CardioExchange Archive

Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery.

Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published simultaneously in The New England Journal of Medicine. In the trial, 795 patients with severe aortic stenosis who who were at high risk for surgery were randomized to surgical aortic valve replacement (SAVR) or TAVR with the Medtronic CoreValve device.

The headline news is the improved mortality with TAVR. In the as-treated analysis, at 1 year the rate of death was 14.2% in the TAVR group versus 19.1% in the SAVR group, a difference that was highly significant for noninferiority (P<0.001) and that reached significance for superiority (P=0.04). A similar pattern occurred in the intention-to-treat analysis: At 1 year, the rates of death were 13.9% for TAVR and 18.7% for SAVR (P<0.001 for non inferiority; P=0.04 for superiority).

However, for the important secondary endpoint of major adverse cardiovascular and cerebrovascular events at 30 days or discharge, TAVR did not meet the prespecified criteria for superiority (8.2% for TAVR vs. 10.9% for SAVR; P=0.10). At 30 days, the stroke rate was 4.9% in the TAVR group and 6.2% in the surgical group (P=0.46). At 1 year, the strokes were 8.8% and 12.6%, respectively (P=0.10).

More pacemakers were implanted in the TAVR group at 1 year (22.3% vs. 11.3% for SAVR), and the TAVR group had more major vascular complications. But bleeding complications occurred more frequently in the surgery group.

In an interview with Rick Lange and David Hillis for CardioExchange, Columbia University interventional cardiologist Ajay Kirtane said that the trial “further tilts the balance toward TAVR in high-risk patients.” He cautioned that it is impossible at this point to compare the CoreValve results with results from the Sapien device in the PARTNER trials. “In the absence of a head-to-head comparison of the short- and long-term performance of these valves, it is really difficult to speculate about valve-specific differences, except theoretically,” he said. “I view this as a ‘win’ for TAVR as a whole.”

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