OPTION trial initiated to compare WATCHMAN FLX left atrial appendage closure platform to first-line oral anticoagulants

Boston Scientific Corporation has initiated the OPTION trial to compare safety and effectiveness of the next-generation WATCHMAN FLX left atrial appendage closure (LAAC) platform to first-line oral anticoagulants (OAC) – including direct oral anticoagulants (DOAC) and warfarin – for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) who undergo a cardiac ablation procedure.

The randomized, controlled OPTION trial will enroll 1,600 patients with non-valvular AF who are suitable for OAC therapy and have recently had or will have an ablation. Patients at as many as 130 global sites will be randomized to receive the newest-generation WATCHMAN FLX device or an OAC, inclusive of commonly prescribed DOACs or warfarin. The primary effectiveness endpoint is all cause death, stroke and systemic embolism through 36 months, and the primary safety endpoint is non-procedural bleeding through 36 months.

The WATCHMAN device has been implanted in more than 80,000 patients worldwide and the latest-generation WATCHMAN FLX device received CE Mark in March 2019. In the U.S., the WATCHMAN FLX device is an investigational device and not available for sale.