2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational...

48
2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored for CME credit by the University of Nebraska Medical Center and Practice Point Communications, Inc.

Transcript of 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational...

Page 1: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

2012 Stable Ischemic Heart Disease (SIHD) Guideline Update

Supported by an independent educational grant from Gilead Sciences Medical Affairs

Jointly sponsored for CME credit by theUniversity of Nebraska Medical Center andPractice Point Communications, Inc.

Page 2: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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Content Development FacultyContent Development Faculty

Julius M. Gardin, MD, MBA, FACC,FACP, FAHA

Professor and ChairDepartment of Medicine

Hackensack University Medical CenterProfessor of Medicine

University of Medicine and Dentistry of New JerseyNew Jersey Medical School

Hackensack, NJ

Page 3: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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Disclosure Information:Disclosure Information:Content Development FacultyContent Development Faculty

Julius M. Gardin, MD, MBA, FACC, FACP, FAHA− Honorarium

• Gilead Sciences

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Copyright & PermissionsCopyright & 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.

Page 5: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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Learning Objectives (CME/CNE/CPE)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

Page 6: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Spectrum of Ischemic Heart Disease:Spectrum of Ischemic Heart Disease:Relevant GuidelinesRelevant Guidelines

6Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

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.

Asymptomatic,Asymptomatic,Without KnownWithout Known

IHDIHD(CV Risk)(CV Risk)

KnownKnownIHDIHD

New-OnsetNew-OnsetChest PainChest Pain

(SIHD, UA/NSTEMI, STEMI)(SIHD, UA/NSTEMI, STEMI)

Stable Angina orStable Angina orLow-Risk UA*Low-Risk UA*(SIHD, PCI/CABG)(SIHD, PCI/CABG)

AsymptomaticAsymptomatic(SIHD)(SIHD)

Acute CoronaryAcute CoronarySyndromesSyndromes

(UA/NSTEMI, STEMI, (UA/NSTEMI, STEMI, PCI/CABG)PCI/CABG)

Sudden CardiacSudden CardiacDeathDeath

(VA-SCD)(VA-SCD)

Non-CardiacNon-CardiacChest PainChest Pain

KnownKnownIHDIHD

Page 7: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

2012 ACCF/AHA Guideline for the 2012 ACCF/AHA Guideline for the Diagnosis and Management of SIHDDiagnosis 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

7Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

Page 8: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

ACCF/AHA Classification of ACCF/AHA Classification of Recommendations and Levels of EvidenceRecommendations and Levels of Evidence

Level A− Multiple populations

evaluated

− Multiple randomized clinical trials or meta-analyses

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

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Class IBenefit >>> Risk

(SHOULD be performed/administered)

Class IIaBenefit >> Risk

(IT IS REASONABLE to be performed/administered Tx)

Class IIbBenefit > Risk(Procedure/treatment

MAY BE CONSIDERED)

Class IIINo Benefit or

Harm

• Is useful/effective• Sufficient

evidence

• Is useful/effective• Evidence from

single randomized trial or non- randomized studies

• Is useful or effective

• Only expert opinion, case studies, or standard of care

• Favors being useful/effective

• Some conflicting evidence

• Favors being useful/effective

• Some conflicting evidence

• Favors being useful or effective

• Only diverging expert opinion, case studies, or standard of care

• Usefulness and efficacy less well established

• Greater conflicting evidence

• Usefulness or efficacy less well established

• Greater conflicting evidence

• Usefulness or efficacy less well 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 non- randomized studies

• Not useful or effective or may be harmful

• Only expert opinion, case studies, or standard of care

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

Estimate of Certainty (Precision) of Treatment Effect

Size of Treatment Effect

Page 9: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

ACP Interpretation of ACCF/AHA SIHD ACP Interpretation of ACCF/AHA SIHD Guideline: Key Diagnostic QuestionsGuideline: Key Diagnostic Questions

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How should a clinician evaluate a patient with chest pain that is consistent with IHD?

What is the role of non-invasive and angiographic testing in the diagnosis of SIHD?

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?

Diagnosis Management

Qaseem A, et al. Ann Intern Med. 2012;157:729-734.Qaseem A, et al. Ann Intern Med. 2012;157:735-745.

Page 10: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Diagnosis: Suspected IHD (or Change Diagnosis: Suspected IHD (or Change in Clinical Status in Known IHD Patient)in Clinical Status in Known IHD Patient)

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Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

Intermediate or High-Risk Unstable AnginaIntermediate or High-Risk Unstable Angina

Comprehensive Clinical Comprehensive Clinical Assessment of RiskAssessment of Risk

Personal CharacteristicsPersonal CharacteristicsCoexisting Cardiac and Medical ConditionsCoexisting Cardiac and Medical Conditions

Health StatusHealth Status

See ACCF/AHASee ACCF/AHAUA/NSTEMI GuidelinesUA/NSTEMI Guidelines

NoNo YesYes

Symptoms or findings suggest high-risk lesion(s)?Symptoms or findings suggest high-risk lesion(s)?

ORORPrior sudden death or serious ventricular arrhythmia?Prior sudden death or serious ventricular arrhythmia?

ORORPrior stent in unprotected left main coronary artery?Prior stent in unprotected left main coronary artery?

YesYes

InitiateInitiateGuideline-Directed Guideline-Directed Medical TherapyMedical Therapy(consider coronary (consider coronary revascularization to revascularization to

improve survival)improve survival)NoNo

Continue AssessmentContinue AssessmentInitiate or continue Guideline-Directed Initiate or continue Guideline-Directed

Medical TherapyMedical Therapy

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Clinical Classification of Chest PainClinical 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 characteristicsCannon 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.

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Pretest Likelihood of CAD by Cardiac Catheterization in Pretest Likelihood of CAD by Cardiac Catheterization in Symptomatic Patients (Diamond/Forrester and CASS)Symptomatic Patients (Diamond/Forrester and CASS)

Non-AnginalChest Pain

Lik

elih

oo

d o

f C

AD

(%

)

30-39

FemaleMale

2%

40-49 50-59 60-69

4%

13%

3%7%

27%

20%14%

Age (years)

0

20

40

60

80

100

AtypicalAngina

Lik

elih

oo

d o

f C

AD

(%

)

30-39

FemaleMale

34%

40-49 50-59 60-69

12%

51%

22%

31%

72%

65%

51%

Age (years)

0

20

40

60

80

100

TypicalAngina

Lik

elih

oo

d o

f C

AD

(%

)

30-39

FemaleMale

76%

40-49 50-59 60-69

26%

87%87%

55%

73%

94%93%

86%

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.Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

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2012 ACCF/AHA Guideline Criteria for2012 ACCF/AHA Guideline Criteria forNon-Invasive Risk StratificationNon-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.

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2012 ACCF/AHA Guideline Criteria for2012 ACCF/AHA Guideline Criteria forNon-Invasive Risk StratificationNon-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

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

CAC: coronary artery calcium; CCTA: coronary CT angiography.

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2012 ACCF/AHA Guideline Criteria for2012 ACCF/AHA Guideline Criteria forNon-Invasive Risk StratificationNon-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

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

CAC: coronary artery calcium; CCTA: coronary CT angiography.

Page 16: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Able to Exercise*Able to Exercise*

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Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

No ContraindicationsNo Contraindicationsto Stress Testingto Stress Testing

No Previous RevascularizationNo Previous RevascularizationInterpretable Resting ECGInterpretable Resting ECG

Previous Revascularization orPrevious Revascularization orResting ECG Not InterpretableResting ECG Not Interpretable

MPI or EchocardiogramMPI or EchocardiogramWith ExerciseWith Exercise

IIa

IIb III

Likelihood of IHDLikelihood of IHD

IntermediateIntermediateStandardStandard

Exercise ECGExercise ECG

IntermediateIntermediateto Highto HighMPI orMPI or

EchocardiogramEchocardiogramWith ExerciseWith Exercise

LowLowStandardStandard

Exercise ECGExercise ECG

IIa

IIb III

I IIb III

*Suspected IHD or change in clinical status in known IHD patients.MPI: myocardial perfusion imaging.

I IIb III

Page 17: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Not Able to Exercise*Not Able to Exercise*

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No ContraindicationsNo Contraindicationsto Stress Testingto Stress Testing

LowLowLikelihood of IHDLikelihood of IHDPharmacologic StressPharmacologic Stress

EchocardiogramEchocardiogram

Intermediate-to-HighIntermediate-to-HighLikelihood of IHDLikelihood of IHD

I IIb III

Pharmacologic StressPharmacologic StressMPI or EchocardiogramMPI or Echocardiogram

Pharmacologic StressPharmacologic StressCMR or CCTACMR or CCTA††

IIa

IIb III I IIb III

OROR

I IIb III

*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.

Page 18: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Contraindications to Stress Testing*Contraindications to Stress Testing*

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ContraindicationsContraindicationsto Stress Testingto Stress Testing

CCTACCTA

I IIb III

OROR

Initiate Guideline-Initiate Guideline-Directed Medical Directed Medical

TherapyTherapy(If treatment is (If treatment is

unsuccessful, consider unsuccessful, consider coronary angiography coronary angiography

and revascularization to and revascularization to improve symptoms)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.

Page 19: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Risk Assessment in Patients With Risk Assessment in Patients With Known SIHDKnown SIHD

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Able to ExerciseAble to Exercise

Resting ECGResting ECGNot InterpretableNot Interpretable

Resting ECGResting ECGInterpretableInterpretable

IIa

IIb III I IIb III

MPI orMPI orEchocardiogramEchocardiogram

With ExerciseWith Exercise

PharmacologicPharmacologicStressStress

CMR or CCTACMR or CCTA

OROR

IIa

IIb III I IIb III

StandardStandardExerciseExercise

TestTest

MPI orMPI orEchocardiogramEchocardiogram

With ExerciseWith Exercise

OROR

I IIa 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.

Page 20: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Risk Assessment in Patients With Risk Assessment in Patients With Known SIHDKnown SIHD

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Unable to Unable to ExerciseExercise

Pharmacologic StressPharmacologic StressMPI or EchocardiogramMPI or Echocardiogram

Pharmacologic StressPharmacologic StressCMR or CCTACMR or CCTA

IIa

IIb III I IIb III

OROR

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.

Page 21: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Risk Assessment in Patients With Known SIHD Risk Assessment in Patients With Known SIHD and Special Circumstances or High-Risk Lesionsand Special Circumstances or High-Risk Lesions

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Non-Invasive TestsNon-Invasive TestsSuggest High-RiskSuggest High-RiskCoronary LesionCoronary Lesion

Risk Assessment TestsRisk Assessment TestsSpecial CircumstancesSpecial Circumstances

(irrespective of exercise ability)(irrespective of exercise ability)

LBBB on ECGLBBB on ECG

Observe Response to Observe Response to Guideline-Directed Guideline-Directed Medical TherapyMedical Therapy

Consider Coronary Consider Coronary Revascularization to Revascularization to

Improve SurvivalImprove Survival(based on patient preferences, (based on patient preferences,

anatomy, other clinical factors, and anatomy, other clinical factors, and local resources and expertise)local resources and expertise)

YesYes NoNo

Risk Assessment TestsRisk Assessment TestsStandard Exercise ECGStandard Exercise ECG

MPI or Echocardiogram With ExerciseMPI or Echocardiogram With ExercisePharmacologic CMR or CCTAPharmacologic CMR or CCTA

Pharmacologic Stress MPI or EchocardiogramPharmacologic Stress MPI or Echocardiogram

Known stenosis ofKnown stenosis ofunclear significanceunclear significancebeing considered for being considered for

revascularizationrevascularization

IndeterminantIndeterminantresults fromresults from

functional testingfunctional testing

NoNo

NoNo

Pharmacologic Pharmacologic MPI or EchoMPI or Echo

With ExerciseWith Exercise(I-B)(I-B)

PharmacologicPharmacologicMPI, Echo,MPI, Echo,

CCTA, or CMRCCTA, or CMR(I-B)(I-B)

CCTACCTA(IIa-C)(IIa-C)

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.

Page 22: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

ACP Interpretation of ACCF/AHA SIHD ACP Interpretation of ACCF/AHA SIHD Guideline: Key Management QuestionsGuideline: Key Management Questions

22

How should a clinician evaluate a patient with chest pain that is consistent with IHD?

What is the role of non-invasive testing in the diagnosis of SIHD?

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?

Diagnosis Management

Qaseem A, et al. Ann Intern Med. 2012;157:729-734.Qaseem A, et al. Ann Intern Med. 2012;157:735-743.

Page 23: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Goals of TherapyGoals 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

23

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

Page 24: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Strategies to Achieve GoalsStrategies 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

24

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

Page 25: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

PCI Versus Medical Therapy: Findings From PCI Versus Medical Therapy: Findings From Studies and Systematic ReviewsStudies 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

25Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

Page 26: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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COURAGE Trial: Optimal MedicalCOURAGE Trial: Optimal MedicalTherapy Therapy ++ PCI for Stable Coronary Disease PCI for Stable Coronary Disease

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(or >80% stenosis + CCS class III angina

without provocation testing)

Randomization1:1 Follow-Up: 2.5 to 7 Years

Boden WE, et al. Am Heart J. 2006;151:1173-1179.Boden WE, et al. N Engl J Med. 2007;356:1503-1516.

Primary Outcome: All-cause mortality, non-fatal MI Secondary Outcomes: Death, MI, stroke, ACS hospitalizationMedian follow-up: 4.6 years

Optimal Medical Therapy + PCI(n=1149)

Optimal Medical Therapy(n=1138)

CCS: Canadian Cardiovascular Society; ACS: acute coronary syndrome.

Page 27: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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COURAGE Study:COURAGE Study:All-Cause Mortality/Non-Fatal MIAll-Cause Mortality/Non-Fatal MI

0.5

0.6

0.7

0.8

0.9

1

Death From Any Cause and Non-Fatal MI

Su

rviv

al F

ree

of

Pri

mar

y O

utc

om

e

0 1 2 3 4 5 6 7

Follow-Up (years)

OMT + PCIOMT

Unadjusted Hazard Ratio1.05 (95% CI 0.87-1.27)

P=0.62

Boden WE, et al. N Engl J Med. 2007;356:1503-1516.

OMT: optimal medical therapy.

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COURAGE Study:COURAGE Study:Impact of Treatment on AnginaImpact of Treatment on Angina

0

20

40

60

80

100Angina Free

Pat

ien

ts (

%)

Follow-Up (years)

Baseline 1 3 5

12%

OMT + PCI (n=1149)

OMT (n=1138)

Boden WE, et al. N Engl J Med. 2007;356:1503-1516.

13%

66%*

58%

72%†

67%

74% 72%

*P<0.001 and †P=0.02 versus OMT (optimal medical therapy).

Page 29: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

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BARI 2D Study: Medical Therapy BARI 2D Study: Medical Therapy Versus RevascularizationVersus Revascularization

0

20

40

60

80

100

Su

rviv

al (

%)

0 1 2 3 4 5Follow-Up (Years)

PCI89.9%

89.2%

P=0.48

Medical therapy

Revascularization

BARI 2D Study Group. N Engl J Med. 2009;360:2503-2515.

Primary Outcome (All-Cause Death)

0

20

40

60

80

100

Su

rviv

al (

%)

0 1 2 3 4 5Follow-Up (Years)

CABG86.4%

83.6%

P=0.33

Medical therapy

Revascularization

Page 30: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

CABG Versus Medical Therapy: Findings CABG Versus Medical Therapy: Findings From Studies and Systematic ReviewsFrom 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)

30

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.Available at: https://www.ischemiatrial.org/.

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Coronary Revascularization toCoronary Revascularization toImprove SurvivalImprove SurvivalClinical 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

Significant (>50%) unprotected left main CAD who have unfavorable anatomy for PCI and are good candidates for CABG

PCI (versus CABG)

III-B HARM

Significant (>50%) left main coronary artery stenosis CABGPCI

I-BIIa-IIb*

Significant (>70%) stenosis in 3-vessel disease with or without proximal LAD artery disease

CABGPCI

I-BIIb-B

Survivors of sudden cardiac death with presumed ischemic-mediated ventricular tachycardia caused by significant (>70%) stenosis in a major coronary artery

CABGPCI

I-BI-C

2-vessel disease with proximal LAD artery disease CABGPCI

I-BII-B

1-vessel proximal LAD artery disease CABG (with LIMA)

PCIIIa-BIIb-B

Left ventricular dysfunction Ejection fraction 35% to 50% Ejection fraction <35% without significant left main CAD

CABGCABG

IIa-BIIb-B

*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.

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Revascularization to Improve Persistent Revascularization to Improve Persistent Symptoms in Patients With SIHDSymptoms in Patients With SIHD

32

PerformPerformCoronary AngiographyCoronary Angiography

Guideline-Directed Guideline-Directed Medical TherapyMedical Therapy

Do results indicate that Do results indicate that revascularization may revascularization may improve symptoms?improve symptoms?

YesYes

NoNo

Persistent Symptoms Despite Adequate TrialPersistent Symptoms Despite Adequate Trialof Guideline-Directed Medical Therapyof Guideline-Directed Medical Therapy

Is potential revascularization warranted based on assessment ofIs potential revascularization warranted based on assessment ofcoexisting cardiac and non-cardiac factors and patient preferences?coexisting cardiac and non-cardiac factors and patient preferences?

Determine PCI or CABGDetermine PCI or CABGGuideline-Directed Medical Therapy Guideline-Directed Medical Therapy

Continued in All PatientsContinued in All Patients

Do lesions correlate with Do lesions correlate with evidence of ischemia?evidence of ischemia?

YesYes

NoNo

YesYesNoNo

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

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33

Coronary Revascularization toCoronary Revascularization toImprove SymptomsImprove Symptoms

Clinical Setting Method Grade

No anatomic or physiologic criteria for revascularization CABG or PCI III-CHARM

>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

PCICABG

IIa-CIIa-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

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

Significant Anatomic (>50% Left Main or >70% Non-Left Main CAD)or Physiologic (FFR <0.80) Coronary Artery Stenosis

TMR: transmyocardial revascularization.

Page 34: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Guideline-Directed Medical TherapyGuideline-Directed Medical Therapyfor Patients With SIHDfor 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

34

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

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35

Risk Factor ModificationRisk Factor Modification

Modifiable Not Modifiable

Kones R. Vasc Health Risk Manag. 2010;6:749-774.

Smoking

Hypertension

Hyperlipidemia

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

Gender

Age

Family history

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36

Lifestyle Modification for Patients With Lifestyle Modification for Patients With SIHD: Additional Risk Factor ModificationSIHD: Additional Risk Factor Modification

Grade Risk Factor Goal

Physical activity

Moderate-intensity aerobic activity 30-60 minutes, 7 days/week (minimum 5 days/week)

Weight management

Body mass index: 18.5 to 24.9 kg/m2

Waist circumference: men (<40 inches), women (<35 inches)

Smoking 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.

IIa

IIb III

I IIb III

I IIa III

I IIb III

IIa

IIb III

IIa

IIb III

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Guideline-Directed Medical Therapy for Guideline-Directed Medical Therapy for SIHD: Risk Factor ModificationSIHD: Risk Factor Modification

37

LipidLipidManagementManagement

IIa

IIb III

I IIb III

Lifestyle modificationLifestyle modification

Blood PressureBlood Pressure>>140/90 mm Hg140/90 mm Hg

DiabetesDiabetesManagementManagement

Dietary therapyDietary therapySaturated fats: <7%Saturated fats: <7%

Trans fatty acids: <1%*Trans fatty acids: <1%*Cholesterol: <200 mg/dLCholesterol: <200 mg/dL

Moderate-to-High Dose StatinModerate-to-High Dose Statin

IIa

IIb III

For Patients Intolerant toFor Patients Intolerant toStatins, Bile Acid SequestrantStatins, Bile Acid Sequestrant

and/or Niacinand/or Niacin

*Percent of total calories.†HbA1c 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

IIa

IIb III

Lifestyle modificationLifestyle modificationAntihypertensive drug therapyAntihypertensive drug therapy

IIa

IIb III

Choice of BP medicationChoice of BP medicationbased on specificbased on specific

patient characteristicspatient characteristics

IIa

IIb III

HbAHbA1c1c goal: <7% goal: <7%††

Initiate pharmacotherapyInitiate pharmacotherapyto achieve goal HbAto achieve goal HbA1c1c

Rosiglitazone shouldRosiglitazone shouldnot be initiatednot be initiated

I IIa IIb

HARMHARM

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

I IIb III

Page 38: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Additional Medical Therapy:Additional Medical Therapy:Prevention of MI in Patients With SIHDPrevention of MI in Patients With SIHD

38

AspirinAspirin

No ContraindicationsNo Contraindications

Beta-BlockerBeta-BlockerRenin-Angiotensin-Renin-Angiotensin-

Aldosterone BlockerAldosterone Blocker

Aspirin 75-162 mg/dayAspirin 75-162 mg/day(continue indefinitely)(continue indefinitely)

Aspirin 75-162 mg/day + Aspirin 75-162 mg/day + clopidogrel 75 mg/dayclopidogrel 75 mg/day(certain high-risk patients)(certain high-risk patients)

Clopidogrel 75 mg/dayClopidogrel 75 mg/day

IIa

IIb III

IIa

IIb III

I IIa III

ContraindicationsContraindications

Normal LV FunctionNormal LV FunctionAfter MI or ACSAfter MI or ACS

Start, continue for 3 yearsStart, continue for 3 years

IIa

IIb III

LV Systolic DysfunctionLV Systolic Dysfunction(EF (EF <<40%) With Heart40%) With Heart

Failure or Prior MIFailure or Prior MICarvedilol, metoprolol Carvedilol, metoprolol succinate, bisoprololsuccinate, bisoprolol

(shown to reduce risk of death)(shown to reduce risk of death)

IIa

IIb III

Hypertension, DiabetesHypertension, DiabetesMellitus, LVEF Mellitus, LVEF <<40%, or40%, orChronic Kidney DiseaseChronic Kidney Disease

ACE inhibitorACE inhibitor

IIa

IIb III

ARB inhibitorARB inhibitor(if intolerant to ACE inhibitor)(if intolerant to ACE inhibitor)

IIa

IIb III

Other Patients With Coronary Other Patients With Coronary or Vascular Diseaseor Vascular Disease

I IIa III

SIHD or OtherSIHD or OtherVascular DiseaseVascular Disease

ACE inhibitorsACE inhibitors

I IIb III

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164. Qaseem A, et al. Ann Intern Med. 2012;157:729-734.

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39

Additional Medical Therapy:Additional Medical Therapy:Prevention of MI in Patients With SIHDPrevention of MI in Patients With SIHDGrade Medical Therapy Comments (Patients With SIHD)

Influenza vaccination

Annually

Estrogen therapy Postmenopausal women: not recommended for reducing cardiovascular risk or improving clinical outcomes

Vitamin CVitamin E

Beta-carotene

All patients: not recommended for reducing cardiovascular risk or improving clinical outcomes

FolateVitamin 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

GarlicCoenzyme Q10

SeleniumChromium

All patients: not recommended for improving symptoms or reducing cardiovascular risk

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

IIa

IIb III

I IIa

IIb

NO BENEFITNO BENEFIT

I IIa

IIb

NO BENEFITNO BENEFIT

I IIa

IIb

NO BENEFITNO BENEFIT

I IIa

IIb

NO BENEFITNO BENEFIT

I IIa

IIb

NO BENEFITNO BENEFIT

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Guideline-Directed Medical Therapy:Guideline-Directed Medical Therapy:Relief of SymptomsRelief of Symptoms

40

Initial TherapyInitial Therapy

IIa

IIb III

I IIb III

ContraindicationContraindication

UnacceptableUnacceptableside effectsside effects

SublingualSublingualNitroglycerin orNitroglycerin or

Nitroglycerin SprayNitroglycerin Spray(for immediate relief)(for immediate relief)

Beta BlockerBeta Blocker(especially if prior MI, heart(especially if prior MI, heartfailure, or other indication)failure, or other indication)

IIa

IIb III

Add/SubstituteAdd/SubstituteCCB and/orCCB and/or

Long-Acting NitrateLong-Acting Nitrate

ContraindicationContraindication

UnacceptableUnacceptableside effectsside effects

Add/SubstituteAdd/SubstituteRanolazineRanolazine

AnginaAngina

Persistent Symptoms Despite Adequate Persistent Symptoms Despite Adequate Trial of Guideline-Directed Medical TherapyTrial of Guideline-Directed Medical Therapy

Consider RevascularizationConsider Revascularizationto Improve Symptomsto 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.

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41

Therapeutic Targets of FDA-Approved Therapeutic Targets of FDA-Approved Agents for Myocardial IschemiaAgents for Myocardial Ischemia

Developmentof Ischemia

Increased oxygen demandTachycardiaHypertension

PreloadContractility

Decreased oxygen supply

Consequencesof Ischemia

Ca2+ overloadElectrical instability

Myocardial dysfunction(decreased systolic function/increased diastolic stiffness)

MyocardialIschemia

β-blockers Nitrates

Calcium Channel Blockers

Ranolazine(reduces late Na+ current)

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42

Chronic Stable Angina: Ideal Candidates for Chronic Stable Angina: Ideal Candidates for ββ-Blockers and Calcium Channel Blockers-Blockers and Calcium Channel Blockers

β-Blockers Calcium Channel 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

Coexistent hypertension

Contraindications/intolerance to β-blockers

Coexisting conduction system disease

− Except verapamil, diltiazem

Prinzmetal angina

Peripheral vascular disease

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

Page 43: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

43

Traditional Anti-Anginal Therapy:Traditional Anti-Anginal Therapy:Conditions That May Limit Their UsesConditions That May Limit Their Uses

Asthma

Severe bradycardia

AV block

Severe depression

Raynaud’s syndrome

Sick sinus syndrome

β-Blockers

Severe aortic stenosis

Hypertrophic obstructive cardiomyopathy

Erectile dysfunction*

Nitrates

AV block

Bradycardia

Heart failure

LV dysfunction

Sinus node dysfunction

CalciumChannel Blockers†

*Treated with PDE5 inhibitors.†Non-dihydropyridine.Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

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44

Ranolazine in Chronic Stable AnginaRanolazine in Chronic Stable Angina

400

425

450

475

500

525

550

575

MARISA (n=191)Exercise-Limiting AnginaRanolazine Monotherapy

Tim

e (s

eco

nd

s)

ExerciseDuration

*†

Onset ofAngina

Onset ofST-SegmentDepression

*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.

*

† †

275

300

325

350

375

400

425

450

CARISA (n=823)Exercise-Induced Angina

Ranolazine Add-On to BB or CCB

Tim

e (s

eco

nd

s)

ExerciseDuration

Onset ofAngina

Onset ofECG

Ischemia

PlaceboRanolazine (bid) 500 mg 1000 mg 1500 mg

PlaceboRanolazine (bid) 750 mg 1000 mg

‡ ‡

‡ ‡

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45

ERICA Study: Angina Frequency and ERICA Study: Angina Frequency and Nitrate ConsumptionNitrate Consumption

0

1

2

3

4

5

6

7

Angina Frequency

Nu

mb

er p

er W

eek

Baseline

Ranolazine (n=277)Placebo (n=281)

5.59

Week 7

Nitrate Use

Stone PH, et al. J Am Coll Cardiol. 2006;48:566-575.

Both groups received amlodipine 10 mg/day bid.*P=0.028 and †P=0.014 versus placebo.

5.68

2.88*3.31

0

1

2

3

4

5

6

7

Nu

mb

er p

er W

eek

Baseline

Ranolazine (n=277)Placebo (n=281)

4.43

Week 7

5.02

2.03†

2.68

Page 46: 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational grant from Gilead Sciences Medical Affairs Jointly sponsored.

Ranolazine Drug InteractionsRanolazine 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

46Ranolazine full prescribing information.

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47

Alternative Therapies: Relief of Symptoms Alternative Therapies: Relief of Symptoms in Patients With Refractory Anginain Patients With Refractory Angina

Grade 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

Fihn SD, et al. J Am Coll Cardiol. 2012;60:e44-e164.

I IIa IIb

NONOBENEFITBENEFIT

I IIa III

I IIa III

I IIa III

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48

SummarySummary

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