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CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

ABSTRACT: INTRODUCTION:Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. METHODS AND ANALYSIS:This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150?mg daily. The comparator will be LMWH (enoxaparin) 40?mg, subcutaneously, daily. Both drugs will commence within 24?hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15?562 patients from 31 hospitals. ETHICS AND DISSEMINATION:Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.

SUBMITTER: Sidhu VS

PROVIDER: S-EPMC6858170 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

Sidhu Verinder Singh VS Graves Steven E SE Buchbinder Rachelle R Naylor Justine Maree JM Pratt Nicole L NL de Steiger Richard S RS Chong Beng H BH Ackerman Ilana N IN Adie Sam S Harris Anthony A Hansen Amber A Cripps Maggie M Lorimer Michelle M Webb Steve S Clavisi Ornella O Griffith Elizabeth C EC Anandan Durga D O'Donohue Grace G Kelly Thu-Lan TL Harris Ian A IA

BMJ open 20191106 11

<h4>Introduction</h4>Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.<h4>Methods and analysis</h4>This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will con ...[more]

PMID: 31699735

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Project description:BackgroundThere is considerable debate regarding the ideal agent for venous thromboembolism (VTE) prophylaxis after TKA. Numerous studies and meta-analyses have yet to provide a clear answer and often omit one or more of the commonly used agents such as aspirin, warfarin, enoxaparin, and factor Xa inhibitors.Questions/purposesUsing a large database analysis, we asked: (1) What are the differences in VTE incidence in primary TKA after administration of aspirin, warfarin, enoxaparin, or factor Xa inhibitors? (2) What are the differences in bleeding risk among these four agents? (3) How has use of these agents changed with time?MethodsWe queried a combined Humana and Medicare database between 2007 and Quarter 1 of 2016, and identified all primary TKAs performed using ICD-9 and Current Procedural Terminology codes. All patients who had any form of antiplatelet or anticoagulation prescribed within 1 year before TKA were excluded from our study cohort. We then identified patients who had either aspirin, warfarin, enoxaparin, or factor Xa inhibitors prescribed within 2 weeks of primary TKA. Each cohort was matched by age and sex. Elixhauser comorbidities and Charlson Comorbidity Index for each group were calculated. We identified 1016 patients with aspirin, and age- and sex-matched 6096 patients with enoxaparin, 6096 patients with warfarin, and 5080 patients with factor Xa inhibitors. Using ICD-9 codes, with the understanding that patients at greater risk may have had more-attentive surveillance, the incidence of postoperative deep venous thrombosis (DVT), pulmonary embolism (PE), bleeding-related complications (bleeding requiring surgical intervention, hemorrhage, hematoma, hemarthrosis), postoperative anemia, and transfusion were identified at 2 weeks, 30 days, 6 weeks, and 90 days postoperatively. A four-way chi-squared test was used to determine statistical significance. Utilization was calculated using compound annual growth rate.ResultsThere was a difference in the incidence of DVT at 90 days (p < 0.01). Factor Xa inhibitors (2.9%) had the lowest incidence of DVT followed by aspirin (3.0%) and enoxaparin (3.5%), and warfarin (4.8%). There was a difference in the incidence of PE at 90 days (p < 0.01). Factor Xa inhibitors (0.9%) had the lowest incidence of PE followed by enoxaparin (1.1%), aspirin (1.2%), and warfarin (1.6%). There was a difference in the incidence of postoperative anemia at 90 days (p < 0.01). Aspirin (19%) had the lowest incidence of postoperative anemia followed by warfarin (22%), enoxaparin (23%), and factor Xa inhibitors (23%). There was a difference in the incidence of a blood transfusion at 90 days (p < 0.01). Aspirin (7%) had the lowest incidence of a blood transfusion followed by factor Xa inhibitors (9%), warfarin (12%), and enoxaparin (13%). There were no differences in bleeding-related complications (p = 0.81) between the groups. Aspirin use increased at a compound annual growth rate of 30%, enoxaparin at 3%, and factor Xa inhibitors at 43%, while warfarin use decreased at a compound annual growth rate of -3%.ConclusionsFactor Xa inhibitors had the highest growth in utilization during our study period, followed by aspirin, when compared with enoxaparin and warfarin. When selected for the right patient, factor Xa inhibitors provided improved VTE prophylaxis compared with enoxaparin and warfarin, with a lower rate of blood transfusion. Aspirin provided comparable VTE prophylaxis compared with factor Xa inhibitors with improved VTE prophylaxis compared with enoxaparin and warfarin with the lowest risk of bleeding.Level of evidenceLevel III, therapeutic study.

Project description:BackgroundAspirin 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.MethodsPatients 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.ResultsWe 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).ConclusionIn 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 registrationChictr.org, ChiCTR18000202894; http://www.chictr.org.cn/showproj.aspx?proj=33284.

Project description:BACKGROUND:Although guidelines now allow the use of aspirin as an alternative to anticoagulants for venous thromboembolism prophylaxis after knee or hip arthroplasty, there is limited data on contemporary use and outcomes with aspirin. OBJECTIVE:To describe the use of pharmacologic thromboprophylaxis and to assess venous thromboembolic risk with aspirin compared with anticoagulation after knee or hip arthroplasty. DESIGN:Retrospective cohort study using data from the US MedAssets database. PATIENTS:Adults with a principal discharge diagnosis of knee or hip arthroplasty between January 1, 2013, and December 31, 2014. MAIN MEASURES:We identified charges for medications used for thromboprophylaxis within 7 days after the index surgery from billing records. The primary outcome was postoperative venous thromboembolism identified by International Classification of Diseases, 9th edition codes, from the index hospitalization, rehospitalization within 30 days, or during an outpatient visit within 90 days postoperatively. We compared postoperative thromboembolic risk in patients receiving aspirin-only and those receiving anticoagulants using propensity score-adjusted multivariable logistic regression models. KEY RESULTS:We identified 74,234 patients with knee arthroplasty and 36,192 with hip arthroplasty who received pharmacologic thromboprophylaxis. Aspirin-only was used in 27.9% of all patients, while 24.2% and 24.1% received warfarin or enoxaparin as prophylactic monotherapy, respectively. Postoperative venous thromboembolism occurred in 495 (0.67%) patients undergoing knee arthroplasty and 145 (0.40%) undergoing hip arthroplasty. Aspirin-only was not related to increased odds of postoperative venous thromboembolism compared with anticoagulants in multivariable adjusted analyses (odds ratio [OR] 0.70; 95% confidence interval [CI], 0.56-0.87, and OR 0.93; 95% CI, 0.62-1.38 for knee or hip arthroplasty, respectively). CONCLUSIONS:More than a fourth of all patients received aspirin as the sole antithrombotic agent after knee or hip arthroplasty. Postoperative thromboprophylaxis with aspirin-only was not associated with a higher risk of postoperative venous thromboembolism compared with anticoagulants after hip or knee arthroplasty.

Project description:IntroductionVenous thromboembolism (VTE) occurs in up to 40%-80% of patients after hip and knee arthroplasty. Clinical decision-making aided by guidelines is the most effective strategy to reduce the burden of VTE. However, the quality of guidelines is dependent on the strength of their evidence base. The objective of this article is to critically evaluate the quality of VTE prevention guidelines and the strength of their recommendations in VTE prophylaxis in patients undergoing hip and knee arthroplasty.MethodsRelevant literature up to 16 March 2020 was systematically searched. We searched databases such as Web of Science, PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature, China National Knowledge Infrastructure and WanFang and nine guidelines repositories. The identified guidelines were appraised by two reviewers using the Appraisal of Guidelines for Research and Evaluation II and appraised the strength of their recommendations independently. Following quality assessment, a predesigned data collection form was used to extract the characteristics of the included guideline.ResultsWe finally included 15 guidelines. Ten of the included guidelines were rated as 'recommended' or 'recommended with modifications'. The standardised scores were relatively high in the domains of Clarity of Presentation, and Scope and Purpose. The lowest average standardised scores were observed in the domains of Applicability and Stakeholder Involvement. In reference to the domains of Rigour of Development and Editorial Independence, the standardised scores varied greatly between the guidelines. The agreement between the two appraisers is almost perfect (intraclass correlation coefficients higher than 0.80). A considerable proportion of the recommendations is based on low-quality or very-low-quality evidence or is even based on working group expert opinion.ConclusionsIn summary, the majority of the recommendations are based on low-quality evidence, and further confirmation is needed. Furthermore, guideline developers should pay more attention to methodological quality, especially in the Stakeholder Involvement domain and the Applicability domain.

Dataset Information

CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

Publications

CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

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