COURAGE to Leave Diseased Arteries Alone

Transcription

1 COURAGE to Leave Diseased Arteries Alone Spencer King MD MACC, FSCAI St. Joseph s s Heart and Vascular Institute Professor of Medicine Emeritus Emory Univ. Atlanta, USA Conflict: I am an Interventionalist

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3 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques CTA Characterization Fuqua Heart Center of Atlanta The ATLANTA Project

4 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques Fuqua Heart Center of Atlanta Plaque Geometry Features: General Morphology A. E. B. F. C. G. D. H. The ATLANTA Project

5 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques Fuqua Heart Center of Atlanta Non-Calcified Plaque Plaque Composition Qualitative Analysis Mixed Plaque Calcified Plaque No standardized definition at this time The ATLANTA Project

6 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques Plaque Composition Qualitative Analysis Fuqua Heart Center of Atlanta 0% 13% 32% TCFA 8% NCP Mixed CAP The ATLANTA Project Pundziute et al. JACC Int; April 2008.

7 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques Correlation Fuqua Heart Center of Atlanta The ATLANTA Project Voros S. J Am Coll Cardiol INT. 2008; April.

8 Assessment of Tissue characteristics, Lesion morphology and hemodynamics by Angiography with fractional flow reserve, intravascular ultrasound and virtual histology and Non-invasive computed Tomography in Atherosclerotic plaques Fuqua Heart Center of Atlanta ATLANTA QCTA Lesion-Based Analysis The ATLANTA Project Rinehart, Voros. i2 Summit 2008; Chicago.

9 Coronary Heart Disease: Clinical Presentations ST Elevation MI Stents Acute Coronary Syndromes---- Stents?Meds?CABG Stable Symptoms Medical (or stents) (or CABG)

10 PCI or Medical Therapy

11 Acute Coronary Syndromes

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13 Recommendations for PCI in Patients With UA/NSTEMI I IIa IIb III An early invasive PCI strategy is indicated for patients with UA/NSTEMI who have no serious comorbidity and who have coronary lesions amenable to PCI and any of the high-risk features listed in the previous section. I IIa IIb III PCI (or CABG) is recommended for UA/NSTEMI patients with 1-1 or 2-vessel 2 CAD with or without significant proximal left anterior descending (LAD) CAD but with a large area of viable myocardium and high-risk criteria on noninvasive testing. *Specific recommendations and their level of evidence can be found in the previous section on Initial Conservative Versus Initial Invasive Strategies.

14 Relative Risk of All-Cause Mortality for Early Invasive Therapy Compared With Conservative Therapy at a Mean Follow-Up of 2 y Bavry AA, et al. J Am Coll Cardiol 2006;48: Reprinted with permission from Elsevier. CI = confidence interval; RR = relative risk.

15 Early Invasive vs. Selective Invasive Management for Acute Coronary Syndromes 1200 NSTEMI pts with + troponin T Recommended medical therapy: ASA and clopidogerl 300, enoxaparin x 48 h, atorvastatin 80 mg Outcomes: MACE 22.7% invasive vs. 21.2% selective Mortality 2.5% in both groups de Winter et al NEJM 9/15/2005

16 Initial Conservative Versus Initial Invasive Strategies I IIa IIb III New I IIa IIb III In initially stabilized patients, an initially conservative (i.e., a selectively invasive) strategy may be considered as a treatment strategy for UA/ NSTEMI patients (without serious comorbidities or contraindications to such procedures) who have an elevated risk for clinical events including those who are troponin positive. The decision to implement an initial conservative (vs. initial invasive) strategy in these patients may be made by considering physician and patient preference. I IIa IIb III New An invasive strategy may be reasonable in patients with chronic renal insufficiency.

17 Stable Ischemic Heart Disease

18 Overall Survival 1.0 PCI + OMT OMT Hazard ratio: % CI ( ) P = 0.38 Number at Risk Years Medical Therapy PCI

19 Long-Term Improvement in Treatment Targets (Group Median ± SE Data) Treatment Targets Baseline 60 Months PCI +OMT OMT PCI +OMT OMT SBP 131 ± ± ± ± 0.92 SBP DBP 74 ± ± ± ± 0.65 DBP Total Cholesterol mg/dl 172 ± ± ± ± 1.64 Total Cholesterol mg/dl LDL mg/dl 100 ± ± ± ± 1.21 LDL mg/dl HDL mg/dl 39 ± ± ± ± 0.75 HDL mg/dl TG mg/dl 143 ± ± ± ± 4.70 TG mg/dl BMI Kg/M² 28.7 ± ± ± ± 0.31 BMI Kg/M Moderate Activity (5x/week) 25% 25% 42% 36%

20 Annual cardiac mortality was less than 0.5%

21 Current Concepts Coronary artery lesions are progressive and the fear is they may lead to myocardial infarction and death PCI and CABG alleviate coronary obstructions and prevent myocardial infarction and death

22 What PCI has actually been documented to do as of 2008? Relieve angina In STEMI, to reduce mortality

23 What does medical therapy do? Reduce angina Reduce myocardial infarction Prolong life

24 PCI vs Medical Therapy in Stable CAD: Meta-Analysis End Points Risk Ratio (95% CI) Angina* 0.70 (0.50 to 0.98) Fatal and non-fatal 1.42 (0.90 to 2.25) Myocardial infarction Death 1.32 (0.65 to 2.70) PCI* 1.29 (0.71 to 3.36) CABG 1.59 (1.09 to 2.32) * Test of heterogeneity P< Favours PTCA Favours Medical Rx Pooled risk ratios for various end points from six randomized controlled trials comparing percutaneous transluminal coronary angioplasty (PTCA) with medical treatment in patients with non-acute coronary heart disease: (CABG: coronary artery bypass grafting; n=953 for PTCA and 951 for medical treatment)

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27 PROVE IT RESULTS: All-Cause Death or Major CV Events in All Randomized Subjects 30 Pravastatin 40mg 537/2063 (26.3%) % with Event Atorvastatin 80mg 464/2099 (22.4%) 16% RRR at 2 years (p = 0.005) Months of Follow-up

28 Relative Risk for CHD What is the Optimal HDL-C? Atherosclerosis Risk in Communities (ARIC) Study Women Medians: mmol/l mg/dl Sharrett AR, et al. Circulation. 2001;104: HDL-C Quintiles Adjusted for age and race; 12-year follow-up

29 HDL Subclass Change T /99 5/99 HDLC % HDL2b 15 % 40 % +167% HDL2a 32 % 28 % HDL3a 34 % 18 % HDL3b 16 % 9 % HDL3c 3 % 5 % Niaspan 0 1,000 3/99 5/99 HDL2b = 15 % HDL 2b 2a 3a 3b 3c HDL2b = 40 % Statins do NOT do this CGHDI

30 2007 CGHDI CV Events & Clinical Trials 25% vs. 90% RR Reduction Percent Clinical Events < % Reduction in Risk -----> 80-90% Risk -16% Reduction CDP-NA SSSS -31% -15% -22% -20% -23% Chol Lowering -23%-26% Worked PROVEIT HPS VA HIT LIPID CARE TNT Chol Lowering Did NOT Work -78% -17% -28% -29% -42% -34% -81% -92% 81% 78% 92% CPPT-LRC AFCAPS/TEX WOSCOPS Oslo Heart Helsinki CLAS FATS HATS (Superko & King. Circulation 2008;117:560-8) % Control % Treatmen Rx Worked

31 Second Generation Stent Trials Event Rate 50% 40% 30% 10% Composite Restenosis Non-Restenosis 0% Cutlip DE, Circulation, 2004 Years 5

32 What is the Future of medical therapy? INDIVIDUALIZED THERAPY Gene Chips Reverse Cholesterol Transport LCAT immunization rhdl AI Milano Gene transfection CETP ABCA1 SRB1

33 Future Concepts Atherosclerosis is stabilized Coronary events become rare MI and death from acute coronary occlusion no longer feared Therefore coronary PCI may be limited to STEMI and angina relief Interventional cardiologists should prepare for this possibility

34 BARI 2D Current Status

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36 Randomization Strata by Site Determined Number of Diseased Vessels 100% 80% 60% 40% 20% 7% CABG Stratum 93% 24% 76% PCI Stratum 55% 45% 0% Single VD (N=612) Double VD (N=795) Triple VD (N=960) 1/30/06

37 Intended Completeness of Revascularization by Mode of Revascularization (if randomized to revascularization) % of pts PCI Intended CABG Intended 0 Anatomic CR Functional CR Neither

38 Intervention vs. Medical Tx This is now the wrong question Medical therapy is now recognized as essential The new question is : Is revascularization in addition to medical therapy needed and in which patients? Are statins enough?

39 Interventional Cardiologists have a major opportunity and responsibility to provide or facilitate optimal care of patients they stent