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

Dan Atar, Håkan Arheden, Alain Berdeaux, Jean-Louis Bonnet, Marcus Carlsson, Peter Clemmensen, Valérie Cuvier, Nicolas Danchin, Jean-Luc Dubois-Randé, Henrik Engblom, David Erlinge, Hüseyin Firat, Sigrun Halvorsen, Henrik Steen Hansen, Wilfried Hauke, Einar Heiberg, Sasha Koul, Alf-Inge Larsen, Philippe Le Corvoisier, Jan Erik NordrehaugFranck Paganelli, Rebecca M Pruss, Hélène Rousseau, Sophie Schaller, Giles Sonou, Vegard Tuseth, Julien Veys, Eric Vicaut, Svend Eggert Jensen

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Abstrakt

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.

OriginalsprogEngelsk
TidsskriftEuropean Heart Journal
Vol/bind36
Udgave nummer2
Sider (fra-til)112-119
Antal sider8
ISSN0195-668X
DOI
StatusUdgivet - 7. jan. 2015

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