The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.
Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk
Open accessAbstract
BACKGROUND In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. OBJECTIVES This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. METHODS This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. RESULTS Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. CONCLUSIONS At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
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Cites
Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1008232 · Cited by 7,205
Self-citationTranscatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
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., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1103510 · Cited by 6,345
Self-citationTranscatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients
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., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1514616 · Cited by 5,053
Self-citationTranscatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., Pibarot, P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1814052 · Cited by 4,847
Self-citationTranscatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients
Popma, J. J., Deeb, G. M., Yakubov, S. J., Mumtaz, M., Gada, H., O’Hair, D., Bajwa, T., Heiser, J. C., Merhi, W., Kleiman, N. S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816885 · Cited by 3,674
Kappetein, A. P., Head, S. J., Généreux, P., Piazza, N., Mieghem, N. M. V., Blackstone, E., Brott, T., Cohen, D., Cutlip, D. E., van Es, G., et al. (2012) · doi:10.48350/15011 · Cited by 3,368
Self-citationSurgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
Reardon, M. J., Van Mieghem, N. M., Popma, J. J., Kleiman, N. S., Søndergaard, L., Mumtaz, M., Adams, D. H., Deeb, G. M., Maini, B., Gada, H., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1700456 · Cited by 3,009
Self-citationTranscatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis
Adams, D. H., Popma, J. J., Reardon, M. J., Yakubov, S. J., Coselli, J. S., Deeb, G. M., Gleason, T. G., Buchbinder, M., Hermiller, J., Kleiman, N. S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1400590 · Cited by 2,902
Mack, M. J., Leon, M. B., Smith, C. R., Miller, D. C., Moses, J. W., Tuzcu, E. M., Webb, J. G., Douglas, P. S., Anderson, W. N., Blackstone, E. H., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(15)60308-7 · Cited by 1,739
Self-citationUpdated Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation
Kappetein, A. P., Head, S. J., Généreux, P., Piazza, N., van Mieghem, N. M., Blackstone, E. H., Brott, T. G., Cohen, D. J., Cutlip, D. E., van Es, G.-A., et al. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.09.001 · Cited by 1,668
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2021 ESC/EACTS Guidelines for the management of valvular heart disease
Vahanian, A., Beyersdorf, F., Praz, F., Milojevic, M., Baldus, S., Bauersachs, J., Capodanno, D., Conradi, L., De Bonis, M., De Paulis, R., et al. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehab395 · Cited by 5,685
Transcatheter Heart Valves: A Biomaterials Perspective
Bui, H. T., Khair, N., Yeats, B., Gooden, S., James, S. P., & Dasi, L. P. (2021) · Advanced Healthcare Materials · doi:10.1002/adhm.202100115 · Cited by 36
Metadata
- Authors
- Leon, M. B., Mack, M. J., Hahn, R. T., Thourani, V. H., Makkar, R., Kodali, S. K., Alu, M. C., Madhavan, M. V., Chau, K. H., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., Blanke, P., Leipsic, J. A., Williams, M. R., McCabe, J. M., Brown, D. L., Babaliaros, V., Goldman, S., Herrmann, H. C., Szeto, W. Y., Genereux, P., Pershad, A., Lu, M., Webb, J. G., Smith, C. R., & Pibarot, P.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2021-03
- Volume
- 77
- Issue
- 9
- Pages
- 1149-1161
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W3133691259
- Cited by
- 325
- References
- 33
- FWCI
- 39.26
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Leon, M. B., Mack, M. J., Hahn, R. T., Thourani, V. H., Makkar, R., Kodali, S. K., Alu, M. C., Madhavan, M. V., Chau, K. H., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., Blanke, P., Leipsic, J. A., Williams, M. R., McCabe, J. M., Brown, D. L., Babaliaros, V., . . . Pibarot, P. (2021). Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2020.12.052
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