The purpose of this phase 2 study was to test the safety and efficacy of new drug bendavia to prevent mitochondrial dysfunction. It was a randomized, double-blind, placebo-controlled study enrolled 58 patients in the bendavia branch and 60 in the control branch. All patients were undergoing anterior ST segment elevation myocardial infarction with TIMI 0/1 of the anterior descending artery in the middle and proximal segments and within 4 hours of symptom onset.
The primary endpoint was the area under the curve of CK Mb at 6 hours that was similar to the group receiving placebo. There were no differences in secondary end points of troponin, ST resolution, ejection fraction, death, or re-hospitalization for heart failure.
Conclusion:
Bendavia to prevent mitochondrial dysfunction and therefore reperfusion injury does not reduce infarct size compared with placebo in patients undergoing an anterior infarction due to occlusion of the proximal or middle segment of the left anterior descending artery.
C. Michael Gibson
2015-03-17
Original title: Bendavia™ on Reperfusion Injury in Patients Treated With Standard Therapy Including Primary PCI and Stenting For STEMI.