Key Takeaways:
- The OPTION TRIAL assessed the safety and efficacy of WATCHMAN FLX in a post-ablation contemporary clinical AF patient population at risk of stroke.
- The 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.
Oral anticoagulation (OAC) is standard after AF ablation in patients at moderate-to-high risk of stroke, but it carries significant bleeding risks. Left atrial appendage closure (LAAC) offers a mechanical alternative to long-term anticoagulation. The OPTION trial aimed to assess whether LAAC could safely reduce bleeding while maintaining efficacy for stroke prevention (OPTION ClinicalTrials.gov number, NCT03795298). The main results were presented at AHA Scientific Sessions 2024 with simultaneous publication in the New England Journal of Medicine.
The OPTION trial was an international, multicenter, randomized study that included 1,600 patients with AF who had a CHA₂DS₂-VASc score of ≥2 for men or ≥3 for women and who underwent catheter ablation. Patients underwent AF ablation and were randomized 1:1 to receive LAAC or OAC. The primary safety endpoint was non-procedure-related major or clinically relevant nonmajor bleeding at 36 months. The primary efficacy endpoint was a composite of all-cause death, stroke, or systemic embolism, tested for noninferiority. The secondary endpoint assessed major bleeding, including procedure-related events.
A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3.
In the LAAC group, 8.5% of patients experienced non-procedure-related bleeding events compared to 18.1% in the OAC group (HR, 0.44; 95% CI, 0.33–0.59; P<0.001 for superiority) at 36 months. The primary composite efficacy endpoint occurred in 5.3% of the LAAC group versus 5.8% in the OAC group (HR, 0.91; 95% CI, 0.59–1.39; P<0.001 for noninferiority). Major bleeding events were reported in 3.9% of patients receiving LAAC compared to 5.0% receiving OAC (HR, 0.77; 95% CI, 0.48–1.24; P<0.001 for noninferiority). Complications from LAAC devices or procedures occurred in 2.9% of patients in the LAAC group.
Dr. Oussama Wazni, the lead investigator, highlighted the significance of these findings: “Left atrial appendage closure represents a viable and potentially safer alternative to oral anticoagulation for stroke prevention in patients after AF ablation.” The OPTION trial demonstrates that LAAC reduces bleeding risks without compromising efficacy, providing a promising treatment pathway for patients at risk of complications from long-term OAC. Further research is warranted to confirm these findings in broader patient populations.