A Cleveland Clinic-led study has shown that left atrial appendage closure (LAAC), a minimally invasive procedure, results in significantly less bleeding for patients undergoing catheter ablation for atrial fibrillation, compared to the use of blood-thinning medications. The study also found that LAAC maintained similar low rates of stroke, blood clots, and death when compared to oral anticoagulants.

This research is the first to directly compare LAAC with blood thinners after catheter ablation for atrial fibrillation. Catheter ablation is a procedure used to treat irregular heartbeats. Current guidelines recommend that patients at high risk for stroke continue taking blood-thinners after atrial fibrillation ablation, often for life.

The findings from the "Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation (OPTION)" trial were presented at the American Heart Association’s Scientific Sessions 2024 and were also published online in the New England Journal of Medicine.

Atrial fibrillation increases the risk of stroke, making blood-thinners or LAAC necessary to manage that risk. However, patients are often required to stay on blood-thinners for long periods, with some discontinuing medication within a few years. Research has shown that stopping blood-thinners after three months can increase the risk of stroke in high-risk patients.

The OPTION trial, which took place from November 2019 to June 2021, included 1,600 patients across 114 global sites. Participants were either assigned to the LAAC group or the blood-thinner group, with a mean age of 69.6 years and moderate to high stroke risk. Most patients in the anticoagulant group (95%) received non-Warfarin oral anticoagulants.

Results from the trial showed that LAAC was successful in 99% of cases. The incidence of any bleeding was significantly lower in the LAAC group (8.5%) compared to the blood-thinner group (18.1%). LAAC was performed either in combination with or after catheter ablation for atrial fibrillation in most patients. The rates of major bleeding were also lower with LAAC (3.9%) compared to anticoagulation (5.0%).

The primary outcomes, including stroke, systemic embolism, and death, were similar between the two groups (5.3% for LAAC vs. 5.8% for anticoagulation). While there were 23 complications related to the LAAC procedure or device, these were relatively few.

The trial suggests that LAAC offers a viable alternative to blood-thinners for patients with atrial fibrillation who are at moderate to high risk of stroke, as it reduces post-procedure bleeding while maintaining low rates of stroke and other complications. This finding could potentially shift clinical practice, providing patients with an option to avoid long-term use of blood-thinners after atrial fibrillation ablation.

The study was funded by Boston Scientific, the manufacturer of the WATCHMAN FLX device. Dr Oussama Wazni, the study's lead author, is a paid consultant for Boston Scientific.




Source: clevelandclinic.org

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