TY - JOUR
T1 - Effect of Aspirin vs Enoxaparin on 90-Day Mortality in Patients Undergoing Hip or Knee Arthroplasty
T2 - A Secondary Analysis of the CRISTAL Cluster Randomized Trial
AU - CRISTAL Study Group
AU - Sidhu, Verinder S.
AU - Kelly, Thu-Lan
AU - Pratt, Nicole
AU - Graves, Stephen E.
AU - Buchbinder, Rachelle
AU - Adie, Sam
AU - Cashman, Kara
AU - Ackerman, Ilana N.
AU - Bastiras, Durga
AU - Brighton, Roger
AU - Burns, Alexander W. R.
AU - Clavisi, Ornella
AU - Cripps, Maggie
AU - Dekkers, Mark
AU - de Steiger, Richard
AU - Dixon, Michael
AU - Griffith, Elizabeth C.
AU - Hale, David
AU - Hansen, Amber
AU - Harris, Anthony
AU - Hau, Raphael
AU - Horsley, Mark
AU - James, Dugal
AU - Khorshid, Omar
AU - Kuo, Leonard
AU - Lewis, Peter
AU - Lieu, David
AU - Lorimer, Michelle
AU - MacDessi, Samuel J.
AU - McCombe, Peter
AU - McDougall, Catherine
AU - Mulford, Jonathan
AU - Naylor, Justine Maree
AU - Page, Richard S.
AU - Radovanovic, John
AU - Solomon, Michael
AU - Sorial, Rami
AU - Summersell, Peter
AU - Tran, Phong
AU - Walter, William L.
AU - Webb, Steve
AU - Wilson, Chris
AU - Wysocki, David
AU - Harris, Ian A.
PY - 2023/6/9
Y1 - 2023/6/9
N2 - Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23458 patients from 31 hospitals were included, with 14156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.
AB - Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23458 patients from 31 hospitals were included, with 14156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.
KW - arthroplasty
KW - venous thromboembolism (VTE)
KW - aspirin
KW - enoxaparin
KW - patient outcomes
KW - clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85162063712&partnerID=8YFLogxK
U2 - 10.1001/jamanetworkopen.2023.17838
DO - 10.1001/jamanetworkopen.2023.17838
M3 - Article
SN - 2574-3805
VL - 6
JO - JAMA network open
JF - JAMA network open
IS - 6
M1 - e2317838
ER -