麻豆传媒

WASHINGTON -- Among extremely high-risk patients -- most in their 80s -- treatment with the Edwards Lifesciences' Sapien transcatheter aortic valve implant (TAVI) added years to their lives compared with similar patients who were treated medically, researchers reported here.

And those added years, were better years with less disability than medically-treated patients.

from the Cleveland Clinic, and colleagues presented the 5-year data from the PARTNER I trial during the first late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics meeting. He called the differences dramatic.

"At 5 years, only one of 179 patients in the standard-care arm was alive compared with 51 of the 179 patients who got a Sapien valve ... And amazingly enough, the survival curves continue to separate out to 5 years. The separation would be even greater if the standard-care patients who got a valve or surgery outside of the trial were excluded," he said.

The original PARTNER I results were reported at the 2010 TCT, and follow-up reports in subsequent years confirmed those initial observations, so 5-year benefit was expected, although perhaps not as robust as reported here.

director of the interventional cardiology fellowship program at Columbia University Medical Center/New York-Presbyterian Hospital in New York City, called the data "unbelievable." Kirtane moderated a TCT press conference where the findings were presented.

, a cardiothoracic surgeon from Baylor College of Medicine in Houston and PARTNERS II principal investigator, noted that survival and quality of life for patients was improved with TAVI. "It became clear during this trial that there were winners and losers depending on what arm you were in," he said.

Mack, who is slated to receive a lifetime achievement award from the TCT, called the PARTNER I follow-up "evidence-based medicine done at its finest."

PARTNER I recruited 378 patients with severe aortic stenosis, who were not candidates for surgery. Patients were evenly randomized to TAVI or standard care. The primary endpoint was all-cause mortality over the length of the trial.

At 5 years, an intention to treat analysis revealed an all-cause mortality rate of 93.6% in the control arm versus 71.8% in the Sapien arm (HR 0.50, 95% CI 0.39-0.65, log rank P<0.0001). The age and gender-matched U.S. population mortality rate at 5 years among the healthy is roughly 40%.

With standard therapy the median survival was 11.1 months versus 29.7 months, Kapadia said (log rank P<0.0001).

But as with the initial PARTNER I findings, stroke was more common among patients who received the valve, at 14.6% versus 5.7%, he said. And the presence of paravalvular leak did increase the risk of cardiovascular mortality, while the presence of oxygen-dependent chronic obstructive pulmonary disease lessened the survival benefit.

Kirtane speculated that the 5-year data will increase the use of the Sapien valve beyond the very-high-risk population.

"When you see this kind of durability, it gives you more enthusiasm to move this to lower-risk patients," Kapadia agreed, "It is hard in my mind to deny this to any patient."

director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, who served as a discussant for the PARTNER I 5-year results, pointed out that these are the patients with the worst outcome, and they still have a significant benefit. "This is the worst of the outcomes we expect to see, and everything from now on will be better than that," he said.

Kapadia said the results also confirmed the valve's durability adding, "there is no indication of decreasing the valve area."

of the Cooper Heart Institute in Camden, N.J., said confirmation of durability was important because it is "a piece of information we haven't been able to give [to patients] ... This is a gold standard study." Turi also served as on the TCT's discussant panel.

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