Edwards Sapien 3 Improves 1-Year Outcomes for Major Endpoints in PARTNER II

April 3, 2016—Findings from the PARTNER II trial, which is assessing long-term outcomes of transcatheter aortic valve replacement (TAVR) with the Sapien 3 valve (Edwards Lifesciences) in intermediate-risk patients versus surgical aortic valve replacement were presented by Prof. Vinod Thourani, MD, at ACC.16, the American College of Cardiology’s 65th annual scientific session held April 2–4 in Chicago, Illinois. The study was published simultaneously online by Prof. Thourani, et al in The Lancet.

According to ACC, patients who received the new Sapien 3 device showed improved outcomes for the study’s primary endpoint, a combination of death, stroke, and moderate or severe aortic insufficiency. These data are in line with findings from an earlier stage of the same study, which showed improved outcomes for Sapien 3 versus surgery at 30 days postprocedure. 

PARTNER II enrolled 1,078 intermediate-risk patients (average age, approximately 82 years) who received TAVR with Sapien 3 at 51 hospitals in the United States. The patients had a Society of Thoracic Surgeons risk score of 4 to 8. To account for baseline differences, TAVR patients were compared by a propensity score analysis with patients randomized to receive surgical intervention in the precursor PARTNER II, cohort A trial. 

In the study’s primary endpoint, a composite of death, stroke, and moderate or severe aortic insufficiency, TAVR with the Edwards Sapien 3 was found to be superior to surgery at 1 year, occurring 9.2% less in the TAVR patients compared with surgery patients.

Sapien 3 TAVR was also superior to surgery for two out of three secondary outcomes, mortality and stroke. In unadjusted 1-year outcomes, all-cause mortality was 7.4% for TAVR versus 13% for surgery. The rate of disabling strokes was also lower in TAVR patients (4.6% vs 8.2%). Surgery was found to be superior to TAVR in moderate to severe aortic insufficiency (TAVR, 1.5% vs surgery, 0.4%). ACC noted that more than moderate aortic insufficiency has been associated with poorer outcomes after TAVR in previous studies. In addition, TAVR patients needed pacemakers at a slightly higher rate at 1 year than did patients receiving surgery.

In the ACC press release, Prof. Thourani commented, “This study shows the lowest mortality rate ever of any transcatheter valve platform after 1 year, which is very exciting for the management of aortic stenosis. A previous analysis by our team showed that almost 20% of all patients undergoing surgical aortic valve replacement in the United States are in the intermediate-risk category, so I believe that this could have a major impact on the treatment options we have available for many of these patients.” Prof. Thourani is Professor of Surgery and Medicine at Emory University School of Medicine, Chief of Cardiothoracic Surgery at Emory University Hospital Midtown, and the Co-Director of the Emory Structural Heart and Valve Center in Atlanta, Georgia.

Prof. Thourani continued, “Taken together, these results demonstrate substantial improvements in outcomes among intermediate-risk patients receiving the Sapien 3 valve as compared in a propensity score analysis in intermediate-risk patients receiving surgery.”

In addition, the intermediate-risk TAVR patients in the new trial showed marked improvements in outcomes as compared to high-risk TAVR patients in previous trials.

Prof. Thourani advised that several factors could account for the overall improved success of the Sapien 3 TAVR procedure. One is that the third-generation model has been modified with an outer skirt designed to reduce leaking by sealing gaps around the valve. Other alterations allow the valve to be delivered with a smaller catheter, increasing the percentage of procedures that can be performed tranfemorally.

Approximately 90% of TAVR procedures in the new trial were performed transfemorally. In addition, heart teams now have more experience performing TAVR, and improved imaging techniques have allowed physicians to utilize more precise information about the valve implantation site and the appropriate valve size.

Prof. Thourani concluded, “Because our techniques have significantly improved, the majority of these patients go home within a day or two after the procedure. The improvements with the Sapien 3 valve have made this an easier procedure to perform and now this study shows that we can do it with extremely low complications and mortality. I believe we are on the cusp of a new indication for TAVR.”