Boston Scientific SIMPLAAFY trial meets primary endpoints for LAA closure device
A clinical study shows simplified drug regimens are non-inferior to dual anti-platelet therapy following WATCHMAN FLX Pro implantation.
Boston Scientific has reported six-month results from the SIMPLAAFY clinical trial, demonstrating that single-drug post-implant regimens are non-inferior to standard dual anti-platelet therapy (DAPT) in patients receiving the WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) device. The trial, which involved 1,857 patients across 86 U.S. sites, sought to identify effective, less-intensive drug protocols following the procedure.
Data presented at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) symposium and published in JAMA showed that patients on either aspirin-only or reduced-dose non-vitamin K antagonist oral anticoagulant (NOAC) regimens experienced equivalent stroke prevention compared to those on DAPT, while also observing reduced bleeding rates. Additionally, imaging at 45 days indicated that device-related thrombus incidence was lower in the reduced-dose NOAC group.
Dr. Saibal Kar, the study co-chair, noted that the findings highlight a potential pathway to reduce medication burden for patients recovering from the procedure. The WATCHMAN FLX Pro, approved by the FDA in 2023, is designed to serve as an alternative to long-term blood thinners for patients with non-valvular atrial fibrillation who face an elevated risk of stroke.