Effects of Acute, Rapid Lowering of Low-Density Lipoprotein Cholesterol With Alirocumab in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI - EPIC-STEMI

Sep 19, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Sanofi; Population Health Research Institute.
Date Presented:
09/19/2022
Date Published:
09/19/2022
Date Updated:
09/19/2022
Original Posted Date:
09/19/2022
References

Contribution To Literature:

The EPIC-STEMI trial showed that alirocumab significantly reduces LDL-C levels compared with sham-control when given acutely during primary PCI.

Description:

The goal of the trial was to evaluate the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab compared with sham-control among patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel
  • Double-blind

STEMI patients undergoing primary PCI were randomized to alirocumab 150 mg subcutaneous injection (n = 38) versus sham-control (n = 30). Study medication was given at baseline, 2 weeks, and 4 weeks. All patients received high-dose statin therapy.

  • Total number of enrollees: 97
  • Total included in per-protocol analysis: 68
  • Duration of follow-up: median 45 days
  • Mean patient age: 61 years
  • Percentage female: 29%
  • Percentage with diabetes: 13%

Inclusion criteria:

  • STEMI patients ≥18 years of age undergoing primary PCI

Exclusion criteria:

  • Pregnancy or breastfeeding
  • Current or planned treatment with a PCSK9 inhibitor
  • Allergy or contraindication to a PCSK9 inhibitor
  • Killip class ≥2
  • Creatinine clearance <30 ml/min
  • Suspected stress-induced cardiomyopathy or acute pericarditis

Principal Findings:

The primary outcome, percent change in low-density lipoprotein cholesterol (LDL-C) level from baseline to 6 weeks for alirocumab vs. sham-control, was: -22.3% (p < 0.001).

Secondary outcomes:

  • Percent change in LDL-C at 6 weeks: -72.9% for alirocumab vs. -48.1% for sham-control (p < 0.001)
  • Creatine kinase-MB (CK-MB) area under the curve: 4,436 for alirocumab vs. 4,416 for sham-control (p = 0.67)

Interpretation:

Among patients with STEMI undergoing primary PCI, alirocumab given at baseline, 2 weeks, and 4 weeks, was associated with a significant reduction in LDL-C level compared with sham-control at 6 weeks. Infarct size was similar between treatment groups. Acute administration of alirocumab during STEMI appears feasible and safe. A large outcomes trial on this strategy is needed.

References:

Mehta SR, Pare G, Lonn EM, et al. Effects of Routine Early Treatment With PCSK-9 Inhibitor in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: A Randomized, Double-Blind, Sham-Controlled Trial. EuroIntervention 2022;Sep 19:[Epub ahead of print].

Presented by Dr. Shamir R. Mehta at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 19, 2022.

Clinical Topics: Acute Coronary Syndromes, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Interventions and ACS, Interventions and Vascular Medicine, Chronic Angina

Keywords: Acute Coronary Syndrome, Cholesterol, Cholesterol, LDL, Creatine Kinase, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Lipoproteins, LDL, Myocardial Infarction, PCSK9 protein, human, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction, TCT22, Transcatheter Cardiovascular Therapeutics


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