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Journal ClubJournal Club
Jeffrey P Schaefer, MDApril 16, 2007
TodayToday• Pursuing Research
– Centre for Advancement of Health
• Article– PCI for stable coronary artery disease
COURAGECOURAGEClinical Outcomes Utlizing Clinical Outcomes Utlizing
Revascularization an dAggressive Drug Revascularization an dAggressive Drug Evaluation TrialEvaluation Trial
Buffalo General Buffalo General HospitalHospital
Potential for Conflict of InterestPotential 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
BackgroundBackground• 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
MethodsMethods• Study Design
– random allocation– 50 centres across US & Canada– estimated n = 2,270
EligibilityEligibility• 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
InterventionIntervention
PCI + Optimal Med Txversus
Optimal Med Tx
PCI < 50% plasty & < 20% stent
OMT ASA or clopidogrelmetoprolol, amlodipine, nitrateACE or ARBLDL < 2.2 HDL > 1.03 TRI < 1.69
Stratified: site & CABG hx
OutcomeOutcome• Primary (composite)
– all-cause death and non-fatal MI
• Secondary (composite)– all-cause death + non-fatal MI +
stroke + hospitalization for ACS– angina– QoL– resources
Results35,539 screened
3,071 eligible2,287 consented
Randomized1,149 PCI 1,138
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 MIRR 1.05 (0.87-1.27) p = 0.62
0.19 – 0.185 = 0.0051/0.005 = 200
Follow-up = 4.6 years9% loss to follow-up
Author’s ConclusionsAuthor’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 AppraisalCritical 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?Type 2 error?• Biases toward the Null?
– population too varied– intervention insufficient– cross-over– observation period– outcome diluted
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