Little to REVEAL: Adding EPO After PCI Does Not Reduce Infarct Size

November 17, 2010

November 17, 2010 (Chicago, Illinois) — A study examining the potential role for erythropoietin (EPO) has shown that an intravenous injection of EPO following successful primary or rescue PCI did not reduce infarct size in ST-segment-elevation MI (STEMI) patients.

"I think we can look at this one of two ways," study investigator Dr Sunil Rao (Duke Clinical Research Institute, Durham, NC) told heartwire . "The first way is to say that this is another trial with EPO in STEMI that failed to show a benefit, and we should probably stop studying it. The other way to look at it is to say, okay, we've done the experiment, we've studied it in a certain way, and we have our result. But are there scientific questions that we can ask to potentially come up with the next study? I think that's the right thing to do."

Presenting the results of REVEAL at the American Heart Association (AHA) 2010 Scientific Sessions in Chicago, IL, Rao said that STEMI survivors are at risk for infarct expansion, left ventricular remodeling, and heart failure, and researchers need to continue to work toward treatments to reduce the impact of these diseases.

With that goal in mind, the researchers randomized patients--all of whom underwent successful primary/rescue PCI within eight hours of symptom onset--to either EPO or matching saline placebo. In total, 68 patients were treated with 60 000 units of EPO and compared with 70 patients randomized to placebo.

Compared with placebo, the administration of EPO following successful primary or rescue PCI did not reduce infarct size, as assessed by MRI at two to six days and at 12 weeks. Similarly, there was no improvement in early or late measurements of left ventricular remodeling. In fact, investigators observed a trend toward harm among older patients, with a larger infarct size among those >70 years of age treated with EPO.

Overall, Rao said the results were surprising, but he is not convinced that researchers should give up on EPO in the STEMI setting. "Once the alarm bells have been activated for a STEMI, the goal is to get the artery open," Rao told heartwire . "Any myocardial-protective strategy has to fit into that paradigm."

Recently, Dr Adriaan Voors (University Medical Center Groningen, the Netherlands), lead investigator of the HEBE III trial, announced that a single dose of EPO following successful PCI failed to improve left ventricular ejection fraction in acute-MI patients who received the investigational treatment. The older REVIVAL-3 trial also failed show an improvement in left ventricular function or reduce infarct size in STEMI patients treated with primary PCI.

Rao reports research funding from Portola Pharmaceuticals, Cordis, and Ikaria and consulting for Sanofi-Aventis, Bristol-Myers Squibb, AstraZeneca, Daiichi Sankyo, Lilly, and Terumo.


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