The ACURATE IDE study evaluated Acurate neo2, a transcatheter aortic valve replacement (TAVR) system, in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. Investigators presented data at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.
Acurate neo2, Boston Scientific’s second-generation TAVR technology, was compared to a pre-defined control valve. That included either the commercially available Edwards Sapien or Medtronic Evolut, selected at the discretion of the implanting physician.
Findings included a 16.16% composite rate of all-cause mortality, stroke or rehospitalization at one year in the Acurate neo2 arm. That compared to 9.53% in the control arm. This failed to meet the pre-specified criterion for non-inferiority. The study had a non-inferiority posterior probability of 77.9%, lower than the non-inferiority test threshold of 97.5%.
Boston Scientific looks to keep progressing Acurate neo2
Boston Scientific also reported data from a post-hoc analysis to identify and evaluate expanded and under-expanded Acurate neo2 frames. This highlighted that approximately 20% of valves were under-expanded. Data also showed a similar rate for death, stroke or rehospitalization at one year between the Acurate neo2 expanded group and the control. However, those who remained under-expanded had worse outcomes.
“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 Dr. Michael Reardon, 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.”
The company said it plans to continue working with the FDA on a regulatory strategy to get the Acurate platform approved in the U.S.
“The data presented today give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve,” said Dr. Janar Sathananthan, 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.”
The analysts’ take
Needham analyst Mike Matson noted that the trial took place over 47 months during the height of the COVID-19 pandemic. He said that resulted in disruptions to enrollment and prevented centers from building “adequate experience” with Acurate neo2.
Matson said the results are unlikely to have a significant impact on Boston Scientific’s international sales for Acurate neo2 (which he estimates come in at more than $350 million annually), as the results appear to reflect a learning curve or training issue. However, it may cast some doubt over the valve’s pathway through the FDA for U.S. commercialization.
“It’s unclear what this means for FDA approval of ACCURATE neo2, but we think approval is less likely, and some sort of additional clinical data may be required,” Matson wrote.