2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Jointly sponsored for CME credit by the University of Nebraska Medical Center and Practice Point Communications, Inc. Supported by an independent educational grant from Gilead Sciences Medical Affairs Content Development Faculty Julius M. Gardin, MD, MBA, FACC, FACP, FAHA Professor and Chair Department of Medicine Hackensack University Medical Center Professor of Medicine University of Medicine and Dentistry of New Jersey New Jersey Medical School Hackensack, NJ 2 Disclosure Information: Content Development Faculty Julius M. Gardin, MD, MBA, FACC, FACP, FAHA − Honorarium • Gilead Sciences 3 Copyright & Permissions 2012 SIHD Guidelines Update is Copyrighted 2013 by Practice Point Communications, unless otherwise noted. All rights reserved. Participants may use these slides for their educational presentations but may not publish or post online without permission from Practice Point Communications, Inc. 4 Learning Objectives (CME/CNE/CPE) At the completion of this educational activity, participants should be able to: − Apply diagnostic modalities in symptomatic patients with suspected stable ischemic heart disease (SIHD) based on the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease − Risk stratify my patients with SIHD for the probability of developing complications based on the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease − Appropriately select optimal medical therapy and revascularization for my patients with SIHD based on the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease 5 Spectrum of Ischemic Heart Disease: Relevant Guidelines Asymptomatic (SIHD) Asymptomatic, Without Known IHD New-Onset Chest Pain Stable Angina or Low-Risk UA* (SIHD, UA/NSTEMI, STEMI) (SIHD, PCI/CABG) Known IHD (CV Risk) Non-Cardiac Chest Pain Sudden Cardiac Death (VA-SCD) Acute Coronary Syndromes (UA/NSTEMI, STEMI, PCI/CABG) Known IHD Relevant guidelines are in parentheses. *UA: features of low-risk unstable angina include age <70 years, exertional pain lasting <20 minutes, pain not rapidly accelerating, normal or unchanged ECG, no elevation of cardiac markers. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 6 2012 ACCF/AHA Guideline for the Diagnosis and Management of SIHD Choices regarding diagnostic and therapeutic options should be made through a process of shared decision making − Patient and provider Explain − Risks − Benefits − Costs Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 7 ACCF/AHA Classification of Recommendations and Levels of Evidence Size of Treatment Effect Estimate of Certainty (Precision) of Treatment Effect Level A − Multiple populations evaluated − Multiple randomized clinical trials or metaanalyses Level B − Limited populations evaluated − Single randomized or non-randomized studies Level C − Very limited populations evaluated − Expert consensus opinion, case studies, or standard of care Class I Class IIa Class III No Benefit or Harm Benefit >>> Risk Benefit >> Risk Benefit > Risk (SHOULD be performed/administered) (IT IS REASONABLE to be performed/administered Tx) (Procedure/treatment MAY BE CONSIDERED) • Is useful/effective • Sufficient evidence • Favors being useful/effective • Some conflicting evidence • Usefulness and efficacy less well • Is useful/effective • Evidence from single randomized trial or nonrandomized studies • Favors being useful/effective • Some conflicting evidence • Usefulness or efficacy less well • Is useful or effective • Only expert opinion, case studies, or standard of care • Favors being useful or effective • Only diverging expert opinion, case studies, or standard of care • Usefulness or efficacy less well Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 8 Class IIb established • Greater conflicting evidence established • Greater conflicting evidence established • Only diverging expert opinion, case studies, or standard of care • Not useful or effective • Some conflicting evidence • Not useful or effective or may be harmful • Evidence from single randomized trial or nonrandomized studies • Not useful or effective or may be harmful • Only expert opinion, case studies, or standard of care ACP Interpretation of ACCF/AHA SIHD Guideline: Key Diagnostic Questions Diagnosis How should a clinician evaluate a patient with chest pain that is consistent with IHD? What is the role of noninvasive and angiographic testing in the diagnosis of SIHD? Management What should be the approach to modifying cardiovascular risk factors to reduce the mortality and morbidity associated with SIHD? What is the role of coronary revascularization in reducing mortality and morbidity associated with SIHD? How should chronic anginal symptoms be managed with medications? Qaseem A, et al. Ann Intern Med. 2012;157:729-734. Qaseem A, et al. Ann Intern Med. 2012;157:735-745. 9 Diagnosis: Suspected IHD (or Change in Clinical Status in Known IHD Patient) Intermediate or High-Risk Unstable Angina No Comprehensive Clinical Assessment of Risk Yes See ACCF/AHA UA/NSTEMI Guidelines Personal Characteristics Coexisting Cardiac and Medical Conditions Health Status Symptoms or findings suggest high-risk lesion(s)? OR Prior sudden death or serious ventricular arrhythmia? OR Prior stent in unprotected left main coronary artery? No Continue Assessment Initiate or continue Guideline-Directed Medical Therapy Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 10 Yes Initiate Guideline-Directed Medical Therapy (consider coronary revascularization to improve survival) Clinical Classification of Chest Pain Typical angina (definite) 1. Substernal chest discomfort with a characteristic quality and duration that is 2. Provoked by exertion or emotion and 3. Relieved by rest or nitroglycerin Atypical angina (probable) − Meets 2 of the characteristics of typical angina Non-cardiac chest pain − Meets <1 of the typical anginal characteristics Cannon CP, et al. In: Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 9th Edition. 2012. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 11 Pretest Likelihood of CAD by Cardiac Catheterization in Symptomatic Patients (Diamond/Forrester and CASS) Atypical Angina Likelihood of CAD (%) 27% 13% 2% 4% 3% 20% 14% Likelihood of CAD (%) 100 Female Male Typical Angina 100 Female Male 80 72% 65% 60 51% 40 34% 51% 31% 22% 20 Likelihood of CAD (%) Non-Anginal Chest Pain 80 Female Male 87% 76% 60 93% 94% 86% 73% 55% 40 26% 20 12% 7% 30-39 40-49 50-59 60-69 0 30-39 40-49 50-59 60-69 Age (years) CASS: Coronary Artery Surgery Study. Diamond GA, et al. N Engl J Med. 1979;300:1350-1358. Chaitman BR, et al. Circulation. 1981;64:360-367. 12 Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Age (years) 0 30-39 40-49 50-59 60-69 Age (years) 2012 ACCF/AHA Guideline Criteria for Non-Invasive Risk Stratification Low risk (<1% annual death or MI) − Low-risk treadmill score (score >5) or no new ST-segment changes or exercise-induced chest pain symptoms, when achieving maximal levels of exercise − Normal or small myocardial perfusion defect at rest or with stress encumbering <5% of myocardium* − Normal stress echocardiographic wall motion or no change of limited resting wall motion abnormalities during stress* − CAC <100 Agatston units − No coronary stenosis >50% on CCTA *Although published data are limited, patients with these findings will probably not be at low risk in the presence of either a high-risk treadmill score or severe resting LV dysfunction (LV ejection fraction <35%). CAC: coronary artery calcium; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 13 2012 ACCF/AHA Guideline Criteria for Non-Invasive Risk Stratification Intermediate risk (1% to 3% annual mortality rate) − Mild/moderate resting LV dysfunction (LVEF 35% to 49%) not readily explained by non-coronary causes − Resting perfusion abnormalities in 5% to 9.9% of the myocardium in patients without a history or prior evidence of MI − >1 mm of ST-segment depression occurring with exertional symptoms − Stress-induced perfusion abnormalities encumbering 5% to 9.9% of the myocardium or stress segmental scores (in multiple segments) indicating 1 vascular territory with abnormalities but without LV dilation − Small wall motion abnormality involving 1 to 2 segments and only 1 coronary bed − CAC score 100 to 399 Agatston units − 1-vessel CAD with >70% stenosis or moderate CAD stenosis (50% to 69% stenosis) in >2 arteries on CCTA CAC: coronary artery calcium; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 14 2012 ACCF/AHA Guideline Criteria for Non-Invasive Risk Stratification High risk (>3% annual mortality rate) − Severe resting LV dysfunction (LVEF <35%) not readily explained by non-coronary causes − Resting perfusion abnormalities >10% of the myocardium in patients without prior history or evidence of MI − Stress-induced • Stress ECG findings including >2 mm of ST-segment depression at low workload or persisting into recovery, exercise-induced ST-segment elevation, or exercise-induced VT/VF • Severe stress-induced LV dysfunction (peak exercise LVEF <45% or drop in LVEF with stress >10%) • Stress-induced perfusion abnormalities encumbering >10% of myocardium or stress segmental scores indicating multiple vascular territories with abnormalities • Stress-induced LV dilation • Inducible wall motion abnormality (involving >2 segments or 2 coronary beds) • Wall motion abnormality developing at a low dose of dobutamine (<10 mg/kg/min) or at a low heart rate (<120 beats/min) − CAC score >400 Agatston units − Multivessel obstructive CAD (>70% stenosis) or left main stenosis (>50% stenosis) on CCTA CAC: coronary artery calcium; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 15 Initial Cardiac Test for Diagnosis: Able to Exercise* No Contraindications to Stress Testing Previous Revascularization or Resting ECG Not Interpretable MPI or Echocardiogram With Exercise No Previous Revascularization Interpretable Resting ECG Likelihood of IHD Low Intermediate Standard Exercise ECG Standard Exercise ECG I IIb III Intermediate to High MPI or Echocardiogram With Exercise IIa IIb III I IIb III *Suspected IHD or change in clinical status in known IHD patients. MPI: myocardial perfusion imaging. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 16 IIa IIb III Initial Cardiac Test for Diagnosis: Not Able to Exercise* No Contraindications to Stress Testing Low Likelihood of IHD Intermediate-to-High Likelihood of IHD Pharmacologic Stress Echocardiogram OR I IIb III Pharmacologic Stress MPI or Echocardiogram IIa IIb III Pharmacologic Stress CMR or CCTA† I IIb III I *Suspected IHD or change in clinical status in known IHD patients. †CMR (recommendation: intermediate-to-high probability); CCTA (recommendation: intermediate probability). MPI: myocardial perfusion imaging; CMR: cardiac magnetic resonance; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 17 IIb III Initial Cardiac Test for Diagnosis: Contraindications to Stress Testing* Contraindications to Stress Testing OR CCTA I IIb III Initiate GuidelineDirected Medical Therapy (If treatment is unsuccessful, consider coronary angiography and revascularization to improve symptoms) *Suspected IHD or change in clinical status in known IHD patients. CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 18 Risk Assessment in Patients With Known SIHD Able to Exercise Resting ECG Not Interpretable Resting ECG Interpretable OR OR MPI or Echocardiogram With Exercise IIa IIb III Pharmacologic Stress CMR or CCTA I IIb III I IIa III Standard Exercise Test IIa IIb III MPI or Echocardiogram With Exercise I IIb III MPI: myocardial perfusion imaging; CMR: cardiac magnetic resonance; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 19 Risk Assessment in Patients With Known SIHD Unable to Exercise OR Pharmacologic Stress MPI or Echocardiogram IIa IIb III Pharmacologic Stress CMR or CCTA I IIb III I IIb III MPI: myocardial perfusion imaging; CMR: cardiac magnetic resonance; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 20 Risk Assessment in Patients With Known SIHD and Special Circumstances or High-Risk Lesions Risk Assessment Tests Risk Assessment Tests Special Circumstances Standard Exercise ECG MPI or Echocardiogram With Exercise Pharmacologic CMR or CCTA Pharmacologic Stress MPI or Echocardiogram (irrespective of exercise ability) LBBB on ECG No Known stenosis of unclear significance being considered for revascularization Pharmacologic MPI or Echo With Exercise (I-B) Pharmacologic MPI, Echo, CCTA, or CMR (I-B) Yes No Indeterminant results from functional testing Non-Invasive Tests Suggest High-Risk Coronary Lesion CCTA (IIa-C) Consider Coronary Revascularization to Improve Survival No Observe Response to Guideline-Directed Medical Therapy (based on patient preferences, anatomy, other clinical factors, and local resources and expertise) MPI: myocardial perfusion imaging; CMR: cardiac magnetic resonance; CCTA: coronary CT angiography. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 21 ACP Interpretation of ACCF/AHA SIHD Guideline: Key Management Questions Diagnosis How should a clinician evaluate a patient with chest pain that is consistent with IHD? What is the role of noninvasive testing in the diagnosis of SIHD? Management What should be the approach to modifying cardiovascular risk factors to reduce the mortality and morbidity associated with SIHD? What is the role of coronary revascularization in reducing mortality and morbidity associated with SIHD? How should chronic anginal symptoms be managed with medications? Qaseem A, et al. Ann Intern Med. 2012;157:729-734. Qaseem A, et al. Ann Intern Med. 2012;157:735-743. 22 Goals of Therapy Minimize the likelihood of death while maximizing health and function − Reduce premature cardiovascular death − Prevent complications of SIHD that directly or indirectly impair patients’ functional well-being • Including non-fatal AMI and heart failure − Maintain or restore a level of activity, functional capacity, and quality of life that is satisfactory to the patient − Completely, or nearly completely, eliminate ischemic symptoms − Minimize costs of health care • Eliminate avoidable adverse effects of tests and treatments by preventing hospital admissions, and by eliminating unnecessary tests and treatments Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 23 Strategies to Achieve Goals Educate and engage patients in treatment decisions − Etiology, clinical manifestations, treatment options, and IHD prognosis Identify and treat conditions that contribute to, worsen, or complicate IHD Effectively modify risk factors for IHD − Pharmacologic and non-pharmacologic methods Use evidence-based pharmacological treatments to improve patients’ health status and survival − Avoid drug interactions and side effects Use revascularization (PCI or CABG) when there is clear evidence of the potential to improve patients’ health status and survival Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 24 PCI Versus Medical Therapy: Findings From Studies and Systematic Reviews PCI reduces the incidence of angina No study has demonstrated that PCI improves survival rates in SIHD PCI may increase the short-term risk of MI PCI does not lower the long-term risk of MI Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 25 COURAGE Trial: Optimal Medical Therapy + PCI for Stable Coronary Disease Randomization 1:1 Follow-Up: 2.5 to 7 Years Patients (n=2287) AHA/ACC Class I/II indications for PCI Suitable coronary artery anatomy >70% stenosis in >1 proximal epicardial vessel Objective evidence of ischemia Optimal Medical Therapy + PCI (n=1149) Optimal Medical Therapy (n=1138) (or >80% stenosis + CCS class III angina without provocation testing) Primary Outcome: All-cause mortality, non-fatal MI Secondary Outcomes: Death, MI, stroke, ACS hospitalization Median follow-up: 4.6 years CCS: Canadian Cardiovascular Society; ACS: acute coronary syndrome. Boden WE, et al. Am Heart J. 2006;151:1173-1179. Boden WE, et al. N Engl J Med. 2007;356:1503-1516. 26 COURAGE Study: All-Cause Mortality/Non-Fatal MI Survival Free of Primary Outcome Death From Any Cause and Non-Fatal MI 1 OMT + PCI OMT 0.9 0.8 0.7 Unadjusted Hazard Ratio 1.05 (95% CI 0.87-1.27) P=0.62 0.6 0.5 0 1 2 3 4 Follow-Up (years) OMT: optimal medical therapy. Boden WE, et al. N Engl J Med. 2007;356:1503-1516. 27 5 6 7 COURAGE Study: Impact of Treatment on Angina Angina Free 100 OMT + PCI (n=1149) OMT (n=1138) Patients (%) 80 74% 72%† 67% 66%* 58% 60 40 20 12% 0 13% Baseline 1 3 Follow-Up (years) *P<0.001 and †P=0.02 versus OMT (optimal medical therapy). Boden WE, et al. N Engl J Med. 2007;356:1503-1516. 28 72% 5 BARI 2D Study: Medical Therapy Versus Revascularization Primary Outcome (All-Cause Death) CABG PCI 100 100 89.9% 89.2% P=0.48 60 40 Medical therapy Revascularization 20 0 1 2 3 83.6% P=0.33 60 40 Medical therapy Revascularization 20 4 5 Follow-Up (Years) BARI 2D Study Group. N Engl J Med. 2009;360:2503-2515. 29 80 Survival (%) Survival (%) 80 0 86.4% 0 0 1 2 3 Follow-Up (Years) 4 5 CABG Versus Medical Therapy: Findings From Studies and Systematic Reviews Surgical techniques and medical therapy have improved substantially over the years − Uncertain if the relative benefits for survival and angina relief observed several decades ago with CABG might no longer be observed − Concurrent administration of GDMT with CABG may substantially improve long-term outcomes compared with GDMT alone ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) − Goal: elimination or reduction of at least moderate myocardial ischemia • Usual care (optimal medical therapy and prompt revascularization when feasible) versus optimal medical therapy alone with deferred revascularization when clinically indicated (excluding left main disease detected by cardiac CT angiography) − Outcome: hard cardiac events − Follow-up: average 4 years (results expected in 2019) − Patients (n=8000) Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Available at: https://www.ischemiatrial.org/. 30 Coronary Revascularization to Improve Survival Clinical Setting Method Grade No anatomic or physiologic criteria for revascularization CABG or PCI III-B HARM 1-vessel disease without proximal LAD artery involvement CABG or PCI III-B HARM PCI (versus CABG) III-B HARM Significant (>50%) left main coronary artery stenosis CABG PCI I-B IIa-IIb* Significant (>70%) stenosis in 3-vessel disease with or without proximal LAD artery disease CABG PCI I-B IIb-B Survivors of sudden cardiac death with presumed ischemic-mediated ventricular tachycardia caused by significant (>70%) stenosis in a major coronary artery CABG PCI I-B I-C 2-vessel disease with proximal LAD artery disease CABG PCI I-B II-B CABG (with LIMA) PCI IIa-B IIb-B CABG CABG IIa-B IIb-B Significant (>50%) unprotected left main CAD who have unfavorable anatomy for PCI and are good candidates for CABG 1-vessel proximal LAD artery disease Left ventricular dysfunction Ejection fraction 35% to 50% Ejection fraction <35% without significant left main CAD 31 *For certain circumstances, there are IIa and IIb (LOE B or C) indications for PCI for left main CAD. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. Revascularization to Improve Persistent Symptoms in Patients With SIHD Persistent Symptoms Despite Adequate Trial of Guideline-Directed Medical Therapy Is potential revascularization warranted based on assessment of coexisting cardiac and non-cardiac factors and patient preferences? Yes No Perform Coronary Angiography Do results indicate that revascularization may improve symptoms? Yes Do lesions correlate with evidence of ischemia? Yes Determine PCI or CABG Guideline-Directed Medical Therapy Continued in All Patients Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 32 No No Guideline-Directed Medical Therapy Coronary Revascularization to Improve Symptoms Significant Anatomic (>50% Left Main or >70% Non-Left Main CAD) or Physiologic (FFR <0.80) Coronary Artery Stenosis Clinical Setting Method Grade No anatomic or physiologic criteria for revascularization CABG or PCI III-C HARM >1 significant stenosis (>70%) amenable to revascularization and unacceptable angina despite GDMT CABG or PCI I-A >1 significant stenosis (>70%) and unacceptable angina in whom GDMT cannot be implemented (medical contraindication, adverse events, preference) CABG or PCI IIa-C Previous CABG with >1 significant stenosis (>70%) associated with ischemia and unacceptable angina despite GDMT PCI CABG IIa-C IIa-B Complex 3-vessel CAD (eg, SYNTAX score >22) with or without involvement of proximal LAD artery and a good candidate for CABG CABG preferred over PCI IIa-B Viable ischemic myocardium that is perfused by coronary arteries that are not amenable to grafting TMR as an adjunct to CABG IIb-B TMR: transmyocardial revascularization. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 33 Guideline-Directed Medical Therapy for Patients With SIHD Risk factor modification Additional medical therapy to prevent MI and death Medical therapy for relief of symptoms Alternative therapies for relief of symptoms in patients with refractory angina Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 34 Risk Factor Modification Not Modifiable Modifiable Smoking Gender Hypertension Age Hyperlipidemia Family history Diabetes, glycemic control Obesity, sedentary lifestyle Hyperuricemia Psychosocial factors − Stress, type A behavior Medications − Progestins, corticosteroids Environmental influences − Climate, air pollution, trace metals in drinking water Kones R. Vasc Health Risk Manag. 2010;6:749-774. 35 Lifestyle Modification for Patients With SIHD: Additional Risk Factor Modification Grade Risk Factor Goal IIa IIb III Physical activity Moderate-intensity aerobic activity 30-60 minutes, 7 days/week (minimum 5 days/week) IIa IIb III Weight management Smoking IIa IIb III I I IIa I IIb III III IIb III Body mass index: 18.5 to 24.9 kg/m2 Waist circumference: men (<40 inches), women (<35 inches) Complete cessation No exposure to environmental tobacco smoke Psychologic factors Consider screening for depression Alcohol consumption Non-pregnant women: 1 drink/day (4 oz wine, 12 oz beer, 1 oz spirits) Men: 1 to 2 drinks/day Exposure to air pollution Avoid Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 36 Guideline-Directed Medical Therapy for SIHD: Risk Factor Modification Lipid Management Blood Pressure >140/90 mm Hg Diabetes Management Lifestyle modification Dietary therapy Lifestyle modification Antihypertensive drug therapy HbA1c goal: <7%† Saturated fats: <7% Trans fatty acids: <1%* Cholesterol: <200 mg/dL IIa IIb III Moderate-to-High Dose Statin IIa IIb III IIa IIb III Choice of BP medication based on specific patient characteristics Initiate pharmacotherapy to achieve goal HbA1c I IIb III IIa IIb III IIa IIb III For Patients Intolerant to Statins, Bile Acid Sequestrant and/or Niacin Rosiglitazone should not be initiated I IIa IIb HARM I IIb III *Percent of total calories. †HbA 1c goal of 7% to 9% is reasonable for certain patients according to age, history of hypoglycemia, presence of microvascular or macrovascular complications, or presence of coexisting medical conditions Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 37 Additional Medical Therapy: Prevention of MI in Patients With SIHD Aspirin Beta-Blocker No Contraindications Aspirin 75-162 mg/day Normal LV Function After MI or ACS (continue indefinitely) Start, continue for 3 years Renin-AngiotensinAldosterone Blocker Hypertension, Diabetes Mellitus, LVEF <40%, or Chronic Kidney Disease ACE inhibitor IIa IIb III IIa IIb III Aspirin 75-162 mg/day + clopidogrel 75 mg/day (certain high-risk patients) LV Systolic Dysfunction (EF <40%) With Heart Failure or Prior MI Carvedilol, metoprolol succinate, bisoprolol I IIa III IIa IIb III ARB inhibitor (if intolerant to ACE inhibitor) (shown to reduce risk of death) IIa IIb III Contraindications II IIb III a Clopidogrel 75 mg/day Other Patients With Coronary or Vascular Disease SIHD or Other Vascular Disease ACE inhibitors IIa IIb III I IIa Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 38 III I IIb III Additional Medical Therapy: Prevention of MI in Patients With SIHD Grade II IIb III a Medical Therapy Influenza vaccination Estrogen therapy I IIa IIb Comments (Patients With SIHD) Annually Postmenopausal women: not recommended for reducing cardiovascular risk or improving clinical outcomes NO BENEFIT I IIa IIb NO BENEFIT I IIa IIb Vitamin C Vitamin E Beta-carotene All patients: not recommended for reducing cardiovascular risk or improving clinical outcomes Folate Vitamin B6 or B12 Elevated homocysteine: not recommended for reducing cardiovascular risk or improving clinical outcomes Chelation therapy All patients: not recommended for improving symptoms or reducing cardiovascular risk Garlic Coenzyme Q10 Selenium Chromium All patients: not recommended for improving symptoms or reducing cardiovascular risk NO BENEFIT I IIa IIb NO BENEFIT I IIa IIb NO BENEFIT Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 39 Guideline-Directed Medical Therapy: Relief of Symptoms Angina Initial Therapy Sublingual Nitroglycerin or Nitroglycerin Spray (for immediate relief) Beta Blocker Contraindication (especially if prior MI, heart failure, or other indication) Unacceptable side effects Add/Substitute CCB and/or Long-Acting Nitrate Contraindication Unacceptable side effects Add/Substitute Ranolazine I IIa IIb III IIa IIb III Persistent Symptoms Despite Adequate Trial of Guideline-Directed Medical Therapy Consider Revascularization to Improve Symptoms Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734. 40 IIb III Therapeutic Targets of FDA-Approved Agents for Myocardial Ischemia Development of Ischemia Consequences of Ischemia Increased oxygen demand Tachycardia Hypertension Preload Contractility Decreased oxygen supply Ca2+ overload Electrical instability Myocardial dysfunction Myocardial Ischemia (decreased systolic function/ increased diastolic stiffness) Ranolazine (reduces late Na+ current) β-blockers Nitrates Calcium Channel Blockers 41 Chronic Stable Angina: Ideal Candidates for β-Blockers and Calcium Channel Blockers β-Blockers Physical activity figures prominently in anginal attacks Coexistent hypertension (combined α-/β-blockers) History of − Supraventricular arrhythmias − Ventricular tachycardia − Congestive heart failure Post-MI angina or LV dysfunction Anxiety associated with angina Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 42 Calcium Channel Blockers Coexistent hypertension Contraindications/intolerance to β-blockers Coexisting conduction system disease − Except verapamil, diltiazem Prinzmetal angina Peripheral vascular disease Traditional Anti-Anginal Therapy: Conditions That May Limit Their Uses β-Blockers Asthma Severe bradycardia AV block Severe depression Raynaud’s syndrome Nitrates Severe aortic stenosis Hypertrophic obstructive cardiomyopathy Erectile dysfunction* Sick sinus syndrome *Treated with PDE5 inhibitors. †Non-dihydropyridine. Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 43 Calcium Channel Blockers† AV block Bradycardia Heart failure LV dysfunction Sinus node dysfunction Ranolazine in Chronic Stable Angina MARISA (n=191) CARISA (n=823) Exercise-Limiting Angina Ranolazine Monotherapy Exercise-Induced Angina Ranolazine Add-On to BB or CCB † Time (seconds) 550 525 Placebo Ranolazine (bid) 500 mg 1000 mg 1500 mg † * † 500 † 475 † † † 450 ‡ ‡ Placebo Ranolazine (bid) 750 mg 1000 mg 425 Time (seconds) 575 400 375 ‡ ‡ 350 325 450 * 300 425 400 Exercise Duration Onset of Onset of Angina ST-Segment Depression *P<0.005; †P<0.001, ‡P<0.05 versus placebo. Chaitman BR, et al. J Am Coll Cardiol. 2004;43:1375-1382. Chaitman BR, et al. JAMA. 2004;291:309-316. 44 275 Exercise Duration Onset of Angina Onset of ECG Ischemia ERICA Study: Angina Frequency and Nitrate Consumption Nitrate Use Angina Frequency 7 5.59 5 4 3.31 2.88* 3 2 Baseline Week 7 Both groups received amlodipine 10 mg/day bid. *P=0.028 and †P=0.014 versus placebo. Stone PH, et al. J Am Coll Cardiol. 2006;48:566-575. 45 5.02 5 4.43 4 3 2.68 2.03† 2 1 1 0 Ranolazine (n=277) Placebo (n=281) 6 5.68 Number per Week Number per Week 6 7 Ranolazine (n=277) Placebo (n=281) 0 Baseline Week 7 Ranolazine Drug Interactions Avoid using ranolazine with strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, saquinavir, nefazodone) Limit the dose of ranolazine to 500 mg bid with moderate CYP3A4 inhibitors (diltiazem, verapamil, erythromycin, fluconazole) P-gp inhibitors (cyclosporine) may require a dose reduction of ranolazine Drugs transported by P-gp or metabolized by CYP2D6 (digoxin) may need a reduced dose when used in combination with ranolazine Ranolazine full prescribing information. 46 Alternative Therapies: Relief of Symptoms in Patients With Refractory Angina Grade I IIa III I IIa III I IIa III Medical Therapy Comments (Patients With Refractory Angina) Enhanced external counterpulsation May be considered an option Transmyocardial revascularization May be considered an option Spinal cord stimulation May be considered an option Acupuncture Not recommended I IIa IIb NO BENEFIT Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. 47 Summary Diagnostic and therapeutic choices in SIHD should be made through a process of shared decision making with patient and provider − Explain the risks, benefits, and costs All patients with angina − Aggressive risk factor modification and optimized medical management must be instituted − β-blocker is a likely first-line agent, however most patients require multiple medications with different mechanisms of action for symptom control Revascularization for high-risk patients or patients with persistent symptoms Angina persists for many patients despite medical therapy and/or revascularization 48