Significant patient benefits with Sapien valve demonstrated in five-year PARTNER trial data


Five-year clinical outcomes for inoperable patients treated in the PARTNER trial, the world’s only prospective randomised trial for transcatheter aortic valve implantation (TAVI) in patients deemed too sick for open-heart surgery, were presented as part of the late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

“These longer term results from PARTNER’s inoperable cohort indicated that TAVI was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalisations,” said Michael J Mack, chair, cardiovascular service line, Baylor Scott & White Health. “It is reassuring now five years later that in this very ill and elderly patient group facing a high likelihood of mortality, more patients treated with Sapien [Edwards Lifesciences] experienced sustained improvements in functional heart status and fewer repeat hospitalisations—two measures that signify an improvement in quality of life. 

“This was the first study of its kind for transcatheter heart valves,” said Mack. “The PARTNER trial has historical significance in the development of TAVI and continues to provide the clinical community with important information about the durability and performance of the Edwards Sapien valves.”

The prospective, multicentre PARTNER trial provided the initial experience with TAVI in the United States. The trial documented the outcomes of 358 inoperable aortic stenosis patients treated at 21 centres between 2007 and 2009. In Cohort B of the PARTNER trial, inoperable patients with severe, symptomatic aortic stenosis were evenly randomised to receive either transfemoral TAVI with the Sapien valve or standard therapy, which included balloon aortic valvuloplasty or medical management of symptoms. The one- and two-year results from the PARTNER trial were published in the New England Journal of Medicine.