Pivotal study of CoreValve shows benefits in TAVR patients-Medtronic

Medtronic has unveiled new two-year data from the High Risk Study of the CoreValve US Pivotal Trial, which continued to show superior survival benefit at two years for transcatheter aortic valve replacement (TAVR) with the CoreValve System compared to patients who underwent surgical aortic valve replacement (SAVR). The CoreValve US Pivotal High Risk Study is the only head-to-head study to show statistically significant survival differences favoring TAVR in aortic stenosis patients who are considered high risk for surgery.

The two-year outcomes from the CoreValve High Risk Study found that the rate of all-cause mortality was significantly lower in TAVR patients than in the SAVR patients (22.2 percent vs. 28.6 percent), with the absolute difference in all-cause mortality increasing between the two groups from 4.8 percent at one year to 6.5 percent at two years. The rate of stroke was significantly lower in the TAVR group as compared to the SAVR group at two years (10.9 percent vs 16.6 percent), and the major stroke rates were comparable (6.8 percent vs. 9.8 percent). The combined endpoint of all-cause mortality or major stroke significantly favored the TAVR group (24.2 percent vs. 32.5 percent).

Rates of major adverse cardiovascular and cerebrovascular events at one year were still superior at two years and were statistically lower in the TAVR group than the SAVR group (29.7 percent vs. 38.6 percent,). While the echocardiographic parameters of effective orifice area and mean aortic-valve gradient remained stable for both groups over the two year period, the TAVR group showed superior hemodynamics (blood flow) compared with the surgical group at all time points during the clinical trial follow-up. Moderate to severe paravalvular regurgitation for the TAVR group at two years (6.1 percent) proved consistent with the low one-year rate. Data were presented as a late-breaking clinical trial at the Annual Scientific Session of the American College of Cardiology.