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Left atrial appendage closure with the Watchman device appears safe, with low stroke risk, for patients contraindicated for the standard anticoagulant used early after implantation, according to 5-year follow-up of the observational ASAP study.

The annual rate of ischemic stroke or systemic embolism was 1.8%, representing a 75% cut from the expected odds of 7.3% for these oral anticoagulant-contraindicated patients, , of New York's Icahn School of Medicine at Mount Sinai, and colleagues reported in the Journal of the American College of Cardiology.

While the device is an alternative to long-term anticoagulation for stroke risk reduction in nonvalvular atrial fibrillation f but with "an appropriate rationale" not to do so, the pivotal trials continued oral anticoagulants for at least 6 weeks. No randomized trials have been done in oral anticoagulant-contraindicated patients.

ASAP was a prospective, nonrandomized trial to fill that gap. It included 150 patients contraindicated for oral anticoagulation, who instead got dual antiplatelet therapy with aspirin and clopidogrel (Plavix) for 6 months, followed by aspirin alone.

The mean CHADS₂ and CHA₂DS₂-VASc scores were 2.8 and 4.4, respectively.

Hemorrhagic strokes occurred at an annual rate of 0.54%, all-strokes at 2.4%, cardiovascular or unexplained deaths at 2.3%, all-cause mortality at 4.6%, transient ischemic attacks at 0.9%, and major bleeding events at 1.8%,

ASAP had previously shown a promising stroke rate of only 1.7% 1 year after Watchman implantation. The 5-year annual frequency of 1.8% is "not appreciably different," the authors wrote, and is "in line with that observed with the trials of warfarin-tolerant patients (PROTECT-AF and PREVAIL): 1.7% versus 1.6%, respectively."

"The hemorrhagic stroke rate was higher than in PROTECT-AF/PREVAIL (0.54% versus 0.15%, respectively), but the lower 95% confidence interval for the hemorrhagic stroke rate was 0.1%, likely related to the smaller size of the ASAP cohort," the authors noted.

Reddy's group added that the present investigation shared similar rates of in major bleeding with the ACTIVE A (1.3%) and AVERROES (1.2%) trials on patients ill-suited for oral anticoagulants.

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