A randomized, double-blind, double-dummy trial compared dabigatran 150 mg twice daily with warfarin for the treatment of acute venous thromboembolism (VTE) in 2589 patients. The primary outcome, recurrent symptomatic VTE or related deaths, occurred in 2.3% of dabigatran patients versus 2.2% of warfarin patients (hazard ratio 1.08; 95% CI 0.64–1.80). Major bleeding occurred in 1.2% of dabigatran patients versus 1.7% of warfarin patients (hazard ratio 0.69; 95% CI 0.36–1.32). Any bleeding occurred in 15.6% of dabigatran patients versus 22.1% of warfarin patients (hazard ratio 0.67; 95% CI 0.56–0.81). Pooled analysis of the RE-COVER II and RE-COVER trials showed hazard ratios for recurrent VTE of 1.09 (95% CI 0.76–1.57), for major bleeding of 0.73 (95% CI 0.48–1.11), and for any bleeding of 0.70 (95% CI 0.61–0.79). Dabigatran had similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin. The study was funded by Boehringer Ingelheim. Dabigatran is an oral direct thrombin inhibitor with efficacy similar to warfarin and reduced risk of bleeding. The results confirm noninferiority of dabigatran to warfarin for preventing recurrent VTE and superiority in reducing clinically relevant bleeding and any bleeding. Dabigatran was noninferior to warfarin for the prevention of recurrent or fatal VTE. The risk of major bleeding was lower with dabigatran compared with warfarin. The results were consistent across subgroups. Dabigatran showed a similar trend for fewer major bleedings. The study also found that dabigatran had a lower risk of bleeding compared with warfarin. The results were consistent with other studies comparing dabigatran with warfarin. Dabigatran was noninferior to warfarin in terms of efficacy and had a lower risk of bleeding. The study also found that dabigatran had a lower risk of bleeding compared with warfarin. The results were consistent with other studies comparing dabigatran with warfarin. Dabigatran was noninferior to warfarin in terms of efficacy and had a lower risk of bleeding.A randomized, double-blind, double-dummy trial compared dabigatran 150 mg twice daily with warfarin for the treatment of acute venous thromboembolism (VTE) in 2589 patients. The primary outcome, recurrent symptomatic VTE or related deaths, occurred in 2.3% of dabigatran patients versus 2.2% of warfarin patients (hazard ratio 1.08; 95% CI 0.64–1.80). Major bleeding occurred in 1.2% of dabigatran patients versus 1.7% of warfarin patients (hazard ratio 0.69; 95% CI 0.36–1.32). Any bleeding occurred in 15.6% of dabigatran patients versus 22.1% of warfarin patients (hazard ratio 0.67; 95% CI 0.56–0.81). Pooled analysis of the RE-COVER II and RE-COVER trials showed hazard ratios for recurrent VTE of 1.09 (95% CI 0.76–1.57), for major bleeding of 0.73 (95% CI 0.48–1.11), and for any bleeding of 0.70 (95% CI 0.61–0.79). Dabigatran had similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin. The study was funded by Boehringer Ingelheim. Dabigatran is an oral direct thrombin inhibitor with efficacy similar to warfarin and reduced risk of bleeding. The results confirm noninferiority of dabigatran to warfarin for preventing recurrent VTE and superiority in reducing clinically relevant bleeding and any bleeding. Dabigatran was noninferior to warfarin for the prevention of recurrent or fatal VTE. The risk of major bleeding was lower with dabigatran compared with warfarin. The results were consistent across subgroups. Dabigatran showed a similar trend for fewer major bleedings. The study also found that dabigatran had a lower risk of bleeding compared with warfarin. The results were consistent with other studies comparing dabigatran with warfarin. Dabigatran was noninferior to warfarin in terms of efficacy and had a lower risk of bleeding. The study also found that dabigatran had a lower risk of bleeding compared with warfarin. The results were consistent with other studies comparing dabigatran with warfarin. Dabigatran was noninferior to warfarin in terms of efficacy and had a lower risk of bleeding.