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Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients

Standard

Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients. / Thyregod, Hans Gustav Hørsted; Ihlemann, Nikolaj; Jørgensen, Troels Højsgaard; Nissen, Henrik; Kjeldsen, Bo Juel; Petursson, Petur; Chang, Yanping; Franzen, Olaf Walter; Engstrøm, Thomas; Clemmensen, Peter; Hansen, Peter Bo; Andersen, Lars Willy; Steinbrüchel, Daniel Andreas; Olsen, Peter Skov; Søndergaard, Lars.

In: CIRCULATION, Vol. 139, No. 24, 2019, p. 2714-2723.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

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

APA

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., Steinbrüchel, D. A., Olsen, P. S., & Søndergaard, L. (2019). Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients. CIRCULATION, 139(24), 2714-2723. https://doi.org/10.1161/CIRCULATIONAHA.118.036606

Vancouver

Thyregod HGH, Ihlemann N, Jørgensen TH, Nissen H, Kjeldsen BJ, Petursson P et al. Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients. CIRCULATION. 2019;139(24):2714-2723. https://doi.org/10.1161/CIRCULATIONAHA.118.036606

Bibtex

@article{57f87855299c41e897e01f984e501595,
title = "Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients",
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 cm2 vs. 1.2 cm2, 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.",
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 Steinbr{\"u}chel, {Daniel Andreas} and Olsen, {Peter Skov} and Lars S{\o}ndergaard",
year = "2019",
doi = "10.1161/CIRCULATIONAHA.118.036606",
language = "English",
volume = "139",
pages = "2714--2723",
journal = "CIRCULATION",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins",
number = "24",

}

RIS

TY - JOUR

T1 - Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients

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 - Steinbrüchel, Daniel Andreas

AU - Olsen, Peter Skov

AU - Søndergaard, Lars

PY - 2019

Y1 - 2019

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 cm2 vs. 1.2 cm2, 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 cm2 vs. 1.2 cm2, 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.

U2 - 10.1161/CIRCULATIONAHA.118.036606

DO - 10.1161/CIRCULATIONAHA.118.036606

M3 - SCORING: Journal article

C2 - 30704298

VL - 139

SP - 2714

EP - 2723

JO - CIRCULATION

JF - CIRCULATION

SN - 0009-7322

IS - 24

ER -