Evidence-Based Diabetes Management May 2015
New Therapeutic Approach Did Not Reduce Scarring After Angioplasty
A drug designed to reduce tissue damage to the heart by targeting mitochondria in the cells did not work as researchers hoped for in a study presented March 15, 2015, at the 64th Annual Scientific Session of the American College of Cardiology, held in San Diego, California.
Patients who received Bendavia before undergoing a procedure to clear blocked arteries after a heart attack either angioplasty or stent showed no significant reduction in scarring com-pared with patients receiving placebo, according to results of the EMBRACE-STEMI study. Results were presented at a late-breaking session by C. Michael Gibson, MD, professor of medicine at Harvard and the study’s lead author.
Among patients with STEMI (ST elevation myocardial infarction), injuries result when blood returns to the area that has been temporarily deprived of oxygen. The process causes the heart to pump blood even harder, which can result in further heart injury. The study drug, Bendavia, is a cell-permeable peptide designed to target cardiolipin, which is found in the inner mitochondrial membrane, to promote improved mitochondrial response during the process and limit the damaging effects of oxygen’s sudden return to the tissue.
The study involved 297 first-time STEMI patients who were randomized to receive the drug (0.05 mg/kg/hr) or blinded placebo more than 15 minutes before a procedure to clear arteries. Pa-tients receiving Bendavia showed a 10% reduction in scarring during the first 3 days after surgery, as measured by the levels of an enzyme called creatinine kinase-MB, the study’s primary end point. However, this difference was not statistically significant. The results also suggested a trend toward improved heart pumping function during the 8 hours after patients received the drug, but that trend also did not reach statis-tical significance.
“Our study found that the drug did not prevent irreversible injury to the heart,” Gibson said. However, the apparent sign that the drug reduced new-onset heart failure in the first hours after infusion may be an indication that Bendavia im-proves the heart pumping function and will be the subject of additional study, he said. The study’s chief limitation was the small number of patients.
Gibson CM, Merkely B, Chakrabarti A, et al. The EMBRACE-STEMI study: a phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and efficacy of intravenous Bendavia on reperfusion injury in patients treated with standard therapy including primary PCI and stenting for ST-segment elevation myocardial infarction. Presented at the 64th Annual Scientific Sessions of the American College of Cardiology; March 15, 2015; San Diego, CA.