November 15, 2011 — A two-year study of patients in the landmark PARTNER trial confirms the one-year findings and supports transcatheter aortic valve replacement (TAVR) as the standard-of-care. The original study compared TAVR in patients who have severe aortic stenosis and are not candidates for open-heart surgery. The results were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Cohort B of the PARTNER trial consisted of those patients with severe aortic stenosis who were not candidates for surgery. 358 patients were randomized to transfemoral TAVR with an early generation balloon-expandable bovine pericardial valve or standard therapy (ST, including balloon valvuloplasty) at 21 centers, emphasizing a multidisciplinary heart team approach.
The primary endpoint was death from any cause at one year; secondary endpoints included symptom status, serial echo assessments (core lab) and early/late adverse events (e.g. strokes).
After two years, the rate of all-cause mortality was 18.2 percent in the TAVR group and 35.1 percent in the standard therapy group. The rate of cardiovascular mortality was 13.2 percent in the TAVR group and 32.1 percent in the standard therapy group.
The rate of repeat hospitalization was 35 percent in the TAVR group and 72.5 percent in the standard therapy group.
The rate of stroke at two years was higher – 13.8 percent in the TAVR group and 5.5 percent in the standard therapy group.
“At two years, in patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery, TAVR remained superior to standard therapy with incremental benefit from one to two years markedly reducing the rates of all cause mortality, cardiovascular mortality and repeat hospitalization,” said Raj R. Makkar, M.D., the principal site investigator for the PARTNER trial. Makkar is director of interventional cardiology and the Cardiac Catheterization Laboratory at Cedars-Sinai Medical Center. He is also associate director of the Cedars- Sinai Heart Institute
“There were more neurologic events in TAVR patients compared to standard therapy (16.2 percent vs. 5.5 percent; p = 0.003) with five new events (three strokes and two TIAs) between one and two years in TAVR patients. After 30 days, differences in stroke frequency were largely due to increased hemorrhagic strokes in TAVR patients.” Makkar said.
“Two year data continues to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates,” he said.
“The ultimate value of TAVR in ‘inoperable’ patients will depend on careful selection of patients who are not surgical candidates, and yet do not have extreme co-morbidities that overwhelm the benefits of TAVR.”
The PARTNER trial was funded by Edwards Lifesciences Inc. Makkar reported consulting fees, grant support and lecture fees from Medtronic, equity from Entourage Medical Technologies and grant support from St. Jude Medical.
For more information: www.crf.org