May 10th, 2011

Trial REVEALs No Benefit and Some Concerns with Erythropoietin After Primary PCI

Erythropoietin alfa failed to reduce infarct size and was associated with more cardiovascular events when given after successful PCI in STEMI patients, according to results from the REVEAL (Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction) trial published in JAMA.

In the trial, which included a dose-escalation safety phase and a single-dose efficacy phase, 222 patients at 28 sites in the U.S. were randomized to epoetin alfa or placebo following successful reperfusion. Overall, there was no difference between the groups in infarct size as assessed by MRI. However, among patients 70 years of age or older (a prespecified subgroup), infarct size in the first week was significantly greater with treatment than with placebo: 19.9% versus 11.7% LV mass (p=0.03).

During the safety phase of the study, the composite endpoint of death, MI, stroke, or stent thrombosis occurred in 5 of the 125 patients in the treatment group compared with none of the 97 patients in the placebo group (p=0.04).

In an accompanying editorial, Deepak Bhatt writes that the results “raise further questions about the safety of epoetin alfa in the context of acute MI.” He continues:

“The totality of evidence strongly suggests that this class of medication has cardiovascular risk, most likely to manifest in higher-risk individuals. Until compelling data become available to support routine use of these agents in patients with anemia, it would be prudent to minimize their use, especially for patients at high risk for cardiovascular disease or with an acute ischemic syndrome.”

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