RE-NOVATE

Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism
after total hip replacement (2007)

Condition

Prophylaxis for VTE after total hip replacement

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Objective

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

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Trial design

Randomized, double-blind phase III study with non-inferiority design
Active treatment: dabigatran 150 mg (n=1174) or 220 mg (n=1157) 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
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=1162)

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Endpoints

Primary efficacy endpoint: composite of total VTE and all-cause mortality during treatment
Secondary efficacy endpoints: all-cause mortality, symptomatic DVT, distal DVT, composite of fatal/non-fatal DVT and PE during follow-up
Primary safety endpoint: major bleeding
Secondary safety endpoints: composite of major and clinically relevant non-major bleeding events, other bleeding events during treatment, liver enzyme elevation and acute coronary events

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Trial participants

3494 patients (mean age 64 years), scheduled for elective total hip replacement

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Results

Efficacy outcome: In patients with evaluable efficacy outcome (n=2651), the primary efficacy endpoint (all VTE and death from any cause) occurred in 75 of 874 patients (8.6%) given 150 mg dabigatran, in 53 of 880 patients (6.0%) given 220 mg dabigatran and in 60 of 897 patients (6.7%) given enoxaparin
Safety outcome: In the patient population for safety analysis of 3463 patients, major bleeding occurred in 15 of 1163 patients (1.3%) receiving 150 mg dabigatran, in 23 of 1146 patients (2.0%) receiving 220 mg dabigatran and in 18 of 1154 patients (1.6%) receiving enoxaparin. Minor bleeding developed in 6.2% of patients on 150 mg dabigatran, 6.1% on 220 mg dabigatran and in 6.2% receiving enoxaparin. Adverse events leading to treatment discontinuation occurred in 8%, 6% and 6% for 150 mg dabigatran, 220 mg dabigatran, and enoxaparin, respectively

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Summary

Efficacy: Oral dabigatran showed statistical non-inferiority to subcutaneous enoxaparin for VTE and all-cause death. There was no significant difference between dabigatran and enoxaparin for major VTE and VTE-related death
Safety: The rates of minor and major bleeding were comparable in all 3 study groups

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Reference

Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007;370:949-956

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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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