The OPTION trial is to compare the compare safety and effectiveness of the next-generation Watchman FLX left atrial appendage closure platform with 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 randomised, controlled OPTION trial will enrol 1,600 patients with non-valvular atrial fibrillation who are suitable for oral anticoagulation therapy and have recently had or will have an ablation. Patients at up to 130 global sites will be randomised to receive the newest-generation Watchman FLX device or an oral anticoagulant, inclusive of commonly prescribed direct oral anticoagulant 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.
Oussama Wazni (Ventricular Arrhythmia Center, Center for Atrial Fibrillation and the Atrial Fibrillation Stroke Prevention Center, Cleveland Clinic, Cleveland, USA), the principal investigator for the OPTION trial, says: “Cardiac ablation is an effective way to treat an abnormal heart rhythm for many patients, though symptomatic relief can lead these patients to stop taking their blood thinners and unknowingly put themselves at an elevated risk for a stroke. This first-of-its-kind trial will explore whether the one-time Watchman FLX device could replace commonly used anticoagulants for long-term stroke risk reduction in this growing patient population.”
Ian Meredith (executive vice president and global chief medical officer, Boston Scientific), says: “Beyond advancing the robust clinical literature supporting the Watchman therapy, findings from the OPTION trial have the potential to expand the number of patients with atrial fibrillation who can receive an alternative to life-long anticoagulants and thus avoid their potential side effects. The unique study design encompasses patients who will receive a Watchman FLX device either after or concurrent to an ablation procedure.”