Download Post Myocardial Infarction

Post Myocardial Infarction
Pharmacotherapy
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Post MI Pharmacologic
Intervention
•
•
•
•
•
ASA & Anti-platelet agents
Anti-coagulation
- blockers
ACE inhibitors
Dyslipidemic therapy
– Statins
– Fibrates
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ASA & Anti-platelet agents
Rationale:
• Ruptured plaque
–
–
–
–
platelet activation & aggregation
thrombus core
downstream and upstream propagation
cyclical patency and re-occlusion v.s. persistent
thrombus formation
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Mechanism of Anti-platelet
Activity
• Class I - ASA, NSAIDs & sulfinpyrazone
– block CO (cyclo-oxygenase)
• Class II - Dypyridamole
– inhibits phosphodiesterase-mediated breakdown of
cyclic AMP
– prevents platelet aggregation
• Class III - thienopyridines (ticlopidine&clopidogrel)
– block binding of ADP to platelet receptor P2Y12 therby
inhibiting adenylyl cyclase
• Class IV - antibody, peptide & small molecule IIb/IIIA
receptor inhibitors
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Antiplatelet Trialists’
Collaboration: Summary
• Meta-analysis of 145 trials included about 70,000 high-risk
patients
• Anti-platelet drugs reduced risk of composite outcome of
ischemic stroke, MI, or vascular death by 27% in high-risk
patients
• The relative odds reduction was consistent:
– Over a wide range of clinical manifestations
(ischemic cerebrovascular, coronary, and atherosclerotic
peripheral arterial disease)
– Across subsets of patients at varying risks within specific
clinical disorders
Antiplatelet Trialists’ Collaboration. BMJ 1994; 308: 81–106.
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Patients with stroke, MI, or
vascular death (%)
Anti-platelet Trialists’
Collaboration: Results
25
22% odds reduction
20
29% odds
reduction
Antiplatelet therapy
Control
25% odds
reduction
27% odds
reduction
15
32% odds
reduction
10
5
0
Prior
Acute
stroke/TIA
MI
Prior MI
Other
All
high risk high risk
Category of trial
Anti-platelet Trialists’ Collaboration. BMJ 1994; 308: 81–106.
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ASA: Efficacy
ASA
Relativerisk
reduction
25%
ASA reduces the
risk of stroke,
MI, or vascular
death by 25%
relative to
placebo
Antiplatelet Trialists’ Collaboration. BMJ 1994; 308: 81–106.
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Clopidogrel in Unstable Angina
to Prevent Recurrent Ischemic Events
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CURE – Design (3)
Day 0
Clopidogrel
300 mg
loading dose
Day 1
Patients with ACS
(unstable angina or
NQMI without ST
elevation)
Clopidogrel 75 mg od
12 months
+ standard therapy†
(n=6259)
R
Placebo
loading dose
Day 1
Placebo 1 tab od
†
12 months + standard therapy
(n=6303)
R=Randomization, occurred within 24 hours of symptom onset
†
Standard therapy always included ASA, and could also include heparin,
heparin, LMWH, GP IIb/
IIb/IIIa inhibitors
post-randomization, beta-blockers, ACE-inhibitors, lipid-lowering agents, and/or other therapies or
interventions (e.g. PTCA, CABG) at physician’s discretion.
LMWH, lowlow-molecularmolecular-weight heparin; GP, glycoprotein;
glycoprotein;
PTCA, percutaneous transluminal coronary angioplasty; CABG, coronary artery bypass graft
CURE Study Investigators. Eur
Heart J 2000;21:2033–
2000;21:2033
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the care gap –2041
The CURE Investigators. N Eng J Med 2001;345:4942001;345:494-502
CURE – Main Efficacy Results
Primary endpoint (2)
% of patients with recurrent ischemic event*
14
Benefits were seen within hours and
continued to increase over the 12 months
12
10
8
20% RRR
p=0.00009
n=12,562
6
4
Standard therapy‡
Clopidogrel + standard therapy‡
2
0
0
1
2
3
4
5
6
7
8
9
10
11
12
Months of follow-up
‡including
ASA Medical Implementation
The CURE Investigators. N
Eng J Medthe
2001;345:494-502
2001;345:494
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care gap
Data on file
*cardiovascular death, MI, or stroke
Primary Outcome in Key Subgroups
Patient characteristics
Overall
2N
% events
Standard
Clopidogrel +
therapy‡
standard therapy‡
12 562
11.4
9.3
ST deviation +
ST deviation -
6275
6287
14.3
8.6
11.5
7.0
Entry enzymes elevated +
Entry enzymes elevated -
3176
9386
13.0
10.9
10.9
8.8
Diabetes +
Diabetes -
2840
9722
16.7
9.9
14.2
7.9
Risk Low
Intermediate
High
4187
4185
4184
6.7
9.4
18.0
5.1
6.5
16.3
Rev after randomization + 4577
Rev after randomization - 7985
13.9
10.0
11.5
8.1
History of rev +
History of rev -
14.4
10.7
8.4
9.5
2246
10 316
RR (95% CI)
- without condition
Rev, revascularization
0.4
0.6
0.8
1.0
1.2
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‡including ASA
The CURE Investigators. N Eng J Med 2001;345:494-502
+ with condition
Unresolved Questions
• Use in all comers with UAP/NSTEMI?
• With IIB/IIA inhibitors?
• How long to use
– With PCI?
– Without PCI?
• Cost efficacy?
• Peri-CABG discontinuation?
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Oral anticoagulant therapy in patients with coronary
artery disease: a meta-analysis.Anand SS; Yusuf S
JAMA 1999 Dec 1;282(21):2058-67
•
•
•
•
44 Trials-23,397 patients
oral anticoagulation for at least three months
acute MI, unstable angina, CABG
high intensity (INR 2.8-4.8) and moderate intensity (INR
2-3)
• Odds Ratio
– death: 22 & 18%
– MI: 42 & 52%
– CVA: 63 & 53%
• Bleeding: 6 & 2.4 X
• No difference in death, MI or CVA v.s. ASA
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Anti-coagulation
•
•
•
•
•
•
Indication post MI:
LV thrombus or aneurysm
LVEF < 30%
CHF
History of thrombo-embolism
Chronic atrial fibrillation-continue
indefinitely
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LV thrombus or aneurysm
• Up to 40% large Q-anterior MIs
– less in smaller MIs
– less post-thrombolysis
• Odds ratio 0.14 for embolization with anticoagulation for 6 months v.s no anticoagulation
– Embolic potential, prevention and management of
mural thrombus complicating anterior myocardial
infarction: a meta-analysis.Vaitkus PT; Barnathan ES
J Am Coll Cardiol 1993 Oct;22(4):1004-9.
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SELECTED RANDOMIZED TRIALS OF
- BLOCKER THERAPY ADMINISTERED
DURING AND AFTER AMI
- Blockers
Agent
# Patients
Duration
RRR of
Death
P Value
During MI
•ISIS I
Atenolol
16027
7 days
0.85
< 0.04
•MIAMI
Metoprolol
5778
15 days
0.87
0.29
•TIMI IIB
Metoprolol
1434
6 days
1.0
0.98
After MI
•Norwegian
Timolol
1884
33 months
0.61
< 0.001
•BHAT
Propranolol
3837
25 months
0.72
< 0.005
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ACC/AHA Guidelines
Rate of heart failure and 1-year survival for older
people receiving low-dose ß-blocker therapy after
myocardial infarction. Lancet 2000; 356: 639 - 644
• Paula A Rochon, Jack V Tu, Geoffrey M Anderson, Jerry H
Gurwitz, Jocalyn P Clark, Paula Lau, John Paul Szalai,
Kathy Sykora, C David Naylor
• 13 623 patients aged 66 years or older discharged from
hospital post myocardial infarction
• No ß-blocker therapy vs received low, standard, or high
doses.
• Of 8232 patients with no previous history of heart failure
– ß-blocker therapy was associated with a 43% reduction
in subsequent admission for heart failure
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Rate of heart failure and 1-year survival for older
people receiving low-dose ß-blocker therapy after
myocardial infarction. Lancet 2000; 356: 639 - 644
• Of 4681(57%) patients prescribed ß-blockers
– Risk of admission was greater in the highdose than in the low-dose group !!!!!
– Iin the cohort, 2326 (17·1%) died by 1 year
– Adjusted risk ratio 0·57 [95% CI 0·48-0·69] compared with
patients not dispensed this therapy
• Compared with those not dispensed ß-blocker therapy, the
adjusted risk ratio for mortality was lower for all three
doses
– low 0·40 [0·34-0·47]
– standard 0·36 [0·31-0·42]
– high 0·43 [0·33-0·56]
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CAPRICORN
CAPRICORN
CArvedilol Post-infaRct survIval
COntRol in LV dysfunctioN
NOT AN APPROVED INDICATION FOR COREG
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Inclusion Criteria
• Confirmed acute myocardial infarction within
3–21 days (mean, 10 d)
• LV ejection fraction 40%
• All appropriate treatments for MI including aspirin,
thrombolysis, and percutaneous interventions
• Receiving an ACE inhibitor for 48 hours
• Patients were usually hospitalized, but may have
been recently discharged
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The CAPRICORN Investigators, Lancet 2001
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NOT AN APPROVED INDICATION FOR COREG
Study Plan
Uptitration
Maintenance
Downtitration
Carvedilol (n=975)
(N=1959)
Placebo (n=984)
Initiation with 6.25 mg or 3.125 mg bid
Uptitration to maximum tolerated dosage
over 2–4 weeks. Target, 25 mg bid
Normally 3–5 days but
up to 21 days postpost-MI
Time to 633 events
Optimum therapy
at investigator’s
discretion
Mean follow up: 1.3 years
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The CAPRICORN Investigators, Lancet 2001
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NOT AN APPROVED INDICATION FOR COREG
0.95
0.9
0.85
0.8
Carvedilol
0.75
Placebo
0.7
Proportion Event Free
1
All-Cause Mortality
0
0.5
1
1.5
2
2.5
Years
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The CAPRICORN Investigators, Lancet 2001
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NOT AN APPROVED INDICATION FOR COREG
All-Cause Mortality
or Recurrent MI
Proportion Event Free
1
0.9
Carvedilol
0.8
Placebo
0.7
0
0.5
1
1.5
2
2.5
Years
© Continuing Medical Implementation
The CAPRICORN Investigators, Lancet 2001
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NOT AN APPROVED INDICATION FOR COREG
CAPRICORN: Summary
• In patients with LV dysfunction following an acute MI,
carvedilol treatment was associated with
– 23% lower risk of all-cause mortality
– 8% lower risk of mortality or CV hospitalizations
– 26% lower risk of sudden death
– 14% lower risk of HF hospitalization
– 41% lower risk of nonfatal myocardial infarction
– 29% lower risk of mortality plus MI
• Carvedilol was well tolerated, and target doses for
treatment were reached in the majority of patients
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The CAPRICORN Investigators, Lancet 2001
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NOT AN APPROVED INDICATION FOR COREG
ACE inhibitors
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SELECTED RANDOMIZED TRIALS OFACE
INHIBITOR THERAPY ADMINISTERED
DURING AND AFTER AMI
Trial
Agent
# Patients
Duration
RRR of
Death
P Value
During MI & 4-6 weeks after
ISIS – 4
Captopril
58050
35 days
0.93
0.02
GIZZI – 3
Lisinopril
19394
42 days
0.88
0.03
Consensus II
Enalaprilat
6090
41-180
days
1.11
0.26
Post MI LV Dysfunction
SAVE
Captopril
2231
42 mo.
0.81
0.02
AIRE
Ramipril
2006
15 mo.
0.73
0.002
TRACE
Trandolapril
1749
24-50 mo.
0.78
< 0.001
ACC/AHA Guidelines
Heart Outcomes Prevention
Evaluation Study
A large, simple, randomized trial of
Ramipril and vitamin E in patients at
high risk for cardiovascular events
Final
Key Inclusion/Exclusion
Criteria
Inclusion Criteria
Patients (age 55) at high risk for cardiovascular
events because of:
• any evidence of vascular disease (CHD, stroke, PVD)
• diabetes + one other coronary risk factor
Exclusion Criteria
Heart failure or low EF
On ACE-I or Vitamin E
Nov. 20, 1999
Final
Primary Adjudicated Events Ramipril vs Placebo 1/2
Ramipril Plac
(%)
(%)
RR
No. Rand.
1 Outcome
MI,Stroke,CVDth
CV Death*
MI*
Stroke*
Non-CV Death
4645
4652
14.1
6.1
9.9
3.4
4.3
10.4
17.7
8.1
12.2
4.9
4.1
12.2
Mortality
*not mutually exclusive
Nov. 20, 1999
0.78
0.75
0.80
0.69
1.03
0.84
95% CI
p
0.70-0.86 0.000002
0.64-0.87 0.0002
0.71-0.91 0.0005
0.56-0.84 0.0003
0.84-1.25
0.78
0.75-0.95 0.0058
Primary Outcome Ramipril vs Placebo
Final
K ap lan -M eier R ates
0.2
Ram ipril
Placebo
0.15
0.1
0.05
0
0
500
1000
1500
D ays of F ollow-up
Nov. 20, 1999
RR=0.78 (0.70-0.86)
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P=0.000002
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Final
Prespecified Subgroups Ramipril vs Placebo
No. Of Pts. Placebo Rate
CVD+ 8160
18.7
CVD- 1137
10.1
Diabetes+ 3578
19.8
Diabetes- 5719
16.5
0.6
Nov. 20, 1999
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0.8
1.0
1.2
RR (95% CI)
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Final
Other Subgroups of Prior Stated
Interest: Ramipril vs Placebo (1/2)
Age<65
Age 65+
Male
Female
Hypertension+
HypertensionCAD+
CADNov. 20, 1999
No. Of Pts.
4169
5128
Placebo
Rate
14.1
20.7
6817
2480
18.7
14.8
4355
4942
19.4
16.3
7475
1822
18.5
14.2
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0.6
0.8
1.0
1.2
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RR (95% CI)
Final
Ramipril vs Placebo
Patients with Documented normal EF
[N= 4759; mean 0.59 (SD 0.11)]
N
Primary
Outcome
CV death
MI
Stroke
All HF
Revasc.
Nov. 20, 1999
Ramipril Placebo
RR 95% CI
P
(%)
(%)
2387
2372
14.0
18.9 0.73 (0.63-0.84) 0.00001
5.2
7.5
0.68 (0.54-0.86) 0.0009
10.7
14.1
0.75 (0.64-0.88) 0.0005
2.9
4.3
0.67 (0.50-0.91) 0.0104
8.3
10.5
0.78 (0.65-0.94) 0.0082
19.9
24.0
0.80 (0.71-0.91) 0.0004
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Final
Conclusions:
Ramipril vs Placebo
There is overwhelming evidence that Ramipril
prevents:
– CV death, strokes and MI
– Heart Failure, Revascularization
– Development of diabetes
– Diabetic microvascular complications and
Nephropathy
These benefits are consistently observed in a very
broad range of high risk patients and in addition to
other effective therapies
The
Nov.
20, 1999only adverse event is a 5% excess of cough
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Statins Post MI
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Major Statin Trials
Trial
Statin
Cholesterol
at baseline
Control
%
ARR
NNT
6.7
5.6
5.4
21.5
17.2
13.7
8.0
3.9
2.7
13
26
37
7.0
5.7
8.4
3.6
2.6
1.4
38
71
Secondary Prevention
4S
Simva
LIPID
Prava
CARE
Prava
Primary Prevention
WOSCOPS Prava
AFCAPS
Lova
Total MI or CV Death
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ACUTE MI GUIDELINES 11/96
Drug Rx Peri MI: Meta-Analyses
Number
RR Death
p value
Beta blocker during MI
28,970
.87 (.77-.98)
0.02
Beta blocker post MI
24,298
.77 (.70-.84)
<0.001
ACEI during MI
100,963
.94 (.89-.98)
0.006
ACEI post MI if LV dysfxn
5,986
.78 (.70-.86)
<0.001
Nitrates during MI
81,908
.94 (.90-.99)
0.03
Ca++ blockers
20,342
1.04 (.95-1.14)
0.41
Magnesium
61,860
1.02 (.96-1.08)
>0.05
Lidocaine
9,155
1.38 (.98-1.95)
>0.05
Class I Antiarrhythmics
6,300
1.21 (1.01-1.44)
0.04
NEJM 335:1662, 1996
Cardiac Rehabilitation Programs
• Definition
– “the enhancement and maintenance of cardiovascular
health through individualized programs designed to
optimize physical, psychological, social, vocational and
emotional status”.1
• May include multifactorial secondary prevention
– defined as “the sum total of all interventions, both
physiological and behavioral, designed to favorably
modify an individual’s lifestyle, and enhance adherence
and compliance with long-term behaviors compatible
with minimizing disease progression”.1
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Benefits
• 20% reduction in mortality after a threeyear follow-up.16
• Improvement in exercise tolerance, blood
lipid levels, and psychosocial well-being.2
• A significantly lower incidence of rehospitalization and visits to the emergency
department at three and 12 months
compared with controls.29
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Needs
•
•
Only 10-20% of appropriate patients in
US currently participate in formal Rehab
Secondary prevention population 1999 in
Ontario
A. Post event (3o prevention)-95,699
B. Pre-event- 332,362
•
High risk primary prevention population
2,140,529
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System requirements
• Assuming
– 40% participation from secondary prevention
A) group
– 20% participation from secondary prevention
B) group
• Systematic capacity required June 2002
100,000
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CCN Network Model
• Coordinating sites
– Regional hub in population areas of > 500,000
• In-patient sites
– All hospitals with in-patient cardiac services
• Out-patient sites
– Hospital or community based provider
– Phase 2&3 care
• Maintenance sites
– Hospital or community based provider
– Phase 4 care
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Guide for Comprehensive
Cardiovascular Risk Reduction
Patients with Coronary and Other Vascular Disease
Patient: _______________________________ Diagnosis: _____________________________
Rx ()
Risk
Recommendations
Intervention
Smoking:
Goal-Complete cessation
Lipid Management:
Primary goal *
LDL  2.5 mmol/l
Secondary goal *
HDL  1.2 mmol/l(men)/
 1.1mmol/l (women)
TG  2.0 mmol/l
Canadian Working
Group on
Hypercholesterolemia
and other
Dyslipidemias
Blood pressure control:
Goal
135/85 mm Hg
2001 CHS
www.chs.md
Guidelines revised
Jan 2002
Diabetes
1998 CDA
www.diabetes.ca
Physical activity:
Minimum goal
30 minutes 3 to 4
times/week
HR guided
Obesity/weight
management:
Ideal body weight
Antiplatelet agents/
anticoagulants:
ACE inhibitors
Post-MI/LV Dysfunction:
ACE inhibitors
Vascular disease
Beta-blockers:
Post-MI
Beta-blockers:
CHF
Homocyst(e)ine
Estrogens:
© Continuing Medical Implementation
Strongly encourage patient and family to stop smoking.
Provide counselling, nicotine replacement, and formal cessation programs as appropriate.
Start hypolipidemic diet in all patients: 30% fat,7%saturated fat, 200mg/day cholesterol.
10 % LDL  achievable with diet. Consider drug Rx in all patients* with LDL  2.8 mmol/L
Assess fasting lipid profile. In post -MI patients, lipid profile may take 4 to 6 weeks to stabilize.
Baseline lipid profile < 24 after acute event. Add drug therapy according to the following guide:
LIPID Profile
1st Line Therapy
2nd Line Therapy
Statin
Resin
LDL 
Statin
Niacin or Fibrate
LDL  & TG 
Fibrate or Niacin
Combination Therapy
LDL  & TG 
Fibrate or Niacin
Combination Therapy
TG  & HDL 
* Primary goal: For patients with any of CAD, TIA, CVA, PVD/bruits, DM (Age  30) or for patients
with very high 10 year risk of CV event ( 30% or  4 risk factors).

Target initial therapy with the medication dose required to achieve target LDL  2.5 mmol/l.

For 3 risk factors (10 yr CV risk 20-30%) LDL target is 3.0 mmol/l. For 2 risk factors (10 yr CV risk
10-20%) LDL target is 4.0 mmol/l. For 1 risk factor (10 yr CV risk  10%) LDL target is 5.0 mmol/l.

Initiate lipid lowering early in high-risk patients (in conjunction with dietary modification).

For specific medications and dosing strategy see Lipid Optimization Tool


Initiate lifestyle modification in all patients with blood pressure  140 systolic or  90 diastolic.
Add Rx individualized to patient requirements and characteristics (i.e., age, race, need for drugs with
specific benefits) if BP is not less than 140 systolic or 90 diastolic in three visitswithout target organ
(TOD) damage or 5 visits with no TOD. Initiate Rx immediately if BP > 180/105.

No age distinction in initial therapy ( avoid -blocker or -blocker as initial Rx HTN  60yr)

Initial Rx: LDD(low dose diuretic)/-blocker/ACE-I/ long-acting DHP-CCB( - blocker not 1st line)

Isolated systolic HTN: LDD/long-acting DHP-CCB

Type 2 diabetes with micro-albuminuria, proteinuria or nephropathy ARBs alternate1st line Rx
Initiate diet, weight loss, education. Consider drug therapy for FBS  7.0 mmol/L
Aggressive BP control. Target130/80 (125/75 if micro-albuminuria: 30-300 mg/day; macro-albuminuria 
300mg/day or albumin/creatinine ratio > 2 mg/mmol-male or 2.8 mg/mmol-female)


Assess risk, preferably with exercise test, to guide prescription.
Encourage minimum of 30-40 minutes of moderate intensity activity 3 or 4 times weekly
(walking, jogging, cycling or other aerobic activity) supplemented by an increase in daily lifestyle
activities (e.g., walking breaks at work, using stairs, gardening, household work)

Maximum benefit 5 to 6 hours per week.

Advise medically supervised programs for moderate to high-risk patients.
Start intensive diet and appropriate physical activity intervention, as outlined above, in patients 120% of ideal
weight for height. Particularly emphasise need for weight loss in patients with hypertension, elevated
triglycerides or elevated glucose levels.
Start aspirin 80-325 mg per day if not contraindicated. Consider clopidogrel 75mg OD post MI, post CABG,
CVA, PVD in ASA intolerant or allergic patients (CAPRIE Trial). Consider clopidogrel 75mg OD + ASA for
ACS: unstable angina/non-ST elevation MI (CURE Trial: duration of therapy 9-12 months)
Consider warfarin for post MI patients not able to take aspirin (maintain INR 2-3).
Start early post-MI in stable high risk patients (anterior MI, previous MI, Killip class II (S3 gallop, rales,
radiographic CHF). Continue indefinitely for all with LV dysfunction (EF40%) or symptoms of CHF.
Use as needed to manage HPT or symptoms in all other patients.
Consider ACE inhibitors in all patients  55 yrs with evidence of vascular disease or diabetes and one other
risk factor: HOPE Trial-Ramipril 2.5 to 10 mg OD
Start acutely or within a few days of event in all post-MI patients (unless contra-indication). Continue
indefinitely if residual ischemia, heart failure LV dysfunction or severe co-morbidity. Continue indefinitely
in low risk patients (IIa). Rx as needed to manage angina, arrhythmia or HPT.
Rx Add Beta-blocker to ACE-inhibitor/diuretic/+/- digoxin in stable Class II-IV CHF/LVEF  40%
Bisoprolol 1.25  10 mg OD, carvedilol 3.125 mg BID  25 mg BID (50 mg BID if weight > 85 kg)
or metoprolol 12.5 mg  75-100 mg BID
Check in patients with premature CAD/CVD/PVD; Family history premature atherosclerosis or manifest
atherosclerosis & no identifiable risk factors.
Rx Folic acid 2.5 mg, B6 25 mg, B12 250 mcg for homocyst(e)ine level  10 mmol/L
HRT not recommended for 10 prevention. Use established preventative strategies. Consider HRT or SERMS
for non-cardiac indications. Individualize recommendations consistent with other health risks (VTE,
endometrial or breast CA). HRT not indicated in 2 0 prevention. D/C HRT in ACS, MI, PTCA,CABG,CHF,Sx.
…...bridging the care gap
We can’t do it alone
© Continuing Medical Implementation
…...bridging the care gap
Conclusions
• Multidisciplinary intervention indicated in
all post MI patients
• Patient education is key to empowerment
and motivation
• Diet, lifestyle,exercise form core
component of 2o prevention strategy
• In hospital timeframes limits educational
opportunity
© Continuing Medical Implementation
…...bridging the care gap
Conclusions
• Optimization of 2o prevention pharmacotherapy
provides opportunity to recapture lost morbidity
and mortality benefit
• Long term follow-up is necessary to ensure
compliance
• Cardiac rehabilitation (formal or informal) creates
the framework for optimal prevention
• Resources are currently inadequate to meet the
demonstrated need
© Continuing Medical Implementation
…...bridging the care gap