Findings from the RE-DUAL PCI study showed favorable safety data for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) dual therapy for patients with non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stenting. The late-breaking data were presented at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain and also published in the New England Journal of Medicine.
The trial evaluated dual therapy vs. triple therapy after PCI with stenting (elective or due to acute coronary syndrome) in 2,727 adults with atrial fibrillation. Study patients were given one of three treatments:
- Pradaxa (110mg twice daily) + ticagrelor or clopidogrel
- Pradaxa (150mg twice daily) + ticagrelor or clopidogrel
- Triple therapy (warfarin + aspirin + ticagrelor or clopidogrel
The primary safety endpoint was defined as time to major bleeding events and clinically relevant non-major bleeding events when compared to triple therapy with warfarin. Secondary outcomes included composite efficacy endpoints of time to death or first thrombotic event and unplanned revascularization.
The data showed the incidence of the primary endpoint was 15.4% in the 110mg dual therapy group vs. 26.9% in the triple therapy group (hazard ratio [HR] 0.52, 95% CI: 0.42 to 0.63; P<0.001 for noninferiority and superiority). The incidence was 20.2% in the 150mg dual therapy group vs. 25.7% in the corresponding triple therapy group (HR 0.72, 95% CI: 0.58 to 0.88; P<0.001 for noninferiority). The authors concluded that among patients with atrial fibrillation who had undergone PCI, two different regimens with Pradaxa + a P2Y12 inhibitor resulted in a lower risk of major or clinically relevant non-major bleeding events vs. triple therapy with warfarin.
Pradaxa, a direct thrombin inhibitor, is currently approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; to reduce the recurrence of DVT and PE in patients who have been previously treated; and for the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery.
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