SIMPLAAFY study of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device meets primary endpoints
Key Highlights
- ➤1,857 patients randomized across 86 U.S. clinical sites in SIMPLAAFY trial
- ➤Aspirin alone achieved noninferiority to DAPT with less bleeding and 0.7% ischemic stroke rate
- ➤Reduced-dose NOAC achieved noninferiority to DAPT with less bleeding and 0.7% ischemic stroke rate
- ➤Reduced-dose NOAC cut device-related thrombus to 0.9% versus 3.4% for DAPT
- ➤WATCHMAN FLX Pro aspirin-only and reduced-dose NOAC regimens remain investigational
Expert Statements
Saibal Kar, M.D., study co-chair and director, Structural Heart Disease Interventions and Clinical Research, Los Robles Health System
“For patients with NVAF who undergo an LAAC procedure, balancing short-term bleeding risk with the need to maintain stroke protection during post-procedure healing is critical.”
Saibal Kar, M.D., study co-chair and director, Structural Heart Disease Interventions and Clinical Research, Los Robles Health System
“The findings from the SIMPLAAFY trial are encouraging and highlight the potential to meaningfully simplify post-procedure care and reduce medication burden for patients following WATCHMAN FLX Pro implantation.”
Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific
“Innovation in LAAC extends beyond device technology to advancing the therapy through improved care delivery and an enhanced experience for physicians and patients.”
Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific
“The SIMPLAAFY trial provides valuable clinical evidence that can help physicians make more informed decisions about post-implant care and tailor treatment to individual patient needs.”
Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific
“Together with advancements like HEMOCOAT Technology, these findings represent meaningful progress toward simplifying treatment and advancing care for patients with atrial fibrillation.”
SIMPLAAFY study of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device meets primary endpoints PR Newswire
Both post-implant monotherapies in the trial achieved non-inferiority compared to dual anti-platelet therapy (DAPT) supporting the potential to simplify post-procedure drug regimens
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