Two-Year Data Published From United States Pivotal Trial of Medtronic's CoreValve TAVR System

July 10, 2015—Two-year outcomes from the United States pivotal trial for the self-expanding CoreValve transcatheter aortic valve replacement (TAVR) system (Medtronic plc) were published by Michael J. Reardon, MD, et al in the Journal of the American College of Cardiology (JACC; 2015;66:113–121).

The investigators noted that the CoreValve trial had previously shown that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with the self-expanding transcatheter CoreValve bioprosthesis than in those treated with a surgical bioprosthesis. The investigators examined longer-term clinical outcomes to confirm whether this mortality benefit was sustained.

As summarized in JACC, the trial recruited patients with severe aortic stenosis who were at increased surgical risk. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the CoreValve device or to aortic valve replacement with a surgical bioprosthesis. A total of 797 patients underwent randomization at 45 centers in the United States. 

The investigators evaluated the 2-year clinical and echocardiographic outcomes in these patients. In the as-treated cohort, the rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test P < .05), with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test P < .05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test P = .01). In patients with severe aortic stenosis who were at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years, concluded the investigators in JACC.

The 2-year data were presented in March 2015 at the 64th annual scientific sessions of the American College of Cardiology in San Diego, California. In 2014, the US Food and Drug Administration approved the CoreValve system for patients at extreme risk and high risk for surgery. The device received European CE Mark approval in 2007. The company announced Japanese regulatory approval in March 2015.