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<0.0001). Median survival was less than a year in the standard therapy group compared with over two years in the TAVR group (11.1 months vs. 29.7 months, p<0.001). Similarly, at five years, re-hospitalizations were nearly half as frequent in TAVR compared to standard therapy patients (87.3 percent in standard group vs. 47.6 percent in TAVR group, p<0.0001). Post-procedural valve areas were maintained in the TAVR group during the entire follow-up period.
Strokes were initially more frequent after TAVR compared to standard therapy, but there was no increased late stroke hazard over five years.
"At five-year follow-up, the benefits of TAVR were sustained - as measured by all-cause mortality, cardiovascular mortality, repeat hospitalization, and functional status," said lead investigator Samir Kapadia, MD, Director, Sones Cardiac Catheterization Laboratory at the Cleveland Clinic. "The valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area."
The PARTNER I trial was funded by Edwards Lifesciences. Dr. Kapadia reported being an unpaid member of the PARTNER steering committee.
The results of the PARTNER I trial will be presented on Saturday, September 13 at 11:00 AM EDT in the Main Arena (Level 3, Ballroom) of the Walter E. Washington Convention Center.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with heart disease through high quality research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. For more than 25 years, TCT has featured major medical research breakthroughs and gathered leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.