Controversies in Interventional Cardiology

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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

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Mr. G 62 yo male h/o renal failure on HD DM Hyperlipidemia h/o IHD on medical therapy Admitted with positive cardiac markers from clinic with c/o recent chest pain Cathed

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Left Coronary

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Ms W 64 yo female Class II angina past 6 to 12 months h/o HTN and hyperlipidemia GXT 7 minutes 24 seconds with Duke score -2 to – 6* with CP but no ECG changes Cathed * Moderate risk, 4 year survival 95%

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Coronary Angiography

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COURAGE Clinical Outcomes Utilizing Revascularization and Aggressive Guideline-Driven Drug Evaluation Boden WE, et al. NEJM 2007;356:1503

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PCI + Optimal Medical Therapy will be Superior to Optimal Medical Therapy Alone Hypothesis

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Primary Outcome Death or Nonfatal MI

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Death, MI, or Stroke Hospitalization for Biomarker (-) ACS Cost, Resource Utilization Quality of Life, including Angina Cost-Effectiveness Secondary Outcomes

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Randomization to PCI + Optimal Medical Therapy vs Optimal Medical Therapy alone Intensive, guideline-driven medical therapy and lifestyle intervention in both groups 2.5 to 7 year (mean 4.6 year) follow-up Design

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Inclusion Criteria Men and Women 1, 2, or 3 vessel disease (> 70% visual stenosis of proximal coronary segment) Anatomy suitable for PCI CCS Class I-III angina Objective evidence of ischemia at baseline ACC/AHA Class I or II indication for PCI

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Exclusion Criteria Uncontrolled unstable angina Complicated post-MI course Revascularization within 6 months Ejection fraction <30% Cardiogenic shock/severe heart failure History of sustained or symptomatic VT/VF

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Optimal Medical Therapy Pharmacologic Anti-platelet: aspirin; clopidogrel in accordance with established practice standards Statin: simvastatin ± ezetimibe or ER niacin ACE Inhibitor or ARB: lisinopril or losartan Beta-blocker: long-acting metoprolol Calcium channel blocker: amlodipine Nitrate: isosorbide 5-mononitrate Applied to Both Arms by Protocol and Case-Managed

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Optimal Medical Therapy Lifestyle Smoking cessation Exercise program Nutrition counseling Weight control Applied to Both Arms by Protocol and Case-Managed

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Enrollment and Outcomes 3,071 Patients met protocol eligibility criteria 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

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Baseline Clinical and Angiographic Characteristics

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Baseline Clinical and Angiographic Characteristics

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Long-Term Improvement in Treatment Targets (Group Median ± SE Data)

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Need for Subsequent Revascularization 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 1st revascularization 77 patients in the PCI group and 81 patients in the OMT group required subsequent CABG surgery Median time to subsequent revascularization was 10.0 mo in the PCI group and 10.8 mo in the OMT group

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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

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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.

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Conclusions 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 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

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Implications 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 * No ACC/AHA Class I indications outside of STEMI/NSTEMI

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Primary and Secondary Outcomes Outcome Hazard Ratio (95% Cl) Number of Events P Value

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COURAGE: SAQ Weintraub WS, et al. NEJM 2008;359:677

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What About Mr G? 62 yo male h/o renal failure on HD DM Hyperlipidemia h/o IHD on medical therapy Admitted with positive cardiac markers from clinic with c/o recent chest pain Cathed Recurrent angina on medical therapy

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Selection of Strategy: Invasive Versus Conservative Strategy 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) 2007 ACC/AHA UA/NSTEMI Guideline Revision Anderson JL, et al. J Am Coll Cardiol. 2007;50:652-726.

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Mr. G

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Ms. W 64 yo female Class II angina past 6 to 12 months h/o HTN and hyperlipidemia GXT 7 minutes 24 seconds with Duke score -2 to – 6 with CP but no ECG changes Treated with aggressive medical therapy: a beta blocker, statin, ASA, and a nitrate

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