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Transcript of The Evidence for Current Cardiovascular Disease Prevention Guidelines: Other Cardiovascular...
The Evidence for Current Cardiovascular Disease
Prevention Guidelines:
Other Cardiovascular Therapies and
Areas with Room for Improvement
American College of Cardiology Best Practice Quality Initiative Subcommittee
and Prevention Committee
Classification of Classification of Recommendations and Levels Recommendations and Levels of Evidenceof Evidence
*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.
†In 2003, the ACC/AHA Task Force on Practice Guidelines developed a list of suggested phrases to use when writing recommendations. All guideline recommendations have been written in full sentences that express a complete thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level.
I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III
I IIa IIb III
Icons Representing the Classification and Icons Representing the Classification and Evidence Levels for RecommendationsEvidence Levels for Recommendations
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Vaccination Evidence Vaccination Evidence and Guidelinesand Guidelines
Source: Nichol KL et al. NEJM 2003;348:1322-1332
Adverse Outcome
Vaccinated
Subjects
(N=77,738)
Unvaccinated
Subjects
(N=62,317)
Adjusted Odds Ratio
P value
Hospitalization for CHD 457 (0.6) 535 (0.9) 0.80 0.001
Hospitalization for HF 466 (0.6) 538 (0.9) 0.81 0.002
Hospitalization for CVD 398 (0.5) 427 (0.7) 0.84 0.018
Death 943 (1.2) 1361 (2.2) 0.52 <0.001
Hospitalization or death 2387 (3.1) 2910 (4.7) 0.65 <0.001
286,383 community-dwelling members aged >65 years of 3 large managed-care organizations evaluated for 1-2 yrs
Influenza vaccination reduces the rate of adverse CV events
Influenza Vaccination:Influenza Vaccination:Primary PreventionPrimary Prevention
CV=Cardiovascular
Source: American Diabetes Association. Diabetes Care 2010;33:S11-61
ADA=American Diabetes Association
• An influenza vaccine should be provided to all diabetic patients >6 months of age annually.
• A pneumococcal polysaccharide vaccine should be administered to all diabetic patients >2 years of age. A one-time revaccination is recommended for individuals >64 years of age that were previously immunized at <65 years of age, if the vaccine was administered >5 years ago. Other indications for repeat vaccination include nephrotic syndrome, chronic renal disease, and other immunocompromised states, such as after transplantation.
ADA Immunization RecommendationsADA Immunization Recommendationsfor Patients with Diabetes Mellitusfor Patients with Diabetes Mellitus
Primary Prevention
Patients with cardiovascular disease should have an annual influenza vaccination
I IIa IIb III
Influenza Vaccination GuidelinesInfluenza Vaccination Guidelines
Source: Smith Jr SC et al. JACC 2011;58:2432-2446
Secondary Prevention
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Ejection Fraction Evidence Ejection Fraction Evidence and Guidelinesand Guidelines
Source: Burns RJ et al. JACC 2002;39:30-36
LV EF=Left ventricular ejection fraction, MI=Myocardial infarction, RNA=Radionuclide angiography, SPECT=Single photon emission computed tomography
1,181 patients with myocardial infarction treated with fibrinolytic therapy that underwent SPECT and RNA to evaluate LV EF
LV EF assessed after MI is predictive of mortality at 6 months
Relationship Between Ejection Relationship Between Ejection FractionFractionPost Myocardial Infarction and Post Myocardial Infarction and MortalityMortality
Echocardiography in those following a STEMI to re-evaluate ventricular function when results are used to guide treatment†
Echocardiography or radionuclide angiography in those following a NSTE-ACS when results are used to guide treatment‡
Ejection Fraction GuidelinesEjection Fraction Guidelines
I IIa IIb III
NSTE-ACS=Non-ST-segment elevation acute coronary syndrome, STEMI=ST-segment elevation myocardial infarction
Sources: †Antman EM et al. JACC 2004;44:671-719
‡Anderson JL et al. JACC 2007;50:652-726
Secondary Prevention
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Aldosterone Antagonist Evidence Aldosterone Antagonist Evidence and Guidelinesand Guidelines
Aldosterone
Sodium and Water
Retention
Edema
Potassium and Magnesium Excretion
Arrhythmias
Collagen deposition
Myocardial and Vascular Fibrosis
Aldosterone Antagonist:Aldosterone Antagonist:Mechanisms of ActionMechanisms of Action
Source: Pitt B et al. NEJM 1999;341:709-717
RR = 0.70, P<0.001
Months
Su
rviv
al (
%)
3633302724211815129630
1.00
.90
.80
.70
.60
.50
0
Randomized Aldactone Evaluation Study (RALES)
EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association
Spironolactone
Placebo
Aldosterone Antagonist:Aldosterone Antagonist:Secondary PreventionSecondary Prevention
1,663 patients with NYHA Class III or IV HF and LVSD (EF <0.35) randomized to spironolactone (25-50mg) or placebo for 24 months
Aldosterone inhibition improves survival in patients with advanced heart failure
RR = 0.85, P=0.008
6 12 18 24 30 360
5
10
15
20
25
0
All
Cau
se M
ort
alit
y (%
)
Month
Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS)
Placebo
Source: Pitt B et al. NEJM 2003;348:1309-1321
EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction, HF=Heart failure
Eplerenone
3,313 patients with evidence of HF and LVSD (EF <0.40) after a MI randomized to eplerenone (25-50 mg) or placebo for 16 months
Aldosterone inhibition improves survival in patients with post-MI HF and LVSD
Aldosterone Antagonist:Aldosterone Antagonist:Secondary PreventionSecondary Prevention
Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF)
Aldosterone Antagonist:Aldosterone Antagonist:Secondary PreventionSecondary Prevention
Primary endpoint**0
50
100
%
18.325.9
12.5 15.5
5
All-cause mortality0
10
%Eplerenone
Placebo
2737 patients with NYHA Class II HF symptoms and LVSD (mean LV EF 26%) randomized to eplerenone (25-50 mg) or placebo for a median of 21 months*
Aldosterone inhibition improves survival in patients with mild HF and LVSD
CV=Cardiovascular, EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart Association
*The study was stopped prematurely
Source: Zannad F et al. NEJM 2011;364:11-21
**Composite of CV death or hospitalization for HF
Use of aldosterone blockade in post-MI patients without significant renal dysfunction* or hyperkalemia** is recommended in patients who are already receiving therapeutic doses of an ACE inhibitor and beta-blocker, who have a LV EF <40%, and who have either DM or HF
ACE=Angiotensin converting enzyme, DM=Diabetes mellitus, EF=Ejection fraction, HF=Heart failure,
LV=Left ventricular, MI=Myocardial infarction
I IIa IIb III
Aldosterone Antagonist GuidelinesAldosterone Antagonist Guidelines
Secondary Prevention
Source: Smith SC Jr. et al. JACC 2011;58:2432-2446
*Estimated creatinine clearance should be >30 ml/min **Potassium should be <5.0 mEq/L
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Digoxin Evidence Digoxin Evidence and Guidelinesand Guidelines
K+ Na+
Na+ K+ Na+ Ca++
Na-Ca ExchangeNa-K ATPase
Myofilaments
Ca++
Contractility
Digoxin
Digoxin:Digoxin:Mechanism of ActionMechanism of Action
Source: Digitalis Investigation Group. NEJM 1997;336:525-533
Digitalis Investigation Group (DIG) Trial6,800 patients with LV systolic dysfunction (EF <45%) randomized to
digitalis (0.25 mg) or placebo for 37 months
Digitalis reduces the rate of hospitalization for heart failure*
*28% relative risk reduction (p<0.001)
Digitalis
Placebo
HR=0.75, P<0.001
Digoxin:Digoxin:Secondary PreventionSecondary Prevention
Digoxin in those with symptomatic HF and LVSD (EF <45%) to reduce hospitalizations for HF*
Digoxin in those with asymptomatic LVSD and normal sinus rhythm
EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic function
*Contraindications include significant sinus or atrioventricular block unless a permanent pacemaker is present
Source: Hunt SA et al. Circulation 2005;112:e154-235
I IIa IIb III
I IIa IIb III
Digoxin GuidelinesDigoxin Guidelines
Secondary Prevention
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Implantable Cardioverter DefibrillatorImplantable Cardioverter Defibrillator Evidence and GuidelinesEvidence and Guidelines
Sources:1Moss AJ et al. NEJM 1996;335:1933-1940
2Buxton AE et al. NEJM 1999;341:1882-18903Moss AF et al. NEJM 2002;346:877-883
54%
75%
55%
73%
31%
61%
27 MonthsEF <35%
39 MonthsEF <40%
20 MonthsEF <30%
% m
orta
lity
redu
ctio
n w
ith IC
D
*Primary prevention of sudden cardiac death
Overall deathArrhythmic death
0
20
40
60
80
MADIT1 MUSTT2 MADIT-II3
Implantable Cardioverter Defibrillator:Implantable Cardioverter Defibrillator:Secondary PreventionSecondary Prevention
EF < 30%
EPS
Yes
+
Source: DiMarco JP et al. NEJM 2003;349:1836-1847
EF 31-40%
No
No ICDMedical Rx
EF > 40%
-
At least one month following MI
EF=Ejection fraction, EPS=Electrophysiology study, ICD=Implantable cardioverter defibrillator, Rx=Treatment
Implantable Cardioverter Defibrillator:Implantable Cardioverter Defibrillator:Algorithm in Secondary PreventionAlgorithm in Secondary Prevention
Patients with an ejection fraction of <35% who are at least 40 days post-MI and are in NYHA functional Class II or III
Patients with an ejection fraction of <30% who are at least 40 days post-MI and are in NYHA functional Class I
Patients with nonsustained VT due to prior MI, an ejection fraction of <40%, and inducible sustained VT or VF at EP study
EP=Electrophysiology, MI=Myocardial infarction, NYHA=New York Heart Association, VF=Ventricular fibrillation, VT=Ventricular tachycardia
Epstein AE et al. Circulation 2008;117:e350-408
Implantable CardioverterImplantable CardioverterDefibrillator GuidelinesDefibrillator Guidelines
I IIa IIb III
I IIa IIb III
Secondary Prevention
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Room for ImprovementRoom for Improvement
ACTION Registry/Get With The Guidelines (GWTG) Data
NSTEMI
STEMI
Source: ACTION Registry-GWTG DATA: January 1, 2010 – December 31, 2010. Courtesy of NCDR 10/21/2011
0%
20%
40%
60%
80%
100%
ASA Beta Blockers ACE-1 or ARB Statins Clopidogrel
99% 97% 97% 95%88%
83%
94%88% 86%
72%
Utilization of Risk Reducing Utilization of Risk Reducing MedicationsMedicationsat Discharge in Acute Coronary at Discharge in Acute Coronary SyndromesSyndromes
NSTEMI=Non-ST-segment elevation myocardial infarction, STEMI=ST-segment elevation myocardial infarction
Duke Databank for Cardiovascular Disease*
Source: Newby LK et al. Circulation 2006;113:203-212
ASA=Aspirin, ACE-I=Angiotensin converting enzyme inhibitor, BB=Beta-blocker, CAD=Coronary artery disease, CHF=Congestive heart failure, HF=Heart failure
Self-Reported Medications in Patients Self-Reported Medications in Patients with with Coronary Artery Disease Coronary Artery Disease ++ Heart Heart FailureFailure
*n=31,750
NHANES III (Phase 2) 1991-1994
NHANES III (Phase 1) 1988-1991
51%
73%68%
31%
55% 54%
10%
29% 27%% A
du
lts
Awareness
NHANES II 1976-1980
Treatment
Control
NHANES 1999-2000
70%
59%
34%
Source: Chobanian AV et al. JAMA 2003;289:2560-2572
National Health and Nutrition Examination Survey (NHANES)
Hypertension Awareness, Treatment, Hypertension Awareness, Treatment, and Control in the United Statesand Control in the United States
0
20
40
60
80
National Health and Nutrition Examination Survey (NHANES)
Source: Gu Q et al. Circulation 2006;113:213-221
ACE=Angiotensin converting enzyme
Antihypertensive Drug UseAntihypertensive Drug Usein the United Statesin the United States
Source: Jackevicius CA et al. JAMA 2002;288:462-467
Adh
e re n
ce R
a te
(%)
0 3 6 9 12 15 18 21 24
Months
0
20
40
60
80
100
Acute Coronary Syndrome
Coronary Artery DiseasePrimary Prevention
n=22379
n=85020n=36106
HMG-CoA Reductase Inhibitor:HMG-CoA Reductase Inhibitor:Adherence to TherapyAdherence to Therapy
National Health and Nutrition Examination Survey (NHANES)*
Keevil JG et al. Circulation 2007;115:1363-1370
*Based on 7,399 subjects in NHANES from 1999-2002
Cholesterol Treatment GapCholesterol Treatment Gapin the United Statesin the United States
Saydah S et al. JAMA 2004;291:335-342
(%)
National Health and Nutrition Examination Survey (NHANES)
BP=Blood pressure, DM=Diabetes mellitus, HbA1C=Glycosylated hemoglobin, TC=Total cholesterol
0102030405060708090
100
HbA1c<7% BP <130/80mm Hg
TC <200mg/dL
Good Control of all 3
NHANES III NHANES IV
Achievement of Risk Factor GoalsAchievement of Risk Factor GoalsAmong Diabetics in the United StatesAmong Diabetics in the United States
ACTION Registry/Get With The Guidelines (GWTG) Data
NSTEMI
STEMI
ACTION Registry-GWTG DATA: January 1, 2010 – December 31, 2010. Courtesy of NCDR 10/21/2011
0%
20%
40%
60%
80%
100%
Exercise Counseling
Dietary Modification
Cardiac Rehab Referral
Smoking Cessation
Utilization of Risk Reducing Utilization of Risk Reducing InterventionsInterventionsat Discharge in Acute Coronary at Discharge in Acute Coronary SyndromesSyndromes
NSTEMI=Non-ST-segment elevation myocardial infarction, STEMI=ST-segment elevation myocardial infarction
Evidence for Current Cardiovascular Evidence for Current Cardiovascular Disease Disease
Prevention GuidelinesPrevention Guidelines
Quality ImprovementQuality ImprovementInitiativesInitiatives
Hospital based performance improvement systems
In-hospital initiation of CV protective therapies
Pay for performance/financial incentives
Nurse or pharmacist managed outpatient CV prevention programs
Preventive cardiology and cardiac rehabilitation centers
Virtual prevention clinics using electronic medical record systems
Combination of CV protective medications
CV=Cardiovascular
Strategies for Initiating and Strategies for Initiating and Optimizing Optimizing Cardiovascular TherapiesCardiovascular Therapies
Get With the Guidelines-Coronary Artery Disease (GWTG-CAD)
Lewis WR et al. Circ Cardiovasc Qual Outcomes 2009;2:633-641
Perc
ent
adhere
nce
Composite performance measure adherence by age and gender
Quarters of participation
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing Therapiesin Coronary Artery Diseasein Coronary Artery Disease
0
5
10
15
20
25
30
35
40
45
In-hospital Mortality
Mo
rta
lity
(%)
Baseline
Post-GAP
P=0.017
P=0.001
P=0.004
Guidelines Applied in Practice (GAP) Initiative
Eagle KA et al. JACC 2005;46:1242-1248
30-day Mortality
1-yrMortality
MI=Myocardial infarction
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing TherapiesAfter Acute Myocardial InfarctionAfter Acute Myocardial Infarction
Fox KAA et al. JAMA 2007;297:1892-1900
Global Registry of Acute Coronary Events (GRACE)
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing TherapiesAfter ST-Segment Elevation Myocardial After ST-Segment Elevation Myocardial InfarctionInfarctionRegistry of 4,608 patients with a ST-segment elevation myocardial
infarction
% P
atie
nts
Fonarow GC et al. Am J Cardiol 2001;87:819-822
Event
Rate
, %
Recurrent MI Heart Failure Hospitalization Total Mortality
Pre-CHAMP*
Post-CHAMP*
7.8
4.7
14.8
7.0
3.1†
2.6
7.6†
3.3†
†P<0.05
Cardiac Hospital Atherosclerosis Management Program (CHAMP)
ACS=Acute coronary syndrome, MI=Myocardial infarction
0
5
10
15
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing TherapiesAfter Non-ST-Segment Elevation ACSAfter Non-ST-Segment Elevation ACS
*1 year outcomes
8
7
6
5
4
3
2
1
01 2 3 4
In-H
osp
ital M
ort
alit
y, %
Hospital Composite GuidelineAdherence Quartiles
NSTE-ACS 8
7
6
5
4
3
2
1
01 2 3 4
In-H
osp
ital M
ort
alit
y, %
Hospital Composite GuidelineAdherence Quartiles
NSTE-MI
Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the
ACC/AHA Guidelines (CRUSADE) Registry
Peterson ED et al. JAMA 2006;295:1912-1920
NSTE-ACS=Non-ST-segment elevation acute coronary syndrome, NSTE-MI=Non-ST segment elevation myocardial infarction
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing TherapiesAfter Non-ST-Segment Elevation ACSAfter Non-ST-Segment Elevation ACS
Global Registry of Acute Coronary Events (GRACE)Registry of 8,375 patients with a non-ST-segment elevation ACS
Fox KAA et al. JAMA 2007;297:1892-1900
Utilization of Risk Reducing TherapiesUtilization of Risk Reducing TherapiesAfter Non-ST-Segment Elevation ACSAfter Non-ST-Segment Elevation ACS
ACS=Acute coronary syndrome
Federal Study of Adherence to Medications in the Elderly (FAME)
*Includes standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific blister packs
Lee JK et al. JAMA 2006;296:2563-2571
200 patients with CV risk factors randomized to pharmacy intervention* or usual care for 6 months
An intervention program significantly improves adherence
Pharmacy Intervention to ImprovePharmacy Intervention to ImproveUtilization of Risk Reducing TherapiesUtilization of Risk Reducing Therapies
CV=Cardiovascular