Calderet in ST Elevation Myocardial Infarction - CASTEMI

May 07, 2004
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Date Presented:
01/01/2004
Date Published:
01/01/2006
Date Updated:
05/07/2004
Original Posted Date:
05/07/2004
References

Description:

The goal of the trial was to evaluate the efficacy of treatment with caldaret, a novel compound inhibiting calcium overload, compared with placebo in patients with large ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Enrolled: 387
Mean Follow Up: 30 days
Mean Patient Age: Mean age 60 years
Female: 20

Patient Populations:

Large STEMI (sum ST elevation ≥10 mm), chest pain onset to randomization <6 hours, and planned primary PCI

Exclusions:

Thrombolytic therapy, prior MI overlapping the current infarct location, cardiogenic shock, sever chronic heart failure, known renal dysfunction, cerebrovascular event within the past 6 months; current therapy with catecholamines, phosphodiesterase inhibitors, or calcium sensitizers.

Primary Endpoints:

Infarct size at day 7 by SPECT in patients with pre-PCI TIMI grade 0 or 1 flow (n=247)

Secondary Endpoints:

Infarct size at day 30, cardiac serum markers AUC, LVESV, EDV, and LVEF

Drug/Procedures Used:

Patients were randomized to either caldaret 57.5 mg (low-dose), 172.5 mg (high-dose), or placebo infusions for 48 hours. Primary PCI was performed, during which time a rapid infusion of the caldaret or placebo was given for 45 minutes. A slow infusion of study drug was given for a total of 48 hours of study drug treatment. SPECT imaging was performed at seven days.

Principal Findings:

Stents were used in 95% of the patients and glycoprotein IIb/IIIa inhibitors were used in 80%. Among patients with pre-PCI TIMI 0/1, there was no difference between the treatment and placebo groups in infarct size by SPECT at day 7 (mean 20.0%, 19.5%, and 22.1% for placebo, low dose and high dose, respectively) or day 30 (16.1%, 16.8%, 19.5%, respectively, p=NS). There was no difference in median time to stable ST-segment resolution (1.4 hours for placebo, 1.6 hours for low dose, 1.3 for high-dose). Mortality by 30 days was 2.4%. Congestive heart failure by 30 days occurred in 15.7% of the placebo group compared with 21.6% of the low dose group and 20.0% of the high dose group. The composite clinical endpoint of death, reinfarction, revascularization, or CHF occurred in 22.5% of the placebo group, 31.8% of the low dose group and 21.4% of the high dose group.

Interpretation:

Among patients with ST elevation MI undergoing primary PCI, treatment with the novel calcium overload inhibitor caldaret was not associated with a difference in infarct size compared with placebo.

The present trial is the first study to evaluate caldaret in this population.

References:

Ba¨r FW, et al. 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. Eur Heart J 2006;27:2516-2523.

Presented by Dr. Dan Tzivoni at the American College of Cardiology Annual Scientific Session, March 2004.

Keywords: Coronary Artery Disease, Myocardial Infarction, Benzenesulfonates, Chest Pain, Tomography, Emission-Computed, Single-Photon, Heart Failure, Piperazines, Stents, Percutaneous Coronary Intervention, Calcium


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