Design and Rationale of the RE‐DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting
Why the study?
Does dual antithrombotic therapy with dabigatran and a P2Y12 inhibitor reduce bleeding compared to triple therapy with warfarin, a P2Y12 inhibitor, and aspirin in nonvalvular AF patients undergoing PCI with stenting?
Population
~2500 patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention…
Comparison
Dual antithrombotic therapy with dabigatran… vs Triple antithrombotic therapy with warfarin, a…
Design
Other, prospective, randomized, open-label, blinded-endpoint
Authors
Discussion
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Implication
Dual therapy may lower bleeding in stented AF patients; leaves open optimal regimen pending larger trials.
Structured PICO
Does dual antithrombotic therapy with dabigatran and a P2Y12 inhibitor reduce bleeding compared to triple therapy with warfarin, a P2Y12 inhibitor, and aspirin in nonvalvular AF patients undergoing PCI with stenting?
P
Population
~2500 patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention with stenting
I
Intervention
Dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibitor (either clopidogrel or ticagrelor)
C
Comparator
Triple antithrombotic therapy with warfarin, a P2Y12 inhibitor (either clopidogrel or ticagrelor), and low-dose aspirin (for 1 or 3 months, depending on stent type)
O
Outcome
Time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding eventsafety
The RE-DUAL PCI trial is designed to determine if dual antithrombotic therapy with dabigatran and a P2Y12 inhibitor improves safety compared to standard triple therapy in patients with nonvalvular atrial fibrillation undergoing PCI.
Cite This Study
Cannon et al. (2016) studied this question.