Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus

作者：Howard C. Herrmann, Roxana Mehran, Daniel J. Blackman, Stephen Bailey, Helge Möllmann, Mohamed Abdel‐Wahab, Walid Ben Ali, Paul Mahoney, Hendrik Ruge, David Wood, Sabine Bleiziffer, Basel Ramlawi, Hemal Gada, Anna Sonia Petronio, Charles D. Resor, William Merhi, Bruno García del Blanco, Guilherme F. Attizzani, Wayne Batchelor, Linda D. Gillam, Mayra Guerrero, Toby Rogers, Joshua D. Rovin, Molly Szerlip, Brian Whisenant, G. Michael Deeb, Kendra J. Grubb, Ratnasari Padang, Myra T Fan, Andrew D. Althouse, Didier Tchétché · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2312573 · 被引用次数：293 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Congenital Heart Disease Studies

Background Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). Methods We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm 2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). Results A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan–Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, −1.2 percentage points; 90% confidence interval [CI], −4.9 to 2.5; P<0.001 for noninferiority). The Kaplan–Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, −32.2 percentage points; 95% ...