Results of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2 Aortic Valve system in the treatment of patients with severe, symptomatic aortic stenosis. Boston Scientific

Boston Scientific Corporation  announced the results of the primary endpoint of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2 Aortic Valve System in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. The data were presented as a late-breaking clinical trial at Transcatheter Cardiovascular Therapeutic  (TCT) 2024, the annual scientific symposium of the Cardiovascular Research Foundation (CRF).

This randomized trial evaluated the ACURATE neo2 valve, the company's second-generation transcatheter aortic valve replacement (TAVR) technology, versus a pre-defined control valve, either the commercially available SAPIEN valve or the Evolut transcatheter aortic valve system, selected at the discretion of the implanting physician. The composite rate of all-cause mortality, stroke or rehospitalization at one year was 16.16% in the ACURATE neo2 arm and 9.53% in the control arm, not meeting the prespecified criterion for non-inferiority (posterior probability for non-inferiority was 77.9%, which is lower than the non-inferiority test threshold of 97.5%).

"This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and co-principal investigator of the ACURATE IDE trial. "These data add to the breadth of clinical knowledge of the ACURATE valve platform and provide compelling insights on the importance of procedural optimization that will be beneficial for TAVR moving forward."

Also presented in the late-breaking session were data from a post-hoc analysis to identify and evaluate expanded and under-expanded ACURATE neo2 valve frames within the ACURATE IDE trial. The company performed a review of key procedural factors, including pre- and post-dilation, which helps to prepare for, enable and confirm proper valve expansion during the procedure. Following this review, an assessment of implant quality for the ACURATE neo2 valve was initiated and highlighted that approximately 20% of the valves were under-expanded. Data from the assessment also demonstrated that the rate for death, stroke or rehospitalization at one year was similar between the ACURATE neo2 expanded group and the control group.

"The data presented give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "We believe the findings from the ACURATE IDE post-hoc analysis and implementation of steps to mitigate valve under-expansion may improve outcomes for the ACURATE valve and have important implications on other commercially available TAVR valves, and we look forward to studying these improved techniques in future trials of the device."

Boston Scientific continues to work closely with the U.S. Food and Drug Administration on the regulatory strategy for approval of the ACURATE valve platform in the U.S.