麻豆传媒

CHICAGO -- For patients at high risk of stroke who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure led to less bleeding compared with oral anticoagulation, the randomized OPTION trial showed.

Non-procedure-related major bleeding or clinically relevant non-major bleeding at 36 months occurred in 8.5% of patients who had left atrial appendage closure compared with 18.1% of patients in the oral anticoagulation group (HR 0.44, 95% CI 0.33-0.59, P<0.001 for superiority), reported Oussama Wazni, MD, of the Cleveland Clinic, during a late-breaker presentation at the American Heart Association annual meeting.

Patients who received the closure device also met the efficacy endpoint of noninferiority in preventing a composite of death from any cause, stroke, or systemic embolism at 36 months, which occurred in 5.3% of patients versus 5.8% in the anticoagulation group (P<0.001 for noninferiority), they noted in their findings, which were also published in the .

Major bleeding, including procedure-related bleeding, through 36 months occurred in 3.9% and 5%, respectively (P<0.001 for noninferiority).

"Catheter ablation for atrial fibrillation is an effective strategy for treating symptomatic atrial arrhythmia," the authors wrote in their study. "However, because of the risk of recurrence of atrial fibrillation, which may be minimally symptomatic, current guidelines recommend indefinite continuation of oral anticoagulation in patients who are at moderate or high risk for stroke, regardless of the perceived outcome of the ablation procedure."

"Oral anticoagulant therapy has important limitations, including a risk of bleeding, patient anxiety, and cost considerations, which result in a quarter of patients stopping oral anticoagulants within a year after starting treatment," they added.

Left atrial appendage closure is an alternative strategy for stroke prophylaxis, Wazni and colleagues noted. "The safety and efficacy of left atrial appendage closure as compared with warfarin has been established, but data comparing left atrial appendage closure devices with contemporary oral anticoagulants are limited."

During his presentation, Wazni said that left atrial appendage closure "is a safe and effective first-line option for atrial fibrillation ablation patients. It has similar thromboembolic protection but superior bleeding outcomes compared with oral anticoagulation."

It also "potentially reduces procedural risks and recovery time for the patient," he added.

Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai in New York City, told 麻豆传媒 that she did not think the trial suggested that "left atrial appendage closure should be routine for individuals undergoing atrial fibrillation ablation."

She said that the trial design, especially the use of non-procedural bleeding as the primary safety endpoint, might have failed to capture the true bleeding risk involved with implantation of the device, and the patient population might not have been sufficient to capture the differences in adverse events.

Meanwhile, the study's discussant, Manesh Patel, MD, of Duke University School of Medicine in Durham, North Carolina, also expressed concerns about the trial design, concluding that the closure device "is a clinical option, likely in patients who have reasons they cannot be on anticoagulation."

For this study, the researchers included 1,600 patients with atrial fibrillation who underwent catheter ablation with an elevated score (≥2 in men and ≥3 in women) on the CHA₂DS₂-VASc scale (range 0-9, with higher scores indicating a greater risk of stroke) across 10 countries. They randomly assigned 803 patients to left atrial appendage closure with the Watchman FLX device and 797 patients to oral anticoagulation therapy from November 2019 through June 2021.

Mean patient age was 69.6, 34% were women, and most were white. The mean CHA₂DS₂-VASc score was 3.5. Across the two groups, 20-21% of the patients had a history of congestive heart failure, 28% had diabetes, 65-67% had hyperlipidemia, 88-90% had hypertension, and 30-33% had a history of cardiovascular disease.

After randomization, catheter ablation was performed in 40.9% of the patients, with radiofrequency ablation used in 59.4% and cryoablation in 33.2%. A return of sinus rhythm after the ablation procedure occurred in 88.1% of patients.

Overall, 95% of patients received a non-warfarin anticoagulant, with 59.3% receiving apixaban (Eliquis), 27.2% getting rivaroxaban (Xarelto), 4.3% receiving edoxaban (Savaysa), and 3.9% getting dabigatran (Pradaxa). Throughout the trial, 84.8% of patients in the anticoagulation group continued to receive oral anticoagulation. In the closure device group, 10.1% of patients were receiving oral anticoagulation at 36 months.

Complications related to the device or procedure occurred in 22 patients in the device group and in one patient in the anticoagulation group who crossed over to receive a device.

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