Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-Risk Atrial Fibrillation Patients - PRAGUE-17

Sep 03, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor:
Ministry of Health, Czech Republic
Date Presented:
09/02/2019
Date Published:
06/22/2020
Original Posted Date:
09/03/2019
References

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  • In the left atrial appendage occlusion group, 5.6% were withdrawn because of lack of informed consent or left atrial appendage thrombus.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.

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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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