SACRE

Study comparing oral anticoagulants with reviparin (2002)

Condition

Extended prophylaxis for VTE after total hip replacement

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Objective

To evaluate the efficacy and safety of fixed-dose reviparin compared with adjusted-dose acenocoumarol for extended out-of-hospital VTE prophylaxis after elective hip surgery

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Trial design

Randomized study with parallel groups
All patients (n=1289) received reviparin, 4200 anti-Xa IU s.c. as an initial dose 12 hours preoperatively and 6–10 hours after surgery 4200 anti-Xa IU s.c. once daily for 3±1 days until randomization
Active treatment: reviparin 4200 anti-Xa IU s.c. once daily (n=644)
Control treatment: acenocoumarol (target INR 2.0–3.0) once daily for 6 weeks(n=645)

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Endpoints

Primary efficacy endpoint: cumulative failure rate of symptomatic VTE, major bleeding, and death
Secondary endpoints: symptomatic VTE, bleeding complications, mortality

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Trial participants

1289 patients aged ≥18 years, scheduled for elective total hip replacement

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Results

Efficacy outcome: In the intent-to-treat population (n=1279), the cumulative failure rate was 3.7% (24 of 643 patients) in the reviparin group compared with 8.3% (53 of 636 patients) in the acenocoumarol group (relative risk reduction 55%). Symptomatic thromboembolic events occurred in 2.3% (15/643) patients vs. 3.3% (23/636) patients receiving reviparin or oral anticoagulants, respectively. 2 patients assigned to acenocoumarol died (0.3% vs. 0%)
Safety outcome: Major bleeding occurred in 1.4% (9/643) patients assigned to reviparin and in 5.5% (35/646) assigned to acenocoumarol. The incidence of clinically serious bleeding was also much less frequent in patients receiving reviparin (0.8% vs. 3.1%). 13 patients (2.0%) in the reviparin group developed minor bleeding, as compared with 17 patients (2.7%) in the acenocoumarol group

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Summary

Efficacy: In patients undergoing elective hip replacement who received extended out-of-hospital prophylaxis, fixed-dose reviparin resulted in a significantly higher benefit-risk ratio as adjusted-dose acenocoumarol
Safety: The incidence of major bleeding complications was significantly lower with reviparin, as compared with acenocoumarol

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Reference

Samama CM, Vray M, Barré J, Fiessinger JN, Rosencher N, Lecompte T, Potron G, Basile J, Hull R, Desmichels D, for the SACRE Study Investigators. Extended venous thromboembolism prophylaxis after total hip replacement: a comparison of low-molecular-weight heparin with oral anticoagulant. Arch Intern Med 2002;162:2191-2196

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Corresponding author

Charles Marc Samama, MD, PhD, Département d’Anesthésie-Réanimation, Hôpital Avicenne-125, route de Stalingrad, 93009 Bobigny CEDEX, France, e-mail: cmsamama@invivo.edu

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