Key result
Dabigatran matches warfarin for recurrent VTE prevention while reducing major bleeding.
Why the study?
The efficacy and safety of dabigatran versus warfarin according to the index event of symptomatic PE with or without DVT, or DVT alone, required investigation.
Does dabigatran prevent recurrent VTE or VTE-related death compared to warfarin in patients with acute pulmonary embolism or DVT?
RCT (n=5,107)
randomized
Does dabigatran prevent recurrent VTE or VTE-related death compared to warfarin in patients with acute pulmonary embolism or DVT?
Hazard Ratio: 1.09 (95% CI 0.77–1.54)
Absolute Event Rate: 2.7% vs 2.4%
Dabigatran is as effective as warfarin for preventing recurrent VTE in patients presenting with acute PE or DVT, with a significantly lower risk of major bleeding.
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Supports dabigatran as alternative to warfarin for recurrent VTE prevention; confirms meta-analytic equivalence in acute PE/DVT.
SCHELLONG et al. (2016) conducted an RCT in Acute pulmonary embolism or deep-vein thrombosis (n=5,107). Dabigatran vs. Warfarin was evaluated on Recurrent VTE/VTE-related death (HR 1.09, 95% CI 0.77, 1.54). Dabigatran was as effective as warfarin in preventing recurrent VTE or VTE-related death (2.7% vs 2.4%; HR 1.09, 95% CI 0.77-1.54) and was associated with a lower risk of major bleeding.
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