Five-Year Outcomes For High-Risk Sapien Patients Demonstrate Equivalence To Surgery, Durable Valve Performance

SAN DIEGO, Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that the final five-year clinical data for high-risk patients treated with the first-generation SAPIEN transcatheter aortic valve in The PARTNER Trial demonstrated equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention. Data from the world's first prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients at high risk for surgery were presented as part of the late-breaking clinical trials at the American College of Cardiology's (ACC) 64th Annual Scientific Session in San Diego, and simultaneously published in The Lancet.

"It's remarkable that this five-year data report continues to show equivalency between what was then a brand new procedure with a first-generation TAVR device and the gold standard of surgery, which has been honed over 50 years of experience," saidMichael J. Mack, M.D., chair, cardiovascular service line, Baylor Scott & White Health. "Just as we observed in the five-year report from The PARTNER Trial on outcomes in inoperable patients treated with SAPIEN, the high-risk patients also had durable valve performance. These data show that TAVR is an effective treatment for these patients."

The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization.

The high-risk surgery cohort (Cohort A) of The PARTNER Trial enrolled between May 2007 and Sept. 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multi-disciplinary Heart Team and randomized to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery. This trial represented the initial TAVR experience for most trial sites in the United States.

The U.S. Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. In June 2014, the FDA approved the next-generation SAPIEN XT valve for the treatment of both inoperable and high-risk patients. The Edwards SAPIEN family of valves are the most studied transcatheter heart valves in history and have been used in the treatment of more than 100,000 patients globally. A second data presentation during the ACC late-breaking clinical trials detailed outcomes with the investigational SAPIEN 3 valve, which is summarized in a separate press release.

Source: Edwards Lifesciences Corporation