1. Survival Benefits in Higher Risk Patients Coronary Revascularization has Revolutionized the Therapy of Ischemic Heart Disease Acute coronary syndromes CP1305484-4 Chronic stable CAD Post MI – residual angina/ischemia Symptom relief – failure of drug therapy LMCA disease MVD and LV dysfunction MVD and severe angina/ischemia Severe LV dysfunction and extensive myocardial viability Severe angina/ischemia and proximal LAD disease?

2. Coronary Revascularization in Mild-Moderate Chronic Stable Angina – Clinical Trials * Benefit noted in LMCA disease, severe angina or LV dysfunction Lack of benefit in death/MI CABG vs medical therapy* PTCA vs medical therapy PTCA vs stents PCI vs medical therapy PTCA vs stents PCI vs medical therapy ACIP pilot study Davies: Circ, 1997 SWISSI II trial Erie: JAMA, 2007 CP1324973-5 Exceptions

3. ACC/AHA 2002 Guidelines for Chronic Stable Angina CP1336021-3 “Unless a patient is documented to have left main, three-vessel or two-vessel coronary artery disease with significant stenosis of the proximal LAD… There is no demonstrated survival advantage associated with revascularization in low-risk patients with chronic stable angina… Thus medical therapy should be attempted before considering PCI or CABG.”

4. Interpretation “Sequential innovations in the catheter-based treatment of non-acute coronary artery disease showed no evidence of an effect on death or myocardial infarction when compared with medical therapy… …lend support to present recommendations to optimise medical therapy as an initial management strategy.” 3000620-1

5. Factors Favoring CABG Over PCI in Patients with Multivessel Disease Diffuse disease Chronic total occlusions Diffuse disease Chronic total occlusions “Complete”revascularization CP942703-49 “Future” culprits Targets Lesion PCI Vessel CABG Secondary prevention

6. Perspectives of the COURAGE Trial CP1339864-1 Trial is unfairly criticized Selection PCI success rates Intensity of medical therapy Trial is inappropriately generalized All patients underwent angiography Results are consistent with published guidelines Utilization of PCI – ? Appropriate Overutilization

7. Determinants of Utilization of Revascularization Procedures Multivariate analysis Hannan: BMC Health Services Research, 2006 Accounts for 94% of variation Accounts for 89% of variation Socioeconomic status CV surgery and cardiology work forces Utilization of diagnostic angiography Burden of CAD Socioeconomic status CV surgery and cardiology work forces Utilization of diagnostic angiography Burden of CAD Surrogate variables no. – 12 Predictors of revascularization Proportion of population that is white No. of cardiac cath/1,000 Medicare enrollees Predictors of cardiac catheterization CHD admission rates No. of cardiac surgeons and Interventional cardiologists/ 100,000 population CP1316257-12

8. Overutilization of PCI Potential contributory factors Overutilization of coronary angiography Unfamiliarity with the data Fear of litigation – ? Lack of checks and balances Self-referral Lack of checks and balances Self-referral Financial incentives Reimbursable Financial incentives Reimbursable “Oculostenotic reflex” Easy to perform Logical – ? Easy to perform Logical – ? CP1333507-3

9. Guideline Indications that Require Documentation of Ischemia on Noninvasive Testing CP1337577-1 1-2 VD without proximal LAD CABG or PCI 2 VD and proximal LAD CABG Stenoses 50-60% (other than LMCA) PCI

10. PCI and CABG in Chronic Stable Angina Clinical assessment and indications Assess severity of symptoms/ ischemia Tolerability and efficacy of medical therapy ComorbiditiesComorbidities Quality of life and realistic expectations ContraindicationsContraindications “Future” culprit lesions cannot be identified No appropriate target for PCI Absence of symptoms or objective evidence of ischemia or hemodynamically significant stenoses CP1339128-1

11. Methods of Revascularization and Outcomes CABG vs PTCA 15 trials – 8,826 pt* BMS vs PTCA 29 trials – 9,918 pt No difference in death/MI BMS vs DES 11 trials – 5,105 pt CABG vs BMS 5 trials – 3,253 pt CABG vs DES ** CARDIA – Diabetics *Diabetics in BARI ** SYNTAX – LMCA/3 VD CP1336220-1

12. BARI SoS BARI SoS 5-12% of all pt undergoing revascularization at participating institutions Limitations of Randomized Trials and Registry Studies COURAGE (6.4% of pt screened) Gersh and Frye: NEJM, 2005 Selection bias Entry bias CP1333507-11 Registry studies Randomized studies “Things may not be as they seem” SYNTAX (41% of pt screened)

13. Diabetics ? CABG/PCI in Patients with Multivessel Disease and Chronic Stable Angina CABG PCI 3VD LV dysfunction LMCA disease** Diffuse disease 3VD LV dysfunction LMCA disease** Diffuse disease 'Advanced' age 'Salvage' procedure 'Advanced' age 'Salvage' procedure 2VD* (not involving prox LAD) Preserved LV function* Suitable anatomy* 2VD* (not involving prox LAD) Preserved LV function* Suitable anatomy* Changing indications *Majority of pt in randomized trials **SYNTAX Trial CP1345306-1

14. 1,228 pt 3 trials 2 nd generation stents 1,228 pt 3 trials 2 nd generation stents 5-Year Clinical Outcomes After Coronary Stenting Cutlip: Circ, 2004 CP1165076-1 Hazard Rates/Year Years Hazard rate (%) 12345 Target lesion event Non-target lesion event

15. Medicare Trust Fund Balance Projections 1990-2019 CP1337577-2 Aging society Economic recession Proliferation and utilization of new technologies Perfect storm % % Historical Estimated www.cms.govwww.cms.gov