What to choose in stable CAD- Medical therapy only or PCI or CABG?

Does Prior -block Therapy Reduce CK-MB Enzyme Release During Coronary Intervention

Samin K. Sharma, MD, FACC, FSCAIDirector, Clinical and Interventional CardiologyPresident Mount Sinai Heart NetworkDean International Clinical AffiliationZena & Michael A. Wiener Professor of MedicineMount Sinai Hospital, New York, USA

What to choose in Stable CAD: Medical Therapy Only or PCI or CABGDisclosure: Speaker bureau for Abbott Vascular Inc, The Medicines Co., BSc, Angioscore, DSI/Lilly

What are the important clinical Questions in Stable CAD?

Does the patient have angina? Does the patient have ischemia? Does the patient have anatomic lesion concordant with the ischemia (location)? Is lesion severe? Does the patient have anatomic lesions suitable for revascularization; PCI vs. CABG? What is the optimal PCI strategy and endpoints?

Appropriateness Use Criteria (AUC): PCI vs. optimal medical therapy (GMT, MMT)

Choice of Revascularization in Complex CAD: CABG vs. PCI, or hybrid approach Coronary Revascularization for Stable CAD:Current Issues

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Coronary Revascularization for Stable CAD:Current Issues

Appropriateness Use Criteria (AUC): PCI vs. optimal medical therapy (GMT, MMT)

Choice of Revascularization in Complex CAD: CABG vs. PCI, or hybrid approach

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Case# BP 2/2/2010 This is a 61 yr old male presenting with new onset mild dyspnea and chest pain, CCS Class I Medical history: Angina CCS Class I, HTN, Hyperlipidemia; Stress MPI suggestive of mild apical lateral ischemia. LVEF 60% Medications: ASA, Ramipril, Simvastatin Hemodynamics:LVEDP normalI vessel CADNormal systolic LV dysfunctionNo aortic stenosis

Cardiac Cath:LM- NormalLAD- Mild diseaseLCx- Dominant Mild disease 85% LPL1




Cardiac Cath:LM- NormalLAD- Mild diseaseLCx- Dominant Mild disease 85% LPL1RCA- Non-dominant

Cardiac Cath:LM- NormalLAD- Mild diseaseLCx- Dominant Mild disease 85% LPL1RCA- Non-dominantLVEF- Normal

Current Treatment Breakdown (USA)CDC MMWR Feb 16, 2007; Anderson et al, J Am Coll Cardiol 2002;39:1096 15 million Americans with reported CAD (CDC survey) 2 million diagnostic caths yearly 1.2 million PCI (8% of CAD)60% for UA10% for AMI30% for stable angina (ACC/NCDR) 350,000 CABG (2% of CAD) 13.5 million (approx 90%) remain on medical therapyASABeta-blockers/Nitrates/Ca++StatinsBlood pressure control

90% Medical therapy

8% PCI

2% CABG

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Trial Results: Medical Therapy vs. PCI in Stable CADTrialClinical ParametersMortality & MIAngina ReliefRepeat RevascularizationRITA-2No differencePCIPCIACMENo differencePCIPCIMASSNo differencePCINo differenceAVERTNo differencePCINo differenceMASS IINo differencePCINo differenceCOURAGENo differencePCINo difference

Superior Treatment ModalityMedicalPCINo difference

PCI can be safely deferred in pts with stable CAD ACC/AHA PCI guidelines Circulation 2006

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Optimal Medical Therapy with or without PCI for Stable Coronary Disease: COURAGE TrialStudy Design2287 patients randomized1149 pt assigned to PCI + medical therapy groupPrimary Outcome: Death and non-fatal MI at 5 yrs FUSecondary Outcomes: Quality of life, use of resources, cost-effectiveness 1138 pt assigned to medical therapy group

Boden et al. N Engl J Med 2007;356:1503

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%

Death and MI Death, MI and Stroke Death Hospitalization for ACS Revascularization19.0P = 0.62Optimal Medical Therapy with or without PCI for Stable Coronary Disease: COURAGE TrialBoden et al. N Engl J Med 2007;356:1503Cumulative Rate of Events at 4.6 Yrs Follow-UpPCI group (n = 1149)Medical therapy group (n = 1138)18.512.411.821.132.6P = 0.56P 5%

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Explanation for the Findings of COURAGE TrialACS/MI(Unstable Plaque) STABLE CAD(Stable Plaque) Vs. Thin fibrous cap Large lipid cores Fewer SMC More macrophages Less collagen Outward remodeling (less occlusion) Thick fibrous cap Smaller lipid cores More SMC Few macrophages More collagen Inward remodeling (more occlusion)

Plaque RuptureMI/Death

Supply-Demand Mismatch Ischemia/AnginaTreatment:PCI Medical Rx

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ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary RevascularizationPatel et al. JACC 2009;53:530-553

ACCF/SCAI/STS/AATS/AHA/ASNC 2012 Appropriateness Criteria for Coronary RevascularizationPatel et al. JACC 2012;59:857.

Appropriateness Score Based on the 9-Point ContinuumAppropriate Care, median score 7 to 9: Procedures or treatments that fall into this category are considered an appropriate option for individual care plans, although not always necessary, depending on physician judgment and patient-specific preferences.

May be Appropriate Care, median score 4 to 6: Treatments or procedures in this classification are at times, an appropriate option for management of patients in this population, due to variable evidence or agreement regarding the benefits/risks ratio, potential benefit based on practice experience in the absence of evidence; and/or variability in the population. Potential Efficacy of treatment in this category need to be determined through consultation between the patient and the doctor based on clinical variables and patient preference.

Rarely Appropriate Care, median score 1 to 3: Treatments and conditions in this category are rarely an appropriate option for management of patients in this population due to lack of a clear benefit/risk advantage; rarely an effective option for individual car plans. Exception should have documentation of the clinical reasons for proceeding with this care option.

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Appropriateness of Coronary Revascularization Important Issues:Symptoms: asymptomatic, Class I-II vs. Class III-IVNon-invasive risk assessment: low, intermediate or high riskMaximal medical therapy: 2 Drugs-Nitrates, Ca+ B, B blocker or RanexaCoronary Anatomy Findings

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary RevascularizationPatel et al. JACC 2009;53:530-553Grading of AP by the Canadian Cardiovascular Society Classification SystemClass IOrdinary physical activity does not cause angina, such as walking, climbing stairs. Angina occurs with strenuous, rapid or prolonged exertion at work or recreation.

Class IISlight limitation of ordiany activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Angina occurs on walking more than 2 blocks on the level and clilmbing more than one flight of ordinary stairs at a normal pace and in normal condition.

Class IIIMarked limitations in ordinary physical activity. Angina occurs on walking one to two blocks on the level and climbing one flight of stairs in normal conditions and at a normal pace.

Class IVInability to carry on any physical activity without discomfort anginal symptoms may be present at rest.

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary RevascularizationPatel et al. JACC 2009;53:530-553Noninvasive Risk StratificationHigh-Risk (greater than 3% annual mortality rate)1. Severe resting left ventricular dysfunction (LVEF less than 35%)2. High-risk treadmill score (score less than or equal to 11)3. Severe exercise left ventricular dysfunction (exercise LVEF less than 35%)4. Stress-induced large perfusion defect (particularly if anterior)5. Stress-induced multiple perfusion defects of moderate size6. Large, fixed perfusion defect with LV dilation or increased lung uptake (thallium-201)7. Stress-induced moderate perfusion defect with LV dilation or increased lung uptake (thallium-201)8. Echocardiographic wall motion abnormality (involving greater than two segments) developing at low dose of dobutamine (less than or equal to 10 mg/kg/min) or at a low heart rate (less than 120 beats/min)9. Stress echocardiographic evidence of extensive ischemiaIntermediate-Risk (1% to 3% annual mortality rate)1. Mild/moderate resting left ventricular dysfunction (LVEF equal to 35% to 49%)2. Intermediate-risk treadmill score (11 less than score less than 5)3. Stress-induced moderate perfusion defect without LV dilation or increased lung intake (thallium-201)4. Limited stress echocardiographic ischemia with a wall motion abnormality only at higher doses of dobutamine involving less than or equal to two segmentsLow-Risk (less than 1% annual mortality rate)1. Low-risk treadmill score (score greater than or equal to 5)2. Normal or small myocardial perfusion defect at rest or with stress3. Normal stress echocardiographic wall motion or no change of limited resting wall motion abnormalities during stress

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Patel et al. JACC 2009;53:530-553Appropriateness Ratings by Low-Risk Findings on Noninvasive Imaging Study and Asymptomatic Low Risk Findings on Noninvasive StudyAsymptomaticSymptomsMed. RxStress TestMed. RxClass III or IVMax RxUAAAAHigh RiskMax RxUAAAAClass I or IIMax RxUUAAAHigh RiskNo/min RxUUAAAAsymptomaticMax RxIIUUUInt. RiskMax RxUUUUAClass III or IVNo/min RxIUAAAInt. RiskNo/min RxIIUUAClass I or IINo/min RxIIUUULow RiskMax RxIIUUUAsymptomaticNo/min RxIIUUULow RiskNo/min RxIIUUUCoronary AnatomyCTO of 1 vz; no other disease1-2 vz. disease; no prox LAD1 vz. Disease of prox LAD2 vz. Disease with prox LAD3 vz. disease; no Left MainCoronary AnatomyCTO of 1 vz; no other disease1-2 vz. disease; no prox LAD1 vz. disease of prox LAD2 vz. disease with prox LAD3 vz. Disease; no Left Main

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Patel et al. JACC 2009;53:530-553Appropriateness Ratings by Intermediate-Risk Findings on Noninvasive Imaging Study and CCS Class I or II Angina Intermediate Risk Findings on Noninvasive StudyCCS Class I or II AnginaSymptomsMed. RxStress TestMed. RxClass III or IVMax RxAAAAAHigh RiskMax RxAAAAAClass I or IIMax RxUAAAAHigh RiskNo/min RxUAAAAAsymptomaticMax RxUUUUAInt. RiskMax RxUAAAAClass III or IVNo/min RxUUAAAInt. RiskNo/min RxUUUAAClass I or IINo/min RxUUUAALow RiskMax RxUUAAAAsymptomaticNo/min RxIIUUALow RiskNo/min RxIIUUUCoronary AnatomyCTO of 1 vz; no other disease1-2 vz. disease; no prox LAD1 vz. disease of prox LAD2 vz. disease with prox LAD3 vz. disease; no Left MainCoronary AnatomyCTO of 1 vz; no other diseae1-2 vz. disease; no prox LAD1 vz. disease of prox LAD2 vz. disease with prox LAD3 vz. disease; no Left Main

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Patel et al. JACC 2009;53:530-553Appropriateness Ratings by High-Risk Findings on Noninvasive Imaging Study and CCS Class III or IV AnginaHigh Risk Findings on Noninvasive StudyCCS Class III or IV AnginaSymptomsMed. RxStress TestMed. RxClass III or IVMax RxAAAAAHigh RiskMax RxAAAAAClass II or IIIMax RxAAAAAHigh RiskNo/min RxAAAAAAsymptomaticMax RxUAAAAInt. RiskMax RxAAAAAClass III or IVNo/min RxAAAAAInt. RiskNo/min RxUUAAAClass I or IINo/min RxUAAAALow RiskMax RxUAAAAAsymptomaticNo/min RxUUAAALow RiskNo/min RxIUAAACoronary AnatomyCTO of 1 vz; no other disease1-2 vz. disease; no prox LAD1 vz. disease of prox LAD2 vz. disease with prox LAD3 vz. disease; no Left MainCoronary AnatomyCTO of 1 vz; no other disease1-2 vz. disease; no prox LAD1 vz. disease of prox LAD2 vz. disease with prox LAD3 vz. disease; no Left Main



Appropriateness Criteria for Coronary Revascularization

Case# BP 2/2/2010 This is a 61 yr old male presenting with new onset mild dyspnea and chest pain, CCS Class I Medical history: Angina CCS Class I, HTN, Hyperlipidemia; Stress MPI suggestive of mild apical lateral ischemia. LVEF 60% Medications: ASA, Ramipril, Simvastatin Hemodynamics:LVEDP normalI vessel CADNormal systolic LV dysfunctionNo aortic stenosisNo PCI was done as per guidelines.Pt was discharged on Metoprolol XL 25mg daily and ISMN 30 mg daily

Case# BP 4/23/2010 Pt continued to have mild symptoms on Metoprolol XL/ISM (not to say both patient and referring physician were upset with me) We brought patient back for elective PCI after 8 weeks of MMT for continued symptoms

Cardiac Cath/PCI:LM- NormalLAD- Mild diseaseLCx- Dominant Mild disease 85% LPL1RCA- Non-dominantLVEF- NormalPCI: Xience V DES (3/28mm)






Case# BP 4/23/2010 Pt continued to have mild symptoms on Metoprolol and ISMN (not to say both patient and referring physician were upset with me) We brought patient back for elective PCI for continued symptom despite MMT Intervention: Successful intervention of LCx-LPL1 (DES Xience V)

Same day discharge with recommendations: - ASA 81 mg daily lifelong and Prasugrel 5mg daily for 1 year- Aggressive CAD risk factor modification- Continue maximal medical therapy

84.611.61.111.20.338.04.198.650.4AppropriateUncertainInappropriate%Appropriateness Use Criteria for PCI

ALL

ACS PCI (71%)

Elective PCI (29%)

AUC Criteria from ACC-NCDR Results (n=500,00)Paul Chan. JAMA 2011;306:53.

Hannan E et al. JACC 2012;59:1870.

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Appropriateness of Revascularization by PCI: NY State vs. MSH for Stable CAD in 2010NYS NYS NYS MSH MSH MSH NStable CAD %Not Rated %NYS 1474337.427.5MSH257562.313.7

%

4040

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MSH Appropriateness of Revascularization by PCI: NYS Data Report %

Inappropriate Category of PCIAppropriate Category of PCI%

4141

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Proportion of non-ACS PCI procedures at MSH classified InappropriateAUC Metrics at MSH compared to US; ACC-NCDR (n=1400 hospitals; >1.3 million PCIs) for Q1-3, 2013Appropriateness of PCI

%

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Referral for Invasive work up of Stable CAD Patient

Stable CAD scheduled for Cath CCS Class III IV ( 2 blocks, > 1 flight) Not on MMTAppropriate Appropriate Inappropriate Intermediate on non invasive Study (EF, Intermediate perfusion default Appropriate

> 2Antianginal If notInappropriate

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Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial:Data from ACC-NCDR CathPCI Registry

PRE- COURAGE (n=173,416)Post- COURAGE (n=293,795)%OMT Pre-PCIOMT Post-PCI43.5W Borden et al. JAMA 2011;305:1882All Cases (N=467,211)COURAGE Trial type Cases (N=265,184)40.041.161.864.344.763.566.0OMT Pre-PCIOMT Post-PCI

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Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial: Data fro ACC-NCDR CathPCI Registry

PRE- COURAGE (n=173,416)Post- COURAGE (n=293,795)%OMT Pre-PCIOMT Post-PCI43.5W Borden et al. JAMA 2011;305:1882All Cases (N=467,211)COURAGE Trial type Cases (N=265,184)40.041.161.864.344.763.566.0OMT Pre-PCIOMT Post-PCIImplications: There is a large practice gap in medical care of PCI pts.Important opportunity to develop innovative and aggressive strategies to increase OMT in PCI pts, both before PCI (by referring MDs) andafter PCI (by the Interventional team)

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Schematic representation of various functional hemodynamic measurements

Diagnostic IVUS Intermediate or Inconclusive or Borderline Angiographic Lesion in a Symptomatic Patient

Lumen CSA of

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What to choose in stable CAD- Medical therapy only or PCI or CABG?