3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial

doi:10.1016/j.jacc.2025.03.535

Valvular & structural heart disease

3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial

J Am Coll CardiolPublished 8 Jul 2025Randomised controlled trial

Primary result · Composite ischemic endpointResultHazard ratio 0.58 95% CI 0.33–1.03

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Authors' conclusion

At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups.

Study context

Population: Patients with AF and high bleeding risk undergoing left atrial appendage closure (LAAC)220 completed LAAC
Participants: 221 patients

Comparison: Amulet vs Watchman FLX for percutaneous LAAC
Primary endpoint: Composite of:
CV death
Stroke
TIA
Systemic embolism
Follow-up: 3 years

Methodological detailsinvestigator-initiated, multicentre (8 centres), 3 patients randomised to Amulet received Watchman FLX, 3-year follow-up rate 96.4% (Amulet) and 97.3% (Watchman)

Investigator-initiated
Multicentre (8 centres)
3 patients randomised to Amulet received Watchman FLX
3-year follow-up rate 96.4% (Amulet) and 97.3% (Watchman)

Primary result

Composite ischemic endpoint

Hazard ratio

0.58

95% CI 0.33–1.03

P = 0.06

By group

Amulet18.2%

Watchman31.0%

Amulet vs Watchman

HR 0.58 (95% CI 0.33–1.03); P = 0.06

As reported in the abstract

Further findings

Outcome	Amulet	Watchman	← Lower risk with amulet ←→ Higher risk with amulet →	HR (95% CI)	P value
Composite ischemic endpoint, as-treated population · 3 years · as-treated	17.0%	31.1%	0.20.5125	0.53 (0.30–0.96)	P = 0.035
Composite ischemic endpoint, per-protocol population · 3 years · per-protocol	16.2%	29.2%	0.20.5125	0.54 (0.29–1.00)	P = 0.049
			0.20.5125Hazard ratio (log scale)

Original publication

3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Published 8 July 2025. doi:10.1016/j.jacc.2025.03.535

Read the original article ↗PubMed

Summarised from the published abstract; every number is checked against it