CoreValve demonstrates superior survival to surgery in aortic stenosis patients- Medtronic

Medtronic has unveiled new clinical data on the self-expanding CoreValve System from the High Risk Study of the CoreValve U.S. Pivotal Trial, showing superior outcomes in survival for transcatheter aortic valve replacement (TAVR) compared to surgery at two years for the subgroup of patients with an STS Predicted Risk of Mortality estimate less than 7 percent. An STS score is used to help physicians determine whether patients with severe aortic stenosis should undergo surgical or transcatheter aortic valve replacements. The analysis of the sub-cohort compared 202 patients treated with the CoreValve System against 181 patients who received surgical aortic valve replacement (SAVR). The CoreValve TAVR patients demonstrated superior outcomes in all-cause mortality at two years compared to patients treated with surgical aortic valve replacement (15.0 percent vs. 26.3 percent). In addition, rates of combined all-cause mortality or major stroke were superior for TAVR with the CoreValve System (17.1 percent vs. 31.9 percent). The data were unveiled at the 65th Annual Scientific Session of the American College of Cardiology (ACC.16).

Patients also experienced significantly better valve hemodynamics (blood flow through the valve) than patients treated with surgery, as both gradients and the rates of severe patient prosthesis mismatch were statistically lower at each time point in the follow-up. Rates of life-threatening or disabling bleeding were also statistically lower in the CoreValve group. (20.2 percent vs. 34.9 percent). The pacemaker rate for the CoreValve group was 27.7 percent at two years, which is in line with CoreValve patients in the broader High Risk Study. These patients also demonstrated notable improvements in their quality of life (QoL). QoL scores for the CoreValve-treated patients showed strong medical benefit defined as KCCQ summary score of at least 60 and with less than a 10-point decrease from baseline.