Cited by 6,345Cardiac Valve Diseases and TreatmentsAortic Disease and Treatment ApproachesInfective Endocarditis Diagnosis and Management

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Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

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Smith, Craig R., Leon, Martin B., Mack, Michael J., Miller, D. Craig, Moses, Jeffrey W., Svensson, Lars G., Tuzcu, E. Murat, Webb, John G., Fontana, Gregory P., Makkar, Raj R., Williams, Mathew, Dewey, Todd, Kapadia, Samir, Babaliaros, Vasilis, Thourani, Vinod H., Corso, Paul, Pichard, Augusto D., Bavaria, Joseph E., Herrmann, Howard C., Akin, Jodi J., Anderson, William N., Wang, Duolao, Pocock, Stuart J.·2011·New England Journal of Medicine

DOI 10.1056/nejmoa1103510

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Abstract

BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).

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Authors: Smith, C. R., Leon, M. B., Mack, M. J., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., Williams, M., Dewey, T., Kapadia, S., Babaliaros, V., Thourani, V. H., Corso, P., Pichard, A. D., Bavaria, J. E., Herrmann, H. C., Akin, J. J., Anderson, W. N., Wang, D., & Pocock, S. J.
Affiliations: NewYork–Presbyterian Hospital (US)
Baylor Scott & White Health (US)
Stanford Medicine (US)
Cleveland Clinic (US)
University of British Columbia (CA)
Cedars-Sinai Medical Center (US)
Medical City Dallas Hospital (US)
Emory University (US)
MedStar Washington Hospital Center (US)
Hospital of the University of Pennsylvania (US)
Edwards Lifesciences (United States) (US)
London School of Hygiene & Tropical Medicine (GB)
ORCID: Smith, Craig R.
Leon, Martin B.
Mack, Michael J.
Miller, D. Craig
Moses, Jeffrey W.
Svensson, Lars G.
Tuzcu, E. Murat
Webb, John G.
Fontana, Gregory P.
Makkar, Raj R.
Williams, Mathew
Kapadia, Samir
Babaliaros, Vasilis
Thourani, Vinod H.
Bavaria, Joseph E.
Herrmann, Howard C.
Anderson, William N.
Wang, Duolao
Pocock, Stuart J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2011-06-09
Volume: 364
Issue: 23
Pages: 2187-2198
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1103510
OpenAlex: W2165258820
Cited by: 6,345
References: 44
Citations by year: 2026: 194 · 2025: 239 · 2024: 315 · 2023: 331 · 2022: 340 · 2021: 396 · 2020: 457 · 2019: 507 · 2018: 503 · 2017: 545 · 2016: 533 · 2015: 502 · 2014: 455 · 2013: 484 · 2012: 449
FWCI: 322.18
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Aortic Disease and Treatment Approaches
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Infective Endocarditis Diagnosis and Management
Keywords: transcatheter aortic valve implantation, surgical aortic valve replacement, severe aortic stenosis, high-risk patients, transapical approach, transfemoral access, non-inferiority, mortality, stroke, vascular complications, hemorrhage, atrial fibrillation, periprocedural risk, symptom improvement, randomized trial comparison
MeSH terms: Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Cardiovascular Diseases, Catheterization, Female, Cardiac Catheterization, Humans, Male, Postoperative Complications, Risk Factors, Heart Valve Prosthesis Implantation, Stroke, Intention to Treat Analysis

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Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

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