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

Nov 05, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Ministry of Health, Czech Republic
Date Presented:
11/05/2021
Date Published:
11/05/2021
Date Updated:
11/05/2021
Original Posted Date:
09/03/2019
References

Contribution To Literature:

Highlighted text has been updated as of November 5, 2021.

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).

Long-term results, median of 3.5 years:

  • For the primary outcome, left atrial appendage occlusion was noninferior to a NOAC (HR 0.81, p for superiority = 0.27, p for noninferiority = 0.006).
  • For clinically relevant bleeding, left atrial appendage occlusion was superior to a NOAC (HR 0.55, p for superiority = 0.039).

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., on behalf of the PRAGUE-17 Investigators. Left Atrial Appendage Closure Versus Non-Warfarin Oral Anticoagulation in Atrial Fibrillation: 4-Year Outcomes of PRAGUE-17. J Am Coll Cardiol 2021;Nov 5:[Epub ahead of print].

Editorial Comment: Merchant FM. Does Percutaneous Left Atrial Appendage Closure Stand the Test of Time? J Am Coll Cardiol 2021;Nov 5:[Epub ahead of print].

Presented by Dr. Pavel Osmancik at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, Orlando, FL, November 5, 2021.

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.

Keywords: Anticoagulants, Arrhythmias, Cardiac, Aspirin, Atrial Appendage, Atrial Fibrillation, Coronary Occlusion, Echocardiography, Transesophageal, Embolism, Hemorrhage, Ischemic Attack, Transient, Myocardial Ischemia, Secondary Prevention, Stroke, Thrombosis, ESC Congress, ESC 19, TCT21, Transcatheter Cardiovascular Therapeutics


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