Results of PARTNER I trial reported at TCT 2014

(Press-News.org) WASHINGTON, DC – September 13, 2014 – New data from a landmark clinical trial found that after five years, transcatheter aortic valve replacement (TAVR) demonstrated a persistent mortality benefit, improved functional status, and resulted in a lower rate of repeat hospitalizations when compared with standard therapy for patients with severe aortic stenosis who are not candidates for surgery.

Findings were reported today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

According to ACC/AHA guidelines, TAVR is the accepted therapy for patients with severe aortic stenosis (AS) who are not candidates for surgery, based upon the initial results of the randomized PARTNER I trial. However, late clinical outcomes in such patients are unknown. In this long-term analysis from PARTNER I, the five-year clinical outcomes of inoperable patients with severe aortic stenosis were reported. The primary endpoint was freedom from all-cause mortality over the duration of the trial. The combination of all-cause mortality and time to first recurrent hospitalization was also examined.

PARTNER was a prospective, active control trial that randomized 358 patients to either transfemoral TAVR or standard therapy, which often included balloon valvuloplasty. Consistent with the very high risk nature of the patient population, the five-year all-cause mortality was 93.6 percent in the standard therapy group, but was significantly lower in the TAVR group (71.8 percent, p END