Watchman Device as Alternative to Warfarin or Coumadin
April 24, 2009 5:21 AM CT
The results of the Watchman device trial, called PROTECT-AF, have just come out of the American College of Cardiology 2009 annual meetings in Orlando.
The Watchman (Atritech) is a device that closes off the left atrial appendage (LAA) to minimize the risk of stroke. It is one of several techniques for closing off the left atrial appendage as an alternative to Coumadin or warfarin—other techniques include removing or clamping off the left atrial appendage during surgery.
The PROTECT-AF trial included atrial fibrillation patients who had CHADS2 scores of 1 or higher, 65% of whom were CHADS 1 or 2. The Watchman device showed reduced risk of hemorrhagic (bleeding) strokes when compared to warfarin, and comparable results between the two for all strokes and overall mortality.
Of some concern is that safety events were double for the Watchman device compared to warfarin, but those events have decreased over time due to enhanced procedures and training.
Researchers concluded that the Watchman could be an option for up to 70% of patients with non-valve-related atrial fibrillation, and may offer an especially good option for those afib patients who cannot take anticoagulants.
The FDA advisory panel is expected to review and advise on the Watchman device on April 23, 2009.
Read more about the study: ACC 2009: PROTECT-AF: Device Closure of LAA May Provide Alternative to Warfarin to Prevent Stroke in AF
The FDA Advisory Committee will meet on Thursday, April 23 to review the data on the Atritech Watchman device and determine whether to recommend that the FDA approve it, or not approve it, for those with non-valvular atrial fibrillation.
The FDA released their internal review documents today in preparation for the Thursday Advisory Committee meeting. FDA staff expressed a number of concerns about the data, including:
- The trial’s exclusion of atrial fibrillation patients at high risk for poor outcomes
- The lack of effectiveness data — there was effectiveness data on only 22 percent of patients after two years
For more information, read: FDA staff cites issues with device data
The FDA and Sponsor briefing documents have been posted at:
Circulatory Devices Panel Meeting, April 23, 2009, Briefing Information
The FDA Advisory Committee voted 7–5 to recommend approval of the Watchman device, but with certain stipulations due to the small study size and safety concerns. The FDA usually follows the recommendations of the Advisory Committee, though it doesn’t have to.
For more information read: FDA advisory panel votes 7 to 5 to recommend approval of Watchman LAA closure device