Comparison of Anticoagulation With Left Atrial Appendage Closure After Atrial Fibrillation Ablation - OPTION

Contribution To Literature:

The OPTION trial showed that left atrial appendage closure after AF ablation was associated with a lower risk of non–procedure-related major or clinically relevant nonmajor bleeding compared with oral anticoagulation.

Description:

The goal of the trial was to evaluate left atrial appendage closure compared with anticoagulation among patients who underwent catheter-based atrial fibrillation (AF) ablation.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients undergoing catheter-based AF ablation were randomized to left atrial appendage closure (n = 803) vs. anticoagulation (n = 797).

In the anticoagulation group, 59.3% received apixaban, 27.2% rivaroxaban, 4.3% edoxaban, 3.9% dabigatran, and 0.3% other.

  • Total number of enrollees: 1,600
  • Duration of follow-up: 36 months
  • Mean patient age: 70 years
  • Percentage female: 34%

Inclusion criteria:

  • Patients with AF undergoing catheter-based ablation procedure
  • CHA2DS2-VASc score of ≥2 for men and ≥3 for women

Principal Findings:

The primary safety outcome, non–procedure-related major bleeding or clinically relevant nonmajor bleeding at 36 months, was: 8.5% in the left atrial appendage closure group vs. 18.1% in the anticoagulation group (p < 0.001).

The primary efficacy endpoint, all-cause mortality, stroke, or systemic embolism at 36 months, was: 5.3% in the left atrial appendage closure group vs. 5.8% in the anticoagulation group (p for noninferiority < 0.001).

Secondary outcomes:

  • Complications related to left atrial appendage closure: 2.7% (0.3% with pericardial tamponade)
  • Complete seal of the left atrial appendage at 12 months: 80%

Interpretation:

Among patients with AF undergoing a catheter-based ablation procedure, left atrial appendage closure was superior to anticoagulation at preventing non–procedure-related major bleeding or clinically relevant nonmajor bleeding at 36 months. Among those randomized to anticoagulation, 95% received a direct oral anticoagulant. Primary efficacy defined as a composite of all-cause mortality, stroke, or systemic embolism was similar between the treatment groups. This trial highlights that bleeding events remain high with anticoagulation.

References:

Wazni OM, Saliba WI, Nair DG, et al., for the OPTION Trial Investigators. Left Atrial Appendage Closure After Ablation for Atrial Fibrillation. N Engl J Med 2024;Nov 16:[Epub ahead of print].

Presented by Dr. Oussama Musbah Wazni at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2024.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Atrial Appendage, Atrial Fibrillation, Catheter Ablation, AHA24, AHA Annual Scientific Sessions


< Back to Listings