RE-COVER (2009)

Warfarin, while effective for VTE treatment, requires frequent monitoring and dose adjustments. This study aimed to determine if dabigatran, an oral direct thrombin inhibitor, could offer a simpler yet equally effective alternative for acute VTE treatment.

RE-COVER was a multicenter, randomized, double-blind, non-inferiority trial comparing dabigatran (after initial parenteral anticoagulation) to warfarin (after initial parenteral anticoagulation) for 6 months in patients with acute VTE. The primary endpoint was recurrent VTE or VTE-related death.

Dabigatran was non-inferior to warfarin for the primary endpoint of recurrent VTE or VTE-related death (2.4% vs. 2.9%; HR 0.82; 95% CI, 0.54-1.26). Major bleeding rates were similar between groups (3.1% for dabigatran vs. 3.6% for warfarin; HR 0.86; 95% CI, 0.60-1.22). The rates of any bleeding were also comparable. This demonstrated that dabigatran was as effective and safe as warfarin.

Dabigatran is a safe and effective alternative to warfarin for the treatment of acute VTE, offering the advantage of fixed dosing without routine laboratory monitoring.

Patients with severe renal impairment were excluded. The study design required an initial 5-10 days of parenteral anticoagulation before starting dabigatran.