Transcript AMI powerpoint from Newfoundland Labrador

Creating a Safer System



24-month national Campaign.
For re-evaluation March 2007.
To help teams develop
skills/capacity to monitor their
performance and make Quality
Improvements (QI)
Focus is harm reduction and
improving care processes and
outcomes for patients
Canadian Adverse Events
Study
7.5% of all hospital admissions are
associated with an adverse event (2000)
 36.9% of which were deemed preventable
 IE: 70,000 preventable adverse events per
year
 Possibly contributing to 9,000 preventable
deaths in Canada (2000)

Adverse Events in Canadian Hospitals (Baker,
R. & Norton, P. et al (2004))


The Key focus of SHN: solving the
implementation issues that stand between
our knowledge of "what works” and our
ability to reliably provide this standard of
care
Safer Healthcare Now! aims to provide
quality improvement ideas, supports and
resources to hospital teams with the goal
of providing safer care.
 160 healthcare organizations and 470
teams enrolled nationwide
(68 teams in Atlantic Canada)
 Partners include CMA, CCHSA, DOH,
Professional Colleges , Associations of
Health Organizations

Six Improvement Initiatives:
– Acute Myocardial Infarction (AMI)
– Medication Reconciliation
– Surgical Site Infection (SSI)
– Rapid Response (RRT)
– Central Line Infection
– Ventilator Associated Pneumonia (VAP)
Cumulative 6-month mortality
from ischemic heart disease
Deaths / 100 pts / month
25
N = 21,761; 1985-1992
Diagnosis on adm to hosp
20
15
Acute MI
Unstable angina
Stable angina
10
5
0
0
1
2
3
4
Months after hospital admission
Duke Cardiovascular Database
5
6
7
Atherosclerosis Timeline
Foam
Cells
Complicated
Lesion/
Fatty Intermediate
Fibrous
Rupture
Streak
Lesion Atheroma Plaque
Endothelial Dysfunction
From First
Decade
From Third
Decade
Adapted from Pepine CJ. Am J Cardiol. 1998;82(suppl 104).
From Fourth
Decade
Plaque Rupture and Clot
Formation
9
Acute Coronary Syndrome
No ST Elevation
ST Elevation
NSTEMI
Unstable Angina
Myocardial Infarction
NQMI
Qwave MI
Serum Cardiac Markers
Dx: MI
Prognosis
Selection of Rx
Dx: Reinfarction
Prognosis
10
Assess Reperfusion
Early Mortality After AMI
% Mortality
25
Mortality at 25 - 30 Days
20
15
10
5
0
1967
1970
1979
Pre-CCU
CCU
b-Block
1986
1990
1993
1997
1999
GISSI-1 ISIS-2 GUSTO GUSTO-3 ASSENT-2
tPA &
SK
tPA &
SK+ASA
tPA
rPA
TNK
12
Definition of AMI




Patients admitted through ER with
diagnosis of AMI confirmed by 2 of :
documented symptoms compatible with AMI
ST elevation in 2 contiguous leads or new
LBBB
documented enzyme elevation.
Ischemic chest pain 30 min
14
Ischemic chest pain 30 min
Acute Anterior Injury
15
Ischemic Chest Pain – 30 min
16
Ischemic Chest Pain – 30 min
Acute inferior injury
17
ST Elevation MI: Management
Principles
1. Achieve early and complete reperfusion of the infarctrelated vessel
a. Primary Percutaneous intervention (PCI)
b. Thrombolytic therapy
2. Use evidence-based adjunctive medical therapy
a. ASA
b. Beta blockers
c. Angiotensin converting enzyme(ACE) inhibitors
d. Statins
e. Antithrombotic therapy (when indicated)
18
Primary PCI vs. Thrombolysis
PAMI TRIAL: 395 patients
Events:
Death, recurrent MI or ischemia requiring
revascularization
53% event free
survival
37 % event free
survival
From www.uptodate.com . Accessed on July 29, 2003
19
Fibrinolytic Therapy
Is It A Treatment of the Past?
• Meta-analysis of 23 randomized
trials
• Primary PCI reduced
Death
7%
vs 9%
Reinfarction
Stroke
2.5% vs
1% vs
Lancet 2003; 361:13-20
6.8%
2%
20
Fibrinolysis vs. Transport for PCI
• On-site (community hospital)
fibrinolysis compared with
immediate transport to a
regional center for PCI for
STEMI
• A consistent 40% reduction
in AE
• Time delay for transport
were 10, 30, 43 min (277 min
Odds ratio and 95% confidence intervals for
the composite end point of death, reinfarction, for PCI vs 245 min for
and stroke at 30 days
fibrinolysis)
ACC Scientific Sessions; March 20, 2002: Atlanta, Ga
ESC; September 1, 2002: Berlin, Germany
J Am Coll Cardiol. 2002; 39: 1713–1719
21
Fibrinolytic Therapy
Is It A Treatment of the Past?
• Resistance to primary PCI
– Not enough Primary PCI studies have
been performed
– Results may not be reproducible in low
volume and less experienced centers
– Withholding thrombolytic while awaiting
PCI may cause harm
22
Benefits of PCI vs Lysis: The Importance of Timing
Kent DM et al Eff Clin Pract 4: 214, 2001
Thrombolytic Therapy: Importance of Early
Therapy
Benefit Greatest within Two hours of therapy
Benefit falls by 1.6 lives per
1000 patients per hour of
treatment delay after two
hours
Data from Boersma,E et al. Lancet 1996;348: 771
24
ST Elevation MI: Importance of Early
Reperfusion
TIMI 0=Occlusion
TIMI 1= Penetration
TIMI 2= Slow Flow
TIMI 3= Normal Flow
25
Thrombolytic Therapy: Ineligible Patients
26
From www.uptodate.com. Accessed July 28, 2003
ST elevation MI
• Fibrinolysis – TNK (tPA, rPA, SK) then
• Low molecular weight heparin (Enoxaparin)
- 30 mg bolus IV under age 75 and
- 1 mg/kg sq bid
- Age 75 and up – 0.75 mg/kg sq bid. or
• Unfractionated heparin for very obese over
145 kg, renal failure
27
Thrombolytic Therapy: Bottom Line
• Earlier (within two hours of symptoms) administration
associated with better outcomes but benefit shown up to 12
hours
• Overall efficacy in achieving TIMI 3 flow is 50-60%
• Risk of Hemmorragic Stroke Low (0.49%-0.72%)
– Less with SK than with t-PA or TnK
• 40% of patients are INELIGIBLE for thrombolytic therapy
• Current Agent of Choice: Tenecteplase (TnK)
• Primary PCI better:
– Higher rate of TIMI 3 flow (>90%)
– Negligible risk of Intracranial Hemmorrhage
– Associated with improved outcomes
28
Summary - STEMI
• ST-segment elevation ACS should
receive reperfusion therapy (PCI or
fibrinolysis) as a medical emergency
• Early use of aspirin, b-blockers, ACE
inhibitors (in LV dysfunction),
antithrombin agents, antiplatelet
therapies
• Center with invasive facilities have
better outcomes
29
Figure 6
TIMI Risk Score for STEMI
Historical
Age 65-74
 75
DM/HTN or angina
Exam
SBP < 100
HR >100
Killip II-IV
Weight < 67 kg
2 points
3 points
1 point
3 points
2 points
2 points
1 point
Presentation
Anterior STE or LBBB
Time to rx > 4 hrs
1 point
1 point
Risk Score = Total
(0 -14)
(FRONT)
Risk Score
0
1
2
3
4
5
6
7
8
>8
Odds of death by 30D*
0.1
0.3
0.4
0.7
1.2
2.2
3.0
4.8
5.8
8.8
(0.1-0.2)
(0.2-0.3)
(0.3-0.5)
(0.6-0.9)
(1.0-1.5)
(1.9-2.6)
(2.5-3.6)
(3.8-6.1)
(4.2-7.8)
(6.3-12)
*referenced to average mortality
(95% confidence intervals)
(BACK)
TIMI Risk Score for STEMI
Palm Pilot
application
available at:
www.timi.org
31
From www.uptodate.com. Accessed June 28, 2003
WMH AMI Committee
Julie SuttonTeam Leader
 Dr. Jamie GrahamCardiac Physician Rep.
 Bonnie WalkerPatient Safety Rep.
 Dr. Peter CallahanER Physician Rep.





Maureen DoodyEducator Rep.
Brenda RexICU Rep.
Suzanne Joseph 3A Manager Rep.
Rhonda Squires3A PCC Rep.
AMI Statistics


Prompt ASA reduces risk of death by
15% ; Beta-blockers reduce risk of
death in first week by 13% and long
term mortality by 23%
RAND study (NEJM) showed only 61%
of AMI patients receive ASA and only
45% receive beta-blockers
AMI Key Components






1. Early administration of aspirin
(within 24 hours)
2. Timely thrombolytic (within 30 minutes)
3. Aspirin at discharge
4. Beta-blocker at discharge
5. ACE-inhibitor at discharge
(if systolic dysfunction)
6. Smoking cessation counseling
Potential Cumulative Impact of 4 Simple
Secondary Prevention Treatments
"Yusuf
S., Unpublished data."
RRR
None
Event rate
8%
ASA
25%
6%
b-Blockers
25%
4.5%
Lipid lowering
30%
3.0%
ACE-inhibitors
25%
2.3%
CUMULATIVE BENEFITS ARE LIKELY TO BE IN EXCESS OF
35
75% RRR, WHICH IS SUBSTANTIAL
AMI Baseline Data

BASED on Retrospective Chart Review
March -September 2005
74 Charts Identified, 20 Excluded
54 reviewed for compliance and
documentation with each of AMI
components and overall (Perfect Care)
AMI Baseline Data vs. Goals
100.0%
90.0%
% of Patients Receiving Intervention
80.0%
70.0%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
Baseline
Goal
Aspirin at Arrival
Thrombolytic
Admin < 30 min
Aspirin at
Discharge
Beta Blocker at
Discharge
ACE or ARB at
Discharge
Smoking
Cessation
"Perfect Care"
91.0%
80.0%
92.5%
90.0%
70.0%
50%
41.0%
90%
85%
90%
90%
85%
100%
95%
Acute MI: ASA benefit
ISIS-2: 17, 187 patients: Acute MI
23%
mortality
reduction
42%
mortality
reduction
38
1.
Early Administration of ASA
Goal: >90% compliance
Aspirin 24 hrs before or after hospitalization
Exclusions:
 Documented contraindications:
(ASA allergy, active bleeding, warfarin before
arrival)
 Transferred in from or out to another acute
care facility
ASA on Arrival
100
90
80
WMRH
Atlantic
Canada
70
60
50
2005
Mar-06
Jun-06
40
Thrombolysis: Decay with
Delay
100
80
Percent
Benefit
60
40
20
0
0
2
4
6
Hours Delay
8
10
12
41
2. Timely Thrombolysis
Goal: >85% compliance
Thrombolytic Agent within 30 minutes (door to
needle)of arrival
Exclusions:
 Transferred in from another facility
 No ST elevation or new LBBB present
 Did not receive a thrombolytic or received
thrombolytic more than 6 hrs after arrival
Thrombolytic within 30 min
100
90
80
70
60
50
40
30
20
10
0
WMRH
Atlantic
Canada
2005
Mar-06
Jun-06
43
Aspirin Evidence: Secondary
Prevention
Effect of antiplatelet therapy* on vascular events**
Category
% Odds Reduction
Acute myocardial infarction
Acute stroke
Prior myocardial infarction
Prior stroke/transient ischemic attack
Other high risk
Coronary artery disease
(e.g. unstable angina, heart failure)
Peripheral arterial disease
(e.g. intermittent claudication)
High risk of embolism (e.g. atrial fibrillation)
Other (e.g. diabetes mellitus)
All trials
0.0
0.5
1.0
1.5
2.0
Antiplatelet better Control better
*Aspirin was the predominant antiplatelet agent studied
**Vascular events include MI, stroke, or death
Antithrombotic Trialist Collaboration. BMJ 2002;324:71–86.
44
Aspirin Evidence: Dose and
Efficacy
Indirect Comparisons of Aspirin Doses on Vascular Events
in High-Risk Patients
Aspirin Dose
No. of Trials
(%)
500-1500 mg
34
19
160-325 mg
19
26
75-150 mg
12
32
<75 mg
3
13
Any aspirin
65
23
0
Odds Ratio for
Vascular Events
P<.0001
0.5
Antiplatelet Better
1.0
1.5
2.0
Antiplatelet Worse
45
Antithrombotic Trialists Collaboration. BMJ. 2002;324:71-86
3. Discharged on ASA
Goal: >90% compliance
Aspirin prescribed on discharge
Exclusions:
 Documented contraindications:
(ASA allergy,active bleeding, warfarin
before arrival)
 Transferred out to another acute care
facility
ASA at Discharge
100
95
90
WMRH
Atlantic
Canada
85
80
75
70
2005
Mar-06
Jun-06
47
Acute MI: Benefit of Beta
Blockers
201, 752 patients with MI
Mortality reduction:
14.4% vs. 23.9% at 2 years
48
Data from Gottlieb, SS et al. NEJM 1998;339:489
b-blocker Evidence
Summary of Secondary Prevention Trials of b-blocker Therapy
Phase of
Treatment
Total #
Patients
RR (95% CI)
Acute
treatment
28,970
0.87 (0.77-0.98)
Secondary
prevention
24,298
0.77 (0.70-0.84)
Overall
53,268
0.81 (0.75-0.87)
0.5
CI=Confidence interval, RR=Relative risk
1.0
RR of death
b-blocker
Placebo
better
better
2.0
Antman E, Braunwald E. Acute Myocardial Infarction. In: Braunwald E, Zipes DP, Libby P, eds. Heart
49
Disease: A textbook of Cardiovascular Medicine, 6th ed., Philadelphia, PA: W.B. Sanders, 2001, 1168.
b-blocker Evidence: Post MI with
Left Ventricular Dysfunction
Carvedilol Post-Infarct Survival Control in LV Dysfunction
(CAPRICORN)
Proportion Event-free
6,644 patients with LVEF <0.40 after a MI with or without HF randomized
to carvedilol or placebo for 24 months
1
0.95
n=975
0.9
Carvedilol
n=984
0.85
0.8
0.75
0.7
RR 0.77 P=.03
0
0.5
1
1.5
Placebo
2
2.5
Years
50
The CAPRICORN Investigators. Lancet. 2001;357:1385–1390.
4. Discharged on Beta Blocker
Goal: >90% compliance
Beta Blocker prescribed on discharge
Exclusions:
 Documented contraindications: (allergy,
bradycardia or BP < 90 systolic day of or day
prior to discharge when not on beta blocker,
2nd/3rd degree HB without a pacemaker,)
 Transferred out to another acute care facility
Beta Blocker at Discharge
100
95
90
WMRH
Atlantic
Canada
85
80
75
70
2005
Mar-06
Jun-06
52
Acute MI: ACE Inhibitor
Benefit
Data from Pfeffer, MA et al.NEJM 1992;327: 669
53
ACE Inhibitor Evidence: Post MI
with LVD or HF
AIRE
SAVE
Probability of Event
Radionuclide
EF  40%
0.4
TRACE
Clinical and/or
radiographic
signs of HF
Echocardiogram
EF  35%
Placebo
0.35
ACE-I
0.3
0.25
0.2
0.15
0.1
OR: 0.74 (0.66–0.83)
0.05
0
0
1
2
3
4
Years
ACE-I=Angiotensin converting enzyme inhibitors, LVSD=Left ventricular systolic dysfunction,
MI=Myocardial infarction, OR=Odds ratio
54
Flather MD, et al. Lancet. 2000;355:1575–1581
% Death, MI, or Stroke
HOPE Primary Results
Benefits of ACE Inhibitors
0.2
Ramipril
Placebo
0.15
0.1
0.05
p<0.001
0
0
500
1000
1500
Days of Follow-up
55
ACE Inhibitor Evidence:
Secondary Prevention
Comparison between the HOPE and PEACE trials
20
HOPE, placebo
MI, Cardiac death,
or Stroke (%)
HOPE, active drug (ramipril)
PEACE, placebo
15
10
5
0
0
1
2
3
4
5
Years
*Reflects greater blood pressure control, revascularization, and use of other risk-reducing medications (i.e.,
antiplatelet therapy, b-blocker, lipid-lowering medication)
CHD=Coronary heart disease, MI=Myocardial infarction
Braunwald, E. et al., NEJM 2004;351:2058-68.
56
ARB Evidence: Heart Failure
Candesartan in Heart Failure Assessment of Reduction in
Mortality and Morbidity (CHARM) Alternative Trial
2,028 patients with symptomatic HF, LVSD (EF <40%), and intolerance to
ACE-I randomized to candesartan (32 mg) or placebo over 34 months
CV Death of
Hospitalization
for HF
50
Placebo
40
Candesartan
30
20
10
HR 0.77 p=0.0004
0
0
1
2
Years
3
ACE-I=Angiotensin converting enzyme inhibitors, ARB=Angiotensin receptor blockers, EF=Ejection
fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction
Granger CB et al. Lancet. 2003;362:772-777
57
ARB Evidence: Post MI with LVD
or HF
Valsartan in Acute Myocardial Infarction Trial (VALIANT)
All Cause Mortality
14,703 patients with post-MI HF or LVSD (EF <0.40) randomized to captopril
(50 mg three times daily), valsartan (160 mg twice daily), or captopril (50
mg three times daily) plus valsartan (80 mg twice daily) over 2 years
0.4
Captopril
0.3
Valsartan
Valsartan and Captopril
0.2
0.1
Valsartan vs. Captopril: HR = 1.00; P = 0.982
Valsartan + Captopril vs. Captopril: HR = 0.98; P = 0.726
0.0
0
6
12
18
24
30
36
Months
EF=Ejection fraction, HR=Hazard ratio, LVSD=Left ventricular systolic dysfunction, MI=Myocardial
infarction, RAS=Renin angiotensin system
58
Pfeffer M et al. NEJM 2003;349:1893-1906.
5. Discharged on ACEI/ARB
Goal: >85% compliance
ACE Inhibitor prescribed on discharge
Exclusions:
 Documented contraindication:
(allergy/intolerance, moderate to severe
aortic stenosis, renal dysfunction,
systolic BP <100mmHg, K+ > 4.5)
 Transferred out to another acute care
facility
ACEI/ARB at Discharge
100
90
80
WMRH
Atlantic
Canada
70
60
50
40
2005
Mar-06
Jun-06
60
Cigarette Smoking Cessation: Risk
of Non-fatal MI*
RR (95% Cl)
Study
Aberg, et al. 1983
0.67 (0.53-0.84)
Herlitz, et al. 1995
0.99 (0.42-2.33)
Johansson, et al. 1985
0.79
Perkins, et al. 1985
3.87 (0.81-18.37)
Sato, et al. 1992
0.10 (0.00-1.95)
Sparrow, et al. 1978
0.76 (0.37-1.58)
Vlietstra, et al. 1986
0.63 (0.51-0.78)
Voors, et al. 1996
0.54 (0.29-1.01)
0.1
Ceased smoking
*Includes those with known coronary heart disease
Critchley JA et al. JAMA. 2003;290:86-97.
1.0
Continued smoking
(0.46-1.37)
10
CI=Confidence interval, RR=Relative risk
61
6. Smoking Cessation
Counseling on Discharge
Goal: 100 % compliance
Received smoking cessation advice,counselling
and/or pharmocological therapy or referral to
Cardiac Rehab during hospitalization
Exclusions:
 No history of smoking cigarettes, cigars or
pipe anytime in year prior to admission
 Transferred out to another acute care facility
Smoking Cessation Advice
90
80
70
60
50
WMRH
Atlantic
Canada
40
30
20
10
0
2005
Mar-06
Jun-06
63
7. “Perfect Care” for AMI
Goal 95%compliance
The percentage of AMI patients who received
all 6 evidence based elements.
 documentation of all 6 elements of care in
appropriate time frames,
 documentation of clearly defined
contraindications .
“Perfect Care”
100
90
80
70
60
50
40
30
20
10
0
WMRH
Atlantic
Canada
2005
Mar-06
Jun-06
65
Acute MI: Statin Benefit
20, 536 patients in Heart Protection Study
66
Data from: Heart Protection Study. Lancet 2002;360:7
HMG-CoA Reductase Inhibitor:
Secondary Prevention
Relationship between LDL Levels and Event Rates in
Secondary Prevention Trials of Patients with Stable CHD
30
4S
Statin
Placebo
Event (%)
25
4S
20
LIPID
15
LIPID
CARE
10
HPS
5
0
CARE
HPS
TNT (atorvastatin 10 mg/d)
TNT (atorvastatin 80 mg/d)
0
70
90
110
130
150
LDL-C (mg/dL)
170
190
210
LDL-C=Low density lipoprotein cholesterol; TNT=Treating to New Targets; HPS=Heart Protection
Study; CARE=Cholesterol and Recurrent Events Trial; LIPID=Long-term Intervention with Pravastatin
in Ischaemic Disease; 4S=Scandinavian Simvastatin Survival Study.
67
LaRosa JC et al. NEJM. 2005;352:1425-1435
Statin at Discharge
100
90
80
70
WMRH
60
50
40
Mar-May 06
June-July 06
68
Improvement Model
PDSA
What are we trying to accomplish?
How will we know that a change is an improvement?
What changes can we make that will result in
improvement?
Act
Plan
Study
Do
Plan a test
 Try it
 Observe the
results
 Act on what is
learned

Act
Plan
Study
Do
make changes
Test again
make changes
Test again
make changes
Test Smoking Rehab
a
e
c
h
a
n
g
e
s
Improvements in Progress



Combining 2 Routine MI order sheets
STEMI / NSTEMI to one
Reviewing Thrombolytic Standing
Order sheet
Reviewing Nicotine Replacement
addition to hospital formulary
Next Steps: Concurrent Data



Uses tests of change that allow
changes while patient still in hospital
Allows identification of missed
interventions so they can be corrected
before the patient is discharged
Results in improved AMI care for
patients
MI
Work
sheet
74
Contraindications – p.2
75
Frontline Staff Can Make a
Difference!



MD’s: please use MI order sheet
Checklist of interventions for
improved care for AMI into care
processes
During hospitalization check for
interventions and document each as
completed or contraindicated
Components of Secondary
Prevention
Cigarette smoking cessation
Blood pressure control
Lipid management to goal
Physical activity
Weight management to goal
Diabetes management to goal
Antiplatelet agents / anticoagulants
Renin angiotensin aldosterone system blockers
Beta blockers
Influenza vaccination
77
Blood Pressure: Lower is Better
Age at Risk (Y)
80-89
256
128
70-79
64
60-69
32
50-59
16
40-49
8
4
2
1
0
Ischemic Heart Disease Mortality
Ischemic Heart Disease Mortality
Ischemic Heart Disease Mortality
256
Age at Risk (Y)
80-89
128
70-79
64
60-69
32
50-59
16
40-49
8
4
2
1
0
120 140 160 180
Usual Systolic BP (mm Hg)
BP=Blood pressure
Prospective Studies Collaboration. Lancet. 2002;360:1903-1913
70 80 90 100 110
Usual Diastolic BP (mm Hg)
78
Exercise Evidence: Mortality Risk
Observational study of self-reported physical activity in 772 men with
established coronary heart disease
Light or moderate exercise is associated with lower risk
Wannamethee SG et al. Circulation 2000;102:1358-1363
79
CV Risk Increases with Body Mass
Index
Hazard Ratio
Hemorrhagic
Stroke
Ischemic
Stroke
Ischemic Heart
Disease
4.0
4.0
4.0
2.0
2.0
2.0
1.0
1.0
1.0
0.5
0.5
0.5
16 20 24 28 32 36
16 20 24 28 32 36
16 20 24 28 32 36
Body Mass Index (kg/m2)*
CV=Cardiovascular
Body mass index is calculated as the weight in
kilograms divided by the body surface area in meters2.
Mhurchu N et al. Int J Epidemiol 2004;33:751-758
80
Clopidogrel Evidence: ACS
(Non-STEMI and UA)
Clopidogrel in Unstable Angina to Prevent Recurrent Events
(CURE) Trial
Rate of death,
myocardial infarction,
or stroke
12,562 patients with a NSTEMI-ACS randomized to daily aspirin (75-325
mg) or clopidogrel (300 mg load, 75 mg thereafter) plus aspirin (75325 mg) for 3-12 months (average 9 months)
0.14
Aspirin + Clopidogrel
Aspirin + Placebo
0.12
0.10
0.08
0.06
0.04
0.02
P<0.001
0.00
0
3
6
9
12
Months of Follow Up
NSTEMI-ACS=Non ST-segment elevation acute coronary syndrome
81
The CURE Trial Investigators. NEJM. 2001;345:494-502
Aldosterone Antagonist: Heart
Failure
Randomized Aldactone Evaluation Study (RALES)
1,663 patients with NYHA Class III or IV HF and LVSD (EF
<0.35) randomized to spironolactone (25 mg) or placebo
(50 mg) for 24 months
Survival (%)
1.00
Spironolactone
Placebo
.90
.80
.70
.60
.50
RR = 0.70, P<0.001
0
0
3
6
9
12 15 18 21 24 27 30 33
36
Months
EF=Ejection fraction, HF=Heart failure, LVSD=Left ventricular systolic dysfunction, NYHA=New York Heart
Association
Pitt B et al. NEJM 1999;341:709-717
82
Aldosterone Antagonist: Post MI HF
and LVSD
Eplerenone Post-Acute Myocardial Infarction Heart Failure
Efficacy and Survival Study (EPHESUS)
All Cause Mortality (%)
6,644 patients with evidence of heart failure and LVSD (EF <0.40) after a
MI randomized to eplerenone (50 mg) or placebo for 16 months
Eplerenone
Placebo
25
20
15
10
5
0
RR = 0.85, P=0.008
0
6
12
18
24
30
36
Month
EF=Ejection fraction, LVSD=Left ventricular systolic dysfunction, MI=Myocardial infarction
Pitt B et al. NEJM 2003;348:1309-21
83
Impact of AHA Get With The
Guidelines-CAD Program on
Quality of Care
Baseline
*
100
90
80
70
60
50
40
30
20
10
0
*
* 97
9796
95
93
Q1
Q2
8787
*
64656567
Aspirin
Q4
* p< 0.05 compared to baseline
*
* * 91
83
79
Q3
68
Beta Blocker ACE Inhibitor
GWTG-CAD: 123 US Hospitals n=27,825
Labresh, Fonarow et al. Circulation 2003;108:IV-722
* *
* 75
73
6770
74
*
* * 82
* 7675
70
57
Lipid Rx
Smoking
Cessation
84
Questions ?