Summary
Dabigatran was non-inferior to warfarin for prevention of recurrent venous thromboembolism
(VTE), and dabigatran had a lower rate of bleeding compared with warfarin in two large-scale
randomised trials, RE-COVER and RE-COVER II. In this study, we investigate the efficacy
and safety of dabigatran versus warfarin according to the index event that qualified
the patient for enrollment, either symptomatic pulmonary embolism (PE) with or without
deep-vein thrombosis (DVT), or DVT alone. We then analyse the anticoagulant effect
of dabigatran vs warfarin on patients enrolled with PE. The pooled dataset for the
efficacy analysis consisted of 2553 and 2554 patients who were randomised to dabigatran
and warfarin, respectively. Recurrent VTE/VTE-related death during the study period
and additional 30-day follow-up occurred in 2.7 % of all patients on dabigatran and
in 2.4 % on warfarin (hazard ratio [HR] 1.09 [95 % confidence interval 0.77, 1.54]).
In patients with PE as their index event, recurrent VTE/VTE-related death occurred
in 2.9 % vs 3.1 % of patients (HR 0.93 [0.53, 1.64]). There were significantly fewer
major bleeding events in patients treated with dabigatran than with warfarin (HR 0.60
[0.36, 0.99]). The pattern was similar both in patients with PE and in those with
DVT alone as the index event. These analyses of the pooled dataset from the RECOVER
and RE-COVER II trials indicate that dabigatran is as effective as warfarin in preventing
recurrent VTE, regardless of whether patients present with symptomatic PE (with or
without DVT) or with symptomatic DVT alone. Dabigatran was also associated with a
lower risk of bleeding than warfarin, regardless of the index event.
Keywords
Dabigatran - pulmonary embolism - venous thrombosis - warfarin
