Five-Year PARTNER Data Continue to Support Edwards Sapien TAVR Device

September 13, 2014—Five-year data from the PARTNER I clinical trial were presented at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The data were presented by lead investigator Samir Kapadia, MD, who is Director of the Sones Cardiac Catheterization Laboratory at the Cleveland Clinic in Ohio.

At 5 years, the PARTNER I study of transcatheter aortic valve replacement (TAVR) demonstrated a persistent mortality benefit, improved functional status, and resulted in a lower rate of repeat hospitalizations when compared with standard therapy for patients with severe aortic stenosis who are not candidates for surgery.

The PARTNER trial is an evaluation of the Edwards Sapien transcatheter heart valve (Edwards Lifesciences) for the treatment of severe aortic stenosis.

According to TCT, PARTNER I is a prospective, active-control trial that randomized 358 patients to either transfemoral TAVR or standard therapy, which often included balloon valvuloplasty. The primary endpoint was freedom from all-cause mortality over the duration of the trial. The combination of all-cause mortality and time to first recurrent hospitalization was also examined.

As summarized by TCT, the results were consistent with the very high-risk nature of the patient population: 5-year all-cause mortality was 93.6% in the standard therapy group and was significantly lower in the TAVR group (71.8%; P < .0001). Median survival was < 1 year in the standard therapy group compared with > 2 years in the TAVR group (11.1 months vs 29.7 months; P < .001). Similarly, at 5 years, rehospitalizations were approximately half as frequent in TAVR compared to standard therapy patients (87.3% in standard group vs 47.6% in TAVR group; P < .0001). Postprocedural valve areas were maintained in the TAVR group during the entire follow-up period. Additionally, strokes were initially more frequent after TAVR compared to standard therapy, but there was no increased late stroke hazard over 5 years.

Dr. Kapadia commented in the TCT press release, “At 5-year follow-up, the benefits of TAVR were sustained—as measured by all-cause mortality, cardiovascular mortality, repeat hospitalization, and functional status. The valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area.”

TCT noted that American College of Cardiology/American Heart Association guidelines recognizing TAVR as an accepted therapy for patients with severe aortic stenosis (AS) who are not candidates for surgery are based upon the initial results of the randomized PARTNER I trial.

One-year PARTNER I results were first presented at TCT in September 2010.

In November 2011, the company announced US Food and Drug Administration (FDA) approval for transfemoral delivery of the Edwards Sapien transcatheter aortic heart valve to treat inoperable patients who have severe symptomatic aortic stenosis. This was the first commercial approval in the United States for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.

In October 2012, Edwards Lifesciences announced FDA approval to treat high-risk aortic stenosis patients with the Edwards Sapien transcatheter aortic heart valve, delivered both transfemorally and transapically.

In a press release issued by Edwards Lifesciences, Michael J. Mack, MD, Chair, cardiovascular service line at Baylor Scott & WhiteHealth, commented, “These longer term results from PARTNER’s inoperable cohort indicated that TAVR was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalizations. It is reassuring now 5 years later that in this very ill and elderly patient group facing a high likelihood of mortality, more patients treated with Sapien experienced sustained improvements in functional heart status and fewer repeat hospitalizations—two measures that signify an improvement in quality of life.”

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