TY - JOUR
T1 - Aspirin or enoxaparin for VTE prophylaxis after primary partial, total or revision hip or knee arthroplasty
T2 - A secondary analysis from the CRISTAL cluster randomized trial
AU - The CRISTAL Study Group
AU - Sidhu, Verinder
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 - Chong, Beng Hock
AU - Jentz, Helen
AU - Cripps, Maggie
AU - Dekkers, Mark
AU - de Steiger, Richard
AU - Dixon, Michael
AU - Ellis, Andrew
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
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 - 2024/4/16
Y1 - 2024/4/16
N2 - Background This study compares aspirin to enoxaparin for symptomatic VTE prophylaxis within 90 days of any type of hip or knee arthroplasty performed for any diagnosis, in patients enrolled in the CRISTAL trial. Materials and methods CRISTAL was a cluster-randomised crossover, registry-nested non-inferiority trial across 31 hospitals in Australia. The primary publication was restricted to patients undergoing primary total hip or knee arthroplasty for a diagnosis of osteoarthritis. This report includes all enrolled patients undergoing hip or knee arthroplasty procedures (partial or total, primary or revision) performed for any indication. Hospitals were randomized to administer patients aspirin (100mg daily) or enoxaparin (40mg daily), for 35 days after hip arthroplasty and 14 days after knee arthroplasty. Crossover occurred after the patient enrolment target had been met for the first group. The primary outcome was symptomatic VTE within 90 days. Analyses were performed by randomization group. Results Between April 20, 2019 and December 18, 2020, 12384 patients were enrolled (7238 aspirin group and 5146 enoxaparin). Of these, 6901 (95.3%) given aspirin and 4827 (93.8%) given enoxaparin (total 11728, 94.7%) were included in the final analyses. Within 90 days, symptomatic VTE occurred in 226 (3.27%) aspirin patients and 85 (1.76%) enoxaparin patients, significant for the superiority of enoxaparin (estimated treatment difference 1.85%, 95% CI 0.59% to 3.10%, p = 0.004). Joint-related reoperation within 90 days was lower in the enoxaparin group (109/4827 (2.26%) vs 171/6896 (2.47%) with aspirin, estimated difference 0.77%; 95% CI 0.06% to 1.47%, p = 0.03). There were no significant differences in the other secondary outcomes. Conclusion In patients undergoing hip or knee arthroplasty (of any type, performed for any indication) enrolled in the CRISTAL trial, aspirin compared to enoxaparin resulted in a significantly higher rate of symptomatic VTE and joint-related reoperation within 90 days. These findings extend the applicability of the CRISTAL trial results.
AB - Background This study compares aspirin to enoxaparin for symptomatic VTE prophylaxis within 90 days of any type of hip or knee arthroplasty performed for any diagnosis, in patients enrolled in the CRISTAL trial. Materials and methods CRISTAL was a cluster-randomised crossover, registry-nested non-inferiority trial across 31 hospitals in Australia. The primary publication was restricted to patients undergoing primary total hip or knee arthroplasty for a diagnosis of osteoarthritis. This report includes all enrolled patients undergoing hip or knee arthroplasty procedures (partial or total, primary or revision) performed for any indication. Hospitals were randomized to administer patients aspirin (100mg daily) or enoxaparin (40mg daily), for 35 days after hip arthroplasty and 14 days after knee arthroplasty. Crossover occurred after the patient enrolment target had been met for the first group. The primary outcome was symptomatic VTE within 90 days. Analyses were performed by randomization group. Results Between April 20, 2019 and December 18, 2020, 12384 patients were enrolled (7238 aspirin group and 5146 enoxaparin). Of these, 6901 (95.3%) given aspirin and 4827 (93.8%) given enoxaparin (total 11728, 94.7%) were included in the final analyses. Within 90 days, symptomatic VTE occurred in 226 (3.27%) aspirin patients and 85 (1.76%) enoxaparin patients, significant for the superiority of enoxaparin (estimated treatment difference 1.85%, 95% CI 0.59% to 3.10%, p = 0.004). Joint-related reoperation within 90 days was lower in the enoxaparin group (109/4827 (2.26%) vs 171/6896 (2.47%) with aspirin, estimated difference 0.77%; 95% CI 0.06% to 1.47%, p = 0.03). There were no significant differences in the other secondary outcomes. Conclusion In patients undergoing hip or knee arthroplasty (of any type, performed for any indication) enrolled in the CRISTAL trial, aspirin compared to enoxaparin resulted in a significantly higher rate of symptomatic VTE and joint-related reoperation within 90 days. These findings extend the applicability of the CRISTAL trial results.
KW - enoxaparin
KW - aspirin
KW - VTE prophylaxis
KW - hip arthroplasty
KW - knee arthroplasty
KW - osteoarthritis
UR - http://www.scopus.com/inward/record.url?scp=85190733129&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0298152
DO - 10.1371/journal.pone.0298152
M3 - Article
C2 - 38626226
AN - SCOPUS:85190733129
SN - 1932-6203
VL - 19
JO - PLoS One
JF - PLoS One
IS - 4
M1 - e0298152
ER -