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Journal Club Presentation

Journal Club Presentation. Kendra Marsh, MD Department of Cardiology University of Illinois at Chicago November 27, 2007. CORONA TRIAL Controlled Rosuvastatin Multinational Trial in Heart Failure. Background.

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Journal Club Presentation

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  1. Journal Club Presentation Kendra Marsh, MD Department of Cardiology University of Illinois at Chicago November 27, 2007

  2. CORONA TRIALControlled Rosuvastatin Multinational Trial in Heart Failure

  3. Background • A large percentage of patients with left ventricular dysfunction have coronary artery disease. • Few of these patients have myocardial infarctions • Statin therapy has been shown to be beneficial in the treatment of coronary artery disease and prevention of myocardial infarction. • Patients with severe LV dysfunction often have lower cholesterol, yet they have worse outcomes.

  4. Potential harm of Statins in Heart Failure • Lipoproteins are postulated to remove endotoxins that seep in through the intestinal wall. • Decreased synthesis of Co-Enzyme Q10 • A co-factor in the mitochondrial electron transport chain • Antioxidant • Decreased production of Selenoproteins • Resulting in skeletal and cardiac myopathies

  5. Potential Benefit of Statins in Heart Failure • Improves endothelial function • Anti-inflammatory activity

  6. Hypothesis • The beneficial results of Rosuvastatin would out-way any theoretical hazards, improve survival, reduce morbidity and increase well being in patients with chronic, symptomatic, systolic ischemic heart failure.

  7. Characteristics of the Patients Patient Characteristics Kjekshus J et al. N Engl J Med 2007;10.1056/NEJMoa0706201

  8. Method • Inclusion criteria • Population: 19 European countries, Russia, South Africa • 60 years or older • New York Heart Association Class II, III or IV • Ejection Fraction less than 40% • Stable medical therapy for 2 weeks

  9. Method • Exclusion Criteria • Previous adverse reaction to statin ( myopathy or hypersensitivity • Decompensated Congestive Heart Failure • Inotropic Therapy • Myocardial Infarction in the past 6 months • Unstable Angina or Stroke within the past 6 months • PCI/CABG/ICD/Biventricular pacemaker within 3 months • Previous or planned heart transplant • Uncorrected primary heart valve • Malfunctioning prosthetic valve • Pericardial or endocardial disease • Abnormal LFT’s • Less than 80% of placebo taken • Abnormal Creatinine Kinase • Poor Compliance

  10. Study Design • Single blinded placebo-control trial. • Rosuvastatin 10 mg oral vs. Placebo • Follow up at 6 weeks and 3 months • If patient was doing well, follow up at 6 months, 15 months and then yearly. • Liver Enzymes were checked at 3 months ad then yearly

  11. Target Outcomes • Primary Outcomes: Composite • Death (Cardiovascular), Non-fatal MI, Non-fatal stroke • Secondary Outcomes • Death, any cause • Any cardiac event: sudden cardiac death, fatal or non fatal MI • Revascularization: PCI, CABG • Hospitalization for unstable angina • Worsening CHF

  12. Statistical Analysis • Anticipated mean Hazard ratio 10.4 % • Projected time for rosuvastatin to show significant effect, 10 months • To achieve a 16% reduction in primary outcomes, a statistical power of 90% was used to detect such a change. • Therefore the projected number of patients needed was 4950. • People were enrolled with intention to treat.

  13. Results

  14. Figure 1. Kaplan–Meier Estimates for the Primary Outcome, Death from Any Cause, and Any Coronary Event.

  15. Discussion • Rosuvastatin 10mg Qdaily did not reduce primary outcomes • Cardiovascular hospitalizations were significantly reduced • There were no significant adverse events when compared to placebo.

  16. Limitations • Older patients • Potentially statin naive with advanced CAD • NYHC III, IV • Perhaps the study should have been extended over a longer period of time • Diastolic Dysfunction, Nonishemic Cardiomyopathy patients not included • Unusually compliant group of patients • Selection bias for patients who would have good follow up.

  17. Thank you!

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