WASHINGTON (dpa-AFX) - Boston Scientific Cor. (BSX) reported that preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The PREVAIL trial evaluated safety and efficacy of the WATCHMAN Left Atrial Appendage Closure device in patients with nonvalvular atrial fibrillation versus long-term warfarin therapy.
The PREVAIL trial met the pre-specified criteria for the first co-primary endpoint of occurrence of all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention. The PREVAIL trial met its pre-specified endpoint for the third co-primary endpoint of the composite of the occurrence of late ischemic stroke and systemic embolism at 18 months.
The trial did not meet the pre-specified criteria for the second co-primary endpoint of the occurrence of all stroke, cardiovascular death and systemic embolism at 18 months.
The PREVAIL trial was designed to confirm the results of the PROTECT AF trial and validate the safety of the implant procedure, including at least 25 percent of subjects treated by new operators.
Boston Scientific said the data from the PREVAIL trial, complemented by the PROTECT AF four-year outcomes data, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data update will be submitted to support device approval by the U.S. Food and Drug Administration.
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