WASHIINGTON, D.C.—Transcatheter aortic valve replacement (TAVR) added more than two years to the life of inoperable patients with severe aortic stenosis, according to five-year results of the PARTNER I trial presented Sept. 13 at the Transcatheter Cardiovascular Therapeutics scientific session. The device also showed good durability, researchers said.
Speaking at a press conference for the late-breaking clinical trials, Samir R. Kapadia, MD, director of the Cleveland Clinic’s Sones Catheterization Laboratory, reviewed the clinical outcomes for patients treated with the Sapien valve (Edwards Lifesciences) in PARTNER I (Prospective, Randomized Trial of Transcatheter Aortic Valve Replacement with a Balloon-Expandable Device Versus Conservative Care in Extremely High-Risk Patients with Aortic Stenosis).
PARTNER was a controlled trial that randomized 358 patients with severe symptomatic stenosis to undergo transfemoral TAVR or standard care. At five years, the all-cause mortality rate for patients in the surgical group was 93.6 percent vs. 71.8 percent for the TAVR group, for an absolute difference of 22 percent. Median survival reached 29.7 months with TAVR vs. 11.1 months with standard care.
“If you do standard therapy you live less than a year and if you do TAVR you live two and a half years,” Kapadia said. “This is a big difference,” he said, adding that the TAVR patients were very functional as well.
The five-year rehospitalization rate was lower in the TAVR group, at 47.6 percent vs. 87.3 percent. Stroke incidence remained higher in the TAVR group than in the standard care group but it mostly plateaued at six months and held steady after that period. “TAVR does not pose a continued risk of stroke,” he said.
Discussant Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, commented that the data would compel him to change his practice for these very high-risk patients, based on the continued benefit shown with treatment. “They get quality of life and they get improvement,” he observed.
Popma called the 71.8 percent mortality rate sobering but Kapadia pointed out that the mortality rate for octogenarians was already 40 percent. The mean age of patients in this cohort was 81.3 years.
PARTNER was conducted at a time when TAVR was still in its infancy in the U.S., Popma said. Since then physicians have gained experience, practices have improved and the devices have been evolving. “This is the worst of it,” Popma said. “Everything from now on will be better than that.”
Kapadia concluded that, given these results, it would be hard to deny TAVR to suitable inoperable patients. He added that beyond the mortality benefit over time, “there was excellent durability of the valve itself.”