The final clinical analysis of the REPAIR-AMI trial is disappointing to me. The authors state that the bone-marrow-derived progenitor cells (BMC) lead to an improvement of function in the infarcted zone, especially in patients with depressed left ventricular function at baseline,1 increasing the ejection fraction by 5% compared with placebo. In the recent article, they concluded that BMC remained a significant predictor of favourable clinical outcome.2 Thus, it seems rational that the beneficial effect of stem cells may decrease the incidence of myocardial infarction, heart failure, or cardiovascular death, or the combined events. However, this was not the case. Cardiovascular death and re-hospitalization for heart failure were not different in the two groups. In the final 1 year follow-up, there was only a trend towards a lower rate of infarction in the target vessel region. However, the authors have summarized all infarctions, namely infarctions in the target vessel and in other vessels, in Table 2. More myocardial infarctions in other vessels are not likely to be related to BMC application in my view and therefore have to be listed separately. More infarctions in other myocardial regions in the placebo group correspond to more coronary dilatations in this group. Therefore, the only clinical difference results from myocardial infarctions and coronary dilatations in coronary vessels, unrelated to the targeted vessel in the trial. It is difficult to understand that stem cells injected into one coronary artery do decrease acute coronary syndromes in other coronary arteries. Analysis of combined endpoints have their own limitations and advantages. Analysis of single clinical endpoints does have more clinical relevance and may shed a clearer light into the fascinating research on stem cells.
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K J Osterziel (2006) studied this question.
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