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PARTNER I: TAVR delivers mortality benefit, decreases rehospitalization at 5 years
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WASHINGTON — In patients with severe, inoperable aortic stenosis, transcatheter aortic valve replacement yielded a sustained mortality benefit, improved functional status and a decreased rate of rehospitalization vs. standard therapy, according to 5-year results from the PARTNER I study presented at TCT 2014.
Samir Kapadia, MD, director of Sones Cardiac Catheterization Laboratory at the Cleveland Clinic, presented the findings of the analysis. In the study, Kapadia and colleagues randomly assigned 358 patients with severe, symptomatic, inoperable aortic stenosis to transcatheter aortic valve replacement (n=179) or standard therapy, which frequently consisted of balloon valvuloplasty (n=179).
Kapadia and colleagues found that 5-year all-cause mortality was 93.6% in the standard therapy cohort and 71.8% in the TAVR group (P<.0001). The standard therapy group had a median survival of less than 1 year vs. over 2 years in the TAVR group (11.1 months vs. 29.7 months; P<.001).
“This is a big difference, and you will see that those 2.5 years are functionally good years, not an invalid 2.5 years,” Kapadia said in a press conference.
The rehospitalization rate at 5 years in the TAVR group was 47.6%, which was nearly half that of the standard therapy group (87.3%; P<.0001). The TAVR group maintained post-procedural mean gradient and valve areas throughout the duration of follow-up.
Although stroke rate was initially higher in the TAVR cohort than in the standard therapy group, there was no disparity at 5 years. The mortality benefits — both CV and all-cause — were observed even in patients with Society of Thoracic Surgeons scores above 15.
Presentation discussant Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center, Boston, said these findings will likely cause him to change his practice, particularly in terms of his hesitancy to treat patients classified as cohort B patients. However, he did express concerns about some of the survival and mortality findings.
Jeffrey J. Popma
“I am impressed with the persistent benefit, but I am also sobered by the 5-year mortality [of 71.8%] and the survival rate as well,” he said.
Popma added that he was encouraged by the findings regarding patients with mild-to-moderate regurgitation.
In the PARTNER I study, patients were considered unsuitable for surgery if they had risk for death or morbidity higher than 50% as determined by a cardiologist and two surgeons. Patients in both groups had a mean age of 83 years. – by Jennifer Byrne
For more information:
Kapadia S. Plenary Session V: Late-Breaking Clinical Trials No. 1. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.
Disclosure: Kapadia reports no relevant financial disclosures. Popma reports receiving grant/research support from Abbott Vascular, Boston Scientific, Cook Medical, ev3 and Medtronic, and consultant fees/honoraria/serving on the speaker’s bureau for Abbott Vascular, Boston Scientific and ev3.