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Medtronic said data from the SURTAVI trial presented Friday at the American College of Cardiology (ACC) annual scientific session showed that transcatheter aortic valve replacement (TAVR) with the company's self-expanding CoreValve system, and the newer-generation CoreValve Evolut R system, met the primary endpoint of all-cause mortality or disabling stroke versus open-heart surgery in patients at intermediate risk of severe aortic stenosis. Rhonda Robb, general manager of the Heart Valve Therapies business, which is part of Medtronic's Cardiac and Vascular Group, stated that the results "have been submitted to the FDA to support an intermediate-risk label expansion."
The randomised trial compared 863 TAVR patients with 794 patients who underwent surgical aortic valve replacement (SAVR). Among those in the TAVR group, 84 percent received the CoreValve system and 16 percent received the smaller CoreValve Evolut R system.
According to the results, which were also published in the NEJM, the rate of all-cause mortality or disabling stroke at two years was 12.6 percent for TAVR-treated patients and 14 percent for the SAVR group. In addition, Medtronic said the TAVR procedure was associated with a significantly better mean aortic valve gradient of 7.8 mm Hg, compared with 11.8 mm Hg for SAVR, while neither procedure "displayed evidence of structural valve deterioration at two years."
Principal investigator Michael Reardon pointed out that "near-term results showed critical insights for the therapy," with TAVR-treated patients in the first 30 days experiencing "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." He noted that "SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation."
Results from a 2015 study of high-risk aortic stenosis patients demonstrated that the CoreValve system was associated with a superior survival benefit at two years, compared with open-heart surgery. Reardon speculated that did not happen this time mainly due to how well SAVR patients fared. "This was the lowest surgical mortality we've seen in a randomised trial, and TAVR did just as well," he said, adding that he expects the SURTAVI data "will lead to rapid approval by the FDA for CoreValve and CoreValve Evolut R in intermediate-risk patients."
The CoreValve system first gained FDA approval in 2014 for patients with severe aortic stenosis deemed unsuitable for valve replacement via traditional open-heart surgery. The indication was later expanded to include patients with severe aortic stenosis at high risk for surgery, as well as for aortic valve-in-valve replacement among those at high or extreme risk for complications associated with open-heart surgery. In 2015, the agency approved the CoreValve Evolut R system for severe aortic stenosis patients at high or extreme risk for surgery. The newer-generation system received the CE mark last year for intermediate-risk severe aortic stenosis patients.
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