Five-Year Clinical and Echocardiographic Outcomes from the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk
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Five-Year Clinical and Echocardiographic Outcomes from the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk. / 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; Steinbruüchel, Daniel Andreas; Olsen, Peter Skov; Søndergaard, Lars.
I: Circulation, Bind 139, Nr. 24, 2019, s. 2714-2723.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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
Y1 - 2019
N2 - Background: The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. Methods: Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (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 Society of Thoracic Surgeons Predicted Risk of Mortality 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% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 versus 1.2 cm2, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention 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: Https://clinicaltrials.gov. Unique identifier: NCT01057173.
AB - Background: The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. Methods: Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (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 Society of Thoracic Surgeons Predicted Risk of Mortality 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% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 versus 1.2 cm2, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention 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: Https://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
U2 - 10.1161/CIRCULATIONAHA.118.036606
DO - 10.1161/CIRCULATIONAHA.118.036606
M3 - Journal article
C2 - 30704298
AN - SCOPUS:85071972277
VL - 139
SP - 2714
EP - 2723
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 24
ER -
ID: 236662523