Two-Year SURTAVI Data Presented for Medtronic's CoreValve Platform in Intermediate-Risk Patients
March 17, 2017—Medtronic plc announced the first presentation of clinical data from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, at ACC.17, the American College of Cardiology's 66th annual scientific session in Washington, DC. The SURTAVI data were published simultaneously online by Michael J. Reardon, MD, et al in The New England Journal of Medicine.
The SURTAVI trial is a global, prospective, multicenter, randomized study evaluating Medtronic's self-expanding transcatheter aortic valve replacement (TAVR) platform (the CoreValve system and the CoreValve Evolut R recapturable and repositionable system) versus surgical aortic valve replacement (SAVR) at 2 years. The trial enrolled intermediate-risk patients and compared 863 TAVR patients to 794 SAVR patients with Society of Thoracic Surgeons risk of 4.4% and 4.5%, respectively. The use of the CoreValve and CoreValve Evolut R systems in intermediate-risk severe aortic stenosis patients is investigational only in the United States, advised Medtronic.
According to the company, the SURTAVI data showed that the Medtronic TAVR platform met its primary endpoint of the rate of all-cause mortality or disabling stroke at 2 years, which was similar to SAVR (12.6% for TAVR vs 14% for SAVR; posterior probability of noninferiority > .999). TAVR also demonstrated a significantly better mean aortic valve gradient (7.8 mm Hg vs 11.8 mm Hg; P < .001) at 2 years. Neither TAVR-treated nor SAVR-treated patients displayed evidence of structural valve deterioration at 2 years.
Dr. Reardon, who serves as Principal Investigator of SURTAVI, commented in Medtronic's press release, “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 TAVR 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. SAVR was associated with less aortic regurgitation, major vascular complications, and need for permanent pacemaker implantation.” Dr. Reardon is Professor of Cardiothoracic Surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center in Houston, Texas.
The CoreValve system was launched in the United States in 2014. The CoreValve Evolut R system was approved in the United States for severe aortic stenosis patients at high or extreme risk for surgery in 2015. The CoreValve Evolut R system received European CE Mark approval for intermediate-risk severe aortic stenosis patients in 2016, stated Medtronic.