Key result
Low-molecular-weight heparin showed no superiority over aspirin for 90-day composite VTE, bleeding, infection, or death in fracture patients (50.4% superiority probability; 95% CI 47.7-53.2%; p=0.73).
RCT (n=329)
Open-label
Randomized
No
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BACKGROUND: Emerging evidence suggests aspirin may be an effective venous thromboembolism (VTE) prophylaxis for orthopaedic trauma patients, with fewer bleeding complications. We used a patient-centered weighted composite outcome to globally evaluate aspirin versus low-molecular-weight heparin (LMWH) for VTE prevention in fracture patients. METHODS: We conducted an open-label randomized clinical trial of adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture. Patients were randomized to receive LMWH (enoxaparin 30-mg) twice daily (n = 164) or aspirin 81-mg twice daily (n = 165). The primary outcome was a composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury. A Global Rank test and weighted time to event analysis were used to determine the probability of treatment superiority for LMWH, given a 9% patient preference margin for oral administration over skin injections. RESULTS: Overall, 18 different combinations of outcomes were experienced by patients in the study. Ninety-nine patients in the aspirin group (59.9%) and 98 patients in the LMWH group (59.4%) were event-free within 90 days of injury. Using a Global Rank test, the LMWH had a 50.4% (95% CI, 47.7-53.2%, p = 0.73) probability of treatment superiority over aspirin. In the time to event analysis, LMWH had a 60.5% probability of treatment superiority over aspirin with considerable uncertainty (95% CI, 24.3-88.0%, p = 0.59). CONCLUSION: The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients. LMWH demonstrated a 60.5% VTE prevention benefit in the weighted time to event analysis. However, this difference did not reach statistical significance and was similar to the elicited patient preferences for aspirin.
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Haac et al. (2020) conducted an RCT in Orthopaedic trauma (operative extremity, pelvis, or acetabular fracture) (n=329). Aspirin vs. Low-molecular-weight heparin (enoxaparin 30 mg twice daily) was evaluated on Composite of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury (event-free survival reported) (Probability of LMWH treatment superiority 50.4% (Global Rank test), 95% CI 47.7-53.2%, p=0.73). Low-molecular-weight heparin showed no superiority over aspirin for 90-day composite VTE, bleeding, infection, or death in fracture patients (50.4% superiority probability; 95% CI 47.7-53.2%; p=0.73).
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