MARLBOROUGH, Mass. and WASHINGTON , Oct. 30, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX ) today announced the results of the primary endpoint of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2 TM 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 Therapeutics ® (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 SAPIENTM valve or the EvolutTM 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 cardiothora.