The risk of bleeding was significantly lower among patients with atrial fibrillation (AFib) undergoing percutaneous coronary intervention (PCI) who received dual therapy with dabigatran and a P2Y inhibitor, compared to those who received triple therapy with warfarin, a P2Y inhibitor and aspirin, said researchers presenting on the RE-DUAL PCI trial on Aug. 27 at the ESC Congress 2017 in Barcelona. Dual therapy was noninferior to triple therapy with respect to risk of thromboembolic events.

The study, which was also published in the New England Journal of Medicine, randomly assigned 2,725 patients with AFib who had undergone PCI to either triple therapy or dual therapy. The triple therapy group received warfarin, plus a P2Y inhibitor (clopidogrel or ticagrelor) and aspirin (for one to three months), while the dual therapy group received dabigatran (110 mg or 150 mg twice daily) plus a P2Y inhibitor (clopidogrel or ticagrelor). The primary endpoint was a major or clinically relevant nonmajor bleeding event during the 14-month follow up period. Secondary endpoints looked at the noninferiority of dual therapy compared to triple therapy with respect to thromboembolic events, death or unplanned revascularization.

Results found the incidence of the primary endpoint was 15.4 percent in the 110 mg dual therapy group compared to 26.9 percent in the triple therapy group, and 20.2 percent in the 150 mg dual therapy group compared to 25.7 percent in the triple therapy group. The rate of serious adverse events did not vary significantly among the groups. The composite incidence of the secondary endpoints was 13.7 percent in the two dual therapy groups combined, compared to 13.4 percent in the triple-therapy group.

“In the dual-therapy regimens, each of the two doses of dabigatran led to a balance between the risk of bleeding and the prevention of thromboembolic events, which offers clinicians two additional options for the treatment of patients with varying risks of thromboembolic events and bleeding,” noted the study authors. 

Keywords: ESC Congress, ESC2017, Warfarin, Aspirin, Atrial Fibrillation, Antithrombins, Ticlopidine, Thromboembolism, Adenosine, Percutaneous Coronary Intervention

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