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  • 1. The “Truth and Consequences” of Objective Ischemia: The COURAGE Trial Nuclear Substudy Dean J. Kereiakes, M.D. Medical Director, The Christ Hospital Heart and Vascular Center and the Lindner Research Center Chairman,Executive Committee, The Ohio Heart and Vascular Center, Cincinnati, Ohio Professor of Medicine, Ohio State University
  • 2. Objectives • Identify pivotal observation(s) from the COURAGE trial nuclear substudy • Is this observation(s) novel? • Is the obsevation realistic and applicable to clinical practice? • What are the limitations & caveats regarding COURAGE observations? • Summary and Conclusions
  • 3. Nuclear Substudy (n=314 / 2,287) Hypothesis: Reduction in ischemia will be greater for patients Randomized to PCI+OMT than for those randomized to OMT Serial rest/stress myocardial perfusion SPECT (MPS) To compare patient management strategy for ischemia reduction Documented Pre-Rx Ischemia PCI + OMT OMT (n=159) (n=155) Repeat MPS* Repeat MPS* at 6-18m at 6-18 m *Timing chosen to occur beyond window of in- stent restenosis and delayed to allow effects of medical Rx to be observed •Pre-Rx = off meds •Post-Rx = on meds Source: Shaw et al. J Nucl Cardiol 2006;13:685
  • 4. MPS Ischemia Based on Total Perfusion Defect (TPD) • TPD: Quantitative measure of defect extent and severity • % Ischemic myocardium = (Stress TPD-Rest TPD) • < 5%: Minimal (“no ischemia”) • 5.0%-9.9%: Mild ∀ ≥ 10%: Moderate to severe • Significant reduction in ischemia ∀ ≥ 5% reduction in ischemic myocardium* Source: Simoka et al. J Nucl Cardiol 2005;12:66 *Threshold exceeds test repeatability TPD Defect Extent Lower NI Limit Defect Severity
  • 5. Pre-Treatment Clinical Characteristics and MPS Results PCI + OMT N=159 OMT N=155 P value Angina CCS* Class I-II 74% 73% 0.99 Angiographic 2-3 vessel CAD 73% 77% 0.38 Rest gated LVEF 57%±11% 58%±9% 0.97 % Ischemic myocardium 8.2% 8.6% 0.63 (95% CI) (7.2-9.3%) (7.5-9.8%) Moderate to Severe Ischemia** 34% 33% 0.81 *CCS=Canadian Cardiovascular Society ** ≥10% ischemic myocardium Compared to main trial, substudy patients more often CCS* class I-II angina (p=0.013) & less multivessel CAD (p=0.05); with similar % of MPS ischemia (p=0.55)
  • 6. 33.3 19.8 0 10 20 30 40 50 PCI + OMT (n=159) OMT (n=155) IschemiaReduction≥5% Primary Endpoint: % with Ischemia Reduction ≥ 5% Myocardium (n=314) P=0.004
  • 7. 31.4 17.8 0 10 20 30 40 50 PCI + OMT (n=53) OMT (n=29) %withLowRisk*MPS Ischemia Normalization* on Follow-Up MPS In Patients with Significant Ischemia Resolution P=0.007 *≤1% ischemic myocardium
  • 8. 13.4 24.7 0 10 20 30 40 50 Ischemia Reduction n=82 No Ischemia Reduction n=232 DeathorMIrate(%) Rates of Death or MI by Ischemia Reduction P=0.037 RR=0.47 (95% CI=0.23-0.95) ≥ 5%* *primary endpoint
  • 9. 16.2 32.4 0 10 20 30 40 50 Ischemia Reduction n=68 No Ischemia Reduction n=37 DeathorMIrate(%) Rates of Death or MI by Ischemia Reduction in Subset of 105 Patients with Moderate to Severe Pre-Rx Ischemia* P=0.001 ≥ 5% *50% reduction
  • 10. 0.0 15.6 22.3 39.3 0 10 20 30 40 50 0% (n=23) 1 - 4.9% (n=141) 5 -9.9% (n=88) 10% (n=62) DeathorMIrate(%) Rates of Death or MI by Residual Ischemia on 6-18m MPS P=0.002 ≥ P=0.023 P=0.063
  • 11. Conclusions • PCI added to OMT was more effective in reducing ischemia and improving angina than OMT alone, particularly in patients with moderate to severe pre-RX ischemia • Is this Observation Novel?
  • 12. 0.3 0.8 2.3 2.9 0.5 2.7 2.9 4.2 0 1 2 3 4 5 Myocardial Infarction Cardiac Death Hachamovitch, Diamond et al. Circ 1998;97:535 Cardiac Death or Myocardial Infarction Rate/Year Stratified by SPECT Quantitative Ischemia EventRate% * Statistically significant increase as function of scan result ** Increased rate of MI vs cardiac death within scan stratum ** * * Normal Mildly Normal Moderately Abnormal Severely Abnormal N = 2946 884 455 898
  • 13. 0.7 1.0 2.9 4.8 6.7 6.3 1.8 3.7 3.3 2.0 0 2 4 6 8 10 7110 16 1331 56 718 109 545 243 252 267 Medical RX Revasc Hachamovitch et al. Circ 2003;107:2900 Cardiac Death Rate Stratified by Spect Quantification of Ischemia and Treatment Modality† CardiacDeathRate(%) 0% 1-5% 5-10% 11-20% >20% *p < 0.0001 % Total Myocardium Ischemic † * §
  • 14. Hachamovitch et al. Circ 2003;107:2900 Mortality Hazard by Treatment Modality and % Ischemic Myocardium logHazardRatio(Mortality) 0 1 2 3 4 5 6 0 12.5% 25% 32.5% 50% *p<0.001 % of Total Myocardium Ischemic Interaction: p=0.030 Medical Rx * Revasc *
  • 15. Relationship Between Baseline Findings and Treatment Strategies with Adverse Outcomes* to 1 Year: ACIP Study** Adapted from Pepine et al. JACC 1997;29:1483 O.R. (95% CI) P Ischemia Driven 0.80 (0.39 – 1.61) 0.41 Medial Therapy Revascularization 0.56 (0.26 – 1.2) 0.05 Strategy AECG Ischemia† 1.06 (1.01 – 1.12) 0.002 0.25 0.5 1.0 1.5 1.75 † 48 hours monitor qualifying visit *Death, non-fatal MI, hospital admission for ischemic event, **558 pts. Objective
  • 16. Ambulatory ECG and SPECT Perfusion Imaging: Lack of Concordance (ACIP Ancillary Study*) Adapted from Mahmarian et al. JACC 1997;29:764-9 AECG SPECT + - + - 50% Concordance (≥ 3% perfusion defect) 52% Concordance (+ any ischemic defect) 45 / 48 33 / 34 20 / 17 8 / 7
  • 17. 0 4 8 12 16 ACIP Study Two-Year Follow-Uppercent 0 4 8 12 16 20 24 Death or MI Months of Follow-up Davies et al. Circ 1997;95:2037 12.1% Angina Guided Med Rx 8.8% Ischemia Guided Med Rx 4.7% Revascularization * *P<0.01 vs. angina guided med Rx
  • 18. Cardiovascular Death or Myocardial Infarction Stratified by Self-Reported Angina and/or Inducible Ischemia*: The Heart and Soul Study 0.5 1 2 3 4 5 6 7 8 9 Adjusted HR† (95% CI) p No angina or ischemia 1 (Reference) Angina alone 1.4 (0.7, 2.9) 0.31 Ischemia alone 2.2 (1.4, 3.5) 0.005 Angina & Ischemia 3.2 (1.4, 7.2) 0.006 Adapted from Gehi, Schiller, Whooley et al. Arch Int Med 2008;168:1423 *stress echo (937 pts. Stable CHD followed 3.9 yrs.) † Adjusted for age, sex, race, Hx MI, Hx CHF, HgA1c, CrCl, LVEF, SBP, DBP, CRP
  • 19. • Is the COURAGE Trial observation Realistic and Applicable to Practice?
  • 20. COURAGE : DemographicsCOURAGE : Demographics 50 Hospitals50 Hospitals 2,287 pts*2,287 pts* enrolled betweenenrolled between 6/99-1/046/99-1/04 1 pt per hospital1 pt per hospital per monthper month 19 US Non-VA Hospitals19 US Non-VA Hospitals 387 pts387 pts (0.5 pts/mo/hosp)(0.5 pts/mo/hosp) *(17% of total)*(17% of total) 15 VA Hospitals15 VA Hospitals 968 pts968 pts (1.6 pts/mo/hosp)(1.6 pts/mo/hosp) (42% of total)(42% of total) 16 Canadian Hospitals16 Canadian Hospitals 932 pts932 pts (1.5 pts/mo/hosp)(1.5 pts/mo/hosp) (41% of total)(41% of total) Boden WE et al. NEJM 2007;356:1503-16Boden WE et al. NEJM 2007;356:1503-16 * 15% women,14% non-caucasian
  • 21. Does COURAGE Represent U.S. PCI Practice ?Does COURAGE Represent U.S. PCI Practice ? 962,732 (98.5%) * 2006* 2006 Boden WE et al. NEJM 2007;356:1503-16 ; US data on file, Boston ScientificBoden WE et al. NEJM 2007;356:1503-16 ; US data on file, Boston Scientific 0 200 400 600 800 1000 1200 1400 1600 1800 2000 US VA US non VA 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 14,268 (1.5%) Hospitals with PCI * Total PCI Volume* 52 (3.5%) 1,422 (96.5%)
  • 22. CompleteComplete revascularizationrevascularization Peri-PCIPeri-PCI MIsMIs COURAGE : Inadequate and Incomplete PCICOURAGE : Inadequate and Incomplete PCI 1149 patients total1149 patients total 46 (4%) procedure not attempted46 (4%) procedure not attempted 27 (2%) no lesions crossed27 (2%) no lesions crossed 1077 pts had PCI attempted / 958 (89%) success1077 pts had PCI attempted / 958 (89%) success [really 958/1149 (83.4%)or 958/1122(87%) success]*[really 958/1149 (83.4%)or 958/1122(87%) success]* 1577/1688(1730)* lesions had PCI success (93%)1577/1688(1730)* lesions had PCI success (93%) Few PCI pts received GPIIb/IIIa inhibitors, bivalirudinFew PCI pts received GPIIb/IIIa inhibitors, bivalirudin or adequate clopidogrel pre-loadingor adequate clopidogrel pre-loading 787 pts (69%) had 2 or 3 vessel ds.787 pts (69%) had 2 or 3 vessel ds. 416 pts (36%) received ≥2 stents416 pts (36%) received ≥2 stents At least 371 of 787 pts (47%) with multivesselAt least 371 of 787 pts (47%) with multivessel disease had incomplete revascularizationdisease had incomplete revascularization 14% PTCA14% PTCA onlyonly 86% stents86% stents 97% BMS97% BMS 3% DES3% DES *Really <89-*Really <89- 91%*(add 1.691%*(add 1.6 lesn x27 pts)lesn x27 pts) PCIsuccessPCIsuccess *SITE
  • 23. COURAGE : Variable PCI Outcomes by LocationCOURAGE : Variable PCI Outcomes by Location Original Trial Hypothesis: 22% reduction D/MI with PCIOriginal Trial Hypothesis: 22% reduction D/MI with PCI Death/MI(%)at4.6yearsDeath/MI(%)at4.6years 29%↓29%↓27%↑27%↑ ↔↔ P≈0.02
  • 24. COURAGE: Mortality by Healthcare System and Randomized Treatment Strategy 12.1 7.9 4.7 8.6 7.7 6.0 0 2 4 6 8 10 12 14 USVA USNVA Canadian OMT PCI + OMT Adapted from Chaitman et al. JACC 2008;51:A222 (abstract) % Mortality P =0.07
  • 25. COURAGE Issues :? Geographic Selection BiasCOURAGE Issues :? Geographic Selection Bias Death/MI(%)at4.6yearsDeath/MI(%)at4.6years All US VA US non-VA Canada N=2287 N=932 N=968 N=387 Original Projection:Original Projection: 3-year death/MI for3-year death/MI for OMTOMT = 21%= 21% ~ 0.4% /Yr Cardiac Mortality in COURAGE~ 0.4% /Yr Cardiac Mortality in COURAGE NEJM 2007;356:1503 AHJ 2006;151:1173NEJM 2007;356:1503 AHJ 2006;151:1173 Very low risk pts!Very low risk pts! Hard to improve uponHard to improve upon ProbablyProbably ~10% at~10% at 3 years3 years
  • 26. Imputed* Effect of Drug-Eluting Stents in the COURAGE Trial: Death / MI 0.00 0.50 1.00 1.50 2.00 2.50 RR (95% CI) BMS+OMT vs. OMT (COURAGE) 1.05 (0.87,1.27) DES+OMT vs. BMS+OMT (historical meta-analysis) 1.30 (0.91,1.86) 1.03 (0.84,1.26) DES vs. OMT (indirect comparison) 1.36 (0.91, 2.04) 1.08 (0.82, 1.43) *Annals Int Med 2006Meta-analysis Diamond, Kaul Viewpoint JACC 2007;50:1604-1609 BMS SES (Cypher) PES (Taxus) Favors PCI Favors OMT
  • 27. 0 4 8 12 16 20 24 0 1 2 3 4 5 BMS (Exp) n = 295 PES n = 287 Clinical Events Following BMS or DES*+ 0 4 8 12 16 20 24 0 1 2 3 4 BMS (EXP+Bx) PES SES Boston Scientific data on file TARGET LESION REVASCULARIZATION CLINICALLY DRIVEN TLR (Taxus IV Non-Angio Cohort) SES vs. BMS: HR 0.30 (0.24-0.37; p<0.0001) PES vs. BMS: HR 0.42 (0.33-0.53; p<0.0001) SES vs. PES: HR 0.70 (0.56-0.84; p=0.0021) BMS 4763 820/4746 53/2795 22/1871 10/1543 PES 6328 448/6280 98/3950 15/1999 6/832 SES 6621 356/6580 68/3801 16/2153 14/999 *Stettler et al. Lancet 2007;370:937 n=18,023 patients / 38 trials % % PES vs. BMS: HR 0.39 (0.23-0.67; p=0.0005) BMS 295 37/254 5/249 3/239 1/229 2/218 PES 287 8/272 4/271 3/258 2/246 3/235 + p=0.0005)
  • 28. Clinical Events Following BMS or DES* 0 2 4 6 8 10 0 1 2 3 4 BMS PES SES ALL DEATH DEATH OR MYOCARDIAL INFARCTION Cumulative Incidence in % Cumulative Incidence in % SES vs. BMS: HR 1.00 (0.82-1.25; p=0.89) HR 0.92 (0.77-1.08; p=0.32) PES vs. BMS: HR 1.03 (0.84-1.22; p=0.75) HR 1.00 (0.84-1.23; p=0.97) SES vs. PES: HR 0.96 (0.83-1.24; p=0.80) HR 0.92 (0.79-1.08; p=0.27) BMS 4921 109/4904 48/3340 31/2264 44/1875 4921 301/4904 62/3208 45/2161 46/1780 PES 6331 138/6283 78/4263 32/2187 15/869 6331 376/6283 115/4087 43/2082 22/833 SES 6771 139/6730 72/4041 38/2340 24/10810 6771 356/6730 86/3888 44/2241 28/1032 0 2 4 6 8 10 12 14 0 1 2 3 4 BMS PES SES *Stettler et al. Lancet 2007;370:937 n=18,023 patients/38 trials
  • 29. Mortality (DES vs. BMS) from 29 Trials / Registries Patient Year Weighted Regression* 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 % Death BMS %DeathDES STENT TSEARCH BASKET DEScover Steinberg et al. REAL ONASSIS Pache et al. PRISON II DIABETES SCANDSTENT TYPHOON SES Smart Western Denmark SCAAR MISSION Ortolani Cypher meta-analysis Taxus SR meta -analysis Ontario PCI Registry WAKE Forest ACUITY PASSION RESEARCH SESAMI NY State ASAN GHOST MIDAS 1 3 2 4 5 9 13 17 21 25 29 6 10 14 18 22 26 28 27 24 23 20 19 16 15 12 11 7 8 1 3 2 4 5 9 13 17 21 25 29 6 10 14 18 22 26 28 27 24 23 20 19 16 15 12 11 7 8 Slope = 1.0 Slope = 0.79 Slope = 0.85 [95% CI] Slope = 0.73 [95% CI] DES Death = 0.79 BMS Death 95% CI Slope = 0.79 ± 0.06 R2 = 0.96 DES Death = 0.79 BMS Death 95% CI Slope = 0.79 ± 0.06 R2 = 0.96 Size of circle adjusted for number of patients 21% Decrease
  • 30. 5.9 11.5 12.9 5.6 7.8 11.9 11.0 7.9 4.2 5.2 8.6 4.8 5.5 9.4 5.7 6.4 0 2 4 6 8 10 12 14 16 18 20 BMS DES DES vs. BMS Registries: All Cause Mortality ASAN GHOST MIDAS NY STATE ONTARIO MASS-DAC STENT Western Denmark % 4,061 3,180 871 483 5,399 5,719 7,834 6,384 3,751 3,751 1,359 5,996 8,847 3,548 p<0.001 p=0.052 p<0.0001 p<0.05 p<0.001 p<0.001 p<0.001 p=0.004 Follow-up: 3 year 3 year 2 year 2 year 3 year 2 year 2 year 2 year5,441 5,441 DJK
  • 31. Late (3 Year) Results of the SCANDSTENT Randomized Trial*Events,% 5.6 2.5 3.7 4.9 8 12.3 1.9 1.3 9.6 33.8 34.4 37.6 0 5 10 15 20 25 30 35 40 SES BMS Kelbaek et al. JACC 2008;51:2011 Death Cardiac Myocardial TLR TVR MACE death infarction p<0.001 p<0.001 p<0.001 * CTO, ostial, bifurcation, angulated p=0.14 p=0.69 p=0.04
  • 32. DES Outcomes (2 Years) in the Elderly: Medicare Case-Control Comparison* %Patients 10.7 9.2 17.2 29.8 13.5 11.2 19.1 34.4 0 10 20 30 40 50 DES BMS Adapted from Groeneveld et al. JACC 2008;51:2017 Death Myocardial Coronary Combined Infarction Revascularization Endpoints p<0.001 p<0.001 p<0.001 p<0.001 *n=76,525 DES Rx vs. contemporary (April-Dec 2003) controls
  • 33. Outcomes Following Coronary Stenting in Medicare Beneficiaries* 0.00 0.10 0.20 0.30 1 90 180 365 730 1 90 180 365 730 Malenka et al. JAMA 2008;299:2868 CumulativeHazard 0.00 0.02 0.04 0.06 0.08 0.10 0.12 # at risk BMS 38917 35610 33155 30437 26822 38917 38001 37362 36332 34275 DES 28086 25660 24386 22737 19943 28086 27473 27021 26301 24311 Repeat Revascularization Death/STEMI BMS era DES era *BMS 38,917 10/02 - 3/03 DES 28,086 09/03 - 12/03
  • 34. DES Versus BMS and All-Cause Mortality: CCF Experience 1 1.0 0.9 0.8 0.7 0.6 1.0 0.9 0.8 0.7 0.6 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Years after Procedure 10.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Years after ProcedureNo. At Risk Drug Eluting Stent: 6053 5467 4771 3939 3145 2295 1552 791 170 Bare-Metal Stent: 1983 1538 1241 1082 990 905 815 723 515 *p<0.001 No. At Risk Drug Eluting Stent: 1801 1654 1466 1251 1037 791 536 261 57 Bare-Metal Stent: 1801 1390 1117 969 884 809 733 653 471 Non-Propensity Matched* Event Free Propensity Matched Event Free Shishenbor et al. JACC 2008 52:1041 Drug-Eluting Stent HR (95% CI) Bare-Metal Stent 0.62( 0.53 - 0.73) Confidence Interval Drug-Eluting Stent HR (95%CI) Bare-Metal Stent 0.54(0.45-0.66) Confidence Interval
  • 35. Anginafree(%)Anginafree(%) CCS Class 0 / 1 P=NS COURAGE : Freedom from Angina with OMTCOURAGE : Freedom from Angina with OMT 40%⇓ P<0.001 <10% crossovers* prespecified! P=NS *due to severe / progressive angina ; remain OMT by ITT
  • 36. Multivariate Predictors of Crossover to PCI Hypercholesterolemia 1.4 (1.0 - 2.0) 3 VD 1.6 (1.1-2.3) SAQ angina frequency score 0.86 (0.81-0.91) Adapted from Spertus et al. JACC 2008;51:A264 (abstract) 0.5 1.0 1.5 2.0 2.5 OR (95% CI)
  • 37. COURAGE : “COURAGE” OMT not RealisticCOURAGE : “COURAGE” OMT not Realistic Follow-upFollow-up AspirinAspirin StatinsStatins BetaBeta blockersblockers 1 years1 years 95%95% 95%95% 89%89% 3 years3 years 95%95% 92%92% 86%86% 5 years5 years 94%94% 93%93% 86%86% LDL < 85 mg per deciliter in ~70% of pts SBP <130 mmHg in ~65% of pts DBP <85 mmHg in ~ 94% of pts HgBA1C <7.0% in ~45% of diabetic pts ⇒⇒ Compliance Treatment to Targets
  • 38. Medication ComplianceMedication Compliance CRUSADECRUSADE Registry (1-Year)Registry (1-Year) Mehta HR et al. Circulation 2005;112:II-793. vs. 95% in COURAGE vs. 95% vs. 89% vs. >90% vs. >90%
  • 39. 82 66 86 69 55 70 0 10 20 30 40 50 60 70 80 90 100 Aspirin B-Blocker Statin/Lipid Lowering Previous PCI (n=12,759) Previous Medical Rx (n=13,784) %Patients Adapted from Steinberg, et al. Am J Cardiol 2007;99:1212 Compliance with Guideline Recommended Therapies in Patients with Established Atherosclerosis: The REACH International Registry
  • 40. 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00 Years Years Ho et al. Am Heart J 2008;155:772 Medical Compliance Effects Survival in CAD Survival(adjusted) Survival(adjusted)0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00 0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8 STATIN BETA-BLOCKERS Adherent Non-Adherent
  • 41. Optimal (<140/90 )* Blood Pressure Control inOptimal (<140/90 )* Blood Pressure Control in Clinical PracticeClinical Practice 1 J HTN 2006;24:51, 2 J HTN 2004;22:2387, 3 HTN 2007;49:69 * < 130(65%) / 85(94%) COURAGE Silvia Study2 (n=2775) Three City Study1 (n=9090) NHANES 2003 – 20043 (n=1614) 31% 37% 33% %Patients%Patients
  • 42. 0 10 20 30 40 50 60 Baseline 1 3 6 12 24 36 PCI + OMT OMT Months Weintraub et al. N Engl J Med 2008;359:677 Freedom from Angina ( SAQ ) Stratified by Treatment P=0.35 P<0.001 P<0.001 P<0.001 P=0.005 P=0.010 P=0.30 n = 21 23 42 33 53 42 56 47 57 50 59 53 59 56 Angina-free(%)
  • 43. Angina Stability and Frequency by SAQ over Time Stratified by Treatment Strategy 0 6 12 24 36 0 6 12 24 36 Months from Baseline Months from Baseline Weintraub et al. N Engl J Med 2008;359:677 MeanScore Angina Stability Angina Frequency MeanScore 100 90 80 70 60 50 0 100 90 80 70 60 50 0 * * * * * * * * * PCI + OMT OMT *p<0.01
  • 44. Quality of Life by SAQ Over Time Stratified by Treatment Strategy 0 6 12 24 36 Months from Baseline Weintraub et al. N Engl J Med 2008;359:677 MeanScore 100 90 80 70 60 50 0 * * * * * PCI + OMT OMT *p<0.01
  • 45. COURAGE Objective Ischemia : Conclusions • Ischemia (SPECT,AECG,SECHO) is qualitatively and quantitatively correlated with adverse clinical outcomes (CVD,MI) • Revascularization (PCI) is more effective in reducing ischemia than medical therapy (OMT) • COURAGE PCI was inadequate (83-87% per-patient ; <89-91% per-lesion success rate) and incomplete (47% MVD) with suboptimal technology (14% POBA, 3% DES)
  • 46. COURAGE Objective Ischemia : Conclusions • COURAGE OMT was unrealistic (>90% compliance through 5 years) in part due to free nurse case management and free medications • Contemporary “real world practice management” (more complete revascularization with DES, less optimal medical compliance) would likely enhance the relative magnitude and durability of demonstrated PCI benefit (angina relief, improved QOL, ischemia reduction)