Three-year results from the OPTION clinical trial, comparing the Watchman FLX (Boston Scientific) left atrial appendage closure (LAAC) system to oral anticoagulation for stroke reduction in patients with non-valvular atrial fibrillation (AF), show that the device was associated with a lower risk of bleeding and non-inferior for all-cause death, stroke or systemic embolism.
Results of the trial were presented by Oussama Wazni (Cleveland Clinic, Cleveland, USA) during a late-breaking science session at the American Heart Association (AHA) 2024 Scientific Session (16–18 November, Chicago, USA) and published simultaneously in The New England Journal of Medicine.
OPTION trial investigators enrolled 1,600 patients at 114 sites across the USA, Europe and Australia, who had an elevated CHA2DS2-VASc score and had undergone catheter ablation for AF, to either LAAC with Watchman FLX or to receive oral anticoagulation. A total of 803 were randomised to the LAAC group, and 797 to receive anticoagulation therapy. Patients had a mean age of 69 years and 34.1% were women.
Wazni reported that the trial met its primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months, with the Watchman FLX device demonstrating superiority to oral anticoagulants (8.5% vs.18.1%; p<0.0001).
Additionally, Watchman FLX also met the primary efficacy endpoint of all-cause death, stroke or systemic embolism at 36 months, with the data showing non-inferiority of the device to oral anticoagulation (5.4% vs. 5.8%; p<0.0001). Additional findings included non-inferiority of the device for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5%; p<0.0001).
“The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the Watchman FLX device is not only as safe, but superior to oral anticoagulation therapy for reducing the risk of long-term bleeding events,” Wazni was quoted as saying in a press release issued by Boston Scientific following the presentation of the results at AHA 2024. “Notably, we found high rates of procedural success in patients who had a Watchman FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischaemic and haemorrhagic stroke within the trial population.”
In the trial, approximately 60% of device patients had their Watchman FLX implant 90–180 days following their ablation procedure. The other nearly 40% of the device patients had the two procedures performed concomitantly, with the Watchman FLX implant taking place after the ablation. Of those in the anticoagulation group, 95% received direct oral anticoagulants (DOACs) and 5% warfarin.
