A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery Article

Full Text via DOI: 10.1016/j.jcin.2015.08.017 PMID: 26718510 Web of Science: 000366945100008
International Collaboration

Cited authors

  • Webb, John G.; Doshi, Darshan; Mack, Michael J.; Makkar, Raj; Smith, Craig R.; Pichard, Augusto D.; Kodali, Susheel; Kapadia, Samir; Miller, D. Craig; Babaliaros, Vasilis; Thourani, Vinod; Herrmann, Howard C.; Bodenhamer, Mark; Whisenant, Brian K.; Ramee, Stephen; Maniar, Hersh; Kereiakes, Dean; Xu, Ke; Jaber, Wael A.; Menon, Venu; Tuzcu, E. Murat; Wood, David; Svensson, Lars G.; Leon, Martin B.


  • OBJECTIVES The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.; BACKGROUND Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) 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, but 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.; METHODS A total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. 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. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography).; RESULTS 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%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value < 0.002); no differences in the other major pre-specified endpoints were found.; CONCLUSIONS In inoperable patients with severe, symptomatic AS, the lower-profile SAPIEN XT is noninferior to SAPIEN with fewer vascular complications and a lesser need for blood transfusion. (C) 2015 by the American College of Cardiology Foundation.

Publication date

  • 2015

Published in

International Standard Serial Number (ISSN)

  • 1936-8798

Start page

  • 1797

End page

  • 1806


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