Boston Scientific reports outcomes from trial of LAAC device

 Boston Scientific has reported positive three-year data from the OPTION global trial of the WATCHMAN FLX left atrial appendage closure (LAAC) device in individuals with atrial fibrillation following a cardiac ablation.

The trial, which included 1,600 patients across 114 sites in Europe, Australia and the US, met its primary safety and efficacy endpoints, demonstrating the device's superiority to oral anticoagulants (OAC).

It demonstrated high procedural success rates, with around 60% of device patients receiving their WATCHMAN FLX implant between 90 and 180 days following their ablation procedure. The remaining nearly 40% had the implant and ablation performed simultaneously.

The OPTION trial of the device achieved the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months.

Furthermore, the data indicated the non-inferiority of the device to OAC when considering all-cause death, stroke, or systemic embolism at the same time frame.

The trial also showed non-inferiority for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months.

In addition to the OPTION trial, the company’s WATCHMAN technology is under evaluation in the CHAMPION-AF randomised trial against direct oral anticoagulants (DOAC) as a first-line therapy for lower-risk patients.

Boston Scientific atrial fibrillation solutions chief medical officer Brad Sutton said: "The OPTION trial is the first large, randomised 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.

"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 the 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."

The latest-generation WATCHMAN FLX Pro LAAC Device was approved in the US last year and is involved in various ongoing trials, including SIMPLAAFY, which is assessing a single-drug alternative to dual anti-platelet therapy post-procedure.

Earlier this month, the company signed a definitive agreement for the acquisition of Cortex to bolster its cardiac ablation portfolio.

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