For patients with atrial fibrillation who have had a percutaneous coronary intervention (PCI), bleeding risk is lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than in those who received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin, according to a study published in the New England Journal of Medicine.
Christopher P Cannon, MD, from the Baim Institute for Clinical Research in Boston, and colleagues conducted a multicenter trial of 2,725 patients with atrial fibrillation who underwent PCI. Patients were assigned either triple therapy with warfarin plus a P2Y12 inhibitor and aspirin (for 1 to 3 months) or dual therapy with dabigatran (110 mg or 115 mg twice daily) plus a P2Y12 inhibitor and no aspirin.
The primary outcome was a major or clinically relevant bleeding event during follow-up. Secondary outcomes included testing 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.
The incidence of bleeding was 15.4% in the 110-mg dual-therapy group compared with 26.9% in the triple-therapy group (hazard ratio [HR], 0.52) and 20.2% in the 150-mg dual-therapy group compared with 25.7% in the corresponding triple-therapy group (HR 0.72). The incidence of the composite efficacy end point was 13.7% in both dual-therapy groups combined compared with 13.4% in the triple-therapy group (HR 1.04). The rate of serious adverse events did not differ significantly among the groups.
“In summary, we found that, among patients with atrial fibrillation who had undergone PCI, dual therapy with dabigatran and a P2Y12 inhibitor resulted in a risk of bleeding events that was significantly lower than the risk with triple therapy with warfarin, a P2Y12 inhibitor, and aspirin,” stated the authors. “In addition, dual therapy with dabigatran was noninferior to triple therapy with warfarin with respect to the rate of thromboembolic events.”
Cannon CP, Bhatt DL, Oldgren J, et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med. 2017 Oct 19;377(16). doi: 10.1056/NEJMoa1708454