Report From HRS: PROTECT AF Positive For Watchman

Article preview from Medtech Insight - May 2013

Boston Scientific is highlighting a secondary-endpoint analysis showing that the left atrial appendage closure device reduced all-cause death by 34%. The company plans to submit a PMA for the device by the end of the second quarter.

Report From HRS: PROTECT AF Positive For Watchman

Article preview from Medtech Insight - May 2013

Four-year follow-up data from the PROTECT AF clinical trial were presented at Heart Rhythm 2013, the Heart Rhythm Society (HRS) meeting held in early May in Denver, CO, and the results appear to provide the boost needed to support US Food and Drug Administration (FDA) approval of Boston Scientific Corp.’s Watchman left atrial appendage (LAA) closure device for stroke prevention in atrial fibrillation (AF) patients.

The results showed, for the first time, that LAA closure with the Watchman was statistically superior to warfarin in terms of efficacy, with Watchman demonstrating a 40% reduction in a composite risk of stroke, systemic embolism, and cardiovascular death; a 60% reduction in cardiovascular mortality; and a 34% reduction in all-cause mortality compared with warfarin.

The four-year PROTECT AF results were presented at the HRS meeting on May 9 by electrophysiologist Vivek Reddy, MD, professor of medicine and cardiology at Mount Sinai Hospital in New York. “To see a mortality benefit in a trial like this – with only 700 patients – is very surprising, and I think that’s something that physicians and regulatory officials are going to look at,” Reddy told “The Gray Sheet.” “Before this presentation, we could say [to patients] ‘We can get you off of warfarin with this device strategy and we can do that with statistically equivalent or perhaps better outcomes.’ But with the new results, physicians can tell Watchman candidates the device reduces the risk of all-cause mortality by about one third.

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