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Meta-analysis: LAA closure confers CV mortality benefit vs. warfarin in AF
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Findings from a meta-analysis of the PROTECT AF and PREVAIL trials indicated that left atrial appendage closure yielded a survival benefit compared with warfarin in patients with nonvalvular AF.
The researchers assessed data from the PROTECT AF and PREVAIL randomized controlled trials to compare left atrial appendage (LAA) closure vs. warfarin for the prevention of stroke, systemic embolism and CV death.
The meta-analysis included 2,406 patients with 5,931 patient-years of follow-up. The mean follow-up duration was 2.69 years.
Closure with the Watchman device (Boston Scientific) yielded 0.15 hemorrhagic strokes per 100 patient-years vs. 0.96 per 100 patient-years with warfarin (HR = 0.22; P = .004). CV or unexplained mortality also was significantly lower in the LAA closure group (1.1 vs. 2.3 events per 100 person-years; HR = 0.48; P = .006), as was nonprocedural bleeding (6% vs. 11.3%; HR = 0.51; P = .006).
Rates of all-cause mortality or systemic embolism were 1.75 per 100 person-years in the LAA closure group vs. 1.87 per 100 person-years in the warfarin group, which the researchers noted were statistically similar (HR = 1.02; 95% CI, 0.62-1.7).
The researchers suggested that the improved mortality rates in the device group may be multifactorial. They noted that novel anticoagulant drugs generally confer a mortality benefit of approximately 10% to 15% compared with warfarin.
Patients treated with the device experienced 1.6 ischemic strokes per 100 person-years, whereas warfarin was associated with 0.9 ischemic strokes per 100 person-years (HR = 1.95; P = .05).
Analysis for the composite efficacy endpoint indicated that event rates were nonsignificantly lower in the LAA closure group (HR = 0.79; P = .22).
David R. Holmes Jr.
“In the setting of [nonvalvular] AF with increased stroke risk, systemic embolism, or CV death, patients who are treated with the Watchman device for [left atrial appendage closure] have marked reduction in hemorrhagic stroke, CV death, and major non–procedural-related bleeding compared to patients treated with chronic warfarin,” David R. Holmes Jr., MD, from the Mayo Clinic in Rochester, Minnesota, and colleagues concluded. “This is balanced by a smaller magnitude increase in ischemic stroke in device-treated patients that may reflect the diverse etiology of stroke in this population.” – by Rob Volansky
Disclosure: The researchers report associations with a number of device and pharmaceutical companies. Please see the full study for a list of all other authors’ relevant financial disclosures.
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