PINNACLE FLX trial of WATCHMAN FLX LAAC meets endpoints in stroke risk reduction.- Boston Scientific

Boston Scientific announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation (NVAF). The study evaluated performance of the WATCHMAN FLX device as an alternative to oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), for stroke risk reduction in patients with NVAF. The prospective, non-randomized PINNACLE FLX trial included 400 patients in the U.S. with NVAF who were eligible for anti-coagulation therapy to reduce the risk of stroke but had an appropriate rationale to seek a non-pharmaceutical alternative. The trial met its primary safety endpoint – defined as occurrence of a major procedure-related complication within 7 days following the procedure or time of hospital discharge, whichever was later – with a low adverse event rate of 0.5%. The study also met its primary effectiveness endpoint, with data demonstrating a 100% rate of effective LAA closure at 12 months post-procedure with peri-device flow less than 5mm. Data from the trial also demonstrated an implant success rate of 98.8% and that no patients experienced peri-procedural death, device embolization or pericardial effusion requiring cardiac surgery, all of which is favorable in the context of previous clinical studies. It revealed that 90 percent of patients showed absolutely no detectable leakage around the device at their 12-month follow up, which compares favorably to the rates of peri-device flow observed in the PROTECT-AF and PREVAIL trials with the predicate WATCHMAN device and may translate into improved long-term clinical outcomes. In addition, 96.2% of patients were able to discontinue oral anticoagulation following their 45-day follow up. Secondary endpoints from the PINNACLE FLX study, including the occurrence of ischemic stroke or systemic embolism, will be reported after 24 months of patient follow-up. The company plans to further evaluate the WATCHMAN FLX device for patients with NVAF via continued enrollment in the ongoing OPTION trial – comparing the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure – as well as in the CHAMPION-AF clinical trial, which will study a broader anticoagulant-eligible patient population to evaluate the device against NOACs for embolic stroke prevention. The data was presented as a late-breaking clinical trial at HRS 2020 SCIENCE.