Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results - PubMed (original) (raw)

Clinical Trial

. 2015 Jan 7;36(2):112-9.

doi: 10.1093/eurheartj/ehu331. Epub 2014 Sep 1.

Håkan Arheden 2, Alain Berdeaux 3, Jean-Louis Bonnet 4, Marcus Carlsson 2, Peter Clemmensen 5, Valérie Cuvier 6, Nicolas Danchin 7, Jean-Luc Dubois-Randé 8, Henrik Engblom 2, David Erlinge 9, Hüseyin Firat 10, Sigrun Halvorsen 11, Henrik Steen Hansen 12, Wilfried Hauke 6, Einar Heiberg 2, Sasha Koul 9, Alf-Inge Larsen 13, Philippe Le Corvoisier 8, Jan Erik Nordrehaug 14, Franck Paganelli 15, Rebecca M Pruss 6, Hélène Rousseau 16, Sophie Schaller 6, Giles Sonou 17, Vegard Tuseth 14, Julien Veys 6, Eric Vicaut 16, Svend Eggert Jensen 18

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Clinical Trial

Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results

Dan Atar et al. Eur Heart J. 2015.

Abstract

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.

Keywords: CMR; Cardiac reperfusion injury; Infarct size; Mitochondria; Primary PCI; STEMI.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

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