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UrduFindings were reported today at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. 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 98.0% of the total study population.
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 (Pnon-inferiority=0.42which 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.
“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, MD, 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.”
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.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 31st year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. TCT also includes interactive training pavilions where clinicians can gain vital skills to apply immediately to their practices.
For more information, visit www.crf.org and www.tctconference.com.
Original post https://alertarticles.info
