CoreValve US Pivotal Trial: TAVR with a Self-Expanding Prosthesis Shows Lower Mortality Than Surgery
Transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis had a significantly higher rate of survival at one year than surgical aortic valve replacement in patients with severe aortic stenosis, according to results of the CoreValve US Pivotal Trial presented March 29 as part of ACC.14 in Washington, DC, and simultaneously published in the New England Journal of Medicine.
The CoreValve trial studied 795 patients with severe aortic stenosis who were at increased surgical risk, as determined by the heart teams at 45 U.S. centers using Society of Thoracic Surgeons (STS) and non-STS incremental risk factors. The patients, with a mean age of 83, were randomized in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to the surgical group.
The rate of death from any cause at one year was significantly reduced with TAVR performed with the CoreValve prosthesis than in the surgical group (14.2 percent vs. 19.1 percent) with an absolute reduction in risk of 4.9 percent (upper boundary of the 95 percent confidence interval, -0.4 percent; P<0.001 for noninferiority; P=0.04 for superiority). Results were similar in in the intention-to-treat analysis; the event rate was 13.9 percent in the TAVR group compared to 18.7 percent in the surgical group. The survival benefit with TAVR was consistent across clinical subgroups.
Further testing showed that echocardiographic indexes of valve stenosis, functional status, and quality of life were noninferior with TAVR. This study was the first to prospectively apply the Valve Academic Research Consortium-1 criteria for all secondary endpoints and major complications.
"This is the first prospective study of any device that suggests TAVR is superior to [surgery] in a predefined population of patients, and that's a provocative finding," said David H. Adams, MD, professor and chairman of the Department of Cardiothoracic Surgery at Mount Sinai Medical Center and co-principal investigator of the study. He emphasized the "outstanding outcomes" in the surgical arm: "The low mortality rates with conventional surgery far exceeded the predicted mortality according to the Society of Thoracic Surgeons predictive model. In order to pass a superiority threshold, transcatheter treatment with the CoreValve device had to exceed excellent surgical outcomes."
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