Boston Scientific reports SIMPLAAFY trial supports less-intensive WATCHMAN FLX Pro drug regimens
Boston Scientific reported on Nov. 2 that the SIMPLAAFY trial found aspirin alone and reduced-dose NOAC therapy noninferior to DAPT after WATCHMAN FLX Pro implantation. The randomized study included 1,857 patients at 86 U.S. sites, and both single-drug approaches produced less bleeding with ischemic-stroke rates equivalent to DAPT at 0.7%. At 45 days, device-related thrombus occurred in 0.9% of the reduced-dose NOAC group versus 3.4% with DAPT, with P=0.01.
Why it matters
Boston Scientific said the findings could support simpler post-implant care and more individualized treatment decisions. The company cautioned that aspirin alone and reduced-dose NOAC alone remain investigational regimens, so the results do not by themselves change established treatment practice.
Key facts
- 1The SIMPLAAFY trial randomized 1,857 patients across 86 clinical study sites in the U.S. prnewswire.com
- 2Aspirin alone and reduced-dose NOAC therapy each met the six-month noninferiority standard versus DAPT. prnewswire.com
- 3The DAPT group had an ischemic-stroke rate of 0.7%, while the two single-drug regimens had equivalent ischemic-stroke rates and less bleeding. prnewswire.com
- 4At 45 days, device-related thrombus was 0.9% with reduced-dose NOAC versus 3.4% with DAPT, with P=0.01. prnewswire.com
- 5Boston Scientific stated that aspirin alone and reduced-dose NOAC alone after WATCHMAN FLX Pro implantation are investigational post-implant drug regimens. prnewswire.com
Open questions
- Material 2 says Boston Scientific did not provide arm-specific bleeding rates or the corresponding ischemic-stroke rates for the non-DAPT groups.
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.