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