Boston Scientific will present, for the first time, preliminary results of all three co-primary endpoints of the Watchman device at the American College of Cardiology 2013 Annual Scientific Sessions.
Boston Scientific has announced that results from the PREVAIL clinical trial, including all three co-primary endpoints that evaluate the safety and efficacy of the Watchman Left Atrial Appendage (LAA) Closure device in patients with non-valvular atrial fibrillation versus long-term warfarin therapy, will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology (ACC; San Francisco, USA, 9–11 March). This will be the first time all three co-primary endpoints in the PREVAIL study will be presented, the company announced.
The preliminary results of the PREVAIL trial will be presented on 9 March by David R Holmes, Mayo Clinic, Rochester, USA. Specifically, Holmes will present initial analysis on the following co-primary endpoints:
- Acute (seven-day) occurrence of death, ischaemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention
- Comparison of composite of stroke, systemic embolism, and cardiovascular/unexplained death at 18 months follow-up
- Comparison of ischaemic stroke or systemic embolism occurring from greater than seven days post randomisation to 18 months follow-up
“This is truly a late-breaking clinical trial presentation,” said Kenneth Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific. “The last patient six-month follow-up occurred in January and the team has been working diligently to complete the preliminary analysis of the data. The acute procedural results were completed first, and we announced earlier this week that those results would be presented. We are pleased to announce that the preliminary analysis of the other two endpoints will now be presented as well. The final fully monitored and adjudicated analysis will be completed in the coming weeks and is expected to be used to support our comprehensive clinical module pre-market application filing of the Watchman device. This filing is also expected to include Protect-AF four-year outcomes data, the Watchman Pilot study six-year data, the ASAP study and the CAP registry data update.”
The Watchman device was approved for sale in Europe in 2005 and in some Asian countries in 2009. It is already commercially available in 40 countries worldwide. In the United States, Watchman is an investigational device, limited by applicable law to investigational use and not available for sale. Results from the PREVAIL confirmatory study are expected to be submitted for approval by the FDA. The device was developed by Atritech, acquired by Boston Scientific in March 2011.