2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement

Michael J. Reardon, David H. Adams, Neal S. Kleiman, Steven J. Yakubov, Joseph S. Coselli, G. Michael Deeb, Thomas G. Gleason, Joon Sup Lee, James B. Hermiller, Stan Chetcuti, John Heiser, William Merhi, George L. Zorn, Peter Tadros, Newell Robinson, George Petrossian, G. Chad Hughes, J. Kevin Harrison, Brijeshwar Maini, Mubashir Mumtaz & 7 others John V. Conte, Jon R. Resar, Vicken Aharonian, Thomas Pfeffer, Jae Kuen Oh, Hongyan Qiao, Jeffrey J. Popma

Research output: Contribution to journalArticle

234 Citations (Scopus)

Abstract

Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p <0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p <0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Original languageEnglish (US)
Article number21354
Pages (from-to)113-121
Number of pages9
JournalJournal of the American College of Cardiology
Volume66
Issue number2
DOIs
StatePublished - Jul 14 2015

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Aortic Valve Stenosis
Bioprosthesis
Aortic Valve
Survival Rate
Numbers Needed To Treat
Mortality
Random Allocation
Transcatheter Aortic Valve Replacement
Stroke
Safety
Therapeutics

Keywords

  • aortic stenosis
  • outcomes
  • TAVR

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Reardon, M. J., Adams, D. H., Kleiman, N. S., Yakubov, S. J., Coselli, J. S., Deeb, G. M., ... Popma, J. J. (2015). 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology, 66(2), 113-121. [21354]. https://doi.org/10.1016/j.jacc.2015.05.017

2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. / Reardon, Michael J.; Adams, David H.; Kleiman, Neal S.; Yakubov, Steven J.; Coselli, Joseph S.; Deeb, G. Michael; Gleason, Thomas G.; Lee, Joon Sup; Hermiller, James B.; Chetcuti, Stan; Heiser, John; Merhi, William; Zorn, George L.; Tadros, Peter; Robinson, Newell; Petrossian, George; Hughes, G. Chad; Harrison, J. Kevin; Maini, Brijeshwar; Mumtaz, Mubashir; Conte, John V.; Resar, Jon R.; Aharonian, Vicken; Pfeffer, Thomas; Oh, Jae Kuen; Qiao, Hongyan; Popma, Jeffrey J.

In: Journal of the American College of Cardiology, Vol. 66, No. 2, 21354, 14.07.2015, p. 113-121.

Research output: Contribution to journalArticle

Reardon, MJ, Adams, DH, Kleiman, NS, Yakubov, SJ, Coselli, JS, Deeb, GM, Gleason, TG, Lee, JS, Hermiller, JB, Chetcuti, S, Heiser, J, Merhi, W, Zorn, GL, Tadros, P, Robinson, N, Petrossian, G, Hughes, GC, Harrison, JK, Maini, B, Mumtaz, M, Conte, JV, Resar, JR, Aharonian, V, Pfeffer, T, Oh, JK, Qiao, H & Popma, JJ 2015, '2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement', Journal of the American College of Cardiology, vol. 66, no. 2, 21354, pp. 113-121. https://doi.org/10.1016/j.jacc.2015.05.017
Reardon, Michael J. ; Adams, David H. ; Kleiman, Neal S. ; Yakubov, Steven J. ; Coselli, Joseph S. ; Deeb, G. Michael ; Gleason, Thomas G. ; Lee, Joon Sup ; Hermiller, James B. ; Chetcuti, Stan ; Heiser, John ; Merhi, William ; Zorn, George L. ; Tadros, Peter ; Robinson, Newell ; Petrossian, George ; Hughes, G. Chad ; Harrison, J. Kevin ; Maini, Brijeshwar ; Mumtaz, Mubashir ; Conte, John V. ; Resar, Jon R. ; Aharonian, Vicken ; Pfeffer, Thomas ; Oh, Jae Kuen ; Qiao, Hongyan ; Popma, Jeffrey J. / 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. In: Journal of the American College of Cardiology. 2015 ; Vol. 66, No. 2. pp. 113-121.
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abstract = "Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2{\%}) than in the surgical group (28.6{\%}; log-rank test p <0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p <0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2{\%}) than in the surgical group (32.5{\%}; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).",
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T1 - 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement

AU - Reardon, Michael J.

AU - Adams, David H.

AU - Kleiman, Neal S.

AU - Yakubov, Steven J.

AU - Coselli, Joseph S.

AU - Deeb, G. Michael

AU - Gleason, Thomas G.

AU - Lee, Joon Sup

AU - Hermiller, James B.

AU - Chetcuti, Stan

AU - Heiser, John

AU - Merhi, William

AU - Zorn, George L.

AU - Tadros, Peter

AU - Robinson, Newell

AU - Petrossian, George

AU - Hughes, G. Chad

AU - Harrison, J. Kevin

AU - Maini, Brijeshwar

AU - Mumtaz, Mubashir

AU - Conte, John V.

AU - Resar, Jon R.

AU - Aharonian, Vicken

AU - Pfeffer, Thomas

AU - Oh, Jae Kuen

AU - Qiao, Hongyan

AU - Popma, Jeffrey J.

PY - 2015/7/14

Y1 - 2015/7/14

N2 - Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p <0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p <0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

AB - Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p <0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p <0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

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KW - outcomes

KW - TAVR

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