Arrhythmias & electrophysiologyRandomised controlled trial
5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
- Randomised controlled trial
- head-to-head device comparison
- 5-year follow-up
Authors' conclusion
The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices.
Study context
- Population
- Patients with nonvalvular AF at high risk of stroke or systemic embolism (CHADS2 score ≥2 or CHA2DS2-VASc score ≥3)1,833 had implant attempt
- Participants
- 1,878 patients
- Comparison
- Amulet occluder vs Watchman 2.5 device for LAAO
- Amuletn = 917
- Watchmann = 916reference
- Primary endpoint
- Oral anticoagulation (OAC) use and key clinical outcomes
- Follow-up
- Through 5 years
Primary result
As reported in the abstract
Freedom from OAC and clinical outcomes · 5 years
Free of OAC
P = 0.009
Ischemic stroke or systemic embolism
P = 0.851
Stroke, systemic embolism or CV death
P = 0.666
CV death
P = 0.429
All-cause death
P = 0.217
| Outcome | Amulet | Watchman | P value |
|---|---|---|---|
| Annualized ischemic stroke rate | 1.6%/y | 1.6%/y |
Further findings
| Outcome | Amulet | Watchman |
|---|---|---|
| Stroke severity | ||
| Nondisabling | 38 | 19 |
| Disabling | 11 | 22 |
| Fatal | 11 | 17 |
| Unknown | 12 | 10 |
| Device factors (device-related thrombus or peridevice leak ≥3 mm) preceding stroke or CV death | 31 events | 63 events |
Stroke severity
- Strokes less severe with Amulet
Safety
Major bleeding · 5 years
P = 0.882
Original publication
5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial. J Am Coll Cardiol. Published 18 November 2024. doi:10.1016/j.jacc.2024.10.101
Summarised from the published abstract; every number is checked against it