Dual antithrombotic therapy with dabigatran plus a P2Y12 inhibitor is safer and as effective as triple therapy (warfarin, a P2Y12 inhibitor, and aspirin) for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI). The results of the RE-DUAL PCI trial, which were presented at the ESC Congress 2017, are “an exciting finding that offers clinicians new options to manage these patients,” comments Christopher Cannon, the lead investigator.

A total of 2,725 patients were randomly assigned to triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dual therapy (dabigatran plus clopidogrel or ticagrelor). Two alternative dosing strategies for dabigatran (110 mg or 150 mg twice daily) were trialled. During follow-up (mean 14 months) the primary end point of major or clinically relevant nonmajor bleeding occurred in 15.4% of patients in the 110 mg dual-therapy group compared with 26.9% in the triple-therapy group (HR 0.52, 95% CI 0.42–0.63, P < 0.001 for superiority). The primary end point was also significantly reduced by 28% in the 150 mg dual-therapy group compared with triple therapy. The composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization occurred in 13.7% of patients in the two dual-therapy groups combined compared with 13.4% in the triple-therapy group (HR 1.04, 95% CI 0.84–1.29, P = 0.005 for noninferiority).

The outcomes of this trial “give us comfort that we are getting good efficacy and seeing these big improvements in safety” by dropping aspirin and replacing warfarin with a non-vitamin K antagonist oral anticoagulant, concludes Cannon. The dose of dabigatran can be adjusted according to the risks of thromboembolic events and bleeding in individual patients.