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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