EMBRACE STEMI | Clinical Trial - EMBRACE STEMI

Mar 15, 2015
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Presenter/Author:
C. Michael Gibson, MD, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Stealth Pharmaceuticals
Date Presented:
03/15/2015
Original Posted Date:
03/15/2015
References

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.

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


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