Dabigatran as Effective Prevention of VTE Recurrence Also in Patients with Thrombophilia
With increasing positive experience with direct oral anticoagulants, the question arises of how these drugs work in different groups of patients − for example, in those who have a congenital or acquired thrombophilic state.
Introduction
The term thrombophilia encompasses congenital and acquired hypercoagulable states that increase the risk of venous or, in some cases, arterial thrombosis. Thrombophilia may increase the risk of recurrent venous thromboembolism (VTE). An unanswered theoretical question remains whether the presence of thrombophilia may increase resistance to anticoagulant therapy.
Analyzed Studies and Monitored Population
A post hoc analysis of the RE-COVER, RE-COVER II, and RE-MEDY studies with dabigatran etexilate focused on comparing the efficacy of dabigatran and warfarin in the management of VTE in patients with thrombophilia or antiphospholipid syndrome (APS). The RE-COVER and RE-COVER II studies were aimed at treating acute VTE, while the RE-MEDY study focused on extended VTE therapy.
The RE-COVER and RE-COVER II studies collectively enrolled 2,553 patients treated with dabigatran and 2,554 receiving warfarin. Thrombophilia was confirmed in 8.2% of patients treated with dabigatran and in 7.8% of participants using warfarin. In the RE-MEDY study, 1,430 patients were treated with dabigatran (18.3% with thrombophilia) and 1,426 with warfarin (18.4% with thrombophilia). Overall, the proportion of study participants with known thrombophilia was 18%. The overall proportion of participants with known APS was 2.2%.
Results
No significant differences were observed in the rate of recurrent symptomatic VTE or VTE-related deaths during the monitored period (6 months from randomization in the RE-COVER studies and 6−36 months in the RE-MEDY study) between patients receiving dabigatran or warfarin with or without thrombophilia. Bleeding episodes occurred less frequently in patients treated with dabigatran compared to warfarin, regardless of the presence of thrombophilia.
No significant differences in the monitored rate of VTE recurrence or VTE-related deaths were observed in patients with APS between the two treatment arms. Again, the rate of bleeding episodes tended to be lower in patients treated with dabigatran compared to warfarin.
Conclusion
Based on data pooled from three key dabigatran studies, it can be concluded that the presence of thrombophilia did not significantly affect the efficacy or safety of dabigatran prescribed for the prevention of VTE recurrence. The efficacy and safety of dabigatran appear to be fully preserved in the group of patients with thrombophilia.
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Source: Goldhaber S. Z., Eriksson H., Kakkar A. et al. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™. Vasc Med 2016; 21 (6): 506−514, doi: 10.1177/1358863X16668588.
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