Boston Scientific announces Champion-AF trial met primary, secondary endpoints

Boston Scientific (BSX) announced that the Champion-AF global clinical trial met all primary and secondary safety and efficacy endpoints. The study evaluated the Watchman FLX Left Atrial Appendage Closure, LAAC, Device compared to non-vitamin K antagonist oral anticoagulants, NOACs, as a first-line option for stroke risk reduction in a broad population of patients with non-valvular atrial fibrillation, NVAF. Key results were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Session & Expo and simultaneously published in The New England Journal of Medicine. The randomized, controlled trial enrolled 3,000 patients with NVAF who were suitable for oral anticoagulation therapy across a broad spectrum of stroke and bleeding risk. At 36 months: The primary safety endpoint was met with data demonstrating the WATCHMAN FLX device was statistically superior to NOACs for non-procedural major and clinically relevant non-major bleeding, achieving a 45% relative reduction in non-procedural bleeding risk. When including procedural bleeding in a secondary analysis, the WATCHMAN FLX device performance was consistent with the primary safety endpoint, demonstrating a significant reduction in bleeding compared to NOACs for major and clinically relevant non-major bleeding, representing a 34% relative reduction in procedural and non-procedural bleeding risk. The primary efficacy endpoint, defined as occurrence of stroke, cardiovascular or unexplained death or systemic embolism, was met with the WATCHMAN FLX device achieving statistical non-inferiority compared to NOACs