Left atrial appendage closure versus medical therapy in patients with atrial fibrillation: the APPLY study.
Abstract | AIMS: METHODS AND RESULTS: Five hundred consecutive patients who underwent LAAC with AMPLATZER occluders were compared to 500 patients with medical therapy by propensity score matching. The primary efficacy endpoint was a composite of stroke, systemic embolism and cardiovascular/unexplained death. The primary safety endpoint consisted of major procedural adverse events and major bleedings. For assessment of net clinical benefit, all of the above-mentioned hazards were combined. After 2,645 patient-years at a mean follow-up of 2.7±1.5 years, the primary efficacy endpoint was reached by 75/1,342, 5.6% in the LAAC group versus 102/1,303, 7.8% per 100 patient-years (hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.53-0.95, p=0.026). The primary safety endpoint occurred in 48/1,342, 3.6% versus 60/1,303, 4.6% per 100 patient-years (HR 0.80, 95% CI: 0.55-1.18, p=0.21), and the combined hazard endpoint in 109/1,342, 8.1% versus 142/1,303, 10.9% per 100 patient-years (HR 0.76, 95% CI: 0.60-0.97, p=0.018). Patients receiving LAAC demonstrated lower rates of both all-cause and cardiovascular mortality (111/1,342, 8.3% vs 151/1,303, 11.6% per 100 patient-years [HR 0.72, 95% CI: 0.56-0.92, p=0.005] and 54/1,342, 4.0% vs 84/1,303, 6.5% per 100 patient-years [HR 0.64, 95% CI: 0.46-0.89, p=0.007]). CONCLUSIONS: LAAC with AMPLATZER devices showed a net clinical benefit over medical therapy by superior efficacy, similar safety and a benefit in all-cause and cardiovascular mortality.
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Authors | Steffen Gloekler, Monika Fürholz, Stefano de Marchi, Caroline Kleinecke, Samuel R Streit, Eric Buffle, Mate Fankhauser, Jonas Dominik Häner, Fabian Nietlispach, Roberto Galea, Stephan Windecker, Bernhard Meier |
Journal | EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
(EuroIntervention)
Vol. 16
Issue 9
Pg. e767-774
(Oct 09 2020)
ISSN: 1969-6213 [Electronic] France |
PMID | 32583806
(Publication Type: Journal Article)
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Topics |
- Atrial Appendage
(diagnostic imaging, surgery)
- Atrial Fibrillation
(complications, drug therapy)
- Cardiac Surgical Procedures
- Humans
- Septal Occluder Device
(adverse effects)
- Stroke
(etiology, prevention & control)
- Treatment Outcome
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