journal club jeffrey p schaefer, md april 16, 2007
TRANSCRIPT
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Journal ClubJournal Club
Jeffrey P Schaefer, MDApril 16, 2007
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TodayToday• Pursuing Research
– Centre for Advancement of Health
• Article– PCI for stable coronary artery disease
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COURAGECOURAGEClinical Outcomes Utlizing Clinical Outcomes Utlizing
Revascularization an dAggressive Drug Revascularization an dAggressive Drug Evaluation TrialEvaluation Trial
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Buffalo General Buffalo General HospitalHospital
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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
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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
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MethodsMethods• Study Design
– random allocation– 50 centres across US & Canada– estimated n = 2,270
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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
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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
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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
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Results35,539 screened
3,071 eligible2,287 consented
Randomized1,149 PCI 1,138
OMT
107 lost97 lost
1,149 1,138
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Baseline- no important differences
- 61 yrs- 85% male- 86% white- 35% diabetes- 66% htn- 11% CABG- 5% hf- 65% multiple defects- .61 EF
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• Targets
*angina*CCB use*NTG use
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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
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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.
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Critical AppraisalCritical Appraisal• Valid?
– randomized– follow-up– analysis– concealment– starting prognosis– one intervention
• Results?– magnitude– precision
• Applicability?– my patients– important outcomes– benefit worth risk
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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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