Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents.

BACKGROUND

Despite guideline recommendations, evidence for the use of non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy in patients with atrial fibrillation after implantation of a drug-eluting stent remains limited.

METHODS

In this multicenter, randomized, open-label, noninferiority trial in South Korea, we assigned patients with atrial fibrillation who had undergone the implantation of a drug-eluting stent at least 1 year earlier in a 1:1 ratio to receive NOAC monotherapy or combination therapy (NOAC plus clopidogrel). The primary end point was net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major bleeding or clinically relevant nonmajor bleeding at 12 months. The noninferiority margin was 3.0 percentage points.

RESULTS

A total of 960 patients underwent randomization: 482 patients to receive monotherapy and 478 to receive combination therapy. The mean age of the patients was 71.1 years, and 21.4% were women. At 12 months, a primary end-point event had occurred in 46 patients (Kaplan-Meier estimate, 9.6%) in the monotherapy group and in 82 patients (Kaplan-Meier estimate, 17.2%) in the combination-therapy group, for an absolute difference of -7.6 percentage points (95.2% confidence interval [CI], -11.9 to -3.3; P<0.001 for noninferiority) and a hazard ratio of 0.54 (95.2% CI, 0.37 to 0.77; P<0.001 for superiority). Major bleeding or clinically relevant nonmajor bleeding occurred in 25 patients (5.2%) in the monotherapy group and in 63 patients (13.2%) in the combination-therapy group (hazard ratio, 0.38; 95% CI, 0.24 to 0.60).

CONCLUSIONS

Among patients with atrial fibrillation who had undergone implantation of a drug-eluting stent at least 1 year earlier, NOAC monotherapy was noninferior to combination therapy for net adverse clinical events. (Funded by Cardiovascular Research Center and Samjin Pharmaceutical; ADAPT AF-DES ClinicalTrials.gov number, NCT04250116.).