From the annual scientific session of the American College of Cardiology, Orlando
Warfarin, the reigning standard therapy for stroke prevention in atrial fibrillation, has long been viewed by the pharmaceutical industry as a big fat sitting duck: it’s a widely prescribed, cheap drug that’s just begging for replacement by one of a host of easier to use and perhaps safer antithrombotic agents in the developmental pipeline.
But warfarin may finally be dethroned not by a better antithrombotic, but by a little plug made of nitinol wire and fabric called the Watchman. It’s a percutaneously implanted permanent device designed to seal off the left atrial appendage, the source of most atrial thrombus.
Here at the ACC meeting Dr. David Holmes of the Mayo Clinic presented the results of the Phase-3 PROTECT AF trial, in which during 900 patient-years of followup the Watchman resulted in a 91% reduction in hemorrhagic strokes and a 32% decrease in the combined endpoint of any stroke or all-cause mortality compared to warfarin.
Atritech, the Watchman’s developer, has a marketing approval hearing before an FDA advisory panel in late April.
Photo of Dr. David Holmes (above) taken by Bruce Jancin.