Dual Antithrombotic Therapy Is Safe for Patients with AF and a New Stent

For stented patients with atrial fibrillation (AF), triple antithrombotic therapy — warfarin, a P2Y₁₂ inhibitor, and low-dose aspirin — is effective in preventing systemic embolism and stent thrombosis, but bleeding risk is markedly elevated. In the PIONEER-AF trial, rivaroxaban at doses lower than that approved for stroke prevention, plus a single P2Y₁₂ inhibitor, did not increase stent-thrombosis risk and lowered bleeding risk, compared with standard triple therapy.

In the manufacturer-funded RE-DUAL trial (NCT02164864), researchers randomized 2725 patients with AF and a new stent to receive either dual therapy with dabigatran (110 or 150 mg twice daily) plus clopidogrel or ticagrelor — or triple therapy with warfarin, clopidogrel or ticagrelor, and ≤100-mg daily aspirin (for 1 or 3 months depending on stent type). Consistent with product labeling in those countries, elderly patients outside the U.S. could not receive 150-mg dabigatran. Mean follow-up was 14 months.

Incidence of the primary endpoint — major or clinically relevant nonmajor bleeding — was significantly lower with 110-mg dabigatran dual therapy than with triple therapy (15% vs. 27%; hazard ratio, 0.52) and with 150-mg dabigatran dual therapy than with triple therapy (20% vs. 26%; HR, 0.72), demonstrating dual therapy's noninferiority at either dabigatran dose. A composite endpoint of thromboembolic events (myocardial infarction, stroke, or systemic thromboembolism), death, or unplanned revascularization did not differ significantly between the dual-therapy groups combined (13.7%) and the triple-therapy group (13.4%). All groups had low stent-thrombosis rates (0.8%–1.5%).