Dabigatran vs. Placebo in the Extended Treatment of VTE - RE-SONATE
The goal of the trial was to evaluate treatment with dabigatran versus placebo among patients with treated venous thromboembolism (VTE).
Dabigatran will be superior in the long-term prevention of recurrent venous thromboembolic events.
- Placebo Controlled
- Patients at least 18 years of age with confirmed pulmonary embolus or proximal deep vein thrombosis treated with an oral vitamin K antagonist for 6-18 months
Number of enrollees: 1,353 patients
- Symptomatic recurrent VTE including unexplained death, pulmonary embolism, or deep vein thrombosis
- Time to first major bleeding event
- Major bleeding or clinically relevant nonmajor bleeding
Patients with treated VTE were randomized to dabigatran 150 mg twice daily (n = 685) versus placebo (n = 668). Study drugs were administered for 6 months.
Overall 1,353 patients were randomized. The primary outcome of symptomatic recurrent VTE occurred in 0.4% of the dabigatran group versus 5.6% of the placebo group (p < 0.0001).
Major bleeding occurred in 0.3% versus 0% (p > 0.99), major bleeding or clinically relevant nonmajor bleeding occurred in 5.3% versus 1.8% (p = 0.0013), and any bleeding occurred in 10.5% versus 5.9% (p < 0.0027), respectively.
Any adverse event occurred in 50.6% versus 49.2%, severe adverse events occurred in 4.4% versus 4.6%, and adverse events leading to discontinuation of the study drug occurred in 7.3% versus 12.3%, respectively.
Any cardiovascular event occurred in 0.4% versus 0.3%, respectively.
Among patients with treated VTE, the use of dabigatran compared with placebo was effective at preventing recurrent VTE. While major bleeding was similar between the groups, a more sensitive assessment of bleeding events was increased with dabigatran.
Schulman S, Kearon C, Kakkar AK, et al., on behalf of the Re-MEDY and RE-SONATE Trials Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709-18.
Presented by Dr. Sam Schulman at the XXIII Congress of the International Society on Thrombosis and Haemostasis, Kyoto, Japan, July 2011.
Keywords: beta-Alanine, Benzimidazoles, Warfarin, Venous Thromboembolism, Hemorrhage
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