Risk-stratified thromboprophylaxis effects of aspirin versus low-molecular-weight heparin in orthopedic trauma patients: A secondary analysis of the PREVENT CLOT trial.

Autor: O'Hara NN; From the Department of Orthopaedics (N.N.O.'H., R.V.O.'T., G.P.S.), R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine; Department of Health Policy and Management (K.P.F., R.C.C., A.R.C.), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Surgery (J.C.), University of California in San Francisco, San Francisco, California; Department of Surgery (E.R.H.), Johns Hopkins Hospital, Baltimore, Maryland; Department of Orthopaedics and Sports Medicine (R.F.), University of Washington, Seattle, Washington; Department of Surgery (A.C.), Carolinas Medical Center, Atrium Health, Charlotte, North Carolina; Department of Orthopaedic Surgery (W.T.O.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Orthopaedics (G.G.), Inova Fairfax Hospital, Fairfax, Virginia; Department of Surgery (M.E.K.), University of Mississippi, Jackson, Mississippi; PREVENT CLOT Patient Stakeholder, (D.M.); and Program in Trauma/Department of Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland., O'Toole RV, Frey KP, Castillo RC, Cuschieri J, Haut ER, Slobogean GP, Firoozabadi R, Christmas AB, Obremskey WT, Carlini AR, Gaski GE, Kutcher ME, Marvel D, Stein DM
Jazyk: angličtina
Zdroj: The journal of trauma and acute care surgery [J Trauma Acute Care Surg] 2024 Apr 01; Vol. 96 (4), pp. 573-582. Date of Electronic Publication: 2023 Dec 08.
DOI: 10.1097/TA.0000000000004226
Abstrakt: Background: The PREVENT CLOT trial concluded that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin (LMWH) in preventing death after orthopedic trauma. However, it was unclear if these results applied to patients at highest risk of thrombosis. Therefore, we assessed if the effect of aspirin versus LMWH differed based on patients' baseline risk of venous thromboembolism (VTE).
Methods: The PREVENT CLOT trial enrolled 12,211 adult patients with fractures. This secondary analysis stratified the study population into VTE risk quartiles: low (<1%) to high (>10%) using the Caprini score. We assessed stratum-specific treatment effects using the win ratio method, in which each patient assigned to aspirin was paired with each assigned to LMWH. In each pair, we compared outcomes hierarchically, starting with death, then pulmonary embolism, deep vein thrombosis, and bleeding. The secondary outcome added patients' medication satisfaction as a fifth composite component.
Results: In the high-risk quartile (n = 3052), 80% had femur fracture, pelvic, or acetabular fractures. Thoracic (47%) and head (37%) injuries were also common. In the low risk quartile (n = 3053), most patients had a tibia fracture (67%), 5% had a thoracic injury, and less than 1% had head or spinal injuries. Among high risk patients, thromboembolic events did not differ statistically between aspirin and LMWH (win ratio, 0.94; 95% confidence interval [CI], 0.82-1.08, p = 0.42). This result was consistent in the low (win ratio, 1.15; 95% CI, 0.90-1.47, p = 0.27), low-medium (win ratio, 1.05; 95% CI, 0.85-1.29, p = 0.68), and medium-high risk quartiles (win ratio, 0.94; 95% CI, 0.80-1.11, p = 0.48). When medication satisfaction was considered, favorable outcomes were 68% more likely with aspirin (win ratio, 1.68; 95% CI, 1.60-1.77; p < 0.001).
Conclusion: Thromboembolic outcomes were similar with aspirin or LMWH, even among patients at highest risk of VTE. Aspirin was favored if medication satisfaction was also considered.
Level of Evidence: Therapeutic/Care Management; Level II.
(Copyright © 2023 American Association for the Surgery of Trauma.)
Databáze: MEDLINE