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Document type:
Journal Article; Randomized Controlled Trial; Multicenter Study; Comparative Study; Equivalence Trial
Author(s):
Herrmann, Howard C; Mehran, Roxana; Blackman, Daniel J; Bailey, Stephen; Möllmann, Helge; Abdel-Wahab, Mohamed; Ben Ali, Walid; Mahoney, Paul D; Ruge, Hendrik; Wood, David A; Bleiziffer, Sabine; Ramlawi, Basel; Gada, Hemal; Petronio, Anna Sonia; Resor, Charles D; Merhi, William; Garcia Del Blanco, Bruno; Attizzani, Guilherme F; Batchelor, Wayne B; Gillam, Linda D; Guerrero, Mayra; Rogers, Toby; Rovin, Joshua D; Szerlip, Molly; Whisenant, Brian; Deeb, G Michael; Grubb, Kendra J; Padang, Ratnasari...     »
Title:
Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.
Abstract:
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 mm2 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% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).
Journal title abbreviation:
N Engl J Med
Year:
2024
Journal volume:
390
Journal issue:
21
Pages contribution:
1959-1971
Fulltext / DOI:
doi:10.1056/NEJMoa2312573
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/38587261
Print-ISSN:
0028-4793
TUM Institution:
Klinik für Herz- und Gefäßchirurgie (DHM) (Prof. Krane)
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