three hours later (group B) or a single bolus followed by two boluses of 1 g IV-TXA three and six hours later (group C). All patients were treated using a standard peri-operative enhanced recovery protocol. Primary outcomes were HBL and the level of haemoglobin (Hb) as well as the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) as markers of inflammation. Secondary outcomes included the length of stay in hospital and the incidence of venous thromboembolism (VTE). RESULTS The mean HBL was significantly lower in group C (402.13 ml standard deviation (sd) 225.97) than group A (679.28 ml sd 277.16, p < 0.001) or B (560.62 ml sd 295.22, p = 0.010). The decrease in the level of Hb between the pre-operative baseline and the level on the third post-operative day was 30.82 g/L (sd 6.31 g/L) in group A, 27.16 g/L (sd 6.83) in group B and 21.98 g/L (sd 3.72) in group C. This decrease differed significantly among the three groups (p < 0.01). The mean level of CRP was significantly lower in group C than in the other two groups on the second (p ≤ 0.034) and third post-operative days (p ≤ 0.014). The levels of IL-6 were significantly lower in group C than group A on the first three post-operative days (p = 0.023). The mean length of stay was significantly lower in group C than group A (p = 0.023). No VTE or other adverse events occurred. CONCLUSION Multiple boluses of IV-TXA can effectively reduce HBL following primary THA. A regime of three boluses leads to a smaller decrease in the level of Hb, less post-operative inflammation and a shorter length of stay in hospital than a single bolus. Cite this article: Bone Joint J 2017;99-B:1442-9.
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Affiliation(s)
- J Xie
- Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China
| | - Q Hu
- Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China
| | - J Ma
- Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China
| | - Q Huang
- Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China
| | - F Pei
- Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China
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Di Benedetto P, Zangari A, De Franceschi D, Di Benedetto ED, Cainero V, Beltrame A, Gisonni R, Causero A. Rivaroxaban and early periprostethic joint infection: our experience. ACTA BIO-MEDICA : ATENEI PARMENSIS 2017; 88:38-42. [PMID: 29083351 DOI: 10.23750/abm.v88i4 -s.6792] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Received: 10/03/2017] [Accepted: 10/03/2017] [Indexed: 11/23/2022]
Abstract
BACKGROUND AND AIM OF THE WORK Periprostethic joint infection (PJI) is a severe post-operative complication after Primary Total Hip Arthroplasty (THA). According to the classification of PJI early acute PJI occurs within 4 weeks from surgery. Some authors think that Rivaroxaban is a risk factor in the incidence of early acute PJI. We analyze our experience about this item. MATERIALS AND METHODS We analyze our experience from 1st January 2015 to 31th December 2016. We consider all consecutive hip arthroplasty implants in this period. RESULTS In the 205 patients analysed we not find early acute PJI in Rivaroxaban group nor in the others assuming another kind of thromboprophylaxis. CONCLUSIONS In our series there is no evidence of association between Rivaroxaban and early acute PJI. This is a retrospective cohort study, so we need more studies and more robust experimental designs to confirm these results.
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Quah C, Bayley E, Bhamber N, Howard P. Fatal pulmonary embolism following elective total knee replacement using aspirin in multi-modal prophylaxis - A 12year study. Knee 2017. [PMID: 28622843 DOI: 10.1016/j.knee.2017.05.021] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/02/2023]
Abstract
BACKGROUND The National Institute for Health and Clinical Excellence (NICE) has issued guidelines on which thromboprophylaxis regimens are suitable following lower limb arthroplasty. Aspirin is not a recommended agent despite being accepted in orthopaedic guidelines elsewhere. We assessed the incidence of fatal pulmonary embolism (PE) and all-cause mortality following elective primary total knee replacement (TKR) with a standardised multi-modal prophylaxis regime in a large teaching district general hospital. METHODS We utilised a prospective audit database to identify those that had died within 42 and 90days postoperatively. Data from April 2000 to 2012 were analysed for 42 and 90day mortality rates. There were a total of 8277 elective primary TKR performed over the 12year period. The multi-modal prophylaxis regimen used unless contraindicated for all patients included 75mg aspirin once daily for four weeks. Case note review ascertained the causes of death. Where a patient had been referred to the coroner, they were contacted for post mortem results. RESULTS The mortality rates at 42 and 90days were 0.36 and 0.46%. There was one fatal PE within 42days of surgery (0.01%) who was taking enoxaparin because of aspirin intolerance. Two fatal PE's occurred at 48 and 57days post-operatively (0.02%). The leading cause of death was myocardial infarction (0.13%). CONCLUSIONS Fatal PE following elective TKR with a multi-modal prophylaxis regime is a very rare cause of mortality.
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Affiliation(s)
- C Quah
- Royal Derby Hospital, Uttoxeter Road, Derby DE223NE, United Kingdom.
| | - E Bayley
- Royal Derby Hospital, Uttoxeter Road, Derby DE223NE, United Kingdom.
| | - N Bhamber
- Royal Derby Hospital, Uttoxeter Road, Derby DE223NE, United Kingdom.
| | - P Howard
- Royal Derby Hospital, Uttoxeter Road, Derby DE223NE, United Kingdom.
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Suen K, Westh RN, Churilov L, Hardidge AJ. Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty. J Arthroplasty 2017; 32:2911-2919.e6. [PMID: 28522244 DOI: 10.1016/j.arth.2017.04.010] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2017] [Revised: 03/12/2017] [Accepted: 04/02/2017] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Venous thromboembolism causes significant morbidity and mortality in patients after total joint arthroplasty. Although network meta-analyses have demonstrated a benefit of various thromboprophylactic agents, there remains a concern in the surgical community regarding the resulting wound complications. There is currently no systematic review of the surgical site bleeding complications of thromboprophylactic agents. The aim of this study was to systematically review the surgical site bleeding outcomes of venous thromboembolism prophylaxis in this population. METHODS A systematic review and meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials comparing more than one of low-molecular-weight heparin (LMWH), warfarin, rivaroxaban, apixaban, dabigatran, aspirin, or no pharmacologic treatment in patients after total hip or knee arthroplasty were selected for inclusion. Five meta-analyses were performed to compare LMWH with control, warfarin, apixaban, rivaroxaban, and dabigatran. RESULTS Forty-five randomized controlled trials of 56,730 patients were included. LMWH had a significantly increased relative risk of surgical site bleeding in comparison with control (relative risk, 2.32; 95% confidence interval, 1.40-3.85) and warfarin (1.54; 1.23-1.94). The relative risk of LMWH trended higher than apixaban (1.27; 1.00-1.63) and was similar to rivaroxaban (0.95; 0.74-1.23). Only 1 study reported the risk of surgical site bleeding in LMWH vs dabigatran (5.97; 2.08-17.11). CONCLUSION LMWH increased the risk of surgical site bleeding compared with control, warfarin. and dabigatran and trended toward an increased risk compared with apixaban. The risk of surgical site bleeding was similar with LMWH and rivaroxaban.
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Affiliation(s)
- Kary Suen
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia
| | - Roger N Westh
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia
| | - Leonid Churilov
- Department of Statistics and Decision Support, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia
| | - Andrew J Hardidge
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia; Department of Statistics and Decision Support, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia
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Tang Y, Wang K, Shi Z, Yang P, Dang X. A RCT study of Rivaroxaban, low-molecular-weight heparin, and sequential medication regimens for the prevention of venous thrombosis after internal fixation of hip fracture. Biomed Pharmacother 2017; 92:982-988. [DOI: 10.1016/j.biopha.2017.05.107] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2017] [Revised: 05/17/2017] [Accepted: 05/22/2017] [Indexed: 11/15/2022] Open
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Papadopoulos DV, Kostas-Agnantis I, Gkiatas I, Tsantes AG, Ziara P, Korompilias AV. The role of new oral anticoagulants in orthopaedics: an update of recent evidence. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY 2017; 27:573-582. [DOI: 10.1007/s00590-017-1940-x] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/13/2016] [Accepted: 03/05/2017] [Indexed: 12/27/2022]
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Wang JW, Chen B, Lin PC, Yen SH, Huang CC, Kuo FC. The Efficacy of Combined Use of Rivaroxaban and Tranexamic Acid on Blood Conservation in Minimally Invasive Total Knee Arthroplasty a Double-Blind Randomized, Controlled Trial. J Arthroplasty 2017; 32:801-806. [PMID: 27663190 DOI: 10.1016/j.arth.2016.08.020] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2016] [Revised: 08/17/2016] [Accepted: 08/18/2016] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Tranexamic acid (TXA) was reportedly to decrease postoperative blood loss after standard total knee arthroplasty (TKA). However, the blood-conservation effect of TXA in minimally invasive TKA, in particular, receiving a direct oral anticoagulant was unclear. The aim of the study was to investigate the efficacy of combined use of TXA and rivaroxaban on postoperative blood loss in primary minimally invasive TKA. METHODS In a prospective, randomized, controlled trial, 198 patients were assigned to placebo (98 patients, normal saline injection) and study group (100 patients, 1g TXA intraoperative injection) during primary unilateral minimally invasive TKA. All patients received rivaroxaban 10 mg each day for 14 doses postoperatively. Total blood loss was calculated from the maximum hemoglobin drop after surgery plus amount of transfusion. The transfusion rate and wound complications were recorded in all patients. Deep-vein thrombosis was detected by ascending venography of the leg 15 days postoperatively. RESULTS The mean total blood loss was lower in the study group (1020 mL [95% confidence interval, 960-1080 mL]) compared with placebo (1202 mL [95% confidence interval, 1137-1268 mL]) (P < .001). The transfusion rate was lower in the study group compared with placebo (1% vs 8.2%, P = .018). Postoperative wound hematoma and ecchymosis were higher in placebo than the study group (P = .003). There was no symptomatic deep-vein thrombosis or pulmonary embolism in either group. CONCLUSION Systemic administration of TXA can effectively reduce the postoperative blood loss which results in lower rate of transfusion requirement and wound hematoma in minimally invasive TKA patients when rivaroxaban is used for thromboprophylaxis. Rivaroxaban has a high rate of bleeding complications when used alone in TKA patients.
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Affiliation(s)
- Jun-Wen Wang
- Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan
| | - Bradley Chen
- Institute of Public Health, National Yangming University, Taipei, Taiwan
| | - Po-Chun Lin
- Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan
| | - Shih-Hsiang Yen
- Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan
| | - Chung-Cheng Huang
- Department of Radiology, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan
| | - Feng-Chih Kuo
- Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan
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Xie J, Ma J, Huang Q, Yue C, Pei F. Comparison of Enoxaparin and Rivaroxaban in Balance of Anti-Fibrinolysis and Anticoagulation Following Primary Total Knee Replacement: A Pilot Study. Med Sci Monit 2017; 23:704-711. [PMID: 28174415 PMCID: PMC5312245 DOI: 10.12659/msm.900059] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023] Open
Abstract
Background This study aimed to assess whether the efficacy of tranexamic acid (TXA) would be altered when rivaroxaban or enoxaparin was used for thromboprophylaxis in primary total knee replacement (TKR). It was hypothesized that the hemostatic effect of TXA would be better with the use of enoxaparin. Material/Methods A randomized clinical trial was conducted on 194 patients undergoing primary TKR for osteoarthritis. An intravenous dose of 15 mg/kg (TXA) and 1 g topical TXA were used. Patients randomly received enoxaparin or rivaroxaban prophylaxis when the drainage was less than 30 ml/h 6–8 h postoperatively. The primary endpoint was hidden blood loss (HBL). Indexes of total blood loss drainage, hemoglobin drop, transfusion, range of motion (ROM), HSS score, VAS pain score, knee swelling, length of hospital stay (LOHS), incidence of venous thromboembolism, major/minor bleeding, and wound complications were also compared between the groups. Results More than 80% of patients initiated anticoagulation within 6 h postoperatively. No statistically significance difference was detected in terms of HBL (679.0±205.6 vs. 770.5±206.1, p=.062) or other bleeding index, ROM, or LOHS. The motion VAS pain score and knee swelling (16.7% vs. 6.1%, p=.021) were significantly lower, and HSS score at discharge was higher in the enoxaparin group. The rivaroxaban group had less asymptomatic deep venous (4.1% vs. 0%, p=.121) and muscular venous thrombosis (2.1% vs. 9.2%, p=.033); more ecchymosis (13.5% vs. 10.2%, p=.472), and wound complications (13.5% vs. 6.1%, p=.082). No episodes of transfusion, pulmonary embolism, or major bleeding occurred in either group. Conclusions More attention should be paid to the increased risk of wound complications and knee swelling associated with rivaroxaban, although the hidden blood loss was similar in both groups.
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Affiliation(s)
- Jinwei Xie
- Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China (mainland)
| | - Jun Ma
- Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China (mainland)
| | - Qiang Huang
- Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China (mainland)
| | - Chen Yue
- Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China (mainland)
| | - Fuxing Pei
- Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China (mainland)
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Beyer-Westendorf J, Mouret P, Turpie AG. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice. Orthop Res Rev 2017; 9:1-11. [PMID: 30774472 PMCID: PMC6209349 DOI: 10.2147/orr.s105227] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use.
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Affiliation(s)
| | - Patrick Mouret
- Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany
| | - Alexander Gg Turpie
- Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada
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Superficial wound infection does not cause inferior clinical outcome after TKA. Knee Surg Sports Traumatol Arthrosc 2016; 24:3088-3095. [PMID: 27567914 DOI: 10.1007/s00167-016-4290-z] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2016] [Accepted: 08/09/2016] [Indexed: 10/21/2022]
Abstract
PURPOSE Superficial wound infections do not lead to chronic prosthetic joint infection. Therefore, it has been hypothesized that a superficial infection of a surgical wound following a successfully treated TKA does not lead to a lower functional outcome at long-term follow-up. This may be due to early diagnosis and proper treatment without interrupting the rehabilitation programme. The purpose of this study was to support the hypothesis by comparing the functional outcome and health-related quality of life (HRQoL) of superficial infections treated successfully after primary total knee arthroplasty (TKA). METHODS In a 3000 prospective TKA cohort, 45 superficial infections were compared to a control group of 629 TKA without complications. The functional outcome, health quality, expectations and revision rate were compared between the study and control groups. RESULTS The groups were comparable in terms of demographic values and preoperative scores. The mean follow-up was 74.57 months (SD ± 7.1). No statistical differences were observed relative to functional outcomes at the final follow-up as measured with the Knee Society Score (156.9 vs 168.4; n.s) and range of motion (0.2-114.4 vs 0.7-112.3; n.s). For the HRQoL, no differences in the physical (40.0 vs 40.6; n.s) and mental (43.2 vs 45.8; n.s) SF-36 scores were found. Neither were there differences in post-operative expectations and the revision rate. CONCLUSIONS In a long-term follow-up, a different clinical outcome and HRQoL were not obtained after a successfully treated superficial infection following a TKA when compared to a TKA without complications. Based on the findings of the study, additional complications are not anticipated after a successfully treated superficial wound infection in TKA. Therefore, a different follow-up to that of a non-complicated TKA is not recommended when the early post-operative superficial wound infection has been appropriately treated. A superficial infection successfully treated in the acute post-operative period should be considered solved at long-term follow-up. LEVEL OF EVIDENCE Therapeutic study, Level III.
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Loganathan V, Hua A, Patel S, Gibbons C, Vizcaychipi MP. Efficacy and safety of rivaroxaban thromboprophylaxis after arthroplasty of the hip or knee: retrospective cohort study. Ann R Coll Surg Engl 2016; 98:507-15. [PMID: 27580310 PMCID: PMC5210016 DOI: 10.1308/rcsann.2016.0197] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/20/2015] [Indexed: 11/22/2022] Open
Abstract
Introduction Venous thromboembolism (VTE) is a potentially fatal complication of hip arthroplasty and knee arthroplasty. The National Institute for Health and Care Excellence recommend rivaroxaban for VTE prevention. Amid concerns over bleeding complications, the modified thromboprophylaxis policy of Chelsea and Westminster Hospital (CWH; London, UK) advises enoxaparin given after surgery in the inpatient setting followed by rivaroxaban upon hospital discharge. This retrospective study investigated the efficacy and safety of rivaroxaban in this novel, modified venous-prophylaxis regimen in a surgical orthopaedic cohort at CWH. Methods A total of 479 patients who received modified thromboprophylaxis treatment at CWH after hip arthroplasty or knee arthroplasty between April 2013 and October 2014 formed the study cohort. Seven outcomes based on efficacy and safety while undergoing treatment with rivaroxaban were investigated: symptomatic deep-vein thrombosis (DVT), pulmonary embolism (PE), death, stroke, myocardial infarction (MI), major bleeding episodes (MBEs) and non-major bleeding episodes (NMBEs). Median follow-up was 369 days. Fisher's exact and Mann-Whitney U-tests were adopted to identify associations with these outcomes. Results Prevalence of symptomatic PE, DVT, death, stroke and MI during treatment was zero. One (0.2%) MBE and nine (1.9%) NMBEs occurred. The MBE (a wound haematoma) required a return to theatre for aspiration. Off-treatment VTEs occurred in four (0.8%) patients after completion of a course of rivaroxaban, and were associated with known risk factors. Conclusions Rivaroxaban is an effective and safe anticoagulant for thromboprophylaxis after hip arthroplasty or knee arthroplasty if used in a modified regimen involving enoxaparin administered in the inpatient setting followed by rivaroxaban upon hospital discharge.
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Affiliation(s)
- V Loganathan
- Magill Department of Anaesthesia, Chelsea and Westminster Hospital , UK
| | - A Hua
- Magill Department of Anaesthesia, Chelsea and Westminster Hospital , UK
| | - S Patel
- Magill Department of Anaesthesia, Chelsea and Westminster Hospital , UK
| | - C Gibbons
- Department of Orthopaedics, Chelsea and Westminster Hospital , UK
| | - M P Vizcaychipi
- Magill Department of Anaesthesia, Chelsea and Westminster Hospital , UK
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Brimmo O, Glenn M, Klika AK, Murray TG, Molloy RM, Higuera CA. Rivaroxaban Use for Thrombosis Prophylaxis Is Associated With Early Periprosthetic Joint Infection. J Arthroplasty 2016; 31:1295-1298. [PMID: 26796776 DOI: 10.1016/j.arth.2015.12.027] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2015] [Revised: 12/03/2015] [Accepted: 12/15/2015] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Periprosthetic joint infection is a disastrous complication after total hip arthroplasty (THA) and total knee arthroplasty (TKA). The use of certain agents to prevent deep vein thrombosis after arthroplasty has been linked to an increased risk of adverse effects including wound drainage and infection. Adverse effects of one alternative, rivaroxaban, was studied in a single community hospital. METHODS International Classification of Diseases, Clinical Modification 9 codes were used to identify primary THAs and TKAs in an administrative database at one large-volume community hospital performed in 2012. Patients were divided into 2 groups: the study group received rivaroxaban, whereas the control group received another form of chemical thromboprophylaxis for at least 2 weeks postoperative. Demographics, risk factors, and illness severity scores were collected for each group. The primary measured outcome was the incidence of deep surgical site infection (SSI) within 30 days postoperative. RESULTS A total of 639 TKA or THA patients were included, with 159 patients who received rivaroxaban and 480 who received another form of chemical thromboprophylaxis. There were no significant differences between groups regarding demographics, risk factors, or illness severity scores. Incidence of early deep SSI in the rivaroxaban group was higher than in the control group (2.5% vs 0.2%; P < .015). CONCLUSION The use of rivaroxaban for thromboprophylaxis led to a significantly increased incidence of deep SSI in a continuous series of patients undergoing primary THA and TKA in a single institution.
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Affiliation(s)
- Olubusola Brimmo
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Margaret Glenn
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Alison K Klika
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Trevor G Murray
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Robert M Molloy
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
| | - Carlos A Higuera
- Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
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Bayley E, Brown S, Bhamber NS, Howard PW. Fatal pulmonary embolism following elective total hip arthroplasty. Bone Joint J 2016; 98-B:585-8. [DOI: 10.1302/0301-620x.98b5.34996] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2014] [Accepted: 11/11/2015] [Indexed: 12/27/2022]
Abstract
Aims The place of thromboprophylaxis in arthroplasty surgery remains controversial, with a challenging requirement to balance prevention of potentially fatal venous thrombo-embolism with minimising wound-related complications leading to deep infection. We compared the incidence of fatal pulmonary embolism in patients undergoing elective primary total hip arthroplasty (THA) between those receiving aspirin, warfarin and low molecular weight heparin (LMWH) for the chemical component of a multi-modal thromboprophylaxis regime. Patients and Methods A prospective audit database was used to identify patients who had died within 42 and 90 days of surgery respectively between April 2000 and December 2012. A case note review was performed to ascertain the causes of death. Results During this period 7983 THAs were performed. The rate of mortality was 0.43% and 0.58% at 42 and 90 days respectively. The groups comprised 1571 patients (19.7%) on warfarin, 1838 (23.0%) on LMWH and 4574 (57.3%) on aspirin. The 90-day mortality for these three groups was 0.38%, 1.09% and 0.43% respectively. The higher mortality rate for LMWH was significant (p < 0.05). There were six fatal pulmonary emboli (PEs) (0.08%). A total of three occurred within 42 days, all in the LMWH group. A total of three occurred between 42 and 90 days; one on warfarin, two on LMWH. The leading causes of death in all three groups were lower respiratory tract infections and myocardial infarction. Conclusion We confirmed that fatal PE following elective THA with a multi-modal prophylaxis regime is rare. We further found that LMWH conferred no benefit over aspirin in this context, and is associated with a higher all-cause rate of mortality. Take home message: This study proposes that aspirin may be an appropriate thromboprophylaxis agent when used as part of a multi-modal regimen, suggesting current guidelines should be reviewed. Cite this article: Bone Joint J 2016;98-B:585–8.
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Affiliation(s)
- E. Bayley
- The Royal Derby Hospital, Uttoxeter
Road, Derby, DE22 3NE, UK
| | - S. Brown
- Royal Hallamshire Hospital, Sheffield
S10 2JF, UK
| | - N. S. Bhamber
- St George’s University Hospital NHS FoundationTrust, Blackshaw Road,
Tooting London SW17 0QT, UK
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Pilge H, Fröbel J, Mrotzek SJ, Fischer JC, Prodinger PM, Zilkens C, Bittersohl B, Krauspe R. Effects of thromboprophylaxis on mesenchymal stromal cells during osteogenic differentiation: an in-vitro study comparing enoxaparin with rivaroxaban. BMC Musculoskelet Disord 2016; 17:108. [PMID: 26927834 PMCID: PMC4772441 DOI: 10.1186/s12891-016-0966-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2016] [Accepted: 02/24/2016] [Indexed: 01/08/2023] Open
Abstract
Background Low-molecular-weight heparins (e.g. Enoxaparin) are widely used to prevent venous thromboembolism after orthopaedic surgery, but there are reports about serious side effects including reduction in bone density and strength. In recent years new oral antithrombotic drugs (e.g. direct Factor Xa-inhibitor, Rivaroxaban) have been used to prevent venous thromboembolism. However, there is lack of information on the effects of these new drugs on human mesenchymal stromal cells during osteogenic differentiation and, therefore, effects during postoperative bone healing. Methods We evaluated the effects of Rivaroxaban and Enoxaparin on the proliferation, mRNA and surface receptor expression as well as differentiation capacity of primary human mesenchymal stromal cells during their osteogenic differentiation. Results Enoxaparin, but not Rivaroxaban treatment significantly increased human mesenchymal stromal cell (hMSC) proliferation during the first week of osteogenic differentiation while suppressing osteogenic marker genes, surface receptor expression and calcification. Conclusions This is the first paper to demonstrate that Rivaroxaban had no significant influence on hMSC differentiation towards the osteogenic lineage, indicating a less affected bone healing process compared with Enoxaparin in vitro. Based on these findings Rivaroxaban seems to be superior to Enoxaparin in early stages of bone healing in vitro. Electronic supplementary material The online version of this article (doi:10.1186/s12891-016-0966-2) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Hakan Pilge
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Julia Fröbel
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Silvia J Mrotzek
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Johannes C Fischer
- Institute for Transplantation Diagnostics and Cell Therapeutics, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Peter M Prodinger
- Department of Orthopaedic Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaninger Str. 22, 81675, Munich, Germany.
| | - Christoph Zilkens
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Bernd Bittersohl
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
| | - Rüdiger Krauspe
- Department of Orthopaedic Surgery, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany
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Pugely AJ, Martin CT, Harwood J, Ong KL, Bozic KJ, Callaghan JJ. Database and Registry Research in Orthopaedic Surgery: Part 2: Clinical Registry Data. J Bone Joint Surg Am 2015; 97:1799-808. [PMID: 26537168 DOI: 10.2106/jbjs.o.00134] [Citation(s) in RCA: 91] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
The use of large-scale national databases for observational research in orthopaedic surgery has grown substantially in the last decade, and the data sets can be categorized as either administrative claims or clinical registries. Clinical registries contain secondary data on patients with a specific diagnosis or procedure. The data are typically used for patient outcome surveillance to improve patient safety and health-care quality. Registries used in orthopaedic research exist at the regional, national, and international levels, and many were designed to specifically collect outcomes relevant to orthopaedics, such as short-term surgical complications, longer-term outcomes (implant survival or reoperations), and patient-reported outcomes. Although heterogeneous, clinical registries-in contrast to claims data-typically have a more robust list of variables, with relatively precise prospective data input, management infrastructure, and reporting systems. Some weaknesses of clinical registries include a smaller number of patients, inconstant follow-up duration, and use of sampling methods that may limit generalizability. Within the U.S., national joint registry adoption has lagged international joint registries. Given the changing health-care environment, it is likely that clinical registries will provide valuable information that has the potential to influence clinical practice improvement and health-care policy in the future.
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Affiliation(s)
- Andrew J Pugely
- Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 01008 JPP, Iowa City, IA 52242. E-mail address for A.J. Pugely:
| | - Christopher T Martin
- Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 01008 JPP, Iowa City, IA 52242. E-mail address for A.J. Pugely:
| | - Jared Harwood
- Department of Orthopaedics, Ohio State University Hospital, 376 West 10th Avenue Suite 725, Columbus, OH 43210
| | - Kevin L Ong
- Exponent, 3440 Market Street, Suite 600, Philadelphia, PA 19104
| | - Kevin J Bozic
- Department of Orthopaedic Surgery, University of California, San Francisco, 3333 California Street, Suite 265, Box 0936, San Francisco, CA 94118
| | - John J Callaghan
- Department of Orthopaedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 01008 JPP, Iowa City, IA 52242. E-mail address for A.J. Pugely:
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Low-molecular-weight heparin and intermittent pneumatic compression for thromboprophylaxis in critical patients. Exp Ther Med 2015; 10:2331-2336. [PMID: 26668637 DOI: 10.3892/etm.2015.2795] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2014] [Accepted: 09/24/2015] [Indexed: 11/05/2022] Open
Abstract
The efficacy and safety of physiotherapeutic prophylaxis for venous thromboembolism in critically ill patients with heparin contraindication remains unclear. In the present study it was hypothesized that physiotherapy prophylaxis with intermittent pneumatic compression (IPC) would be safe and effective for patients unable to receive low-molecular-weight heparin (LMWH). In addition, this study investigated whether a combined therapy of IPC with LMWH would be more effective for the prophylaxis of deep vein thrombosis (DVT) in critical patients. A total of 500 patients were divided into four groups according to the prophylaxis of DVT. The IPC group consisted of 95 patients with heparin contraindication that received IPC treatment; the LMWH group consisted of 185 patients that received an LMWH injection; the LMWH + IPC group consisted of 75 patients that received IPC treatment and LMWH injection; and the control group consisted of 145 patients that received no IPC treatment or injection of LMWH. Each patient was evaluated clinically for development of DVT and the diagnosis was confirmed by Doppler study. Venous thromboembolism was a common complication among the trauma patients with severe injuries. Patients responded positively to the treatment used in the intervention groups. Patients exhibited an improved response to LMWH + ICP compared with IPC or LMWH alone, while no significant difference was detected between the IPC and LMWH groups. These results were applicable to patients that had a Wells score of ≥3; however, no significant differences in DVT incidence were observed among the patients who had a Wells score of <3. In this observational study, LMWH + ICP appeared to be more effective than either treatment alone in treating critically ill trauma patients with severe injuries that are at high risk for VTE and bleeding simultaneously.
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Pellegrini VD. Prophylaxis Against Venous Thromboembolism After Total Hip and Knee Arthroplasty: A Critical Analysis Review. JBJS Rev 2015; 3:01874474-201509000-00001. [PMID: 27490672 DOI: 10.2106/jbjs.rvw.n.00111] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Affiliation(s)
- Vincent D Pellegrini
- Department of Orthopaedics, Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, SC 29425
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Rivaroxaban Versus Enoxaparin for Venous Thromboembolism Prophylaxis after Hip and Knee Arthroplasty. J Arthroplasty 2015; 30:1277-80. [PMID: 25724111 DOI: 10.1016/j.arth.2015.02.009] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/27/2014] [Revised: 01/31/2015] [Accepted: 02/11/2015] [Indexed: 02/01/2023] Open
Abstract
The oral Factor Xa inhibitor rivaroxaban (Xarelto) has been the pharmacologic agent used for venous thromboembolism (VTE) prophylaxis after primary hip and knee arthroplasty (THA/TKA) at our institution since February 2012. The purpose of our study was to compare rates of VTE and major bleeding between rivaroxaban and our previous protocol of enoxaparin after THA/TKA. A retrospective cohort study was performed including 2406 consecutive patients at our institution between 1/1/11 and 9/30/13. Patients who did not have unilateral primary THA/TKA or who received other anticoagulants were excluded. Of the 1762 patients included, 1113 patients (63.2%) received enoxaparin and 649 patients (36.8%) received rivaroxaban. This study found no demonstrable differences between these two anticoagulants in rates of VTE, infection, reoperation, transfusion, or major bleeding. Therapeutic, Retrospective comparative study, Level III.
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Bottle A, Oragui E, Pinder E, Aylin P, Loeffler M. The effect of new oral anticoagulants and extended thromboprophylaxis policy on hip and knee arthroplasty outcomes: observational study. Arthroplast Today 2015; 1:45-50. [PMID: 28326369 PMCID: PMC4926817 DOI: 10.1016/j.artd.2015.03.004] [Citation(s) in RCA: 2] [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: 01/08/2015] [Revised: 02/26/2015] [Accepted: 03/02/2015] [Indexed: 11/29/2022] Open
Abstract
The efficacy and safety of the new oral anticoagulants (NOAC) and the benefits of extended duration thromboprophylaxis following hip and knee replacements remain uncertain. This observational study describes the relations between thromboprophylaxis policies following hip and knee replacements across England's NHS and patient outcomes between January 2008 and December 2011. From the national administrative database, we analyzed mortality, thromboembolic complications, emergency readmission, and bleeding rates for 201,418 hip and 230,282 knee replacements. There were no differences in outcomes for either LMWH or NOAC. We found no advantage in favor of any single anticoagulation policy or in changing policy. This study supports the American Academy of Orthopaedic Surgeons' recommendation that the choice and duration of thromboprophylaxis prophylaxis be decided by the treating surgeon.
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Affiliation(s)
- Alex Bottle
- Department of Primary Care and Public Health, Dr Foster Unit at Imperial College London, London, UK
| | - Emeka Oragui
- Department of Orthopaedics, Colchester General Hospital, Colchester, Essex, UK
| | - Elizabeth Pinder
- Department of Orthopaedics, Colchester General Hospital, Colchester, Essex, UK
| | - Paul Aylin
- Department of Primary Care and Public Health, Dr Foster Unit at Imperial College London, London, UK
| | - Mark Loeffler
- Department of Orthopaedics, Colchester General Hospital, Colchester, Essex, UK
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