Newer-Generation Transcatheter Valve Outperforms Safety of Earlier Iteration

Data from the PARTNER II Cohort B trial indicate that both overall and major vascular complications are lower at 30 days among inoperable patients who received transcatheter aortic valve replacement (TAVR) with a newer-generation heart valve (Sapien XT; Edwards Lifesciences; Irvine, CA) compared with an earlier iteration (Sapien; Edwards Lifesciences; Irvine, CA).

“The Sapien XT is an incremental improvement from the prior generation of TAVR technology with a reduced risk of vascular injury and bleeding events requiring transfusion,” the researchers wrote.

For the PARTNER II Cohort B trial, researchers examined the Sapien XT transcatheter valve to see whether it could improve periprocedural complications among inoperable patients (n=560) compared with the larger-profile, first-generation Sapien device.

Patients were enrolled at 28 US sites between April 2011 and February 2012, and were randomly assigned to receive either the Sapien (n=276) or Sapien XT (n=284) device.

A nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population served as the primary end point. Several pre-specified secondary end points were also analyzed: cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-minute walk distance, and valve performance.

According to 30-day results, there were lower rates of overall (15.5% vs 22.1%; P=.04) and major vascular (9.5% vs 15.2%; P=.04) complications for patients receiving the Sapien XT valve, as well as a lower rate of bleeding requiring blood transfusions (5.3% vs 10.6%; P=.02).

At 1 year, the primary end point was similar between the 2 groups (Sapien, 37.7% vs Sapien XT, 37.2%; P for noninferiority <.002).

There were no significant differences in the other major pre-specified end points.

“The SAPIEN XT should be regarded as the next standard of care for patients undergoing balloon-expandable TAVR,” the researchers wrote.

Up ahead, the researchers noted that investigation is planned that will compare the even newer-generation transcatheter valve (Sapien 3; Edwards Lifesciences; Irvine, CA) with its 2 earlier-generation models.

Reference

Webb JG, Doshi D, Mack MJ, et al. A randomized evaluation of the Sapien XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. JACC: Cardiovasc Interv. 2015;8(14):1797-1806.