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European Heart Journal Advance Access published online on October 9, 2006
European Heart Journal, doi:10.1093/eurheartj/ehl304
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received December 23, 2005
Revised August 31, 2006
Accepted September 21, 2006

Clinical research

Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial Infarction: the randomized multicentre CASTEMI study

Frits W. Bär 1 *, Dan Tzivoni 2, Maurits T. Dirksen 3, Antonio Fernández-Ortiz 4, Guy R. Heyndrickx 5, Johannes Brachmann 6, Johan H.C. Reiber 7, Neelima Avasthy 8, Jun Tatsuno 9, Martin Davies 8, Mark G. Hibberd 10, and Mitchell W. Krucoff 11, on behalf of the CASTEMI Study Group

1 Department of Cardiology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands
2 Shaare Zedek Medical Centre, Jerusalem, Israel
3 Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
4 Hospital Clinico San Carlos, Madrid, Spain
5 Onze Lieve Vrouwziekenhuis, Aalst, Belgium
6 Medizinischen Klinik, Coburg, Germany
7 Heart Core, Leiden, The Netherlands
8 Mitsubishi Pharma Europe Ltd, London, UK
9 Mitsubishi Pharma Corporation, Tokyo, Japan
10 CardioCorp, Lexington, MA, USA
11 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

* To whom correspondence should be addressed.
Frits W. Bär, E-mail: f.baer{at}cardio.azm.nl


  Abstract

Aims To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Methods and results STEMI patients (n = 387) with ≥10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted.

Conclusion This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.

Keywords: Reperfusion damage; Acute myocardial infarction; Primary PCI.
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