Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy - CARIN
The goal of the trial was to compare the safety and efficacy of CMX-2043 in reducing acute kidney injury (AKI) following percutaneous coronary intervention (PCI).
Contribution to the Literature: The CARIN study suggests that CMX-2043 at three different doses was not more efficacious than placebo in reducing AKI following coronary angiography/PCI.
Patients undergoing coronary angiography were randomized in a 1:1:1:1 fashion to CMX-2043 2.4 mg/kg (n = 87), 3.6 mg/kg (n = 94), 4.8 mg/kg (n = 87), or placebo (n = 93).
- Total number of enrollees: 3,503
- Duration of follow-up: 90 days
- Mean patient age: 67 years
- Percentage female: 42%
Other salient features/characteristics:
- Baseline estimated glomerular filtration rate (eGFR) 45 ml/min/1.73 m2
- Hydration therapy: 45%
- Coronary angiography with high probability of PCI
- Either acute coronary syndrome (excluding ST-elevation myocardial infarction [STEMI]), planned PCI with >75 ml of contrast, or≥2 abnormal ischemic regions by stress test
- Either eGFR 15.0-45.0 ml/min or eGFR 45.1-60.0 ml/min and at least one of the following:
- >75 years of age
- Diabetes mellitus
- Ejection fraction <40%
- Congestive heart failure
- End-stage renal disease (eGFR <15)
- Cardiac arrest
- Life-threatening arrhythmia
Primary outcome, AKI at 4 days, for CMX-2043 2.4 mg/kg vs 3.6 mg/kg vs 4.8 mg/kg vs. placebo: 25.6% vs. 25.3% vs. 18.9% vs. 18.6%, p > 0.05
- Mean eGFR at 90 days: 42.7 vs. 45.8 vs. 43.8 vs. 44.6, p > 0.05
- Major adverse kidney events: 48.2% vs. 55.6% vs. 46.3% vs. 38.2%, p > 0.05
- Dialysis: 1.2% vs. 1.1% vs. 0% vs. 1.1%, p > 0.05
- Major adverse cardiac events: 2.4% vs. 11.1% vs. 3.8% vs. 4.5%, p > 0.05
- MI: 1.2% vs. 7.8% vs. 1.3% vs. 1.1%, p > 0.05
The results of this trial indicate that CMX-2043 at three different doses was not more efficacious than placebo in reducing AKI following coronary angiography/PCI. There were also no differences in periprocedural MI or other cardiovascular outcomes. CMX-2043 is a potent version of alpha-lipoic acid and is thought to have salutary effects on kidney tissue by multiple mechanisms.
Presented by Dr. Deepak L. Bhatt at the American College of Cardiology Annual Scientific Session, Chicago, IL, April 4, 2016.
Clinical Topics: Acute Coronary Syndromes, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Lipid Metabolism, Acute Heart Failure, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: ACC Annual Scientific Session, Acute Coronary Syndrome, Acute Kidney Injury, Coronary Angiography, Diabetes Mellitus, Exercise Test, Glomerular Filtration Rate, Heart Failure, Hypotension, Myocardial Infarction, Percutaneous Coronary Intervention, Renal Dialysis, Secondary Prevention, Thioctic Acid
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