June 12, 2019 — Boston Scientific Corp. 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) for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) who undergo a cardiac ablation procedure. OACs used in the trial will include direct oral anticoagulants (DOAC) and warfarin.
Approximately 33 million patients worldwide have AF, a common heart rhythm disorder.1 In recent years, the number of U.S. patients who have undergone an in-hospital cardiac ablation procedure to prevent abnormal electrical signals from moving through the heart has grown tenfold.2 More than 50 percent of those patients become asymptomatic, making them less likely to adhere to current guidelines recommending the continuation of OAC post-procedure to reduce the risk of stroke.3,4 Stroke is five times more likely to occur in patients with AF than in someone with a normal heart rhythm.5
"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 Oussama Wazni, M.D., 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."
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.
For more information: www.bostonscientific.com
1. Chugh S.S., et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation 2014;129:837–847. doi: https://doi.org/10.1161/CIRCULATIONAHA.113.005119.
2. Hosseini S., et al. Catheter ablation for cardiac arrhythmias: utilization and in-hospital complications 2000-2013. JACC: Clinical Electrophysiology. 2017. doi: https://doi.org/10.1016/j.jacep.2017.05.005.
3. Arbelo E., et al. Contemporary management of patients undergoing atrial fibrillation ablation: in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry. European Heart Journal. 2017. doi: https://doi.org/10.1093/eurheartj/ehw564.
4. Calkins H., et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial Fibrillation. Heart Rhythm Journal. 2017. doi: https://doi.org/10.1016/j.hrthm.2017.07.009.
5. Atrial Fibrillation Fact Sheet. Centers for Disease Control and Prevention. http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm.