Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study
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Treatment of aortic stenosis with a self-expanding transcatheter valve : the International Multi-centre ADVANCE Study. / Linke, Axel; Wenaweser, Peter; Gerckens, Ulrich; Tamburino, Corrado; Bosmans, Johan; Bleiziffer, Sabine; Blackman, Daniel; Schäfer, Ulrich; Müller, Ralf; Sievert, Horst; Søndergaard, Lars; Klugmann, Silvio; Hoffmann, Rainer; Tchétché, Didier; Colombo, Antonio; Legrand, Victor M; Bedogni, Francesco; lePrince, Pascal; Schuler, Gerhard; Mazzitelli, Domenico; Eftychiou, Christos; Frerker, Christian; Boekstegers, Peter; Windecker, Stephan; Mohr, Friedrich-Wilhelm; Woitek, Felix; Lange, Rüdiger; Bauernschmitt, Robert; Brecker, Stephen; ADVANCE study Investigators.
In: European Heart Journal, Vol. 35, No. 38, 2014, p. 2672-2684.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Treatment of aortic stenosis with a self-expanding transcatheter valve
T2 - the International Multi-centre ADVANCE Study
AU - Linke, Axel
AU - Wenaweser, Peter
AU - Gerckens, Ulrich
AU - Tamburino, Corrado
AU - Bosmans, Johan
AU - Bleiziffer, Sabine
AU - Blackman, Daniel
AU - Schäfer, Ulrich
AU - Müller, Ralf
AU - Sievert, Horst
AU - Søndergaard, Lars
AU - Klugmann, Silvio
AU - Hoffmann, Rainer
AU - Tchétché, Didier
AU - Colombo, Antonio
AU - Legrand, Victor M
AU - Bedogni, Francesco
AU - lePrince, Pascal
AU - Schuler, Gerhard
AU - Mazzitelli, Domenico
AU - Eftychiou, Christos
AU - Frerker, Christian
AU - Boekstegers, Peter
AU - Windecker, Stephan
AU - Mohr, Friedrich-Wilhelm
AU - Woitek, Felix
AU - Lange, Rüdiger
AU - Bauernschmitt, Robert
AU - Brecker, Stephen
AU - ADVANCE study Investigators
N1 - Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.
PY - 2014
Y1 - 2014
N2 - AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres.METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively.CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.
AB - AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres.METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively.CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.
U2 - 10.1093/eurheartj/ehu162
DO - 10.1093/eurheartj/ehu162
M3 - Journal article
C2 - 24682842
VL - 35
SP - 2672
EP - 2684
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 38
ER -
ID: 138618170