This study, RE-COVER II, confirms the results of RE-COVER, showing that dabigatran is noninferior to warfarin in preventing recurrent venous thromboembolism (VTE) and has a lower risk of clinically relevant bleeding and any bleeding. The primary outcome, recurrent symptomatic VTE and related deaths during 6 months of treatment, occurred in 2.3% of dabigatran patients and 2.2% of warfarin patients (hazard ratio, 1.08; 95% CI, 0.64–1.80). Major bleeding occurred in 1.2% of dabigatran patients and 1.7% of warfarin patients (hazard ratio, 0.69; 95% CI, 0.36–1.32). Any bleeding occurred in 15.6% of dabigatran patients and 22.1% of warfarin patients (hazard ratio, 0.67; 95% CI, 0.56–0.81). The pooled analysis of RE-COVER and RE-COVER II showed similar results, with dabigatran being noninferior to warfarin for recurrent VTE and having a lower risk of clinically relevant bleeding and any bleeding. The study concludes that dabigatran is a safe and effective alternative to warfarin for the treatment of acute VTE.This study, RE-COVER II, confirms the results of RE-COVER, showing that dabigatran is noninferior to warfarin in preventing recurrent venous thromboembolism (VTE) and has a lower risk of clinically relevant bleeding and any bleeding. The primary outcome, recurrent symptomatic VTE and related deaths during 6 months of treatment, occurred in 2.3% of dabigatran patients and 2.2% of warfarin patients (hazard ratio, 1.08; 95% CI, 0.64–1.80). Major bleeding occurred in 1.2% of dabigatran patients and 1.7% of warfarin patients (hazard ratio, 0.69; 95% CI, 0.36–1.32). Any bleeding occurred in 15.6% of dabigatran patients and 22.1% of warfarin patients (hazard ratio, 0.67; 95% CI, 0.56–0.81). The pooled analysis of RE-COVER and RE-COVER II showed similar results, with dabigatran being noninferior to warfarin for recurrent VTE and having a lower risk of clinically relevant bleeding and any bleeding. The study concludes that dabigatran is a safe and effective alternative to warfarin for the treatment of acute VTE.