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PROTECT AF: Long-term data confirm safety, sustained efficacy of Watchman device
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DENVER — Long-term follow-up data from the PROTECT AF trial indicate that left atrial appendage closure with the Watchman device was superior to warfarin for the prevention of death and was associated with reduced risk for hemorrhagic stroke in patients with nonvalvular atrial fibrillation.
This intention-to-treat analysis included 707 patients randomly assigned 2:1 to the Watchman device (n=463; Atritech/Boston Scientific) or warfarin (n=244; Coumadin, Bristol-Myers Squibb). Mean CHADS2 score was 2.2 ± 1.2 and 2.3 ± 1.2, respectively.
Average follow-up was 45 months (2,578 patient-years of data).
Vivek Y. Reddy
According to results presented by Vivek Y. Reddy, MD, at the Heart Rhythm Society’s Annual Scientific Sessions, the primary efficacy endpoint of stroke, systemic embolism or CV/unexplained death was not just noninferior, but for the first time superior in the Watchman group over the warfarin group (2.3 per 100 patient-years vs. 3.8 per 100 patient-years; RR=0.6; 95% CI, 0.41-1.05; posterior probability of superiority=96%), Reddy said.
In addition, the Watchman device was associated with superior rates of all-cause mortality (3.2% vs. 4.8%; RR=0.66; 95% CI, 0.45-0.98) and CV mortality (1 per 100 person-years vs. 2.4 per 100 person-years; RR=0.4; 95% CI, 0.21-0.72) compared with warfarin.
In addition, rate of hemorrhagic stroke was lower in the Watchman group (0.2% vs. 1%; RR=0.18; 95% CI, 0.04-0.6).
“Of the patients who had an implant, 86% were able to get off warfarin in a 6-month time frame. There are fewer CV deaths, fewer pulmonary-disease related deaths, fewer hemorrhagic stroke-related deaths in the Watchman group compared with the warfarin group,” Reddy, professor of medicine at Mount Sinai School of Medicine, said at a press conference. “We need randomized controlled trials to compare novel devices to either oral anticoagulants or a device that has been shown to work.”
The multicenter, prospective study was conducted at 59 investigational sites.
An earlier analysis of the PROTECT AF trial demonstrated that left atrial appendage closure with the Watchman device was noninferior to warfarin for the primary endpoint after an average 2.3 years of follow-up. – by Deb Dellapena
For more information:
Reddy VY. LB01-03. Presented at: Heart Rhythm Society’s Annual Scientific Sessions; May 8-11, 2013; Denver.
Disclosure: Reddy reports consulting, serving on the medical advisory board and receiving research grant support from Boston Scientific Corp. The other researchers report no relevant financial disclosures.
Perspective
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Jagmeet Singh, MD, PhD
It was a question of long-term follow-up to really elucidate the differences between the two arms in the PROTECT AF study. I am not surprised that significant differences emerged, at the 4-year mark. There was a substantial reduction in overall and cardiovascular mortality and also hemorrhagic strokes. Going forward, the device needs to be FDA-approved. The panel needs to review the data, which are now substantially stronger than before. The evidence suggests that this device has stood the test of time.
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