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Journal Club

Journal Club. Jeffrey P Schaefer, MD April 16, 2007. Today. Pursuing Research Centre for Advancement of Health Article PCI for stable coronary artery disease. COURAGE Clinical Outcomes Utlizing Revascularization an dAggressive Drug Evaluation Trial. Buffalo General Hospital.

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Journal Club

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  1. Journal Club Jeffrey P Schaefer, MD April 16, 2007

  2. Today • Pursuing Research • Centre for Advancement of Health • Article • PCI for stable coronary artery disease

  3. COURAGEClinical Outcomes Utlizing Revascularization an dAggressive Drug Evaluation Trial

  4. Buffalo General Hospital

  5. Potential for Conflict of Interest • We all have conflicts… • Merck • Pfizer • BMS • Fujisawa • Kos Pharmaceuticals • Datascope • Astrazenca • Key Pharmceutical • Sanofi – Aventis • First Horizon • GE Healthcare • US VA • CIHR

  6. Background • Percutaneous Coronary Intervention • 30 years • common initial therapy despite guideline • 2004  1 million in USA • 85% done on stable CAD • benefit shown for ACS • no benefit shown for stable CAD

  7. Methods • Study Design • random allocation • 50 centres across US & Canada • estimated n = 2,270

  8. Eligibility • Entry • CAD • stable or medically stabilized • 70% or more stenosis • ischemia • resting ECG or stress induced or • 80% with angina • Exclusion • Class IV CCS angina, cardiogenic shock, refractory HF, EF < 30%, can’t PCI

  9. Intervention PCI + Optimal Med Tx versus Optimal Med Tx PCI  < 50% plasty & < 20% stent OMT  ASA or clopidogrel metoprolol, amlodipine, nitrate ACE or ARB LDL < 2.2 HDL > 1.03 TRI < 1.69 Stratified: site & CABG hx

  10. Outcome • Primary (composite) • all-cause death and non-fatal MI • Secondary (composite) • all-cause death + non-fatal MI + stroke + hospitalization for ACS • angina • QoL • resources

  11. Results 35,539 screened 3,071 eligible 2,287 consented Randomized 1,149 PCI 1,138 OMT 107 lost 97 lost 1,1491,138

  12. Baseline • no important differences • 61 yrs • 85% male • 86% white • 35% diabetes • 66% htn • 11% CABG • 5% hf • 65% multiple defects • .61 EF

  13. Targets *angina *CCB use *NTG use

  14. Primary: death + non-fatal MI RR 1.05 (0.87-1.27) p = 0.62 0.19 – 0.185 = 0.005 1/0.005 = 200 Follow-up = 4.6 years 9% loss to follow-up

  15. Author’s Conclusions • PCI for initial management of CAD reduces symptoms of angina but does not alter mortality, non-fatal MI, or hospitalization for ACS.

  16. Critical Appraisal • Valid? • randomized • follow-up • analysis • concealment • starting prognosis • one intervention • Results? • magnitude • precision • Applicability? • my patients • important outcomes • benefit worth risk

  17. Type 2 error? • Biases toward the Null? • population too varied • intervention insufficient • cross-over • observation period • outcome diluted

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