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


Prophylaxis for VTE after total hip replacement

Close this section


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

Close this section

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)

Close this section


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

Close this section

Trial participants

4541 patients ≥18 years scheduled for elective total hip replacement

Close this section


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%)

Close this section


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

Close this section


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

Close this section

Corresponding author

Bengt I. Eriksson, MD, Orthopedic Department, Sahlgrenska University Hospital – Ostra, Smorslottsgatan 1, SE-41685 Gothenburg, Sweden

Close this section

Back To List

Recommend pageBack to top