CHICAGO -- In the OPTION trial, left atrial appendage closure resulted in similar thromboembolic protection but superior bleeding outcomes compared with oral anticoagulation among patients who underwent ablation for atrial fibrillation.
OPTION is the first head-to-head comparison of left atrial appendage (LAA) closure with the Watchman FLX device (Boston Scientific) and oral anticoagulation in patients with AF who had catheter-based ablation, Oussama Wazni, MD, MBA, vice chairman of cardiovascular medicine and section head of cardiac electrophysiology at Cleveland Clinic, said during the American Heart Association Scientific Sessions.
Oral anticoagulation is recommended after AF ablation for patients with high risk for stroke, but data on the use of LAA closure are lacking, according to the researchers.
The OPTION trial included 1,600 patients with moderate-high risk for stroke who underwent AF ablation for AF (mean age, 70 years; 34% women; mean CHADS-VASc score, 3.5). The trial was conducted at 106 sites in 10 countries.
Patients underwent catheter ablation (59.4% radiofrequency ablation, 33.2% cryoablation) 90 to 180 days before randomization to LAA closure or oral anticoagulation. After LAA closure, patients received oral anticoagulants and aspirin for 90 days, then aspirin alone until 12 months. Those assigned oral anticoagulation started or continued approved agents at the treating physician's discretion. Ninety-five percent of patients used a non-warfarin anticoagulant, most commonly apixaban (59%; Eliquis, Bristol Myers Squibb/Pfizer) or rivaroxaban (27%; Xarelto; Janssen/Bayer).
The results were reported here and simultaneously published in The New England Journal of Medicine.
At 36 months:
The two strategies provided equivalent thromboembolic protection at 36 months, Wazni said. When the researchers looked at individual components of the primary efficacy outcome, ischemic stroke occurred in 1.2% of the LAA closure group compared with 1.3% of the oral anticoagulation group and systemic embolism occurred in 0.3% compared with 0.1%, respectively.
Device- or procedure-related complications occurred in 23 patients, according to the results.
"Although the attribution of specific complications to left atrial appendage closure as compared with catheter ablation is confounded when these procedures are performed concomitantly, the most serious procedure-related complication, pericardial tamponade, occurred in 0.3% of patients assigned to undergo left atrial appendage closure and in 0.7% assigned to receive oral anticoagulation. The low incidence of complications is consistent with advances in device technology," Wazni and colleagues wrote in NEJM.
Forty percent of patients underwent concomitant ablation and LAA closure, which was defined as within 10 days after randomization. This can potentially reduce procedural risks and recovery times for patients, Wazni said during the presentation.
The researchers noted several limitations of the OPTION trial, including the unavailability of pulsed field ablation at the time, exclusion of patients with a left ventricular ejection fraction of less than 30% and its open-label design.
"Watchman FLX is safe and effective as a first-line option for AF ablation patients, with similar thromboembolic protection and superior bleeding outcomes" compared with oral anticoagulation," Wazni concluded.