Three-Year PARTNER Data Show Increased Survival Benefit With Edwards Sapien TAVR Device

October 24, 2012—Edwards Lifesciences Corporation (Irvine, CA) announced 3-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve. The data from the PARTNER trial (Cohort B) demonstrated a sustained and increasing survival benefit for Sapien valve patients at 3 years, as well as significantly less time spent in the hospital. The new results were presented at the TCT 2012: Transcatheter Cardiovascular Therapeutics (TCT) conference in Miami, Florida.

The US Food and Drug Administration (FDA) approved the Sapien valve in November 2011 for the treatment of inoperable patients via the transfemoral approach. On October 19, 2012, the company announced that it has received FDA approval to treat high-risk aortic stenosis patients with the Edwards Sapien transcatheter aortic heart valve delivered both transfemorally and transapically.

Edwards Lifescience noted that this trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Sapien valve or standard medical therapy.

According to Edwards Lifesciences, the 3-year all-cause mortality rate, by Kaplan-Meier estimates, for transcatheter aortic valve replacement (TAVR) patients was 54.1%, as compared to 80.9% for those patients receiving standard therapy. Despite the advanced age and comorbidities of this inoperable patient population, the mortality rates in the third year of follow-up were 19.3% for TAVR patients and 40.3% for control. Additionally, TAVR patients experienced a median period of time out of the hospital that was more than two-and-a-half times longer than that of standard therapy patients. At 3 years, the median days alive outside of the hospital were 944 (233-1096) for TAVR and 368 (147-1096) for standard medical therapy.

The company advised that the results showed that there was a higher stroke rate in the transcatheter group as compared to standard therapy, although the two additional events between the second and third years of follow-up were adjudicated not to be related to the procedure or the device.