March 17, 2015 — Five-year data suggest that the Sapien transcatheter heart valve (Edwards Lifesciences) is a feasible option for patients with severe aortic stenosis deemed to be at high risk for open-heart surgery, though valve leakage was more common with the first-generation valve evaluated in this study than with surgery, according to research from PARTNER I presented at the American College of Cardiology’s (ACC) 2015 Annual Scientific Session.
The final 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. There was also no structural valve deterioration requiring intervention. Data from the 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 ACC 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," said Michael Mack, M.D., chair, cardiovascular service line, Baylor Scott and 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 surprise is that there were no surprises,” Mack said. “The findings at five years confirm the earlier findings that outcomes are equivalent in high-risk surgical patients with surgery and with TAVR.” There were no signs of structural valve deterioration or loss of valve function with TAVR, he said.
The high-risk surgery cohort (Cohort A) of The PARTNER Trial enrolled between May 2007 and September 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multidisciplinary 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.
At five years, death and stroke rates were statistically the same in both groups: 67.8 percent of TAVR patients and 62.4 percent of surgery patients had died, with median survival of 44.5 months with TAVR and 40.6 months with surgery. Stroke rates were 15.9 percent for TAVR patients and 14.7 percent for surgery patients. Rehospitalization rates and functional outcomes also were the same in both groups.
Transcatheter valves have not approached the low leakage rate around the valve that can be achieved by an open-heart operation. As in previous findings, the rate of moderate or severe leaking around the valve remained significantly higher for the TAVR group — 14 percent with TAVR and 2.1 percent with surgery — and at five years, that higher leakage rate still led to an increase in deaths with the death rate in patients with leakage 9 percent greater than in patients who didn’t have a significant leak. The firstgeneration valve used in this trial has already been replaced by a second-generation device that is approved in the United States, and a third-generation valve has been designed specifically to reduce leakage. Thirty-day results for the third-generation valve will be reported separately at the ACC meeting.
Data analysis identified several indications and cautions for both procedures. Kidney disease was a significant issue with TAVR but not surgery; a high Society of Thoracic Surgeons risk score, which indicates the patient is sicker at the time of treatment, was a predictor of death in the surgery group; and liver disease was a significant factor in both groups. TAVR patients will be followed annually for life in the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapies registry; surgery patients will not be followed beyond five years.
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.
For more information: acc.org, www.edwards.com