Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial

Jan Hofland; Alexandre Ouattara; Jean-Luc Fellahi; Matthias Gruenewald; Jean Hazebroucq; Claude Ecoffey; Pierre Joseph; Matthias Heringlake; Annick Steib; Mark Coburn; Julien Amour; Bertrand Rozec; Inge de Liefde; Patrick Meybohm; Benedikt Preckel; Jean-Luc Hanouz; Luigi Tritapepe; Peter Tonner; Hamina Benhaoua; Jan Patrick Roesner; Berthold Bein; Luc Hanouz; Rob Tenbrinck; Ad J. J. C. Bogers; Bert G. Mik; Alain Coiffic; Jochen Renner; Markus Steinfath; Helga Francksen; Ole Broch; Assad Haneya; Manuella Schaller; Patrick Guinet; Lauren Daviet; Corinne Brianchon; Sebastien Rosier; Jean-Jacques Lehot; Hauke Paarmann; Julika Schön; Thorsten Hanke; Joachym Ettel; Silke Olsson; Stefan Klotz; Amir Samet; Giedrius Laurinenas; Adrien Thibaud; Mircea Cristinar; Olivier Collanges; François Levy; Rolf Rossaint; Ana Stevanovic; Gereon Schaelte; Christian Stoppe; Nora Ait Hamou; Sarah Hariri; Astrid Quessard; Aude Carillion; Hélène Morin; Jacqueline Silleran; David Robert; Anne-Sophie Crouzet; Kai Zacharowski; Christian Reyher; Sonja Iken; Nina C. Weber; Marcus Hollmann; Susanne Eberl; Giovanni Carriero; Daria Collacchi; Alessandra Di Persio; Olivier Fourcade; Stefan Bergt; Angela Alms

doi:https://doi.org/10.1097/ALN.0000000000001873

Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial

Jan Hofland, Alexandre Ouattara, Jean-Luc Fellahi, Matthias Gruenewald, Jean Hazebroucq, Claude Ecoffey, Pierre Joseph, Matthias Heringlake, Annick Steib, Mark Coburn, Julien Amour, Bertrand Rozec, Inge de Liefde, Patrick Meybohm, Benedikt Preckel, Jean-Luc Hanouz, Luigi Tritapepe, Peter Tonner, Hamina Benhaoua, Jan Patrick RoesnerBerthold Bein, Luc Hanouz, Rob Tenbrinck, Ad J. J. C. Bogers, Bert G. Mik, Alain Coiffic, Jochen Renner, Markus Steinfath, Helga Francksen, Ole Broch, Assad Haneya, Manuella Schaller, Patrick Guinet, Lauren Daviet, Corinne Brianchon, Sebastien Rosier, Jean-Jacques Lehot, Hauke Paarmann, Julika Schön, Thorsten Hanke, Joachym Ettel, Silke Olsson, Stefan Klotz, Amir Samet, Giedrius Laurinenas, Adrien Thibaud, Mircea Cristinar, Olivier Collanges, François Levy, Rolf Rossaint, Ana Stevanovic, Gereon Schaelte, Christian Stoppe, Nora Ait Hamou, Sarah Hariri, Astrid Quessard, Aude Carillion, Hélène Morin, Jacqueline Silleran, David Robert, Anne-Sophie Crouzet, Kai Zacharowski, Christian Reyher, Sonja Iken, Nina C. Weber, Marcus Hollmann, Susanne Eberl, Giovanni Carriero, Daria Collacchi, Alessandra Di Persio, Olivier Fourcade, Stefan Bergt, Angela Alms

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

37 Citations (Scopus)

Abstract

Background: Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. Methods: In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. Results: The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. Conclusions: In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible

Original language	English
Pages (from-to)	918-933
Journal	Anesthesiology
Volume	127
Issue number	6
Early online date	2017
DOIs	https://doi.org/10.1097/ALN.0000000000001873
Publication status	Published - 2017

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Hofland, J., Ouattara, A., Fellahi, J.-L., Gruenewald, M., Hazebroucq, J., Ecoffey, C., Joseph, P., Heringlake, M., Steib, A., Coburn, M., Amour, J., Rozec, B., Liefde, I. D., Meybohm, P., Preckel, B., Hanouz, J.-L., Tritapepe, L., Tonner, P., Benhaoua, H., ... Alms, A. (2017). Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial. Anesthesiology, 127(6), 918-933. https://doi.org/10.1097/ALN.0000000000001873

Hofland, Jan ; Ouattara, Alexandre ; Fellahi, Jean-Luc et al. / Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial. In: Anesthesiology. 2017 ; Vol. 127, No. 6. pp. 918-933.

@article{85daf8f7d8634ffdbb35aa43df6c1fbc,

title = "Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial",

abstract = "Background: Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. Methods: In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. Results: The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. Conclusions: In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible",

author = "Jan Hofland and Alexandre Ouattara and Jean-Luc Fellahi and Matthias Gruenewald and Jean Hazebroucq and Claude Ecoffey and Pierre Joseph and Matthias Heringlake and Annick Steib and Mark Coburn and Julien Amour and Bertrand Rozec and Liefde, {Inge de} and Patrick Meybohm and Benedikt Preckel and Jean-Luc Hanouz and Luigi Tritapepe and Peter Tonner and Hamina Benhaoua and Roesner, {Jan Patrick} and Berthold Bein and Luc Hanouz and Rob Tenbrinck and Bogers, {Ad J. J. C.} and Mik, {Bert G.} and Alain Coiffic and Jochen Renner and Markus Steinfath and Helga Francksen and Ole Broch and Assad Haneya and Manuella Schaller and Patrick Guinet and Lauren Daviet and Corinne Brianchon and Sebastien Rosier and Jean-Jacques Lehot and Hauke Paarmann and Julika Sch{\"o}n and Thorsten Hanke and Joachym Ettel and Silke Olsson and Stefan Klotz and Amir Samet and Giedrius Laurinenas and Adrien Thibaud and Mircea Cristinar and Olivier Collanges and Fran{\c c}ois Levy and Rolf Rossaint and Ana Stevanovic and Gereon Schaelte and Christian Stoppe and Hamou, {Nora Ait} and Sarah Hariri and Astrid Quessard and Aude Carillion and H{\'e}l{\`e}ne Morin and Jacqueline Silleran and David Robert and Anne-Sophie Crouzet and Kai Zacharowski and Christian Reyher and Sonja Iken and Weber, {Nina C.} and Marcus Hollmann and Susanne Eberl and Giovanni Carriero and Daria Collacchi and {Di Persio}, Alessandra and Olivier Fourcade and Stefan Bergt and Angela Alms",

year = "2017",

doi = "https://doi.org/10.1097/ALN.0000000000001873",

language = "English",

volume = "127",

pages = "918--933",

journal = "Anesthesiology",

issn = "0003-3022",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

Hofland, J, Ouattara, A, Fellahi, J-L, Gruenewald, M, Hazebroucq, J, Ecoffey, C, Joseph, P, Heringlake, M, Steib, A, Coburn, M, Amour, J, Rozec, B, Liefde, ID, Meybohm, P, Preckel, B, Hanouz, J-L, Tritapepe, L, Tonner, P, Benhaoua, H, Roesner, JP, Bein, B, Hanouz, L, Tenbrinck, R, Bogers, AJJC, Mik, BG, Coiffic, A, Renner, J, Steinfath, M, Francksen, H, Broch, O, Haneya, A, Schaller, M, Guinet, P, Daviet, L, Brianchon, C, Rosier, S, Lehot, J-J, Paarmann, H, Schön, J, Hanke, T, Ettel, J, Olsson, S, Klotz, S, Samet, A, Laurinenas, G, Thibaud, A, Cristinar, M, Collanges, O, Levy, F, Rossaint, R, Stevanovic, A, Schaelte, G, Stoppe, C, Hamou, NA, Hariri, S, Quessard, A, Carillion, A, Morin, H, Silleran, J, Robert, D, Crouzet, A-S, Zacharowski, K, Reyher, C, Iken, S, Weber, NC, Hollmann, M, Eberl, S, Carriero, G, Collacchi, D, Di Persio, A, Fourcade, O, Bergt, S & Alms, A 2017, 'Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial', Anesthesiology, vol. 127, no. 6, pp. 918-933. https://doi.org/10.1097/ALN.0000000000001873

Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial. / Hofland, Jan; Ouattara, Alexandre; Fellahi, Jean-Luc et al.
In: Anesthesiology, Vol. 127, No. 6, 2017, p. 918-933.

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

TY - JOUR

T1 - Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial

AU - Hofland, Jan

AU - Ouattara, Alexandre

AU - Fellahi, Jean-Luc

AU - Gruenewald, Matthias

AU - Hazebroucq, Jean

AU - Ecoffey, Claude

AU - Joseph, Pierre

AU - Heringlake, Matthias

AU - Steib, Annick

AU - Coburn, Mark

AU - Amour, Julien

AU - Rozec, Bertrand

AU - Liefde, Inge de

AU - Meybohm, Patrick

AU - Preckel, Benedikt

AU - Hanouz, Jean-Luc

AU - Tritapepe, Luigi

AU - Tonner, Peter

AU - Benhaoua, Hamina

AU - Roesner, Jan Patrick

AU - Bein, Berthold

AU - Hanouz, Luc

AU - Tenbrinck, Rob

AU - Bogers, Ad J. J. C.

AU - Mik, Bert G.

AU - Coiffic, Alain

AU - Renner, Jochen

AU - Steinfath, Markus

AU - Francksen, Helga

AU - Broch, Ole

AU - Haneya, Assad

AU - Schaller, Manuella

AU - Guinet, Patrick

AU - Daviet, Lauren

AU - Brianchon, Corinne

AU - Rosier, Sebastien

AU - Lehot, Jean-Jacques

AU - Paarmann, Hauke

AU - Schön, Julika

AU - Hanke, Thorsten

AU - Ettel, Joachym

AU - Olsson, Silke

AU - Klotz, Stefan

AU - Samet, Amir

AU - Laurinenas, Giedrius

AU - Thibaud, Adrien

AU - Cristinar, Mircea

AU - Collanges, Olivier

AU - Levy, François

AU - Rossaint, Rolf

AU - Stevanovic, Ana

AU - Schaelte, Gereon

AU - Stoppe, Christian

AU - Hamou, Nora Ait

AU - Hariri, Sarah

AU - Quessard, Astrid

AU - Carillion, Aude

AU - Morin, Hélène

AU - Silleran, Jacqueline

AU - Robert, David

AU - Crouzet, Anne-Sophie

AU - Zacharowski, Kai

AU - Reyher, Christian

AU - Iken, Sonja

AU - Weber, Nina C.

AU - Hollmann, Marcus

AU - Eberl, Susanne

AU - Carriero, Giovanni

AU - Collacchi, Daria

AU - Di Persio, Alessandra

AU - Fourcade, Olivier

AU - Bergt, Stefan

AU - Alms, Angela

PY - 2017

Y1 - 2017

N2 - Background: Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. Methods: In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. Results: The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. Conclusions: In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible

AB - Background: Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models. Methods: In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia. Results: The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns. Conclusions: In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible

U2 - https://doi.org/10.1097/ALN.0000000000001873

DO - https://doi.org/10.1097/ALN.0000000000001873

M3 - Article

C2 - 28872484

SN - 0003-3022

VL - 127

SP - 918

EP - 933

JO - Anesthesiology

JF - Anesthesiology

IS - 6

ER -

Hofland J, Ouattara A, Fellahi JL, Gruenewald M, Hazebroucq J, Ecoffey C et al. Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial. Anesthesiology. 2017;127(6):918-933. Epub 2017. doi: https://doi.org/10.1097/ALN.0000000000001873