RE-DUAL PCI trial - percutaneous coronary intervention in patient with atrial fibrillation treated with dabigatran
Abstract
Antithrombotic therapy in patients with atrial fibrillation who undergo percutaneous coronary intervention with stent implantation is characterized by the need for dual antiplatelet therapy for prevention of stent thrombosis and simultaneous anticoagulant therapy for prevention of thromboembolic events. However, triple antithrombotic regimen is associated with elevated risk of bleeding complications.
The RE‑DUAL PCI was randomized, open‑label trial comparing dual antithrombotic therapy with dabigatran etexilate (110 mg or 150 mg twice daily) and P2Y12 inhibitor (either clopidogrel or ticagrelor) with triple antithrombotic therapy with warfarin, P2Y12 inhibitor, and low‑dose aspirin. The primary end point of major or clinically relevant nonmajor bleeding event occurred in 15,4% of patients in dual‑therapy group with lower dose of dabigatran as compared to 26,9% in corresponding triple‑therapy group, and in 20,2% of patients in dual‑therapy group with higher dose of dabigatran as compared with 25,7% in the triple‑therapy group.
The incidence of the composite efficacy end point of thromboembolic events, death, or unplanned revascularization was similar in the both dabigatran groups combined and triple‑therapy group (13,7% vs 13,4%). Therefore, among patients with atrial fibrillation undergoing coronary stenting, combination of dabigatran and P2Y12 inhibitor was safer than triple‑therapy in terms of serious bleeding complications.
The incidence of thromboembolic and ischaemic events was comparable.