REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 2 Study in Patients Undergoing Elective Total Hip Replacement (2008)


Prophylaxis for VTE after total hip replacement

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To compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin 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, beginning 6–8 hours after wound closure, for 31–39 days, plus placebo injection for
10–14 days (n=1252)
Control treatment: enoxaparin 40 mg s.c. once daily, initiated 12 hours before surgery and restarted 6–8 hours after wound closure, for 10–14 days, plus placebo tablet for 31–39 days (n=1257)

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Primary efficacy endpoint: composite of any DVT, non-fatal PE, and allcause mortality up to day 36±6
Secondary efficacy endpoints: major VTE (proximal DVT, non-fatal PE, and VTE-related death), DVT (any, proximal, distal), symptomatic VTE during treatment and follow-up, and death during the follow-up period
Primary safety endpoint: major bleeding (beginning after the first blinded dose up to 2 days after the last dose)
Secondary safety endpoints: any on-treatment bleeding, non-major bleeding, hemorrhagic wound complications, adverse events, and death

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Trial participants

2509 patients ≥18 years scheduled for elective total hip replacement

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Efficacy outcome: In the modified ITT population (n=1733), the primary efficacy endpoint occurred in 17 of 864 patients (2.0%) in the rivaroxaban group and in 81 of 869 patients (9.3%) in the enoxaparin group (absolute risk reduction 7.3%, relative risk reduction 79%)
Safety outcome: The incidence of any on-treatment bleeding was similar in both groups: 81 events in 1228 patients (6.6%) in the rivaroxaban safety population vs. 68 events in 1229 patients (5.5%) in the enoxaparin safety population (p=0.25). Major bleeding occurred in one patient in each group (<0.1%). Both treatments were associated with a similar number of adverse events (rivaroxaban 62.5% vs. enoxaparin 65.7%)

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Efficacy: Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin for the prevention of VTE in patients undergoing total hip arthroplasty
Safety: The rates of major and clinically relevant non-major bleeding were low and much the same in both groups

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Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008;372:31-39

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Corresponding author

Prof. Ajay K. Kakkar, Barts and the London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK, e-mail:

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