October 2, 2019 – The first randomized trial to compare the safety and efficacy of the new Boston Scientific Acurate neo transcatheter heart valve with the Edwards Lifesciences Sapien 3 transcatheter aortic valve replacement (TAVR) device did not meet non-inferiority in patients with severe aortic stenosis.
Findings were reported at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The study was also published simultaneously in The Lancet.
Between February 2017 and February 2019, a total of 739 patients with severe, symptomatic aortic stenosis at increased surgical risk were randomized 1:1 to transfemoral TAVR with the Acurate neo (n=372) or the Sapien 3 (n=367) system at 20 European sites. Clinical follow-up information at 30 days was available for 98.9% and echocardiographic follow-up for 98% of the total study population.
“Acurate neo did not meet non-inferiority compared to the Sapien 3 device regarding the primary composite safety and efficacy endpoint at 30 days,” said Jonas Lanz, M.D., MSc, with the department of cardiology at Bern University Hospital – INSELSPITAL. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”
The study was designed to investigate non-inferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium-2 criteria and included all cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, re-hospitalization for valve-related symptoms or congestive
heart failure, moderate or severe prosthetic valve regurgitation or prosthetic valve stenosis at 30 days.
The primary endpoint rate in the intention-to treat cohort for Acurate neo was 23.7% compared to 16.5% with Sapien 3 (P non-inferiority = 0.42), which did not meet non-inferiority. The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the Sapien 3 device.
SCOPE I was an investigator-initiated and conducted study funded by a dedicated research grant from Symetis SA, Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had nothing to disclose.
1. Jonas Lanz, Won-Keun Kim, Thomas Walther, et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. The Lancet. Published online September 27, 2019. DOI:https://doi.org/10.1016/S0140-6736(19)32220-2