Arrhythmias & electrophysiology
Incidence, Predictors, Management, and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: The Amulet IDE Randomized Clinical Trial
Authors' conclusion
In this study, MB was common in this high-risk population and largely related to underlying patient factors. Early MB risk was highest 6 months post-LAAO, then dropped considerably. Most events were gastrointestinal and occurred even in patients on minimal or no antithrombotic therapy. MB after LAAO was strongly associated with increased stroke and mortality.
Study context
- Population
- Patients undergoing attempted left atrial appendage occlusion (LAAO) (Amulet or Watchman) with contraindications to OAC1,878 randomised
- Participants
- 1,833 patients
- Comparison
- Patients with vs without major bleeding after LAAO
- Major bleeding (MB)n = 331
- Primary endpoint
- Outcomes in pooled (Amulet and Watchman) patients with vs without MB (BARC ≥3: overt bleeding with transfusion and ≥3 g/dL hemoglobin drop)
- Follow-up
- 5 years
Methodological detailspooled Amulet and Watchman, 5-year follow-up
- Pooled Amulet and Watchman
- 5-year follow-up
Primary result
As reported in the abstract
Major bleeding (BARC ≥3)
Hazard ratio (95% CI)
Increasing age
1.04(1.02–1.06)
Female sex
1.25(1.01–1.56)
Diabetes
1.26(1.01–1.58)
Prior MB
1.93(1.55–2.40)
Kidney disease
2.15(1.48–3.12)
- MB incidence over 5 years
- 331 patients (18.1%)
- Annualized MB rate
- 5.9% per year
- MB risk first 6 months after LAAO
- 20.5% per year
- MB risk thereafter through 5 years
- 3.9% per year
- Nonprocedural MB events
- 88.8%
- GI bleeding events
- 252 of 438
- Not receiving antithrombotic therapy at first MB
- 47.1%
- Patients with recurrent MB
- 92
Further findings
Composite of stroke, systemic embolism or CV death · composite
P < 0.001
Stroke
CV death
All-cause mortality
- All-cause mortality also higher with MB than without MB
- 49.2% vs 25.4%; P < .001
MB risk over time
Per year
- First 6 months after LAAO
- 20.5%
- Thereafter through 5 years
- 3.9%
Safety
Fatal MB (BARC 5)
- Fatal MB
- 25 patients (1.4%)
Original publication
Incidence, Predictors, Management, and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: The Amulet IDE Randomized Clinical Trial. JAMA Cardiol. Published 1 May 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →