Boston Scientific unveils superiority data in bleeding risk reduction post-cardiac ablation

The rise in cardiac ablation procedures for atrial fibrillation offers symptom relief, but the risk of recurrence means patients must continue long-term oral anticoagulation (OAC) therapy. This creates a dilemma: stopping blood thinners raises stroke risk, while long-term OAC use heightens the risk of serious bleeding.

Boston Scientific’s OPTION clinical trial has delivered promising results, offering a potential alternative with its WATCHMAN FLX left atrial appendage closure (LAAC) device. The trial’s three-year primary endpoint results, presented during a late-breaking science session at the American Heart Association’s scientific session, compared the device to first-line OAC – primarily direct oral anticoagulants (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation after cardiac ablation.

Key findings from the trial highlight the WATCHMAN FLX device’s advantages. It achieved the primary safety endpoint by demonstrating superiority to OAC in reducing non-procedural major bleeding or clinically relevant non-major bleeding at 36 months (8.5% vs. 18.1%; P<0.0001).

Additionally, it met the primary efficacy endpoint, showing non-inferiority to OAC in preventing all-cause death, stroke, or systemic embolism at 36 months (5.4% vs. 5.8%; P<0.0001). Secondary outcomes also supported the device’s efficacy, with non-inferiority for the combined endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001).

“The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the WATCHMAN FLX device is not only as safe, but superior to OAC therapy for reducing the risk of long-term bleeding events,” said Dr Oussama Wazni, vice chairman of Cardiovascular Medicine and section head of Cardiac Electrophysiology at Cleveland Clinic, and principal investigator of the trial.

“Notably, we found high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and haemorrhagic stroke within the trial population.”

The randomised, controlled OPTION trial enrolled 1,600 patients across 114 sites in Australia, the United States, and Europe, with impressive procedural success rates. Among device recipients, 60% received their WATCHMAN FLX implant 90-180 days after ablation, while the remaining 40% underwent the implant concomitantly with the ablation procedure.

“The OPTION trial is the first large, randomized trial to rigorously evaluate LAAC as a safe and effective stroke risk reduction treatment following a cardiac ablation in a head-to-head fashion against commonly used oral anticoagulants, including DOAC,” said Dr Brad Sutton, chief medical officer for Atrial Fibrillation Solutions at Boston Scientific.

“These positive primary outcomes mean that patients receiving the WATCHMAN FLX device were able to eliminate long-term medication use while maintaining stroke protection. With this data, we see potential to both expand the indication for the WATCHMAN FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke.”

Beyond the OPTION trial, WATCHMAN technology is undergoing further evaluation. The CHAMPION-AF randomized trial is comparing it to direct oral anticoagulants as a first-line therapy for lower-risk patients. Meanwhile, the latest-generation WATCHMAN FLX Pro LAAC Device is being studied in the SIMPLAAFY trial, which explores a single-drug alternative to dual antiplatelet therapy as a post-procedural regimen.

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