RECORD1

REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 1 (2008)

Condition

Prophylaxis for VTE after total hip replacement

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Objective

To compare the efficacy and safety of rivaroxaban with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty

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Trial design

Randomized, double-blind phase 3 study
Active treatment: rivaroxaban 10 mg p.o. once daily, starting 6–8 hours after wound closure, through day 35 after surgery, plus placebo injections as in control treatment (n=2266)
Control treatment: enoxaparin 40 mg s.c. once daily, initiated 12 hours before surgery and restarted 6–8 hours after wound closure, administered for 35 days, plus placebo tablets as in active treatment (n=2275)

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Endpoints

Primary efficacy endpoint: composite of DVT, non-fatal PE, or death from any cause up to 36±6 days
Secondary efficacy endpoints: major VTE (proximal DVT, non-fatal PE, or death from VTE), DVT (any, proximal, distal), symptomatic VTE during treatment and follow-up, and death during the follow-up period
Primary safety endpoint: major bleeding
Secondary safety endpoints: any on-treatment bleeding, non-major bleeding, hemorrhagic wound complications, adverse events, and death

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Trial participants

4541 patients ≥18 years scheduled for elective total hip replacement

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Results

Efficacy outcome: In the modified ITT population (n=3153), the primary efficacy endpoint (total VTE) occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction 2.6%, relative risk reduction 70%)
Safety outcome: The superior efficacy of rivaroxaban was not associated with any significant increases in the incidence of major bleeding or any other bleeding events. Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 patients (0.1%) in the enoxaparin group. The number of adverse events was similar for rivaroxaban (65.8%) and enoxaparin (66.1%)

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Summary

Efficacy: Oral rivaroxaban was superior to subcutaneous enoxaparin for prevention of venous thromboembolic events
Safety: The rates of all bleeding events, hemorrhagic wound complications, and adverse events were similar in both groups

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Reference

Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765-2775

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Corresponding author

Bengt I. Eriksson, MD, Orthopedic Department, Sahlgrenska University Hospital – Ostra, Smorslottsgatan 1, SE-41685 Gothenburg, Sweden
e-mail: b.eriksson@orthop.gu.se

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