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

Publication ,  Journal Article
Reardon, MJ; Adams, DH; Kleiman, NS; Yakubov, SJ; Coselli, JS; Deeb, GM; Gleason, TG; Lee, JS; Hermiller, JB; Chetcuti, S; Heiser, J; Merhi, W ...
Published in: J Am Coll Cardiol
July 14, 2015

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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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 14, 2015

Volume

66

Issue

2

Start / End Page

113 / 121

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Male
  • Humans
  • Female
  • Echocardiography
  • Cardiovascular System & Hematology
  • Cardiac Catheterization
  • Bioprosthesis
  • Aortic Valve Stenosis
 

Citation

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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. J Am Coll Cardiol, 66(2), 113–121. https://doi.org/10.1016/j.jacc.2015.05.017
Reardon, Michael J., David H. Adams, Neal S. Kleiman, Steven J. Yakubov, Joseph S. Coselli, G Michael Deeb, Thomas G. Gleason, et al. “2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.J Am Coll Cardiol 66, no. 2 (July 14, 2015): 113–21. https://doi.org/10.1016/j.jacc.2015.05.017.
Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, et al. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2015 Jul 14;66(2):113–21.
Reardon, Michael J., et al. “2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.J Am Coll Cardiol, vol. 66, no. 2, July 2015, pp. 113–21. Pubmed, doi:10.1016/j.jacc.2015.05.017.
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. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2015 Jul 14;66(2):113–121.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 14, 2015

Volume

66

Issue

2

Start / End Page

113 / 121

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Male
  • Humans
  • Female
  • Echocardiography
  • Cardiovascular System & Hematology
  • Cardiac Catheterization
  • Bioprosthesis
  • Aortic Valve Stenosis