Boston Scientific Corp., of Marlborough, Mass., reported the kickoff of the OPTION trial to evaluate the safety and effectiveness of the next-generation Watchman Flx left atrial appendage closure (LAAC) platform vs. first-line oral anticoagulants (OAC) for stroke risk reduction in patients with non-valvular atrial fibrillation who undergo a cardiac ablation procedure.
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, said 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.
The randomized, controlled OPTION trial will enroll patients with non-valvular atrial fibrillation 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. Meanwhile, the primary safety endpoint is non-procedural bleeding through 36 months.
We plan to enroll 1,600 patients and follow them for three years, the company told BioWorld MedTech. We anticipate enrollment completion in 2021, and to submit results of the study to the FDA in 2024.
The company pegged the number of patients with atrial fibrillation at 33 million globally. The number of patients treated with ablation is rising. However, more than 50% of those patients become asymptomatic and are less like to adhere to current guidelines recommending the continuation of OAC post-procedure to reduce the risk of stroke.
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 Ian Meredith, executive VP 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.
Increased patient range
The company noted that this new device is designed for simplified implantation to fit a host of patients, irrespective of whether they have simple or complex anatomies. It allows for implantation flexibility, permitting customized placement with a fully enclosed, rounded frame. In addition, it permits clinicians to recapture and reposition the device during procedure. Furthermore, the frame of the new device is designed to enhance sealing within the left atrial appendage, the company explained.
When asked about the experience with the device in Europe, the company noted that there are an estimated 11 million people who live with atrial fibrillation there. The Watchman Flx device is poised to take additional market share in Europe due to its design differentiation, and we expect it will take a strong leadership position when it is fully launched later this year, the company said, adding that it anticipates expanding commercialization to more European sites in the second half of the year.
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.
Earlier this month, Cowen s Joshua Jennings noted that the company discussed Watchman Flx and the study at the 2019 Heart Rhythm Society (HRS) meeting. Jennings highlighted that the company was pleased with European feedback. This trial is a potential game-changer since it s the first in which Watchman is used in patients who are explicitly candidates for either an oral anticoagulant or the device, he wrote. Separately, BSX said it believes [Abbott] will enter the U.S. market around 2021, which underscores the exclusive growth opportunity Watchman still has in the U.S.
During HRS, Nick Spadea-Anello, VP & GM of Interventional Cardiology, noted the company s goal of being ahead of the competitor. [W]e re working with the FDA on that.