PARTNER II Data Published for Edwards Sapien XT

December 23, 2015—John G. Webb, MD, et al conducted a randomized evaluation of the Sapien XT transcatheter heart valve system (Edwards Lifesciences) in patients with aortic stenosis who are not candidates for surgery. The investigators published these findings from the PARTNER II trial in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2015;8:1797–1806).

According to the investigators, the purpose of this study was to determine the safety and effectiveness of the Edwards Sapien XT system versus the Edwards Sapien system in patients with symptomatic, severe aortic stenosis who were not candidates for surgery.

The background of the study is that transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic aortic stenosis. In the PARTNER IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable Sapien transcatheter heart valve compared with standard therapy; however, the Sapien valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile Sapien XT system was developed to reduce these adverse events, advised the investigators.

As summarized in JACC: Cardiovascular Interventions, 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to undergo TAVR with the Sapien or Sapien XT system. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Prespecified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-minute walk distance, and valve performance (assessed by echocardiography).

The investigators reported that both overall and major vascular complications were higher at 30 days in patients undergoing TAVR with Sapien compared with Sapien XT (overall, 22.1% vs 15.5%; major, 15.2% vs 9.5%; both P = .04). Bleeding requiring blood transfusions was also more frequent with Sapien compared with Sapien XT (10.6% vs 5.3%; P = .02). 

At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar between the Sapien and Sapien XT groups (37.7% vs 37.2%; noninferiority P < .002); no differences in the other major prespecified endpoints were found.

In inoperable patients with severe, symptomatic aortic stenosis, the lower-profile Sapien XT is noninferior to Sapien with fewer vascular complications and a lesser need for blood transfusion, concluded the investigators in JACC: Cardiovascular Interventions.