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https://swslhd.intersearch.com.au/swslhdjspui/handle/1/904| Title: | Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial |
| Authors: | Sidhu, V. S. Kelly, T. L. Pratt, N. Graves, S. E. Buchbinder, R. Adie, S. Cashman, K. Ackerman, I. Bastiras, D. Brighton, R. Burns, A. W. R. Chong, B. H. Clavisi, O. Cripps, M. Dekkers, M. De Steiger, R. Dixon, M. Ellis, A. Griffith, E. C. Hale, D. Hansen, A. Harris, A. Hau, R. Horsley, M. James, D. Khorshid, O. Kuo, L. Lewis, P. Lieu, D. Lorimer, M. Macdessi, S. McCombe, P. McDougall, C. Mulford, J. Naylor, J. M. Page, R. S. Radovanovic, J. Solomon, M. Sorial, R. Summersell, P. Tran, P. Walter, W. L. Webb, S. Wilson, C. Wysocki, D. Harris, I. A. |
| SWSLHD Author: | Lieu, David Naylor, Justine M. |
| Affiliates: | School of Clinical Medicine, UNSW Medicine and Health, UNSW Sydney, Sydney, NSW, Australia Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia Clinical and Health Sciences, Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, SA, Australia Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, SA, Australia Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, VIC, Australia School of Clinical Medicine, UNSW Medicine and Health, St George and Sutherland Clinical Campuses, Faculty of Medicine and Health, UNSW SydneyNSW, Australia South Australian Health and Medical Research Institute, Adelaide, SA, Australia Orthopaedic Department, Westmead Private Hospital, Westmead, Sydney, Australia Orthopaedic Department, Lakeview Private Hospital, Baulkham Hills, Sydney, NSW, Australia Orthopaedic Department, Calvary John James Hospital, Deakin, Canberra, Australia Department of Medicine, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia Department of Hematology, New South Wales Pathology, Kogarah Campus, Sydney, NSW, Australia Musculoskeletal Australia, Melbourne, VIC, Australia Orthopaedic Department, Greenslopes Private Hospital, Greenslopes, Brisbane, QLD, Australia Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia Orthopaedic Department, Kareena Private Hospital, Sutherland, Sydney, NSW, Australia Orthopaedic Department, Royal North Shore Hospital, St Leonard's, Sydney, NSW, Australia Sydney Musculoskeletal Health Flagship Centre, The University of Sydney, Royal North Shore Hospital, St Leonard's, Sydney, NSW, Australia Orthopaedic Department, Hornsby and Kuringai Hospital, Hornsby, Sydney, NSW, Australia Centre for Health Economics, Monash Business School, Monash University, Melbourne, VIC, Australia Eastern Health Clinical School, Monash University, Box Hill, VIC, Australia Orthopaedic Department, Royal Prince Alfred Hospital, Camperdown, Sydney, NSW, Australia Bendigo Healthcare Group, Bendigo Hospital, Bendigo, VIC, Australia Orthopaedic Department, Fremantle Hospital, Fremantle, WA, Australia Orthopaedic Department, Canterbury Hospital, Canterbury, Sydney, NSW, Australia Orthopaedic Department, Calvary Hospital, Adelaide, SA, Australia Orthopaedic Department, Fairfield Hospital, Fairfield, Sydney, NSW, Australia Orthopaedic Department, St George Private Hospital, Kogarah, Sydney, NSW, Australia Orthopaedic Department, Frankston Hospital, Frankston, Melbourne, VIC, Australia Orthopaedic Department, The Prince Charles Hospital, Chermside, Brisbane, QLD, Australia Orthopaedic Department, Launceston General Hospital, Launceston, TAS, Australia School of Medicine, St John of God Hospital and Barwon Health, Deakin University, Geelong, VIC, Australia Orthopaedic Department, Mater Hospital, Raymond Terrace, Brisbane, QLD, Australia Orthopaedic Department, Prince of Wales Hospital, Randwick, Sydney, NSW, Australia Orthopaedic Department, Nepean Hospital, Nepean, Sydney, NSW, Australia Orthopaedic Department, Coffs Harbour Base Hospital, Coffs Harbour, NSW, Australia Orthopaedic Department, Western Health, Melbourne, VIC, Australia The Kolling Institute, Faculty of Medicine and Health, The University of Sydney, The Northern Sydney Local Health District, Sydney, NSW, Australia Orthopaedic Department, Flinders Medical Centre, Bedford Park, Adelaide, SA, Australia Department of Medicine and Public Health, Flinders University, Adelaide, SA, Australia Orthopaedic Department, Sir Charles Gardiner Hospital, Perth, WA, Australia Institute of Musculoskeletal Health, School of Public Health, The University of Sydney, Sydney, NSW, Australia |
| Department: | Fairfield Hospital, Department of Orthopaedics |
| Issue Date: | 2022 |
| Journal: | JAMA |
| Abstract: | Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA. Design, setting, and participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021. Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation. Main outcomes and measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group. Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group. Conclusions and relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis. Trial registration: ANZCTR Identifier: ACTRN12618001879257. Conflict of interest statement Conflict of Interest Disclosures: Drs de Steiger and Lewis reported being deputy directors of the AOANJRR, under whose registry nested clinical trials platform this study was performed. Dr McDougall reported consulting for Johnson & Johnson in the field of orthopedic instruments and giving paid teaching presentations for Stryker on total knee replacement. Dr Page reported receipt of institutional education and research support from DePuy Synthes. Dr Walter reported receipt of research support grants and personal consulting fees from DePuy Synthes, receipt of royalties from and holding shares in MatOrtho, holding shares in Navbit, receipt of personal consulting fees from Smith + Nephew, receipt of personal consulting fees from MicroPort, and receipt of research support from Think Surgical; in addition, Dr Walter had a patent issued with Navbit not related to anticoagulation. Dr Wilson reported receipt of personal fees from DePuy Australia. No other disclosures were reported. |
| URI: | https://swslhd.intersearch.com.au/swslhdjspui/handle/1/904 |
| Digital object identifier: | 10.1001/jama.2022.13416 |
| Appears in Collections: | Fairfield Hospital |
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