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

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

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

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

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

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 1.03 TRI < 1.69 Stratified:site & CABG hx

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

Results 35,539 screened 3,071 eligible 2,287 consented Randomized 1,149 PCI1,138 OMT 107 lost97 lost 1,149 1,138

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

Targets *angina *CCB use *NTG use

Primary: death + non-fatal MI RR 1.05 ( ) p = – = /0.005 = 200 Follow-up = 4.6 years 9% loss to follow-up

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.

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

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