At 3 years, Amulet device for LAAO remains noninferior for safety, efficacy vs. Watchman
BOSTON — At 3 years, the Amplatzer Amulet device remained superior at left atrial appendage occlusion and noninferior for safety and effectiveness compared with the Watchman device, researchers reported at TCT 2022.
The large-scale randomized head-to-head Amulet IDE trial compared two left atrial appendage occlusion (LAAO) devices, Amulet (Abbott) and Watchman 2.5 (Boston Scientific), in patients with nonvalvular atrial fibrillation requiring stroke prevention.
“The take-home message for the general public is the confidence in the Amulet occluder to provide immediate and prolonged closure so patients can safely remove oral anticoagulant medications from their everyday life,” Dhanunjaya Lakkireddy, MD, clinical electrophysiologist and medical director for the Kansas City Heart Rhythm Institute at HCA Midwest Health, said during a press conference. “It reinforces the initial findings and our knowledge about these devices.”
According to a company press release issued when the device received FDA approval in August 2021, Amulet features “dual-seal technology” for immediate LAAO, lowering risk for stroke and eliminating the need for oral anticoagulation. The Watchman 2.5 uses a single seal for occlusion.
For the Amulet IDE trial, researchers randomly assigned 1,878 patients with nonvalvular AF at high risk for stroke to undergo LAAO with the Amulet or Watchman devices (mean age, 75 years; 60% men).
As Healio previously reported, the Amulet device was superior for LAAO and noninferior for safety and effectiveness at 18 months compared with the Watchman 2.5 device.
For the present analysis, researchers assessed the 3-year efficacy and safety of Amulet compared with Watchman. Outcomes of interest included a composite of stroke, systemic embolism or CV death; all-cause death and CV death; major bleeding; and composite of ischemic stroke or systemic embolism.
More patients from the Amulet group completed 3-year follow-up compared with the Watchman group (92% vs. 86.7%) due to more deaths and withdrawals in the Watchman group by 18 months, Lakkireddy said at the press conference.
At 3 years, more patients in the Watchman arm were on oral anticoagulation due to device-related thrombus compared with the Amulet group (3.7% vs. 7.3%; P < .01), according to the study.
Researchers reported a trend toward reduced CV and all-cause death among participants assigned to Amulet compared with Watchman 2.5.
The rates of ischemic stroke/systemic embolism (Amulet, 5%; Watchman, 4.6%) and major bleeding (Amulet, 16.1%; Watchman, 14.7%) were similar between the two groups (P > .05 for both).
Moreover, device-related factors such as thrombus or peri-device leak more often preceded stroke after LAAO with Watchman compared with Amulet (17 patients vs. 4 patients) after 6 months.
“The outcomes were comparable for 3 years,” Lakkireddy said during the presentation. “There was a slight trend towards a higher CV death and all-cause death in the Watchman arm ... however, the systemic embolism and CV composite; ischemic stroke/systemic embolism composite; and major bleeding outcome were not significantly different between these two groups.”
Since the Amulet IDE study was conducted, a new generation of the Watchman device, Watchman-FLX, has entered the market, Lakkireddy noted during the press conference.
References:
- Lakkireddy D, et al. Circulation. 2021;doi:10.1161/CIRCULATIONAHA.121.057063.
- Abbott's Amplatzer Amulet Device Approved by FDA to Treat People with Atrial Fibrillation at Risk of Stroke. abbott.mediaroom.com/2021-08-16-Abbotts-Amplatzer-TM-Amulet-TM-Device-Approved-by-FDA-to-Treat-People-With-Atrial-Fibrillation-at-Risk-of-Stroke. Published on Aug. 16, 2021. Accessed on Sep. 17, 2022.
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Lakkireddy D, et al. Late-Breaking Science in Structural Heart Disease: Session II, in Collaboration With The European Heart Journal/Eurointervention. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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