OPTION: LAAC over OAC after ablation in patients with AF and increased stroke risk

Ablation plus left atrial appendage closure (LAAC) resulted in similar efficacy outcomes and better safety outcomes than ablation plus oral anticoagulation (OAC) in patients with atrial fibrillation (AF) who underwent ablation and had an increased risk for stroke in the international OPTION trial.

The OPTION trial (NCT03795298) assessed LAAC and OAC in patients with AF who underwent ablation and were at a moderate-to-high risk of stroke [1,2]. Participants with AF indicated for ablation (n=1,600) were randomised 1:1 to ablation plus LAAC (WATCHMAN FLX) or ablation plus OAC. “Patients in the LAAC arm received OAC plus aspirin for 3 months after which they continued on aspirin only,” added Prof. Oussama Wazni (Cleveland Clinic, OH, USA) [1]. The primary endpoint was a composite of all-cause death, stroke, or systemic embolism at 36 months, which was tested for non-inferiority. The primary safety endpoint was non-procedural ISTH major bleeding or clinically relevant non-major bleeding at 36 months, which was tested for superiority. “About 95% of the patients on OACs received direct OACs [DOACs],” said Prof. Wazni.

At 36 months, ablation plus LAAC was non-inferior to ablation plus OAC for efficacy, with incidence rates of 5.3% and 5.8%, respectively (HR 0.91; 95% CI 0.59–1.39; P_{non-inferiority}<0.0001). In terms of the primary safety endpoint, ablation plus LAAC was superior to ablation plus OAC, with rates of 8.5% and 18.1% (HR 0.44; 95% CI 0.33–0.59; P<0.0001).

“WATCHMAN FLX is a safe and effective first-line option for patients with AF undergoing ablation,” concluded Prof. Wazni. “Interestingly, 40% of the patients in the study received a concomitant ablation and LAAC procedure, potentially reducing AF burden, the risk for stroke, and the risk for bleeding in one procedure.”

1. 
   
   1. Wazni OM, et al. Randomized comparison of left atrial appendage closure with oral anticoagulation after catheter ablation for atrial fibrillation. LBS.02, AHA Scientific Sessions 2024, 16–18 November, Chicago, USA.
   2. Wazni OM, et al. N Engl J Med 2024; Nov 16. DOI: 10.1056/NEJMoa2408308.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 20 November 202420 November 2024