SAN DIEGO—High-risk patients with severe aortic stenosis had similar outcomes at five years in both arms of the PARTNER I trial, a finding that the presenter at the American College of Cardiology scientific session called a win for the intervention.
Michael Mack, MD, of Baylor Scott and White Health in Dallas, presented five-year results of the landmark trial on March 15 at the late-breaking clinical trials session. PARTNER I randomized 699 patients to either treatment with Edwards Lifesciences’ Sapien transcatheter aortic valve replacement (TAVR) device or surgery. Before unveiling the results, he reminded the audience that the study used a first-generation valve that is no longer commercially available and recruited cardiac surgeons who perforce were getting their first experience with TAVR through the trial.
At five years, the all-cause mortality rate was 67.8 percent in the TAVR group and 62.4 percent in the surgery group and cardiovascular mortality was 53.1 percent vs. 47.6 percent. The stroke rate totaled 15.9 percent with TAVR and 14.7 percent with surgery. The repeat hospitalization rates and functional outcomes were similar was well.
“TAVR is not a predictor of five-year mortality,” Mack said. He added that men tended to do better with surgery while women seemed to fare better with TAVR.
The mean gradient was sustained at five years with the Sapien valve and there were no signs of structural valve deterioration. That prompted panelist Jeffrey J. Popma, MD, to ask whether the question of durability was answered with this data. Mack replied that in the past at five years the durability of other valves has appeared good but was not sustained.
The durability results provide “some degree of reassuredness,” he offered.
Since the inception of PARNTER I, the technology has been revised, 3D imaging protocols introduced, heart teams have gained experience and programs have gotten wiser about selecting appropriate patients, Mack pointed out at a press conference.
“The fact that this is a tie means TAVR wins,” he said.
The five-year findings were published simultaneously in The Lancet. The study was funded by Edwards Lifesciences.