Abstract
Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with non-valvular atrial fibrillation (AF).
Aims: The SAFE-PROTECT trial was designed to evaluate the safety and efficacy of the AnchorMan, a novel LAA closure device, compared with the Watchman 2.5 device for patients with AF at high risk of ischaemic stroke.
Methods: SAFE-PROTECT was a multicentre, open-label, non-inferiority trial of patients with non-valvular AF at high risk of ischaemic stroke, randomised 1:1 to LAA closure with the AnchorMan or the Watchman device. The 12-month primary endpoint was clinical success (freedom from ischaemic/haemorrhagic stroke, systemic embolism, cardiovascular or unexplained death); the secondary efficacy endpoint was echocardiography-defined LAA occlusion (peridevice leak <5 mm) at 12 months.
Results: A total of 216 patients were randomised to either an AnchorMan (n=108) or to a Watchman (n=108) device. The AnchorMan was non-inferior to Watchman for the primary endpoint (98.1% vs 98.1%;p>0.99; difference –0.3; 95% confidence interval [CI]: –3.9 to 3.5; pnon-inferiority=0.0004) and the powered secondary efficacy endpoint of LAA closure (100% vs 100%; difference 0%; 95% CI: –3.60 to 3.50; pnon-inferiority=not applicable). The rates of all-cause death, stroke, major bleeding, and device-related complications were low and similar between groups.
Conclusions: Among patients with non-valvular AF at high risk of ischaemic stroke, the AnchorMan device met its prespecified non-inferiority primary clinical success and secondary LAA occlusion endpoints compared with the Watchman 2.5 device. ClinicalTrials.gov: NCT04479722
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