One-Year PARTNER II Data Presented for Edwards' Sapien 3 TAVR System in High-Risk and Inoperable Patients

October 15, 2015—One-year patient outcomes from the PARTNER II trial showed that the low rate of 30-day complications with Edwards Lifesciences’ Sapien 3 balloon-expandable transcatheter aortic valve replacement (TAVR) system in high-risk and inoperable patients with aortic stenosis persisted with follow up to 1 year. The data were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation, being held October 11–15 in San Francisco, California.

As noted in the TCT announcement, the initial PARTNER I trial demonstrated the early promise of TAVR with first-generation devices for high-risk (HR) and inoperable (INOP) patients. The PARTNER II Sapien 3 trial was designed as two single-arm, nonrandomized, historical-controlled study of the newest generation balloon-expandable TAVR device. Thirty-day outcomes, which demonstrated very low rates of adverse events, were reported in March 2015 at the American College of Cardiology’s 64th annual scientific session in San Diego, California. 

The HR/INOP cohort of PARTNER II was composed of 583 patients with severe aortic stenosis who were deemed high-risk or inoperable for surgery. Patients were enrolled at 29 sites in the United States. The follow-up rate at 1 year was 98.6%, and the all-cause survival rate was 85.6%. Survival was 87.7% for transfemoral (TF) access procedures and 89.3% for high-risk patients treated by the TF route. The study also found that there was a low rate of disabling stokes at 1 year (2.4%) with no difference between HR and INOP or TF and TA.

Additionally, paravalvular aortic regurgitation remained low: with 2.7% of patients experiencing moderate regurgitation and 29.1% with mild regurgitation at 1 year. There was no increased mortality in the patients with moderate regurgitation as compared to those with none or mild, and no patient had severe regurgitation. Hemodynamic valve performance and early symptomatic improvement were also sustained at 1 year.

In the TCT press release, study investigator Howard C. Herrmann, MD, commented, “The combination of new design features, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of adverse events and a high rate of 1-year survival in TAVR for high-risk and inoperable patients with severe aortic stenosis. This represents a 50% reduction in mortality in both HR and INOP patients as compared with the first-generation TAVR device.” 

Dr. Herrmann, who is from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania, added, “These 1-year follow-up data support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis.”