Five-year data from PREVAIL study of Watchman LAAC shows safety and effectiveness in stroke risk reduction.- Boston Scientific.

Boston Scientific announced final five-year outcomes data from the PREVAIL study of the Watchman Left Atrial Appendage Closure (LAAC) Device. The PREVAIL data, combined with final five-year outcomes from the PROTECT-AF clinical trial, demonstrated the Watchman device continues to be a safe and effective alternative to long-term warfarin therapy offering comparable stroke risk reduction for patients with non-valvular atrial fibrillation (AF).

In the PREVAIL and PROTECT-AF randomized clinical trials, LAAC with the Watchman device was compared to warfarin for stroke prevention in high-risk patients with non-valvular AF. Upon completion of five-year follow up in both trials, study authors conducted a meta-analysis combining all data from the 1,114 randomized patients for a total of 4,343 patient-years. In addition to stroke prevention comparable to warfarin, the analysis concluded the Watchman device also effectively reduced non-procedure related major bleeding, disabling or fatal stroke, and mortality. The comprehensive analysis confirmed a 55% reduction in disabling or fatal stroke, largely driven by an 80% statistically significant reduction in hemorrhagic stroke.

Further, the combined data demonstrated a 52% decrease in non-procedure related major bleeding and 27% reduction in all-cause mortality when compared to long-term warfarin therapy. Data were presented during a late-breaking clinical trial session at the 29th Transcatheter Cardiovascular Therapeutics symposium. .

"With complete five-year follow up in two randomized clinical trials, left atrial appendage closure with the Watchman device continues to demonstrate statistically significant reductions in death," said Vivek Reddy, M.D., principal investigator and director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and the Mount Sinai Health System. "Importantly, the data further prove the Watchman device is a safe and effective therapeutic alternative for stroke prevention in appropriate patients, enabling them to stop taking warfarin."

See- "Long-Term Results with Left Atrial Appendage Closure: Watching the Watchman."- Jacqueline Saw.- Journal of the American College of Cardiology November 02, 2017, 24392; DOI: 10.1016/j.jacc.2017.10.056.