Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-Risk Atrial Fibrillation Patients - PRAGUE-17
Contribution To Literature:
The PRAGUE-17 trial showed that left atrial appendage occlusion was noninferior to a NOAC at preventing net ischemic/bleeding events.
Description:
The goal of the trial was to evaluate left atrial appendage occlusion compared with a novel oral anticoagulant (NOAC) among patients with nonvalvular atrial fibrillation.
Study Design
- Randomized
- Parallel
- Open-label
Patients with nonvalvular atrial fibrillation were randomized to left atrial appendage occlusion (n = 201) versus a NOAC (n = 201).
In the left atrial appendage occlusion group, the Amulet or the Watchman device could be used. Patients were treated with dual antiplatelet therapy for 3 months, at which time a transesophageal echocardiogram was performed. If no thrombus, aspirin alone was maintained. Antiplatelet/anticoagulation therapy could be modified depending on bleeding/thrombotic risk.
In the NOAC group, any agent could be given; however, apixaban was preferred.
- Total number of enrollees: 402
- Duration of follow-up: 20.8 months
- Mean patient age: 73 years
- Percentage female: 35%
- Percentage with diabetes: 45%
Inclusion criteria:
Subjects with nonvalvular atrial fibrillation and one of the following:
- Bleeding requiring hospitalization or intervention
- History of cardioembolic event while on anticoagulation
- CHA2DS2-VASc score ≥3
- HAS-BLED score ≥2
Exclusion criteria:
- Mechanical heart valve or mitral stenosis
- Alternative reason for anticoagulation
- Patent foramen ovale with large atrial septal aneurysm
- Mobile aortic plaque
- Symptomatic carotid disease
- Pericardial effusion
- Clinically significant bleeding within the last 30 days
- Acute coronary syndrome within the last 90 days
- Creatine clearance <30 cc/min
- Left atrial appendage thrombus
Other salient features/characteristics:
- Mean CHA2DS2-VASc score: 4.7
- Mean HAS-BLED score: 3.0
- In the left atrial appendage occlusion group, 5.6% were withdrawn because of lack of informed consent or left atrial appendage thrombus. In an additional 9.4%, the procedure was unsuccessful and these patients crossed over to a NOAC.
Principal Findings:
The primary net outcome of cardiovascular death, stroke/transient ischemic attack, systemic embolism, clinically significant bleeding (ISTH major or nonmajor clinically significant bleeding), or significant procedure/device-related complication was similar between the two treatment groups (hazard ratio [HR] 0.84, p for noninferiority = 0.004).
For secondary outcomes: Major or nonmajor clinically significant bleeding was similar between the two treatment groups (HR 0.81, p = not significant).
Interpretation:
Among patients with nonvalvular atrial fibrillation, left atrial appendage occlusion was noninferior to a NOAC (apixaban) at preventing net ischemic/bleeding events. Many questions remain regarding proper selection of patients and best practice for this technology.
References:
Osmancik P, Herman D, Neuzil P, et al. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol 2020;75:3122-35.
Editorial Comment: Price MJ, Saw J. Transcatheter Left Atrial Appendage Occlusion in the DOAC Era. J Am Coll Cardiol 2020;75:3136-9.
Presented by Dr. Pavel Osmancik at the European Society of Cardiology Congress, Paris, France, September 2, 2019.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: ESC Congress, Anticoagulants, Arrhythmias, Cardiac, Aspirin, Atrial Appendage, Atrial Fibrillation, Coronary Occlusion, Echocardiography, Transesophageal, Embolism, Hemorrhage, Ischemic Attack, Transient, Myocardial Ischemia, Secondary Prevention, Stroke, Thrombosis, ESC 19
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