3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement

CoreValve US Clinical Investigators

Research output: Contribution to journalArticle

152 Citations (Scopus)

Abstract

Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (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)
Pages (from-to)2565-2574
Number of pages10
JournalJournal of the American College of Cardiology
Volume67
Issue number22
DOIs
StatePublished - Jun 7 2016

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Surgical Instruments
Aortic Valve Stenosis
Aortic Valve
Transcatheter Aortic Valve Replacement
Hemodynamics
Stroke
Aortic Valve Insufficiency
Mortality
Random Allocation
Thrombosis
Safety
Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{9c207d01bd8b4dc3baf25ff7f6900d9d,
title = "3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement",
abstract = "Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3{\%} vs. 46.7{\%} in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9{\%} vs. 39.1{\%}, respectively; p = 0.068), all stroke (12.6{\%} vs. 19.0{\%}, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2{\%} vs. 47.9{\%}, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8{\%} vs. 0.0{\%} in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve {\circledR} System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)",
author = "{CoreValve US Clinical Investigators} and Deeb, {G. Michael} and Reardon, {Michael J.} and Stan Chetcuti and Patel, {Himanshu J.} and Grossman, {P. Michael} and Yakubov, {Steven J.} and Kleiman, {Neal S.} and Coselli, {Joseph S.} and Gleason, {Thomas G.} and Lee, {Joon Sup} and Hermiller, {James B.} and John Heiser and William Merhi and Zorn, {George L.} and Peter Tadros and Newell Robinson and George Petrossian and Hughes, {G. Chad} and Harrison, {J. Kevin} and Brijeshwar Maini and Mubashir Mumtaz and John Conte and Jon Resar and Vicken Aharonian and Thomas Pfeffer and Oh, {Jae K.} and Hongyan Qiao and Adams, {David H.} and Popma, {Jeffrey J.}",
year = "2016",
month = "6",
day = "7",
doi = "10.1016/j.jacc.2016.03.506",
language = "English (US)",
volume = "67",
pages = "2565--2574",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "22",

}

3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. / CoreValve US Clinical Investigators.

In: Journal of the American College of Cardiology, Vol. 67, No. 22, 07.06.2016, p. 2565-2574.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement

AU - CoreValve US Clinical Investigators

AU - Deeb, G. Michael

AU - Reardon, Michael J.

AU - Chetcuti, Stan

AU - Patel, Himanshu J.

AU - Grossman, P. Michael

AU - Yakubov, Steven J.

AU - Kleiman, Neal S.

AU - Coselli, Joseph S.

AU - Gleason, Thomas G.

AU - Lee, Joon Sup

AU - Hermiller, James B.

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

AU - Resar, Jon

AU - Aharonian, Vicken

AU - Pfeffer, Thomas

AU - Oh, Jae K.

AU - Qiao, Hongyan

AU - Adams, David H.

AU - Popma, Jeffrey J.

PY - 2016/6/7

Y1 - 2016/6/7

N2 - Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (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 In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (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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U2 - 10.1016/j.jacc.2016.03.506

DO - 10.1016/j.jacc.2016.03.506

M3 - Article

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AN - SCOPUS:84977636597

VL - 67

SP - 2565

EP - 2574

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 22

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