Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results
Research output: Contribution to journal › Journal article › Research › peer-review
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.
Original language | English |
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Journal | European Heart Journal |
Volume | 36 |
Issue number | 2 |
Pages (from-to) | 112-9 |
Number of pages | 8 |
ISSN | 0195-668X |
DOIs | |
Publication status | Published - 7 Jan 2015 |
- Angioplasty, Balloon, Area Under Curve, Cardiotonic Agents, Combined Modality Therapy, Coronary Occlusion, Double-Blind Method, Female, Humans, Magnetic Resonance Angiography, Male, Middle Aged, Mitochondrial Membrane Transport Proteins, Myocardial Infarction, Myocardial Reperfusion Injury, Oximes, Prospective Studies, Secosteroids, Treatment Outcome
Research areas
ID: 162598119