EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2026
Left atrial appendage closure with the AnchorMan or Watchman devices: 12-month results of the SAFE-PROTECT randomised trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Wang Binhao, Cai Heng, Wu Yanqing, Chen Manhua, Wang Changqian, Jiang Xiaofei, Tao Siming, Zhong Zhixiong, Zeng Jie, Wang Fengling, Ning Zhongping, Yuan Zuyi, He Jiangui, Francese Dominic P, Lansky Alexandra J, He Ben, Chu Huimin, Of The Safe-Protect Investigators On Behalf
Аннотация
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.
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.