Boston Scientific (NYSE:BSX) said yesterday that it’s launching a large clinical trial to compare the latest iteration of its Watchman heart implant with anticoagulant drugs in reducing the risk of stroke in atrial fibrillation patients.
The 1,600-patient Option randomized trial is designed to compare first-line oral anticoagulants with left atrial appendage occlusion using Watchman FLX in subjects treated via ablation for non-valvular atrial fibrillation. The primary safety endpoint is non-procedural bleeding, with a primary efficacy endpoint of all-cause death, stroke and systemic embolism, all through 36 months.
“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,” said Dr. Oussama Wazni, co-director of the Ventricular Arrhythmia Center, Center for Atrial Fibrillation and the Atrial Fibrillation Stroke Prevention Center at Cleveland Clinic and the principal investigator for the OPTION trial. “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.”
“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,” said Dr. Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific. “The unique study design encompasses patients who will receive a Watchman FLX device either after or concurrent to an ablation procedure.”
Boston won a second CE Mark approval in the European Union for Watchman FLX in March, three years after taking it off the market there after receiving reports of device embolization. The initial CE Mark came in November 2015.