LAA Closure vs. DOACs in High-Risk AF Patients

Jun 24, 2020
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Authors:
Osmancik P, Herman D, Neuzil P, et al., on behalf of the PRAGUE-17 Trial Investigators.
Citation:
Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol 2020;75:3122-3135.
Summary By:
Mollie McDermott, MD, MS

Quick Takes

  • Left atrial appendage closure (LAAC) has been shown to be noninferior to warfarin in preventing stroke or systemic embolism in patients AF.
  • The efficacy and safety of LAAC compared to direct oral anticoagulants (DOACs) is unknown.
  • In this randomized controlled trial, LAAC was noninferior to DOACs for the composite endpoint of stroke/TIA, systemic embolism, significant bleeding, cardiovascular death, or periprocedural/device-related complications.

Study Questions:

In high-risk patients with atrial fibrillation (AF), is left atrial appendage closure (LAAC) noninferior to the use of direct oral anticoagulants (DOACs) in preventing adverse cerebrovascular and cardiovascular outcomes?

Methods:

In the PRAGUE-17 (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation) trial, eligible patients had nonvalvular AF, an indication for oral anticoagulation (OAC), and one of the following: 1) history of bleeding requiring intervention or hospitalization, 2) history of a cardioembolic event while on OAC, or 3) CHA2DS2-VASc ≥3 plus HAS-BLED ≥2. Subjects were randomized 1:1 to a DOAC (rivaroxaban, apixaban, or dabigatran) or to LAAC (Watchman or Amulet). The recommended antithrombotic regimen after LAAC was dual antiplatelet therapy (aspirin and clopidogrel) for 3 months. Follow-up occurred at 6 weeks and at 3, 6, 9, and 12 months and every 6 months thereafter. The primary endpoint was a composite of: 1) stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA), 2) systemic embolism, 3) clinically significant bleeding, 4) cardiovascular death, or 5) significant periprocedural or device-related complications.

Results:

A total of 402 patients were randomized (201 in each group). The median follow-up was 21.1 months in the DOAC group and 19.3 months in the LAAC group; 192 (95.5%) of the DOAC group was placed on apixaban. The composite primary outcome occurred in 35 patients with LAAC (17.4%; 10.99% per 100 patient-years) compared to 41 patients with DOACs (20.4%; 13.42% per 100 patient-years), and the criteria for noninferiority of LAAC were met (p = 0.004). The annual rate of all stroke/TIA was 2.6% in both groups. Mortality rates were similar between the two groups. Two deaths (1%) in the LAAC group were classified as being procedure- or device-related.

Conclusions:

In this randomized controlled trial of high-risk AF patients, LAAC was noninferior to DOACs for the composite endpoint of stroke/TIA, systemic embolism, significant bleeding, cardiovascular death, or periprocedural/device-related complications.

Perspective:

This is a well-designed trial with pragmatic features that lends support to consideration of LAAC in high-risk AF patients, particularly those who may have a contraindication to OAC. The two procedure- or device-related deaths in the LAAC group (without an increased overall risk of death compared to the DOAC group) is a notable finding that should enter into conversations with patients.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Prevention, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Aspirin, Atrial Appendage, Atrial Fibrillation, Fibrinolytic Agents, Geriatrics, Ischemic Attack, Transient, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, Vascular Diseases


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