OPTION Trial: Left Atrial Appendage Closure

Atrial fibrillation ablation is a valid strategy. However, reoccurrence is frequent in these cases, often with asymptomatic presentation.

Anticoagulation with warfarin has proven effective in this context. In situations where the bleeding risk is high, left atrial appendage closure (LAAC) emerges as a viable alternative.

While the combination of LAAC and warfarin has shown benefits, evidence of LAAC with new anticoagulants is limited.

The OPTION study included 1600 patients with atrial fibrillation who underwent ablation. Of these, 803 underwent LAAC with the Watchman device along aspirin (ASA) and anticoagulation for 90 days, followed by ASA alone for 12 months. The other 797 patients received oral anticoagulation (OAC) only. The choice of anticoagulant was left to the treating physician. Participants were selected based on the CHA2DS2-VASc score, requiring at least 2 points for men and 3 for women.

The primary safety endpoint (PSE) was a composite of major bleeding unrelated to the procedure and clinically relevant non-major bleeding per ISTH criteria, requiring medical intervention, hospitalization, or increased level of care, assessed at 36 months.

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The primary efficacy endpoint (PEE) was a composite of all-cause mortality, stroke, or systemic embolization, assessed at 36 months.

The secondary Endpoint (SE) was major bleeding, including procedure-related events, according to ISTH criteria.

The groups were comparable, with a mean age of 70 years; 65% of participants were men. The most commonly used anticoagulants were as follows:

• Apixaban (59%)
• Rivaroxaban (27%)
• Edoxaban (4%)
• Dabigatran (4%)
• Warfarin (~5%)

LAAC device implantation was successful in 98.8% of patients, with low rates of procedure-related complications.

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At 36 months, the PSE was 8.5% in the LAAC group vs. 18.1% in the OAC group, thus achieving statistical significance for superiority (P <0.001). The PEE was 5.3% in the LAAC group vs. 5.8% in the OAC group, which demonstrated non-inferiority (P <0.0001). Finally, the SE was 3.9% in the LAAC group vs. 5% in the OAC group, also showing non-inferiority (P <0.0001).

The rate for major bleeding, including device-related events, was 3.9% in the LAAC group vs. 5% in the OAC group, with a difference of -1.1%, thus meeting criteria for non-inferiority (hazard ratio [HR]: 0.77; 95% confidence interval [CI]: 0.48–1.24). Statistical significance for superiority was not achieved (P = 0.28).

There were no significant differences between groups regarding all-cause mortality, hemorrhagic stroke, pericardial effusion, or systemic embolism.

Conclusion

In patients undergoing atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of major or clinically relevant non-major bleeding unrelated to the procedure. Furthermore, it was non-inferior when compared to oral anticoagulation in terms of all-cause mortality, stroke, or systemic embolization at 36 months.

Original Title: Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. OPTION Trial.

Reference: O.M. Wazn, et al. NEJM DOI: 10.1056/NEJMoa2408308.