Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results
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Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction : MITOCARE study results. / Atar, Dan; Arheden, Håkan; Berdeaux, Alain; Bonnet, Jean-Louis; Carlsson, Marcus; Clemmensen, Peter; Cuvier, Valérie; Danchin, Nicolas; Dubois-Randé, Jean-Luc; Engblom, Henrik; Erlinge, David; Firat, Hüseyin; Halvorsen, Sigrun; Hansen, Henrik Steen; Hauke, Wilfried; Heiberg, Einar; Koul, Sasha; Larsen, Alf-Inge; Le Corvoisier, Philippe; Nordrehaug, Jan Erik; Paganelli, Franck; Pruss, Rebecca M; Rousseau, Hélène; Schaller, Sophie; Sonou, Giles; Tuseth, Vegard; Veys, Julien; Vicaut, Eric; Jensen, Svend Eggert.
In: European Heart Journal, Vol. 36, No. 2, 07.01.2015, p. 112-9.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction
T2 - MITOCARE study results
AU - Atar, Dan
AU - Arheden, Håkan
AU - Berdeaux, Alain
AU - Bonnet, Jean-Louis
AU - Carlsson, Marcus
AU - Clemmensen, Peter
AU - Cuvier, Valérie
AU - Danchin, Nicolas
AU - Dubois-Randé, Jean-Luc
AU - Engblom, Henrik
AU - Erlinge, David
AU - Firat, Hüseyin
AU - Halvorsen, Sigrun
AU - Hansen, Henrik Steen
AU - Hauke, Wilfried
AU - Heiberg, Einar
AU - Koul, Sasha
AU - Larsen, Alf-Inge
AU - Le Corvoisier, Philippe
AU - Nordrehaug, Jan Erik
AU - Paganelli, Franck
AU - Pruss, Rebecca M
AU - Rousseau, Hélène
AU - Schaller, Sophie
AU - Sonou, Giles
AU - Tuseth, Vegard
AU - Veys, Julien
AU - Vicaut, Eric
AU - Jensen, Svend Eggert
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 - 2015/1/7
Y1 - 2015/1/7
N2 - AIM: The MITOCARE study evaluated the efficacy and safety of TRO40303 for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI).METHODS: Patients presenting with STEMI within 6 h of the onset of pain randomly received TRO40303 (n = 83) or placebo (n = 80) via i.v. bolus injection prior to balloon inflation during primary percutaneous coronary intervention in a double-blind manner. The primary endpoint was infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and for troponin I (TnI) over 3 days. Secondary endpoints included measures of infarct size using cardiac magnetic resonance (CMR) and safety outcomes.RESULTS: The median pain-to-balloon time was 180 min for both groups, and the median (mean) door-to-balloon time was 60 (38) min for all sites. Infarct size, as measured by CK and TnI AUCs at 3 days, was not significantly different between treatment groups. There were no significant differences in the CMR-assessed myocardial salvage index (1-infarct size/myocardium at risk) (mean 52 vs. 58% with placebo, P = 0.1000), mean CMR-assessed infarct size (21.9 g vs. 20.0 g, or 17 vs. 15% of LV-mass) or left ventricular ejection fraction (LVEF) (46 vs. 48%), or in the mean 30-day echocardiographic LVEF (51.5 vs. 52.2%) between TRO40303 and placebo. A greater number of adjudicated safety events occurred in the TRO40303 group for unexplained reasons.CONCLUSION: This study in STEMI patients treated with contemporary mechanical revascularization principles did not show any effect of TRO40303 in limiting reperfusion injury of the ischaemic myocardium.
AB - AIM: The MITOCARE study evaluated the efficacy and safety of TRO40303 for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI).METHODS: Patients presenting with STEMI within 6 h of the onset of pain randomly received TRO40303 (n = 83) or placebo (n = 80) via i.v. bolus injection prior to balloon inflation during primary percutaneous coronary intervention in a double-blind manner. The primary endpoint was infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and for troponin I (TnI) over 3 days. Secondary endpoints included measures of infarct size using cardiac magnetic resonance (CMR) and safety outcomes.RESULTS: The median pain-to-balloon time was 180 min for both groups, and the median (mean) door-to-balloon time was 60 (38) min for all sites. Infarct size, as measured by CK and TnI AUCs at 3 days, was not significantly different between treatment groups. There were no significant differences in the CMR-assessed myocardial salvage index (1-infarct size/myocardium at risk) (mean 52 vs. 58% with placebo, P = 0.1000), mean CMR-assessed infarct size (21.9 g vs. 20.0 g, or 17 vs. 15% of LV-mass) or left ventricular ejection fraction (LVEF) (46 vs. 48%), or in the mean 30-day echocardiographic LVEF (51.5 vs. 52.2%) between TRO40303 and placebo. A greater number of adjudicated safety events occurred in the TRO40303 group for unexplained reasons.CONCLUSION: This study in STEMI patients treated with contemporary mechanical revascularization principles did not show any effect of TRO40303 in limiting reperfusion injury of the ischaemic myocardium.
KW - Angioplasty, Balloon
KW - Area Under Curve
KW - Cardiotonic Agents
KW - Combined Modality Therapy
KW - Coronary Occlusion
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Magnetic Resonance Angiography
KW - Male
KW - Middle Aged
KW - Mitochondrial Membrane Transport Proteins
KW - Myocardial Infarction
KW - Myocardial Reperfusion Injury
KW - Oximes
KW - Prospective Studies
KW - Secosteroids
KW - Treatment Outcome
U2 - 10.1093/eurheartj/ehu331
DO - 10.1093/eurheartj/ehu331
M3 - Journal article
C2 - 25179768
VL - 36
SP - 112
EP - 119
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 2
ER -
ID: 162598119