The WATCHMAN FLX left atrial appendage (LAA) closure device has been shown to be a reasonable alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF) after ablation. These findings were published in the American Journal of the Heart.
The multinational, multicenter, prospective, randomized trial comparing anticoagulation with left atrial appendage closure after AF ablation (OPTION) (ClinicalTrials.gov identifier: NCT03795298) began in May 2019. The estimated completion date of the study is November 2024.
Researchers sought to determine if LAA closure with the WATCHMAN FLX device is an acceptable option for PAO after percutaneous catheter ablation in people at high risk for stroke and AF. The WATCHMAN FLX device is a self-expanding nitinol frame structure that contains fixation barbs, a closed distal end, and a permeable polyester fabric that covers the AGA ostium. The device is available in 5 sizes, with diameters ranging from 20 mm to 35 mm. The device size chosen is based on the maximum diameter of the LAA ostium, as measured by transesophageal echocardiography or intracardiac echocardiography.
The primary efficacy endpoint is stroke, both ischemic and haemorrhagic, death from any cause or systemic embolism during the 36 months following randomisation. The primary safety endpoint is non-procedural bleeding for 36 months, which is based on the International Society of Thrombosis and Hameostasis (ISTH) definitions of major bleeding or clinically relevant non-major bleeding. The secondary safety endpoint is ISTH major bleeding over 36 months, including procedural bleeding. Additional endpoints include the individual components of the primary endpoints, disabling and non-disabling stroke, and cardiovascular or unknown and non-cardiovascular deaths.
Patients with CHA2DS2-VASc risk score of 2 or greater in men and 3 or greater in women who underwent an AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or those planning to receive an Catheter ablation within 10 days of randomization (concurrent) will be randomly assigned in a 1:1 ratio to the device or WATCHMAN FLX (OAC) control. Individuals in the control group will initiate or continue market-approved OAC therapy for the duration of the study.
A total of 1600 patients were randomly assigned to the study from 130 global investigation sites. Patient follow-up in the device and control groups will take place at 3 months, 12 months, 24 and 36 months.
A major limitation of the OPTION study is that it is not powered to assess individual parameters of the composite efficacy endpoint. Because patients who received sequential and concurrent ablation procedures with WATCHMAN FLX are combined, generalizability beyond the enrolled patient population is therefore limited.
Disclosure: Some of the study authors have disclosed affiliations with biotechnology, pharmaceutical and/or device companies. Please see the original citation for a full list of author disclosures.
Wazni O, Boersma L, Healey JS, et al. Comparison of Anticoagulation with Left Atrial Appendage Closure After AF Ablation: Rationale and Design of the OPTION Randomized Trial. Am Heart J. Published online May 6, 2022. doi:10.1016/j.ahj.2022.05.003