August 31st, 2010

Positive Results for Rivaroxaban in EINSTEIN-DVT

The EINSTEIN-DVT study tested the effect of the new oral anticoagulant rivaroxaban in the setting of DVT. The open-label, non-inferiority study randomized more than 3,400 patients with acute, symptomatic DVT to either oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months, based on the attending physician’s assessment at baseline.

Dr. Harry Büller reported that recurrent symptomatic venous thromboembolism took place in 2.1% of patients in the rivaroxaban group compared to 3.0% of the subjects on conventional therapy (p<0.0001 for non-inferiority). The rate of major and clinically relevant non-major bleeding was 8.1% in each group. Büller reported there were no signals of liver toxicity and that the drug was well-tolerated during the trial.

Here are additional results (rivaroxban versus conventional therapy):

  • Net clinical benefit (the composite of the primary efficacy outcome plus major bleeding): 2.9% vs. 4.2% (HR 0.67, CI: 0.47 – 0.95).
  • All-cause mortality: 2.2% vs. 2.9% (HR 0.67, CI: 0.44 – 1.02)
  • Cardiovascular events: 0.7% vs. 0.8% (HR 0.79, CI: 0.36 – 1.71)

“The single-drug approach with rivaroxaban will provide clinicians and patients with an attractive, simple, alternative regimen for the initial and long-term treatment of deep vein thrombosis.” said Büller, in an ESC press release. The results of ROCKET-AF, which is testing the efficacy of rivaroxaban for stroke prevention in AF, are scheduled to be presented in November at the AHA.

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