Controversies in Interventional Cardiology

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Controversies in Interventional Cardiology

  1. 1. Controversies in Interventional Cardiology Larry S. Dean, MD Professor of Medicine and Surgery University of Washington School of Medicine Director, UW Medicine Regional Heart Center
  2. 2. Mr. G <ul><li>62 yo male </li></ul><ul><li>h/o renal failure on HD </li></ul><ul><li>DM </li></ul><ul><li>Hyperlipidemia </li></ul><ul><li>h/o IHD on medical therapy </li></ul><ul><li>Admitted with positive cardiac markers from clinic with c/o recent chest pain </li></ul><ul><li>Cathed </li></ul>
  3. 3. Left Coronary
  4. 4. Ms W <ul><li>64 yo female </li></ul><ul><li>Class II angina past 6 to 12 months </li></ul><ul><li>h/o HTN and hyperlipidemia </li></ul><ul><li>GXT 7 minutes 24 seconds with Duke score -2 to – 6* with CP but no ECG changes </li></ul><ul><li>Cathed </li></ul>* Moderate risk, 4 year survival 95%
  5. 5. Coronary Angiography
  6. 6. COURAGE C linical O utcomes U tilizing R evascularization and A ggressive G uideline-Driven Drug E valuation Boden WE, et al. NEJM 2007;356:1503
  7. 7. PCI + Optimal Medical Therapy will be Superior to Optimal Medical Therapy Alone Hypothesis
  8. 8. Primary Outcome Death or Nonfatal MI
  9. 9. <ul><li>Death, MI, or Stroke </li></ul><ul><li>Hospitalization for Biomarker (-) ACS </li></ul><ul><li>Cost, Resource Utilization </li></ul><ul><li>Quality of Life, including Angina </li></ul><ul><li>Cost-Effectiveness </li></ul>Secondary Outcomes
  10. 10. <ul><li>Randomization to PCI + Optimal Medical Therapy vs Optimal Medical Therapy alone </li></ul><ul><li>Intensive, guideline-driven medical therapy and lifestyle intervention in both groups </li></ul><ul><li>2.5 to 7 year (mean 4.6 year) follow-up </li></ul>Design
  11. 11. Inclusion Criteria <ul><li>Men and Women </li></ul><ul><li>1, 2, or 3 vessel disease </li></ul><ul><li>(> 70% visual stenosis of proximal coronary segment) </li></ul><ul><li>Anatomy suitable for PCI </li></ul><ul><li>CCS Class I-III angina </li></ul><ul><li>Objective evidence of ischemia at baseline </li></ul><ul><li>ACC/AHA Class I or II indication for PCI </li></ul>
  12. 12. Exclusion Criteria <ul><li>Uncontrolled unstable angina </li></ul><ul><li>Complicated post-MI course </li></ul><ul><li>Revascularization within 6 months </li></ul><ul><li>Ejection fraction <30% </li></ul><ul><li>Cardiogenic shock/severe heart failure </li></ul><ul><li>History of sustained or symptomatic VT/VF </li></ul>
  13. 13. <ul><li>Pharmacologic </li></ul><ul><li>Anti-platelet: aspirin; clopidogrel in accordance with established practice standards </li></ul><ul><li>Statin: simvastatin ± ezetimibe or ER niacin </li></ul><ul><li>ACE Inhibitor or ARB: lisinopril or losartan </li></ul><ul><li>Beta-blocker: long-acting metoprolol </li></ul><ul><li>Calcium channel blocker: amlodipine </li></ul><ul><li>Nitrate: isosorbide 5-mononitrate </li></ul>Optimal Medical Therapy Applied to Both Arms by Protocol and Case-Managed
  14. 14. Optimal Medical Therapy <ul><li>Lifestyle </li></ul><ul><li>Smoking cessation </li></ul><ul><li>Exercise program </li></ul><ul><li>Nutrition counseling </li></ul><ul><li>Weight control </li></ul>Applied to Both Arms by Protocol and Case-Managed
  15. 15. Enrollment and Outcomes <ul><li>3,071 Patients met protocol eligibility criteria </li></ul>2,287 Consented to Participate (74% of protocol-eligible patients) 1,149 Were assigned to PCI group 46 Did not undergo PCI 27 Had a lesion that could not be dilated 1,006 Received at least one stent 784 Did not provide consent - 450 Did not receive MD approval - 237 Declined to give permission - 97 Had an unknown reason 107 Were lost to follow-up 1,149 Were included in the primary analysis 1,138 Were assigned to medical-therapy group 97 Were lost to follow-up 1,138 Were included in the primary analysis
  16. 16. Baseline Clinical and Angiographic Characteristics Characteristic PCI + OMT (N=1149) OMT (N=1138) P Value Age – yr. 62 ± 10.1 62 ± 9.7 0.54 Sex % 0.95 Male 85 % 85 % Female 15 % 15 % Race or Ethnic group % 0.64 White 86 % 86 % Non-white 14 % 14 % CLINICAL Angina (CCS – class) % 0.24 0 and I 42 % 43 % II and III 59 % 56 % Median angina duration 5 (1-15) months 5 (1-15) months Median angina episodes/week 3 (1-6) 3 (1-6)
  17. 17. Baseline Clinical and Angiographic Characteristics Characteristic PCI + OMT (N=1149) OMT (N=1138) P Value CLINICAL Stress test 0.84 Total patients - % 85 % 86 % Treadmill test 57 % 57 % 0.84 Pharmacologic stress 43 % 43 % Nuclear imaging - % 70 % 72 % 0.59 Single reversible defect 22 % 23 % 0.09 Multiple reversible defects 65 % 68 % 0.09 ANGIOGRAPHIC Vessels with disease – % 0.72 1, 2, 3 31, 39, 30 % 30, 39, 31 % Disease in graft 62 % 69 % 0.36 Proximal LAD disease 31 % 37 % 0.01 Ejection fraction 60.8 ± 11.2 60.9 ± 10.3 0.86
  18. 18. Long-Term Improvement in Treatment Targets (Group Median ± SE Data) Treatment Targets Baseline 60 Months PCI +OMT OMT PCI +OMT OMT SBP 131 ± 0.77 130 ± 0.66 124 ± 0.81 122 ± 0.92 DBP 74 ± 0.33 74 ± 0.33 70 ± 0.81 70 ± 0.65 Total Cholesterol mg/dL 172 ± 1.37 177 ± 1.41 143 ± 1.74 140 ± 1.64 LDL mg/dL 100 ± 1.17 102 ± 1.22 71 ± 1.33 72 ± 1.21 HDL mg/dL 39 ± 0.39 39 ± 0.37 41 ± 0.67 41 ± 0.75 TG mg/dL 143 ± 2.96 149 ± 3.03 123 ± 4.13 131 ± 4.70 BMI Kg/M ² 28.7 ± 0.18 28.9 ± 0.17 29.2 ± 0.34 29.5 ± 0.31 Moderate Activity (5x/week) 25% 25% 42% 36%
  19. 19. Need for Subsequent Revascularization <ul><li>At a median 4.6 year follow-up, 21.1% of the PCI patients required an additional revascularization, compared to 32.6% of the OMT group who required a 1 st revascularization </li></ul><ul><li>77 patients in the PCI group and 81 patients in the OMT group required subsequent CABG surgery </li></ul><ul><li>Median time to subsequent revascularization was 10.0 mo in the PCI group and 10.8 mo in the OMT group </li></ul>
  20. 20. Survival Free of Death from Any Cause and Myocardial Infarction Number at Risk Medical Therapy 1138 1017 959 834 638 408 192 30 PCI 1149 1013 952 833 637 417 200 35 Years 0 1 2 3 4 5 6 0.0 0.5 0.6 0.7 0.8 0.9 1.0 PCI + OMT Optimal Medical Therapy (OMT) Hazard ratio: 1.05 95% CI (0.87-1.27) P = 0.62 7
  21. 21. Freedom from Angina During Long-Term Follow-up The comparison between the PCI group and the medical-therapy group was significant at 1 year ( P<0.001) and 3 years (P=0.02) but not at baseline or 5 years. Characteristic PCI + OMT OMT CLINICAL Angina free – no. <ul><ul><li>Baseline </li></ul></ul>12% 13% <ul><ul><li>1 Yr </li></ul></ul>66% 58% <ul><ul><li>3 Yr </li></ul></ul>72% 67% <ul><ul><li>5 Yr </li></ul></ul>74% 72%
  22. 22. Conclusions <ul><li>As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, MI, or other major cardiovascular events when added to optimal medical therapy </li></ul><ul><li>As expected, PCI resulted in better angina relief during most of the follow-up period, but medical therapy was also remarkably effective, with no between–group difference in angina-free status at 5 years </li></ul>
  23. 23. Implications <ul><li>Our findings reinforce existing* ACC/AHA clinical practice guidelines, which state that PCI can be safely deferred in patients with stable CAD, even in those with extensive, multivessel involvement and inducible ischemia, provided that intensive, multifaceted medical therapy is instituted and maintained </li></ul>* No ACC/AHA Class I indications outside of STEMI/NSTEMI
  24. 24. Primary and Secondary Outcomes Outcome Hazard Ratio (95% Cl) Number of Events P Value PCI+OMT OMT Death and nonfatal MI 211 202 1.05 (0.87-1.27) 0.62 Death 68 74 Periprocedural MI 35 9 MI 108 119 Death, MI, and stroke 222 213 1.05 (0.87-1.27) 0.62 Hospitalization for ACS 135 125 1.07 (0.84-1.37) 0.56 Death 85 95 0.87 (0.65-1.16) 0.38 Total nonfatal MI 143 128 1.13 (0.89-1.43) 0.33 Periprocedural MI 35 9 MI 108 119 Revascularization (PCI or CABG) 228 348 0.60 (0.51-0.71) <0.001
  25. 25. Copyright ©2008 American Heart Association Shaw, L. J. et al. Circulation 2008;117:1283-1291 COURAGE: Survival for Patients by Residual Ischemia After 6 to 18 months of PCI+OMT or OMT
  26. 26. COURAGE: SAQ Weintraub WS, et al. NEJM 2008;359:677
  27. 27. What About Mr G? <ul><li>62 yo male </li></ul><ul><li>h/o renal failure on HD </li></ul><ul><li>DM </li></ul><ul><li>Hyperlipidemia </li></ul><ul><li>h/o IHD on medical therapy </li></ul><ul><li>Admitted with positive cardiac markers from clinic with c/o recent chest pain </li></ul><ul><li>Cathed </li></ul><ul><li>Recurrent angina on medical therapy </li></ul>
  28. 28. Selection of Strategy: Invasive Versus Conservative Strategy <ul><li>An early invasive strategy (ie, diagnostic angiography with intent to perform revascularization) is indicated in UA/NSTEMI patients who have refractory angina or hemodynamic or electrical instability (Class I, Level of Evidence: B) </li></ul>2007 ACC/AHA UA/NSTEMI Guideline Revision Anderson JL, et al. J Am Coll Cardiol. 2007;50:652-726.
  29. 29. Mr. G
  30. 30. Ms. W <ul><li>64 yo female </li></ul><ul><li>Class II angina past 6 to 12 months </li></ul><ul><li>h/o HTN and hyperlipidemia </li></ul><ul><li>GXT 7 minutes 24 seconds with Duke score -2 to – 6 with CP but no ECG changes </li></ul><ul><li>Treated with aggressive medical therapy: a beta blocker, statin, ASA, and a nitrate </li></ul>

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