Further information: Venous Disease (see p1705) from Cardiovascular Medicine, 3rd Edn*

After myocardial infarction (MI) and stroke, venous thromboembolism (VT) is the third most common cause of vascular death. The anticoagulant warfarin is the current standard treatment for VT, but it requires constant monitoring and is subject to interactions with foods and other drugs. In this study, the investigators for the RE-COVER study [1] conducted a double-blind, double-dummy, randomized trial to compare the use of dabigatran, as an alternate therapy, with warfarin for patients with AVT. From April 2006 through November 2008, 2539 patients were enrolled from 228 clinical centers in 29 countries. The patients were 18 years of age or older and had acute, symptomatic, proximal deep-vein thrombosis of the legs or pulmonary embolism and were patients for whom 6 months of anticoagulant therapy was appropriate. A total of 1274 patients received a dose of 150 mg of dabigatran twice daily, and 1265 patients received warfarin that was dose-adjusted to achieve an international normalized ratio (INR) of 2.0–3.0. The primary outcomes were a recurrent incidence of VT and related deaths at 6-months. The safety end points were bleeding events, acute coronary syndromes (ACS), other adverse events, and results of liver-function tests.

Results showed that the effectiveness and the safety of each drug were similar. For patients given dabigatran, 30 had recurrent thromboembolism, as compared to 27 patients who were in the warfarin arm. The difference in risk was 0.4% (95% confidence interval [CI], -0.8 to 1.5; P<0.001 for the prespecified noninferiority margin). Hazard ratio (HR) for dabigatran patients was 1.10 (95% CI, 0.65–1.84). Twenty dabigatran patients had major bleeding episodes, as compared to 24 warfarin patients (HR with dabigatran, 0.82; 95% CI, 0.45–1.48). For episodes of any bleeding, 205 occurred in dabigatran patients and 277 in warfarin patients (HR with dabigatran, 71; 95% CI, 0.59–0.85). For both groups of patients, the number of deaths, ACS, and abnormal liver-function tests were similar. The data from this study support the use of dabigatran because it has no known interactions with foods, minimal interactions with other drugs, and thus, does not require routine monitoring.

On the Cardiovascular-Medicine.com website, a summary of an article from The New England Journal of Medicine (N Engl J Med 2009;361:1139-1151) was posted on October 27, 2009 on the use of the dabigatran as compared to warfarin for patients with atrial fibrillation (AF) [2], and it may be of interest to the readers of this summary.

[1] Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism (RE-COVER). N Engl J Med 2009;361:2342-52

[2] Dabigatran Versus Warfarin in Patients with Atrial Fibrillation (RE-LY). http://cardiovascular-medicine.com/?p=193

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