ACC 2017: CoreValve non-inferior to surgery in intermediate-risk patients

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Medtronic CoreValve Evolut R

Results from the SURTAVI clinical trial, which were presented today at the 2017 scientific sessions of the American College of Cardiology (17–19 March, Washington, DC, USA), indicate that transcatheter aortic valve implantation (TAVI) with self-expanding CoreValve device (Medtronic) is associated with a similar rate of all-cause mortality or disabling stroke as surgery in patients at intermediate risk at two years.

In the global, prospective, multicentre, randomised study, intermediate-risk patients with aortic stenosis were randomised to undergo TAVI (863) with either CoreValve or CoreValve Evolut R or to surgical aortic valve replacement. Rates of all-cause mortality or disabling stroke at two years—the study’s primary endpoint—were similar between groups: 12.6% for TAVI vs. 14% for surgery (p for non-inferiority >0.999). TAVI was also associated with significantly better mean aortic valve gradient at two years than was surgery (7.8mmHg vs. 11.8mmHg, respectively; p<0.001).

Author of SURTAVI Michael Reardon (Houston Methodist DeBakey Heart & Vascular Center, Houston, USA), who presented the study at ACC 2017, comments: “We observed excellent outcomes in both arms of the study and were pleased to see the self-expanding platform perform as well as the gold standard of surgery in this intermediate-risk patient population. Importantly, near-term results showed critical insights for the therapy. In the first 30 days, patients treated with TAVI experienced statistically lower rates of stroke, lower rates of new onset atrial fibrillation, a quicker hospital discharge, less acute kidney injury and transfusions, and an improved quality of life. Surgical aortic valve replacement was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.”

The study was simultaneously published in The New England Journal of Medicine 

Read our interview with Michael Reardon