Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents
is the standard of care after percutaneous coronary intervention (PCI) for patients
with atrial fibrillation, but this therapy is associated with a high risk of bleeding.
Methods In this multicenter trial, we randomly assigned 2725 patients with atrial
fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor
(clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group)
or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor
(clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups).
Outside the United States, elderly patients (>/=80 years of age; >/=70 years of age
in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy
group. The primary end point was a major or clinically relevant nonmajor bleeding
event during follow-up (mean follow-up, 14 months). The trial also tested for the
noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy
with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic
events (myocardial infarction, stroke, or systemic embolism), death, or unplanned
revascularization. Results The incidence of the primary end point was 15.4% in the
110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard
ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; P<0.001 for noninferiority;
P<0.001 for superiority) and 20.2% in the 150-mg dual-therapy group as compared with
25.7% in the corresponding triple-therapy group, which did not include elderly patients
outside the United States (hazard ratio, 0.72; 95% CI, 0.58 to 0.88; P<0.001 for noninferiority).
The incidence of the composite efficacy end point was 13.7% in the two dual-therapy
groups combined as compared with 13.4% in the triple-therapy group (hazard ratio,
1.04; 95% CI, 0.84 to 1.29; P=0.005 for noninferiority). The rate of serious adverse
events did not differ significantly among the groups. Conclusions Among patients with
atrial fibrillation who had undergone PCI, the risk of bleeding was lower among those
who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who
received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy
was noninferior to triple therapy with respect to the risk of thromboembolic events.
(Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864
.).
