RECORD3

REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 3 (2008)

Condition

Prophylaxis for VTE after total knee arthroplasty

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Objective

To compare the efficacy and safety of rivaroxaban with those of enoxaparin for the prevention of venous thromboembolism after elective total knee replacement

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Trial design

Randomized, double-blind phase III study
Active treatment: rivaroxaban 10 mg p.o. once daily, beginning 6–8 hours after surgery and continued for 10–14 days; placebo injections as in control treatment (n=1254)
Control treatment: enoxaparin 40 mg s.c. once daily, initiated 12 hours before surgery and restarted 6–8 hours after wound closure, administered for at least 10 days and up to day 14; placebo tablets as in active treatment (n=1277)

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Endpoints

Primary efficacy endpoint: composite of any DVT, non-fatal PE, and allcause mortality within 13–17 days after surgery
Secondary efficacy endpoints: major VTE (proximal DVT, non-fatal PE, or 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 occurring between intake of the first dose of study drug and 2 days after the last dose
Secondary safety endpoints: any on-treatment bleeding, non-major bleeding, hemorrhagic wound complications, other adverse events, and death

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Trial participants

2531 patients ≥18 years scheduled for elective total knee replacement

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Results

Efficacy outcome: In the modified ITT population (n=1702), the primary efficacy endpoint (total VTE) occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction 9.2%, relative risk reduction 49%). There were no pulmonary emboli or deaths in the rivaroxaban group; in the enoxaparin group, 4 patients had a pulmonary embolus and an additional 2 patients died
Safety outcome: In the safety population (n=2459), major bleeding occurred in 7 of 1220 patients (0.6%) who received rivaroxaban and in 6 of 1239 patients (0.5%) who received enoxaparin. The incidences of drug-related adverse events were similar in the two groups: 12.0% with rivaroxaban and 13.0% with enoxaparin

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Summary

Efficacy: Oral rivaroxaban was superior to subcutaneous enoxaparin for thromboprophylaxis after total knee arthroplasty
Safety: Both groups showed similar rates of all bleeding events, hemorrhagic wound complications, and adverse events

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Reference

Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AGG for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358:2776-2786

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Corresponding author

Michael R. Lassen, M.D., Department of Orthopedic Surgery, Nordsjallands Hospital, Usserd Kongevej 102, DK-2970 Horsholm, Denmark, e-mail: mirula@noh.regionh.dk

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