Comprehensive analysis of mortality among patients undergoing TAVR: Results of the PARTNER trial

Lars G. Svensson, Eugene H. Blackstone, Jeevanantham Rajeswaran, Nicholas Brozzi, Martin B. Leon, Craig R. Smith, Michael Mack, D. Craig Miller, Jeffrey W. Moses, E. Murat Tuzcu, John G. Webb, Samir Kapadia, Gregory P. Fontana, Raj R. Makkar, David L. Brown, Peter C. Block, Robert A. Guyton, Vinod H. Thourani, Augusto D. Pichard, Joseph E. BavariaHoward C. Herrmann, Mathew R. Williams, Vasilis Babaliaros, Philippe Genereux, Jodi J. Akin

Research output: Contribution to journalArticle

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Abstract

Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Original languageEnglish (US)
Pages (from-to)158-168
Number of pages11
JournalJournal of the American College of Cardiology
Volume64
Issue number2
DOIs
StatePublished - Jul 15 2014
Externally publishedYes

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Aortic Valve
Mortality
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Therapeutics
Standard of Care
Random Allocation
Surgical Instruments

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Svensson, L. G., Blackstone, E. H., Rajeswaran, J., Brozzi, N., Leon, M. B., Smith, C. R., ... Akin, J. J. (2014). Comprehensive analysis of mortality among patients undergoing TAVR: Results of the PARTNER trial. Journal of the American College of Cardiology, 64(2), 158-168. https://doi.org/10.1016/j.jacc.2013.08.1666
Svensson, Lars G. ; Blackstone, Eugene H. ; Rajeswaran, Jeevanantham ; Brozzi, Nicholas ; Leon, Martin B. ; Smith, Craig R. ; Mack, Michael ; Miller, D. Craig ; Moses, Jeffrey W. ; Tuzcu, E. Murat ; Webb, John G. ; Kapadia, Samir ; Fontana, Gregory P. ; Makkar, Raj R. ; Brown, David L. ; Block, Peter C. ; Guyton, Robert A. ; Thourani, Vinod H. ; Pichard, Augusto D. ; Bavaria, Joseph E. ; Herrmann, Howard C. ; Williams, Mathew R. ; Babaliaros, Vasilis ; Genereux, Philippe ; Akin, Jodi J. / Comprehensive analysis of mortality among patients undergoing TAVR : Results of the PARTNER trial. In: Journal of the American College of Cardiology. 2014 ; Vol. 64, No. 2. pp. 158-168.
@article{3b994e15d3f44a4e8f6c24eb92f8ab5c,
title = "Comprehensive analysis of mortality among patients undergoing TAVR: Results of the PARTNER trial",
abstract = "Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37{\%}, 43{\%}, and 20{\%}, respectively, versus 22{\%}, 41{\%}, and 37{\%}, respectively, for TA-TAVR and 33{\%}, 43{\%}, and 24{\%}, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60{\%} per year; TF-TAVR reduced risk to 20{\%} per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).",
author = "Svensson, {Lars G.} and Blackstone, {Eugene H.} and Jeevanantham Rajeswaran and Nicholas Brozzi and Leon, {Martin B.} and Smith, {Craig R.} and Michael Mack and Miller, {D. Craig} and Moses, {Jeffrey W.} and Tuzcu, {E. Murat} and Webb, {John G.} and Samir Kapadia and Fontana, {Gregory P.} and Makkar, {Raj R.} and Brown, {David L.} and Block, {Peter C.} and Guyton, {Robert A.} and Thourani, {Vinod H.} and Pichard, {Augusto D.} and Bavaria, {Joseph E.} and Herrmann, {Howard C.} and Williams, {Mathew R.} and Vasilis Babaliaros and Philippe Genereux and Akin, {Jodi J.}",
year = "2014",
month = "7",
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doi = "10.1016/j.jacc.2013.08.1666",
language = "English (US)",
volume = "64",
pages = "158--168",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
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Svensson, LG, Blackstone, EH, Rajeswaran, J, Brozzi, N, Leon, MB, Smith, CR, Mack, M, Miller, DC, Moses, JW, Tuzcu, EM, Webb, JG, Kapadia, S, Fontana, GP, Makkar, RR, Brown, DL, Block, PC, Guyton, RA, Thourani, VH, Pichard, AD, Bavaria, JE, Herrmann, HC, Williams, MR, Babaliaros, V, Genereux, P & Akin, JJ 2014, 'Comprehensive analysis of mortality among patients undergoing TAVR: Results of the PARTNER trial', Journal of the American College of Cardiology, vol. 64, no. 2, pp. 158-168. https://doi.org/10.1016/j.jacc.2013.08.1666

Comprehensive analysis of mortality among patients undergoing TAVR : Results of the PARTNER trial. / Svensson, Lars G.; Blackstone, Eugene H.; Rajeswaran, Jeevanantham; Brozzi, Nicholas; Leon, Martin B.; Smith, Craig R.; Mack, Michael; Miller, D. Craig; Moses, Jeffrey W.; Tuzcu, E. Murat; Webb, John G.; Kapadia, Samir; Fontana, Gregory P.; Makkar, Raj R.; Brown, David L.; Block, Peter C.; Guyton, Robert A.; Thourani, Vinod H.; Pichard, Augusto D.; Bavaria, Joseph E.; Herrmann, Howard C.; Williams, Mathew R.; Babaliaros, Vasilis; Genereux, Philippe; Akin, Jodi J.

In: Journal of the American College of Cardiology, Vol. 64, No. 2, 15.07.2014, p. 158-168.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comprehensive analysis of mortality among patients undergoing TAVR

T2 - Results of the PARTNER trial

AU - Svensson, Lars G.

AU - Blackstone, Eugene H.

AU - Rajeswaran, Jeevanantham

AU - Brozzi, Nicholas

AU - Leon, Martin B.

AU - Smith, Craig R.

AU - Mack, Michael

AU - Miller, D. Craig

AU - Moses, Jeffrey W.

AU - Tuzcu, E. Murat

AU - Webb, John G.

AU - Kapadia, Samir

AU - Fontana, Gregory P.

AU - Makkar, Raj R.

AU - Brown, David L.

AU - Block, Peter C.

AU - Guyton, Robert A.

AU - Thourani, Vinod H.

AU - Pichard, Augusto D.

AU - Bavaria, Joseph E.

AU - Herrmann, Howard C.

AU - Williams, Mathew R.

AU - Babaliaros, Vasilis

AU - Genereux, Philippe

AU - Akin, Jodi J.

PY - 2014/7/15

Y1 - 2014/7/15

N2 - Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

AB - Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

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