Boston Scientific WATCHMAN FLX™ Left Atrial Appendage Closure Device Demonstrates Superior Bleeding Risk Reduction to Oral Anticoagulation Following a Cardiac Ablation in the OPTION Clinical Trial

Rhea-AI Summary

Boston Scientific announced positive three-year results from the OPTION clinical trial of its WATCHMAN FLX™ Left Atrial Appendage Closure Device. The study compared the device to oral anticoagulation (OAC) for stroke risk reduction in patients with non-valvular atrial fibrillation following cardiac ablation. The device showed superior bleeding risk reduction (8.5% vs 18.1%) and non-inferior efficacy in preventing death, stroke, or systemic embolism (5.4% vs 5.8%) compared to OAC. The trial included 1,600 patients across 114 sites, with approximately 60% receiving the implant 90-180 days post-ablation and 40% during the same procedure.

Positive

• Superior bleeding risk reduction compared to OAC (8.5% vs 18.1%)
• Non-inferior efficacy in preventing death, stroke, or systemic embolism (5.4% vs 5.8%)
• High procedural success rates across 1,600 patients
• Potential expansion of WATCHMAN FLX platform indication

Negative

• None.

Insights

Medical Research Analyst

The OPTION trial results represent a significant advancement in stroke prevention for atrial fibrillation patients post-cardiac ablation. The WATCHMAN FLX device demonstrated superior bleeding risk reduction (8.5% vs 18.1%) compared to oral anticoagulants while maintaining equivalent stroke protection. This is particularly noteworthy as it addresses a critical medical need for the growing population of ablation patients.

The trial's robust design with 1,600 patients across 114 sites and high procedural success rates strengthens the reliability of these findings. The device's effectiveness in both concomitant and delayed implantation scenarios (40% and 60% respectively) provides valuable flexibility in treatment timing. The potential expansion of indications could significantly impact Boston Scientific's market position in the structural heart segment.

Financial Analyst

These clinical results could substantially expand Boston Scientific's addressable market in the structural heart space. The WATCHMAN franchise, already a key growth driver, could see accelerated adoption with this new data supporting its use in post-ablation patients. The superior bleeding risk profile and non-inferior stroke prevention create a compelling value proposition for both healthcare providers and payers.

The timing is strategic as it coincides with the recent approval of the next-generation WATCHMAN FLX Pro device. This positions BSX to potentially capture a larger share of the growing atrial fibrillation treatment market, estimated to be worth billions globally. The positive data could drive both procedure volumes and reimbursement coverage, potentially boosting the company's revenue growth in coming quarters.

Data also demonstrates that the stroke risk reduction device is as effective as oral anticoagulants for patients with atrial fibrillation following a cardiac ablation

MARLBOROUGH, Mass. and CHICAGO, Nov. 16, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Key findings from the study comparing the device to first-line oral anticoagulation (OAC) – including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation were presented in a late-breaking science session at the American Heart Association's Scientific Sessions 2024, and simultaneously published in The New England Journal of Medicine.

The trial met the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months, with the WATCHMAN FLX device demonstrating superiority to OAC (8.5% vs.18.1%; P<0.0001). It also met the primary efficacy endpoint of all-cause death, stroke or systemic embolism at 36 months, with the data showing non-inferiority of the device to OAC (5.4% vs. 5.8%; P<0.0001). Additional findings included non-inferiority of the WATCHMAN FLX device for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001).

In recent years, the number of patients with atrial fibrillation who have undergone a cardiac ablation procedure to prevent symptoms has grown significantly. Due to the risk of atrial fibrillation recurrence following an ablation, current treatment guidelines recommend that patients with multiple stroke risk factors remain on OAC long term to reduce the risk of stroke. However, symptomatic relief can lead these patients to stop taking their blood thinners, increasing this risk, while long-term use of OAC also presents a risk of serious bleeding.

"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, Cardiac Electrophysiology, Cleveland Clinic, and principal investigator of the OPTION 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 hemorrhagic stroke within the trial population."

The randomized, controlled OPTION trial included 1,600 patients enrolled across 114 sites in the United States, Europe and Australia, and demonstrated high rates of procedural success. In the trial, approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure. The other nearly 40% of the device patients had the two procedures performed concomitantly, with the WATCHMAN FLX implant taking place after the ablation.

"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 Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, 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."

In addition to the OPTION trial, the WATCHMAN technology is being evaluated against DOAC as a first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial. The latest-generation WATCHMAN FLX™ Pro LAAC Device, which was approved in the United States in 2023, is similarly being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial that is evaluating a single-drug alternative to dual anti-platelet therapy as a post-procedural regimen.

For more information on the OPTION trial, visit https://www.watchman.com/en-us-implanter/clinical-evidence/option.html.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.

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CONTACTS:
Angela Mineo
Media Relations
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Angela.Mineo@bsci.com

Jon Monson
Investor Relations
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*Dr. Oussama Wazni is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

 

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SOURCE Boston Scientific Corporation

FAQ

What were the main results of Boston Scientific's OPTION trial for WATCHMAN FLX (BSX)?

The OPTION trial showed that WATCHMAN FLX achieved superior bleeding risk reduction (8.5% vs 18.1%) and non-inferior efficacy in preventing death, stroke, or systemic embolism (5.4% vs 5.8%) compared to oral anticoagulation over 36 months.

How many patients were enrolled in the WATCHMAN FLX OPTION trial (BSX)?

The OPTION trial enrolled 1,600 patients across 114 sites in the United States, Europe, and Australia.

When do patients receive the WATCHMAN FLX implant after cardiac ablation (BSX)?

In the trial, 60% of patients received the WATCHMAN FLX implant 90-180 days after ablation, while 40% received it during the same procedure as their ablation.