6/29/23, 1:08 AM RECORD1 Pathway Feedback Search Clinical Topics Home Studies RECORD1 RECORD1 Disease Disease Hip fracture Hip osteoarthritis Trial question What is the effect of rivaroxaban for extended thromboprophylaxis in patients undergoing total hip arthroplasty? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.7% female N = 4541 44.3% male 4541 patients (2462 female, 1971 male) Inclusion criteria: patients undergoing total hip arthroplasty Key exclusion criteria: bilateral hip arthroplasty, pregnant or breast-feeding, active bleeding or a high risk of bleeding, or a contraindication for prophylaxis with enoxaparin or a condition that might require an adjusted dose of enoxaparin, substantial liver disease, or severe renal impairment Interventions N=2209 rivaroxaban (10 mg PO once daily) N=2224 enoxaparin (40 mg SC once daily) https://web.pathway.md/studies/reckGSL1azqrstvxv 1/2 6/29/23, 1:08 AM RECORD1 Pathway Primary outcome Deep vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days 3.7 % 3.7 2.8 % 1.9 % Significant increase 1.1 0.9 % NNH = 38 0.0 % Rivaroxaban Enoxaparin Significant increase in deep vein thrombosis, nonfatal PE, or death from any cause at 36 days (1.1% vs. 3.7%; ARR 2.6, 95% CI 1.5 to 3.7) Secondary outcomes Significant increase in major VTE (0.2% vs. 2%; ARR 1.7, 95% CI 1 to 2.5) Significant increase in DVT (0.8% vs. 3.4%; ARR 2.7, 95% CI 2.7 to 1.2) Safety outcomes No significant differences in major bleeding (0.3% vs. 0.1%, p=0.18). Conclusion In patients undergoing total hip arthroplasty, rivaroxaban was superior to enoxaparin with respect to deep vein thrombosis, nonfatal PE, or death from any cause at 36 days. Reference Eriksson BI, Borris LC, Friedman RJ et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. Open reference URL https://web.pathway.md/studies/reckGSL1azqrstvxv 2/2