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Results of PARTNER II QUALITY OF LIFE Study Presented at TCT 2016

WASHINGTON – November 1, 2016 – Patients with severe aortic stenosis (AS) at intermediate surgical risk, and who are treated with transcatheter aortic valve replacement (TAVR) had improved health status at one month compared with surgical aortic valve replacement (SAVR) but two-year quality of life outcomes were similar. Prior studies have shown that TAVR results in an early quality of life (QoL) benefit in patients at high surgical risk; however, the effect of TAVR versus. SAVR on QoL in intermediate risk patients was unknown prior to this study.

Findings from the PARTNER II QUALITY OF LIFE study were reported today at the 28th 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.

Between 2011 and 2013, 2,032 intermediate risk patients with severe AS were randomized to TAVR with the SAPIEN XT valve (n=1,011) or SAVR (n=1,021) in the PARTNER II Trial. Quality of life was assessed on all patients at baseline, one, 12 and 24 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D.

The study found that at two year follow-up, both TAVR and SAVR were associated with clinically and statistically significant improvements in disease-specific and generic QoL measures as compared with baseline. The two year change in KCCQ Overall Summary Score was 19.2 points with TAVR compared with 18.3 points for SAVR. Similarly, the two year change in the SF-36 Physical Component Summary Score was 3.0 points with TAVR versus 2.7 points with SAVR. In contrast, at one month, TAVR was associated with significantly better QoL than SAVR, but this difference was restricted to patients who were treated via transfemoral (TF) access and was not seen in patients that were treated via alternative (transapical or transaortic) access (p<0.01 for interaction). There were no significant differences between TAVR and SAVR in any QoL measures at one year or two years.

“This study shows that among intermediate risk patients with severe AS, quality of life improved significantly and to a similar extent with TAVR and SAVR through two years. However, transfemoral (but not transthoracic) TAVR was associated with a substantial and clinically important early health status benefit compared with SAVR.,” said lead investigator David J. Cohen, MD, MSc Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute in Kansas City, MO.

“We believe that these early differences in quality of life may be important to many patients who are suitable candidates for both procedures. Longer term follow up is needed to assess the durability of quality of life improvement with TAVR versus SAVR in this intermediate risk population.”

The PARTNER II trial was funded by Edwards Lifesciences. Dr. Cohen reports research grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific, and consulting income from Medtronic and Abbott Vascular.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th 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.

For more information, visit www.crf.org and www.tctconference.com.