Cleveland Clinic-Led Trial Finds Heart Implant May Be Effective Alternative to Blood Thinners for Those with Atrial Fibrillation

A new Cleveland Clinic-led trial found that a minimally-invasive procedure – left atrial appendage closure – resulted in significantly less bleeding in patients undergoing a catheter ablation to treat atrial fibrillation, compared to blood thinners, while preserving low rates of stroke, blood clots and death.

The study is the first direct comparison between oral anticoagulants – commonly referred to as blood thinners – and left atrial appendage closure (LAAC) following catheter ablation. Catheter ablation is a minimally invasive procedure that treats an irregular heartbeat.

Current guidelines recommend continuation of blood-thinner medication following atrial fibrillation ablation in patients at high risk for stroke. This often means that patients are required to be on blood thinners for the rest of their lives.

Findings from the “Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation (OPTION)” trial were presented today during a late-breaking science session at the American Heart Association’s Scientific Sessions 2024. It was simultaneously published online in the New England Journal of Medicine.

“Atrial fibrillation patients are five times more likely to suffer a stroke, and their two options to help manage that risk are to take oral anticoagulants indefinitely or to get their left atrial appendage closed,” said the study’s lead author Oussama Wazni, M.D., MBA, section head of Cardiac Electrophysiology and Pacing at Cleveland Clinic. “The question we wanted to answer with this trial was if LAAC would safely reduce bleeding rates while maintaining low stroke rates compared to oral anticoagulants after atrial fibrillation ablation.”

For patients who undergo atrial fibrillation ablation and are at a high risk of stroke, current guidelines recommend that they take a daily blood thinner to reduce the chance of having a stroke, although it’s been reported that 19-29% of atrial fibrillation patients stop taking oral anticoagulants after two years. Additional studies found that beyond three months, oral anticoagulant discontinuation is associated with increased stroke in high-risk patients.

In OPTION, the randomized trial took place between November 6, 2019, and June 28, 2021, and included 1,600 patients across 114 global sites, with patients assigned to either the LAAC group or the blood-thinner group. Patients had a mean age of 69.6 years and had a moderate-high risk of stroke. Patients randomized to anticoagulation mostly (95.0%) received a non-Warfarin oral anticoagulant.

Results showed that LAAC was successful in 99% of patients. The rates of any bleeding were significantly lower with LAAC than anticoagulation (8.5% vs. 18.1%). LAAC was performed in combination with (40.8%) or sequentially after (59.2%) catheter ablation for atrial fibrillation.

Primary efficacy event rates were comparable between LAAC and anticoagulation (5.3% vs. 5.8%) and major bleeding rates were comparable between LAAC and anticoagulation (3.9% vs. 5.0%). LAAC device or procedure-related complications occurred in 23 patients.

“We found that among moderate-high risk patients undergoing atrial fibrillation ablation, LAAC resulted in significantly less post-procedure bleeding than oral anticoagulation, while preserving similarly low rates of stroke, systemic embolism or death,” said Dr. Wazni. “This has the possibility of changing clinical practice because patients will now know they have another option to taking blood-thinners following atrial fibrillation ablation.”

The OPTION trial was funded by Boston Scientific, the company that makes WATCHMAN FLX. Dr. Oussama Wazni is a paid consultant of Boston Scientific Corporation.