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Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Open access
Leon, Martin B., Smith, Craig R., Mack, Michael J., Makkar, Raj R., Svensson, Lars G., Kodali, Susheel K., Thourani, Vinod H., Tuzcu, E. Murat, Miller, D. Craig, Herrmann, Howard C., Doshi, Darshan, Cohen, David J., Pichard, Augusto D., Kapadia, Samir, Dewey, Todd, Babaliaros, Vasilis, Szeto, Wilson Y., Williams, Mathew R., Kereiakes, Dean, Zajarias, Alan, Greason, Kevin L., Whisenant, Brian K., Hodson, Robert W., Moses, Jeffrey W., Trento, Alfredo, Brown, David L., Fearon, William F., Pibarot, Philippe, Hahn, Rebecca T., Jaber, Wael A., Anderson, William N., Alu, Maria C., Webb, John G.·2016·New England Journal of Medicine

Abstract

BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

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Metadata

Authors
Leon, M. B., Smith, C. R., Mack, M. J., Makkar, R. R., Svensson, L. G., Kodali, S. K., Thourani, V. H., Tuzcu, E. M., Miller, D. C., Herrmann, H. C., Doshi, D., Cohen, D. J., Pichard, A. D., Kapadia, S., Dewey, T., Babaliaros, V., Szeto, W. Y., Williams, M. R., Kereiakes, D., Zajarias, A., Greason, K. L., Whisenant, B. K., Hodson, R. W., Moses, J. W., Trento, A., Brown, D. L., Fearon, W. F., Pibarot, P., Hahn, R. T., Jaber, W. A., Anderson, W. N., Alu, M. C., & Webb, J. G.
Venue
New England Journal of Medicine
Published
2016-04-28
Volume
374
Issue
17
Pages
1609-1620
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2324073140
Cited by
5,053
References
8
FWCI
491.29
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. https://app.cochat.ai/papers/10.1056/nejmoa1514616
The paper
Leon, M. B., Smith, C. R., Mack, M. J., Makkar, R. R., Svensson, L. G., Kodali, S. K., Thourani, V. H., Tuzcu, E. M., Miller, D. C., Herrmann, H. C., Doshi, D., Cohen, D. J., Pichard, A. D., Kapadia, S., Dewey, T., Babaliaros, V., Szeto, W. Y., Williams, M. R., Kereiakes, D., . . . Webb, J. G. (2016). Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1514616

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.