Arrhythmias & electrophysiologyRandomised controlled trial
Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation
- Randomised controlled trial
- multicentre
- non-inferiority
Authors' conclusion
Among patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure was not noninferior to physician-directed best medical care with regard to a composite end point of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death.
Study context
- Population
- Patients with AF at high risk of stroke and bleeding, Germanyprimary analysis: 446 device, 442 medical therapy
- Participants
- 912 patients
- Comparison
- LAAO vs physician-directed best medical care
- Devicen = 446
- Medical therapyn = 442reference
- Primary endpoint
- Composite of:
- Stroke (ischaemic or haemorrhagic)
- Systemic embolism
- Major bleeding
- CV or unexplained death (time-to-event)
- Follow-up
- Median 3 years
Primary result
As reported in the abstract
Difference in restricted mean survival time
−0.36 years
95% CI −0.70 to −0.01
P = 0.44 for non-inferiority
Events by treatment group
Device
16.8 per 100 patient-years
155 of 446
Medical therapy
13.3 per 100 patient-years
127 of 442
Non-inferiority margin 1.3 as printed, not drawn
Safety
Serious adverse events
Original publication
Summarised from the published abstract; every number is checked against it