WASHINGTON (dpa-AFX) - Boston Scientific Corp. (BSX) announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX Left Atrirl Appendage Closure (LAAC) Device. The device demonstrated superior bleeding risk Reduction to oral Anticoagulation following a Cardiac Ablation in the trial.
The data also demonstrated that the stroke risk reduction device is as effective as oral anticoagulants for patients with atrial fibrillation following a cardiac ablation.
The company noted that 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. 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. 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.
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 company noted that 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.
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