EMBRACE STEMI | Clinical Trial - EMBRACE STEMI

Description:

The goal of this phase 2 trial was to assess the safety and efficacy of bendavia, a novel agent that targets mitochondrial dysfunction.

Contribution to the Literature: The EMBRACE STEMI study suggests that bendavia does not affect infarct size in patients with anterior STEMI due to proximal/mid occlusion of the LAD compared with placebo.


Study Design

  • Randomized
  • Double-blind
  • Placebo-controlled

Patients were randomized in a 1:1 fashion to either bendavia 0.05 mg/kg/hr (n = 58) or placebo (n = 60).

Patient population:

  • Total number of enrollees: 118
  • Duration of follow-up: 30 days
  • Mean patient age: 60 years
  • Percentage female: 28%
  • Percentage diabetics: 10%
  • Ischemia time: 151 minutes
  • Left anterior descending artery (LAD) area at risk: 85%
  • Aspiration thrombectomy prior to percutaneous coronary intervention (PCI): 68%

Inclusion criteria:

  • First anterior ST-segment elevation myocardial infarction (STEMI) with TIMI 0/1 flow in the proximal or mid LAD
  • Anticipated symptoms to PCI <4 hours
  • Shock

Principal Findings:

The primary outcome, area under the curve (AUC) creatine kinase-myocardial band (CK-MB) at 6 hours, was similar in the bendavia and placebo arms: 217.4 vs. 266.6 (p > 0.05).

Secondary outcomes:

  • AUC troponin I: 144.6 vs. 139.3, p > 0.05
  • Complete ST-segment resolution immediately post-PCI: 14.6% vs. 22%, p > 0.05
  • At day 4: infarct volume: 43.1 vs. 48.4, p > 0.05
  • Left ventricular ejection fraction: 44.0% vs. 41.9%, p > 0.05
  • At day 30: infarct volume: 30.1 vs. 31.5
  • Death/new-onset chronic heart failure rehospitalization: 22.4% vs. 28.3%, p > 0.05

Interpretation:

The results of this trial indicate that bendavia, a novel agent to prevent mitochondrial dysfunction, and thus potentially reperfusion injury, does not reduce infarct size compared with placebo in patients with anterior STEMI due to proximal/mid occlusion of the LAD. Further phase 3 trials are ongoing.

References:

Presented by Dr. C. Michael Gibson at ACC.15, San Diego, CA, March 15, 2015.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, ACS and Cardiac Biomarkers, Implantable Devices, Lipid Metabolism, Interventions and ACS, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Nuclear Imaging

Keywords: ACC Annual Scientific Session, Acute Coronary Syndrome, Area Under Curve, Biological Markers, Cardiolipins, Heart Conduction System, Myocardial Infarction, Myocardium, Oligopeptides, Percutaneous Coronary Intervention, Reactive Oxygen Species, Reperfusion Injury, Troponin I, Angiography


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