Only one month of dual antithrombotic therapy followed by direct oral anticoagulant (DOAC) monotherapy proved to be noninferior in terms of efficacy and superior in terms of bleeding outcomes to the standard 12-month dual antithrombotic therapy post PCI among patients with atrial fibrillation (AFib), according to results of the OPTIMA-AF trial published July 15 in The Lancet.

In this active-control trial, 1,088 patients across 75 sites in Japan were randomized to either one month of dual antithrombotic therapy (DOAC + P2Y12 inhibitor) followed by DOAC monotherapy or 12 months of dual antithrombotic therapy following PCI with intravascular imaging. Of the patients, 1,079 were included in the final analysis: 542 in the one-month arm and 537 in the 12-month arm. Median age was 76 years and 21% were women. Most had chronic coronary syndrome (94%), and 48% had paroxysmal AFib, 21% had persistent AFib and 30% had long-standing persistent AFib. Median CHADS2 score and median HAS-BLED score were both 2.

Results at a median follow-up of 540 days showed that the primary efficacy endpoint, a composite of all-cause death or thromboembolic events, occurred in 29 patients in the one-month arm vs. 23 in the 12-month arm (5.4% vs. 4.3%; absolute difference, 1.1 percentage points; hazard ratio [HR], 1.25) and the primary safety endpoint, major or clinically relevant bleeding, occurred in 24 vs. 47 patients (4.5% vs. 8.8%; absolute difference, –4.4 percentage points; HR, 0.50; p=0.0041 for superiority).

All-cause mortality was numerically higher in the one-month arm (4.1% vs. 2.8%), driven primarily by noncardiovascular deaths. Incidence of major bleeding was similar between the two (HR, 0.77), and clinically relevant nonmajor bleeding was lower in the one-month arm (HR, 0.26).

“Because the observed event rates were lower than anticipated under a fixed non-inferiority margin, efficacy estimates warrant cautious interpretation,” write investigators Yohei Sotomi, MD, FACC, et al. “Further adequately powered trials are needed to clarify applicability in acute coronary syndrome populations and in clinically important subgroups.”

Although they ask for additional data from more diverse populations, Gregory Y. H. Lip, MD, FACC, and Lukasz Kuźma, MD, PhD, call the trial potentially practice-changing in an editorial comment, writing that it “nicely illustrates that less is more, especially in regard to the beneficial effect of less bleeding without an increase in thromboembolism by shortening the use of dual therapy.”