Dabigatran vs. Placebo in the Extended Treatment of VTE - RE-SONATE

Aug 09, 2011
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Date Presented:
01/01/2011
Date Published:
01/01/2013
Date Updated:
08/09/2011
Original Posted Date:
08/09/2011
References

Description:

NOTE: See the combined RE-MEDY and RE-SONATE trial update at: http://www.cardiosource.org/Science-And-Quality/Clinical-Trials/R/REMEDY-and-RESONATE.aspx.

The goal of the trial was to evaluate treatment with dabigatran versus placebo among patients with treated venous thromboembolism (VTE).

Hypothesis:

Dabigatran will be superior in the long-term prevention of recurrent venous thromboembolic events.

Study Design

  • Randomized
  • Parallel
  • Placebo Controlled

Patient Populations:

  • 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

Primary Endpoints:

  • 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

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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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