New Five-Year Data Shows Similar Outcomes for TAVR and SAVR in Patients with Severe Aortic Stenosis and Intermediate Surgical Risk

SAN FRANCISCO – September 28, 2019 – Five-year results from the PARTNER 2A trial found that patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR.

Findings 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.

Two-year results from the PARTNER 2A trial concluded that TAVR was similar to surgery for the primary endpoint of death or disabling stroke in patients with severe AS and intermediate surgical risk. However, there are limited data on longer-term clinical outcomes and bioprosthetic valve function in this population. The goal of the current trial was to compare the key clinical outcomes, bioprosthetic valve function, and quality-of-life measures at five years for TAVR versus surgery.

Researchers randomly assigned 2,032 intermediate-risk patients with severe AS to either TAVR or SAVR at 57 centers. The two-year primary endpoint was all-cause death or disabling stroke in the intention-to-treat (ITT) population. At five years, all primary and secondary clinical and echo endpoints were analyzed in both ITT and pre-specified as-treated (AT) populations.

At five years, event rates for the primary endpoint of death or disabling stroke were 47.9% after TAVR and 43.4% after SAVR (HR: 1.09; 95% CI: 0.95 to 1.25; P=0.21). In the transfemoral cohort, there also was no difference at five years (44.5% TAVR versus 42.0% SAVR; HR: 1.02; 95% CI: 0.87 to 1.20; P=0.80). However, in the transthoracic cohort, the rate of death or disabling stroke was significantly higher after TAVR (59.3% versus 48.3%; HR: 1.32; 95% CI: 1.02 to 1.71; P=0.03). In addition, early improvements in functional status and quality of life were maintained through five years for both TAVR and SAVR patients.

“In the longest follow-up for intermediate-risk patients with severe AS, TAVR and SAVR had similar rates of death or disabling stroke,” said Vinod H. Thourani, MD, Chair of the Department of Cardiac Surgery at Medstar Heart and Vascular Institute. “Therefore, TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. However, in patients without acceptable transfemoral access, surgery may be the preferred alternative.”

The PARTNER 2A study was funded by Edward Lifesciences. Dr. Thourani disclosed grant/research support from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve and Cryolife; sitting on Steering Committees for Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, Cryolife, and Gore Vascular; and honoraria from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, Cryolife, and Gore Vascular.

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.

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