PARTNER: TAVI in high-risk surgical patients linked with reduced mortality rates

Although an association between transcatheter aortic valve implantation and improved mortality was reported, it came at the price of increased stroke incidence

Issue: November 2010

Transcatheter aortic valve implantation was associated with reduced mortality in patients who were at heightened risk for conventional valve replacement surgery, newly published results from the PARTNER trial suggested.

Researchers enrolled 358 patients who had aortic stenosis, cardiac symptoms and who were deemed unsuitable for conventional valve replacement surgery, which included balloon aortic valvuloplasty. Patients were randomly assigned to two cohorts: those who were at high risk for surgery but who received standard therapy (n=179) and those at high risk for surgery and underwent transcatheter aortic valve implantation (TAVI; n=179). The primary study endpoint was the rate of death from any cause during the study period.

According to the results, a Kaplan-Meier analysis showed that 1-year rate of death from any cause was 30.7% in the TAVI group vs. 50.7% with standard therapy (HR with TAVI=0.55; 95% CI, 0.40-0.70). The composite endpoint of death from any cause or repeat hospitalization was also lower in the TAVI group vs. the standard therapy group (42.5% vs. 71.6%; HR=0.46; 95% CI, 0.35-0.59). The rate of cardiac symptoms was lower at 1 year in patients who underwent TAVI vs. those who received standard therapy (25.2% vs. 58%; P<.001).

Despite improvements in death from any cause and other endpoints, TAVI was also associated with an elevated incidence of major strokes vs. standard therapy (5% vs. 1.1%; P=.06), as well as an increase in the incidence of vascular complications (16.2% vs. 1.1%; P<.001).

“Although we were optimistic about the results of the trial, it ended up exceeding our expectations,” Michael Mack, MD, a study co-author and vice president of the Society of Thoracic Surgeons, told Cardiology Today. “Although this trial was unprecedented because we have randomized data available for the first time, just about as important will be the data from cohort A, which will be available in the spring, because that will compare the results with those of conventional surgery.”

Mack said the results will likely have a positive effect on the incorporation of the procedure into practice.

“This trial being positive will positively influence and catalyze the adoption of the procedure, but what it won’t do is change the regulatory process, and that will have to play out,” he said. “What it will do, though, is increase the enthusiasm for the procedure. If this trial was negative, it would have significantly negatively impacted the whole field.” – by Eric Raible

Leon M. N Engl J Med. 2010;doi:10.1056/NEJMoa1008232.

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