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AF Symposium 25: LAA Closure Vs Oral Anticoagulation After Catheter Ablation for AF: Concomitant and Sequential Cohorts of OPTION
Published: 20 Jan 2025
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AF Symposium 25 - Left atrial appendage (LAA) closure using the WATCHMAN FLX device (Boston Scientific) showed lower risk of bleeding and non-inferiority in efficacy endpoints to oral anticoagulation in patients who have received or are planning to receive AF ablation.
Dr Walid Saliba (Cleveland Clinic, OH, US) joins us onsite at AF Symposium 25 to discuss the findings from the concomitant and sequential cohorts of the OPTION trial comparing LAA closure with the WATCHMAN FLX device verses oral anticoagulation. The primary safety endpoint was non–procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy endpoint was a composite of all-cause mortality, stroke, or systemic embolism.
Findings showed that in the concomitant and sequential cohorts, the three-year efficacy outcomes were similar in both treatment arms, whilst the safety outcomes revealed that LAAC with the WATCHMAN FLX device reduced non-procedural bleeding outcomes compared to oral anticoagulation.
Interview Questions:
1. Could you give a brief summary of the trial and the reasoning behind it?
2. What was the patient population and study design?
3. What are the key findings?
4. How should these findings impact patient treatment?
Recorded on-site at AF Symposium in Boston, 2025.
Editors: Yazmin Sadik, Jordan Rance
Videographers: Oliver Miles, David Ben-Harosh
Interviewer: David Ramsey
Support: This is an independent interview produced by Arrhythmia Academy.
I'm Walid Saliba. I'm one of the electrophysiologists at the Cleveland Clinic and I'm the director of the Atrial Fibrillation Center.
Could you give a brief summary of the trial and the reasoning behind it?
So the OPTION trial is a trial of comparison of oral anticoagulation versus implantation of a WATCHMAN FLX in a population of patients who are having or have had atrial fibrillation ablation.
The reasoning behind it is that, first of all, the current recommendation is that in patients who have atrial fibrillation undergoing ablation and at a high risk of stroke by virtue of their CHA2DS2–VASc score, these patients, despite the fact that they have a successful ablation, the recommendation currently is to continue oral anticoagulation because for many reasons. Atrial fibrillation might come back, it has the likelihood of being more asymptomatic and patients are still at an increased risk of stroke.
And also, there is a tendency for patients to stop their oral anticoagulation following an ablation, and that automatically increases the risk of stroke. So there was definitely a need to evaluate what is the best strategy for stroke prevention following an atrial fibrillation ablation and more importantly, what is the role of left atrial appendage closure in that patient population and how does it compare to oral anticoagulation.
What was the patient population and study design?
So the OPTION trial included essentially two cohorts of patients, if you want, just by study design. There were patients who already have had an ablation and three to six months later were enrolled in the study, and these patients were randomized to either having the WATCHMAN FLX or continued oral anticoagulation.
So that is the sequential arm because they had already an ablation, and then afterwards they were enrolled to have the WATCHMAN or continue oral anticoagulation. And there was the concomitant arm, which are patients who are planning to have an ablation. And those patients also got randomized to either WATCHMAN FLX placement or continuing of oral anticoagulations. So if they were randomized to the WATCHMAN FLX placement, the procedure was done concomitantly with the atrial fibrillation ablation. And if actually they were randomized to oral anticoagulation, then they underwent only atrial fibrillation ablation and continued on oral anticoagulation.
So these are essentially two separate ways to enter the study, to be enrolled in the study: the sequential arm and the concomitant arm.
What are the key findings?
So if you look at the concomitant arm, the three-year efficacy was similar between the WATCHMAN FLX and the oral anticoagulation arm, maintaining actually the safety advantage of the WATCHMAN FLX in terms of reducing the risk of bleeding in that patient population.
More importantly, I think the addition of the WATCHMAN FLX implantation procedure to the ablation procedure did not increase any adverse effects or any adverse procedural effects compared to, say, an ablation procedure by itself. So if you do a concomitant procedure, you are not having increased adverse effects compared to just an ablation, which is very important because that is something that people are concerned about. What happens if actually we add another procedure and do a concomitant procedure to already an ablation procedure? So that was pretty good.
The sequential cohort showed similar findings in terms of the efficacy. There was similar efficacy between the WATCHMAN FLX and the oral anticoagulation arm, also again maintaining the advantage of safety in terms of having reduced incidence of bleeding events in the WATCHMAN FLX arm. Now, the reduction in that bleeding event and the oral anticoagulation arm and maintain also the improved safety with the WATCHMAN FLX compared to the anticoagulation arm.
How should these findings impact patient treatment?
I think that the number one message that I have from the OPTION trial is the fact that the incidence of ischemic stroke was similar in the WATCHMAN FLX and in the oral anticoagulation arm, meaning that we are able to reduce the risk of stroke with the WATCHMAN FLX to the same extent as oral anticoagulation, yet without the risk of bleeding that comes with the oral anticoagulation.
So in patients who are coming for atrial fibrillation ablation and who have a high risk of stroke by virtue of their CHA2DS2–VASc score, I think it is reasonable to offer them the possibility of having a concomitant procedure to have the ablation done.
And since you're there, you might as well just put the WATCHMAN device in and obviate the need to have long-term oral anticoagulation with its potential deleterious effect, yet having the protection against stroke that is needed in this patient population.
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