Boston Scientific initiates trial of WATCHMAN FLX appendage closure platform
Boston Scientific has initiated the OPTION trial to compare safety and effectiveness of the next-generation WATCHMAN FLX left atrial appendage closure platform to first-line oral anticoagulants - including direct oral anticoagulants and warfarin - for stroke risk reduction in patients with non-valvular atrial fibrillation 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.