Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk

Hans Gustav Hørsted Thyregod; Nikolaj Ihlemann; Troels Højsgaard Jørgensen; Henrik Nissen; Bo Juel Kjeldsen; Petur Petursson; Yanping Chang; Olaf Walter Franzen; Thomas Engstrøm; Peter Clemmensen; Peter Bo Hansen; Lars Willy Andersen; Daniel Andreas Steinbruüchel; Peter Skov Olsen; Lars Søndergaard

doi:10.1161/CIRCULATIONAHA.118.036606

Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk

Hans Gustav Hørsted Thyregod^*
, Nikolaj Ihlemann
, Troels Højsgaard Jørgensen
, Henrik Nissen
, Bo Juel Kjeldsen
, Petur Petursson
, Yanping Chang
, Olaf Walter Franzen
, Thomas Engstrøm
, Peter Clemmensen
, Peter Bo Hansen
, Lars Willy Andersen
, Daniel Andreas Steinbruüchel
, Peter Skov Olsen
, Lars Søndergaard

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

Abstract

BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.

METHODS: Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.

RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% vs. 36.3%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm 2 vs. 1.2 cm 2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% vs. 0.0%, p<0.001) and a new pacemaker (43.7% vs. 8.7%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes.

CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.

CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

Original language	English
Pages (from-to)	2714-2723
Number of pages	10
Journal	Circulation
Volume	139
Issue number	24
Early online date	1 Feb 2019
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.118.036606
Publication status	Published - 11 Jun 2019

Funding

This work was supported by the Danish Heart Foundation (grant numbers: 09-10-AR76-A2733-25400, 12-04-R90-A3879-22733, and 13-04-R94-A4473-22762). Dr Ihlemann has received speaker fees from Medtronic. Dr Kjeldsen is a proctor for Edwards Lifesciences. Y. Chang is an employee and shareholder of Medtron-ic. Dr Franzen has received research contracts from Abbott Vascular and St. Jude Medical, and consulting fees from Edwards Lifesciences. Dr Engstrøm has received fees from St. Jude Medical, Bayer, Boston Scientific, and AstraZen-eca. Dr Clemmensen has received research contracts and speaker fees from Medtronic, Eli-Lilly, Daichii-Sankyo, AstraZeneca, Bayer, Boehringer-Ingelheim, Sanofi, Pfizer, and BMS. Dr Hansen has received speaker fees from Medtronic. Dr Steinbrü eceived research contracts from Medtronic and St. Jude Medical. Dr Olsen has received research contracts from Medtronic, St. Jude Medical, and Abbott Vascular. Dr Søndergaard has received consultant fees and institutional research grants from Medtronic, St. Jude Medical, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Symetis. The other authors report no conflicts.

Keywords

Aortic valve stenosis
Follow-up studies
Surgical aortic valve replacement
Surgical low-risk
Transcatheter aortic valve implantation
transcatheter aortic valve implantation
follow-up studies
surgical low-risk
aortic valve stenosis
surgical aortic valve replacement

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Thyregod, H. G. H., Ihlemann, N., Jørgensen, T. H., Nissen, H., Kjeldsen, B. J., Petursson, P., Chang, Y., Franzen, O. W., Engstrøm, T., Clemmensen, P., Hansen, P. B., Andersen, L. W., Steinbruüchel, D. A., Olsen, P. S., & Søndergaard, L. (2019). Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk. Circulation, 139(24), 2714-2723. https://doi.org/10.1161/CIRCULATIONAHA.118.036606

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title = "Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk",

abstract = "BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.METHODS: Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0\%±1.7\%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0\% vs. 36.3\%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm 2 vs. 1.2 cm 2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2\% vs. 0.0\%, p<0.001) and a new pacemaker (43.7\% vs. 8.7\%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.",

keywords = "Aortic valve stenosis, Follow-up studies, Surgical aortic valve replacement, Surgical low-risk, Transcatheter aortic valve implantation, transcatheter aortic valve implantation, follow-up studies, surgical low-risk, aortic valve stenosis, surgical aortic valve replacement",

author = "Thyregod, \{Hans Gustav H{\o}rsted\} and Nikolaj Ihlemann and J{\o}rgensen, \{Troels H{\o}jsgaard\} and Henrik Nissen and Kjeldsen, \{Bo Juel\} and Petur Petursson and Yanping Chang and Franzen, \{Olaf Walter\} and Thomas Engstr{\o}m and Peter Clemmensen and Hansen, \{Peter Bo\} and Andersen, \{Lars Willy\} and Steinbru{\"u}chel, \{Daniel Andreas\} and Olsen, \{Peter Skov\} and Lars S{\o}ndergaard",

year = "2019",

month = jun,

day = "11",

doi = "10.1161/CIRCULATIONAHA.118.036606",

language = "English",

volume = "139",

pages = "2714--2723",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "24",

}

Thyregod, HGH, Ihlemann, N, Jørgensen, TH, Nissen, H, Kjeldsen, BJ, Petursson, P, Chang, Y, Franzen, OW, Engstrøm, T, Clemmensen, P, Hansen, PB, Andersen, LW, Steinbruüchel, DA, Olsen, PS & Søndergaard, L 2019, 'Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk', Circulation, vol. 139, no. 24, pp. 2714-2723. https://doi.org/10.1161/CIRCULATIONAHA.118.036606

TY - JOUR

T1 - Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk

AU - Thyregod, Hans Gustav Hørsted

AU - Ihlemann, Nikolaj

AU - Jørgensen, Troels Højsgaard

AU - Nissen, Henrik

AU - Kjeldsen, Bo Juel

AU - Petursson, Petur

AU - Chang, Yanping

AU - Franzen, Olaf Walter

AU - Engstrøm, Thomas

AU - Clemmensen, Peter

AU - Hansen, Peter Bo

AU - Andersen, Lars Willy

AU - Steinbruüchel, Daniel Andreas

AU - Olsen, Peter Skov

AU - Søndergaard, Lars

PY - 2019/6/11

Y1 - 2019/6/11

N2 - BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.METHODS: Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% vs. 36.3%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm 2 vs. 1.2 cm 2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% vs. 0.0%, p<0.001) and a new pacemaker (43.7% vs. 8.7%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

AB - BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) was designed to compare transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients 70 years or older with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.METHODS: Patients were enrolled at three Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bio-prostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.RESULTS: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean STS-PROM score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% vs. 36.3%, log-rank test p=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm 2 vs. 1.2 cm 2, p<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg vs. 13.7 mm Hg, p<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% vs. 0.0%, p<0.001) and a new pacemaker (43.7% vs. 8.7%, p<0.001). Four patients had prosthetic re-intervention and no difference was found for functional outcomes. CONCLUSIONS: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

KW - Aortic valve stenosis

KW - Follow-up studies

KW - Surgical aortic valve replacement

KW - Surgical low-risk

KW - Transcatheter aortic valve implantation

KW - transcatheter aortic valve implantation

KW - follow-up studies

KW - surgical low-risk

KW - aortic valve stenosis

KW - surgical aortic valve replacement

UR - https://www.scopus.com/pages/publications/85071972277

U2 - 10.1161/CIRCULATIONAHA.118.036606

DO - 10.1161/CIRCULATIONAHA.118.036606

M3 - Article

C2 - 30704298

AN - SCOPUS:85071972277

SN - 0009-7322

VL - 139

SP - 2714

EP - 2723

JO - Circulation

JF - Circulation

IS - 24

ER -

Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk

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