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Transcript of 2012 Stable Ischemic Heart Disease (SIHD) Guideline Update Supported by an independent educational...
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.
2
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
3
Disclosure Information:Disclosure Information:Content Development FacultyContent Development Faculty
Julius M. Gardin, MD, MBA, FACC, FACP, FAHA− Honorarium
• Gilead Sciences
4
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.
5
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
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
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.
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
8
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
ACP Interpretation of ACCF/AHA SIHD ACP Interpretation of ACCF/AHA SIHD Guideline: Key Diagnostic QuestionsGuideline: Key Diagnostic Questions
9
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.
Diagnosis: Suspected IHD (or Change Diagnosis: Suspected IHD (or Change in Clinical Status in Known IHD Patient)in Clinical Status in Known IHD Patient)
10
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
11
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.
12
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.
13
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.
14
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.
15
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.
Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Able to Exercise*Able to Exercise*
16
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
Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Not Able to Exercise*Not Able to Exercise*
17
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.
Initial Cardiac Test for Diagnosis:Initial Cardiac Test for Diagnosis:Contraindications to Stress Testing*Contraindications to Stress Testing*
18
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.
Risk Assessment in Patients With Risk Assessment in Patients With Known SIHDKnown SIHD
19
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.
Risk Assessment in Patients With Risk Assessment in Patients With Known SIHDKnown SIHD
20
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.
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
21
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.
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.
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.
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.
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.
26
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.
27
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.
28
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).
29
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
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/.
31
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.
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.
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.
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.
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
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
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
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.
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
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.
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)
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.
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.
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
‡ ‡
‡ ‡
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
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.
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
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