Abstract

To the Editor: During the randomized start phase of the study by Walter et al,1 there was 1 death and 3 major amputations among the 19 patients who got cell injections and 1 major amputation among the 21 patients in the placebo group. The 3-month combined mortality and major amputation rate for the 3 cell injection groups was 10 of 51 versus 1 of 21 in the placebo group. The differences would have been significant if the same rates had been observed in only twice as many patients. Because previous intracoronary cell injection studies had not shown consistently positive effects,2 there was …

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