RE-NOVATE II

Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (2011)

Condition

Prophylaxis for VTE after total hip arthroplasty

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Objective

To compare the efficacy and safety of dabigatran and enoxaparin in the prevention of VTE after total hip arthroplasty

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Trial design

Randomized, double-blind phase III study with non-inferiority design
Active treatment: dabigatran 220 mg p.o. once daily, starting 1–4 hours after surgery with half dose on the first day, for 28–35 days; placebo injections as in control treatment (n=1010)
Control treatment: enoxaparin 40 mg s.c. once daily, starting in the evening before surgery, for 28–35 days; placebo tablets as in active treatment (n=1003)

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Endpoints

Primary efficacy endpoint: composite of total VTE and all cause mortality during the treatment period
Secondary efficacy endpoints: major VTE and VTE-related mortality
Safety endpoints: major bleeding events, clinically relevant bleeding events, any bleeding events

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Trial participants

2055 patients aged ≥18 years, scheduled for elective total hip arthroplasty

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Results

Efficacy outcome: In patients with evaluable efficacy outcome (n=1577), the primary efficacy endpoint (all VTE and death from any cause) occurred in 61 of 792 patients (7.7%) given dabigatran and in 69 of 785 patients (8.8%) given enoxaparin
Safety outcome: In the patient population for safety analysis of 2013 patients major bleeding occurred in 14 of 1010 patients (1.4%) receiving dabigatran and in 9 of 1003 patients (0.9%) receiving enoxaparin. Minor bleeding developed in 6.0% of the patients assigned to dabigatran and in 5.4% of the patients treated with enoxaparin. Adverse events leading to treatment discontinuation occurred in 5.9% and 5.2% for dabigatran and enoxaparin

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Summary

Efficacy: Extended prophylaxis with dabigatran was as effective as prophylaxis with enoxaparin in reducing the risk of VTE after total hip arthroplasty, and superior to enoxaparin in reducing the risk of major VTE
Safety: The risk of bleeding and safety profiles were similar in both study groups

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Reference

Eriksson BE, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, Schnee JM, Friedman RJ; RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). Thromb Haemost 2011;105:721-729

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Corresponding author

B.I. Eriksson, Orthopaedics Department, Sahlgrenska University Hospital/Östra, SE-41685 Göteborg, Sweden, e-mail: b.eriksson@orthop.gu.se

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