One-month dual antithrombotic strategy after PCI reduced bleeding without higher 12‑month thromboembolic risk in OPTIMA‑AF trial

A large randomized trial published in The Lancet found that in patients with atrial fibrillation who underwent PCI, stopping dual antithrombotic treatment after one month and continuing with a direct oral anticoagulant alone reduced bleeding without worsening 12-month risks of death or thromboembolic events, compared with staying on dual therapy for 12 months.

The finding matters because these patients face a difficult balancing act after getting a coronary stent. They need anticoagulation to lower the risk of stroke from atrial fibrillation, an irregular heart rhythm, but they also need antiplatelet therapy to help prevent clots around the stent. Using more anti-clotting drugs can reduce clotting events, but it also raises the risk of bleeding.

The study, OPTIMA-AF, was a multicenter, randomized, open-label controlled trial conducted at 75 hospitals in Japan. It tested whether one month of dual antithrombotic therapy — a direct oral anticoagulant, or DOAC, plus a P2Y12 inhibitor, a type of antiplatelet drug — could be followed safely by DOAC monotherapy after PCI, compared with 12 months of dual therapy. Enrollment ran from October 2019 through September 2024. About 1,100 patients were enrolled, with secondary summaries reporting roughly 1,079 patients in the final analysis. The average age was about 75, and about one in five participants were women.

The trial population was mostly stable and relatively selected. About 94% of patients had chronic coronary syndrome, or stable coronary disease. Patients with myocardial infarction, commonly called heart attack, were excluded, though unstable angina was allowed. PCI was guided by intravascular imaging in more than 99% of cases, a level of imaging use that is not routine in many countries.

The primary efficacy endpoint was death or thromboembolic events at 12 months. That occurred in 5.4% of the one-month dual-therapy group and 4.5% of the 12-month dual-therapy group, meeting the trial’s prespecified standard for non-inferiority. The primary safety endpoint, major or clinically relevant non-major bleeding at 12 months, occurred in 4.8% of patients assigned to the shorter regimen, compared with 9.5% of those kept on dual therapy for 12 months. On bleeding, the shorter strategy was superior.

“Previous studies confirmed that using two anti-clotting agents instead of three reduced bleeding, however, no study has tested whether the duration of dual therapy could be safely shortened to just one month,” Yohei Sotomi said in an American Heart Association news release. “Our study is the first to show that a one-month strategy is both safe and effective, offering real-world benefits for patients and doctors.”

Still, the results come with important limits. As commentary on the trial noted, “Event rates for both efficacy and safety endpoints were substantially lower than anticipated.” The study used a non-inferiority margin of 5 percentage points for the efficacy outcome, based on an expected event rate of about 10%, but the actual rates were much lower. That means the efficacy finding should be interpreted cautiously.

Generalizability is also limited. The trial was conducted entirely in Japan, enrolled a predominantly male population, included mostly patients with stable coronary disease and excluded heart attack patients. Nearly all procedures also used intravascular imaging.

Earlier trials had already pushed treatment away from older three-drug regimens and toward DOAC-based dual therapy for much of the first year after PCI. OPTIMA-AF addresses the next practical question: whether, in selected patients like those studied here, that dual-therapy period can be shortened to just one month.