Left atrial appendage closure safe, effective first-line option for AF ablation patients
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Key takeaways:
- OPTION is a head-to-head trial of left atrial appendage closure with Watchman FLX vs. anticoagulation after ablation for atrial fibrillation.
- Strategies provided equivalent thromboembolic protection at 3 years.
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 CHA2DS2-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:
- a primary safety endpoint event, which included non-procedure-related major bleeding or clinically relevant nonmajor bleeding, occurred in 8.5% of the LAA closure group vs. 18.1% of the oral anticoagulation group (HR = 0.44; 95% CI, 0.33-0.59; P < .001 for superiority);
- A primary efficacy endpoint event, which included a composite of death from any cause, stroke or systemic embolism, occurred in 5.3% of the LAA closure group vs. 5.8% of the oral anticoagulation group (HR = 0.91; 95% CI, 0.59-1.39; P < .001 for noninferiority); and
- major bleeding, a secondary endpoint, occurred in 3.9% of the LAA closure group vs. 5% of the oral anticoagulation group (HR = 0.77; 95% CI, 0.48-1.24; P < .001 for noninferiority).
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.
Reference:
Perspective
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The OPTION trial is phenomenal. It takes on a very important question: What to do with patients who are having an ablation and need a downstream stroke prevention strategy? This is already a problematic question because the current guidelines don’t link the outcome of the ablation with the decision of anticoagulation. In other words, there is no input in terms of the success of the ablation into the decision of whether to continue anticoagulation for stroke prevention. Anticoagulation is decided based on the CHA2DS2-VASc score or other clinical risk models that we use.
That is an open question, and the essence of the problem is that if you have a patient with a successful AF ablation and you are continuing anticoagulation, you are basically not benefiting at all from the anticoagulation aspect of the drug, but you are exposing the patient to a substantial risk for bleeding.
LAA occlusion has been an option for patients who cannot receive anticoagulation, but it was not known if it was a reasonable alternative strategy for stroke prevention in conjunction with ablation.
This study had two major findings. No. 1, over a very long follow-up period of 36 months, there was absolutely no difference in the stroke rate between patients who received an anticoagulant vs. the LAA occlusion device. No. 2, there was a significant increase in risk for bleeding in patients who received an anticoagulant vs. those who received the LAA occlusion device. That supports that it is reasonable to consider LAA occlusion in conjunction to catheter ablation for AF as opposed to continuing on oral anticoagulants.
There are many caveats to the trial. One is that there are different types of AF and it is not one size fits all. But overall, the population is pretty reflective of the typical AF population, with a CHA2DS2-VASc score of 3.5. For a vast group of patients, this is a very relevant question, addressed by a well-executed trial.
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Wazni OM. LBS.02. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2024; Chicago.
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