ACC 2014 Report: Transcatheter aortic valve replacement (TAVR) with a self-expanding prosthesis achieves lower mortality than surgery: CoreValve US Pivotal Trial

by Bruce Sylvester – Severe aortic stenosis patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis have achieved a significantly higher rate of survival at one year than surgical aortic valve replacement patients.

Researchers reported findings from the CoreValve US Pivotal Trial on March 29, 2014 at American College of Cardiology/ACC 2014. The findings were published simultaneously in the New England Journal of Medicine.

“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 in New York  and co-principal investigator of the study.  “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,” he added.

The researchers enrolled 795 subjects with severe aortic stenosis who were also at increased surgical risk. Eligibility was determined using Society of Thoracic Surgeons (STS) and non-STS incremental risk factor criteria.

Subjects were a mean age of 83.

They were randomized 1:1 to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgery.

The primary endpoint of the studied was death from any cause within 12 months of TAVR or surgical intervention.

The investigators reported  that  the  rate of death from any cause at one year was significantly lower among subjects undergoing  TAVR performed with the CoreValve prosthesis than those undergoing surgery (14.2 percent vs. 19.1 percent), with an absolute reduction in risk of 4.9 percent ( P<0.001 for noninferiority; P=0.04 for superiority).

Survival benefit with TAVR was consistent across clinical subgroups.

Also echocardiographic indexes of valve stenosis, functional status, and quality of life were non-inferior with TAVR.