CVD Critical Pathways Group Teleconference Highlights from the 54th Annual Scientific Session of the

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CVD Critical Pathways Group Teleconference
Highlights from the 54th Annual Scientific
Session of the ACCApril 13, 2005
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Faculty

• Christopher P. Cannon, MD
• Associate Professor of Medicine
• Harvard Medical School
• Senior Investigator, TIMI Study Group
• Associate Physician, Cardiovascular Division
• Brigham and Womens Hospital
• Boston, Massachusetts

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Disclosure Statement

• The Network for Continuing Medical Education
  requires that CME faculty disclose, during the
  planning of an activity, the existence of any
  personal financial or other relationships they or
  their spouses may have with the commercial
  supporter of the activity or with the
  manufacturer of any commercial product or service
  discussed in the activity.

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Faculty Disclosure Statement

• Christopher P. Cannon, MD, has served as a
  consultant to AstraZeneca Pharmaceuticals LP,
  Bristol-Myers Squibb Company, GlaxoSmithKline,
  Guilford Pharmaceuticals, Merck/Schering-Plough
  Pharmaceuticals, Pfizer Inc., Sanofi-Aventis,
  Schering-Plough Corporation, and Vertex
  Pharmaceuticals Inc. He has also received
  research support from AstraZeneca Pharmaceuticals
  LP, Bristol-Myers Squibb Company, Merck Co.,
  Inc., and Sanofi-Aventis.
• Christiana Care Health Services team members
  report no such relationships.

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Polling Question 1

• What is your institutions status in terms of
  establishing critical pathways for ACS?
• 1) ACS pathways not in place
• 2) ACS pathways in place, but not updated per
  current ACC/AHA UA/NSTEMI and STEMI Guidelines
• 3) ACS pathways up-to-date, not regularly
  implemented
• 4) ACS pathways up-to-date and regularly followed

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Highlights From ACC 2005

• CLARITY-TIMI 28 CLopidogrel as Adjunctive
  Reperfusion TherapY Thrombolysis In Myocardial
  Infarction (TIMI) 28
• COMMIT ClOpidogrel and Metoprolol in Myocardial
  Infarction Trial
• Womens Health Study Low-Dose Aspirin in Primary
  Prevention Trial
• ARMYDA-2 Antiplatelet Therapy for Reduction of
  MYocardial Damage During Angioplasty
• Pioglitazone Trial Pioglitazone Reduces
  Neointima Formation After Coronary Stent
  Implantation
• TNT Treating to New Targets Study
• RIO-Europe Trial Rimonabant In Obesity Europe

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CLARITY-TIMI 28 Trial Study Design
Double-blind, randomized, placebo-controlled
trial in3491 patients, aged 18-75 yrs, with
STEMI lt12 hours
Fibrinolytic, ASA, Heparin
Randomized
Clopidogrel 300 mg 75 mg qd
Placebo
Study Drug
Primary end point Occluded artery (TIMI flow
grade 0/1) or death/MI by time of angio
Coronary Angiogram (2-8 days)
Open-label clopidogrel per MD inboth groups
30-day clinical follow-up
Sabatine M. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla. Sabatine MS, et
al. N Engl J Med. 20053521179-1189.
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CLARITY-TIMI 28 Trial Primary End Point
Occluded Artery (or Death/MI Through Angio/HD)
Odds Ratio 0.64(95 CI, 0.53-0.76)
36 Odds Reduction
21.7
P0.00000036
15.0
Occluded Artery or Death/MI ()
1.0
0.4
0.6
0.8
1.2
1.6
Clopidogrel better
Placebo better
n1752
n1739
Placebo
Clopidogrel
Sabatine M. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla. Sabatine MS, et
al. N Engl J Med. 20053521179-1189.
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CLARITY-TIMI 28 Trial CV Death, MI, RI ? Urg
Revasc
15
Placebo
20
Clopidogrel
10
End Point ()
Odds Ratio 0.80 (95 CI, 0.65-0.97) P0.026
5
0
0
5
10
15
20
25
30
Days
Sabatine M. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla. Sabatine MS, et al.
N Engl J Med. 20053521179-1189.
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CLARITY-TIMI 28 Trial Bleeding
P value
Placebo ()
Clopidogrel ()
Outcome
Through angiography
1.1
NS
1.3
TIMI major (Hgb ? gt5 g/dL or ICH)
0.5
NS
1.0
TIMI minor (Hgb ? 3-5 g/dL)
0.7
NS
0.5
Intracranial hemorrhage
Through 30 days
1.7
NS
1.9
TIMI major
NS
7.2
7.5
In those undergoing CABG
CABG w/in 5 d of study med
NS
7.9
9.1
0.9
NS
1.6
TIMI minor
Sabatine M. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla. Sabatine MS, et
al. N Engl J Med. 20053521179-1189.
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Evolution of Pharmacologic Reperfusion
CLARITY-TIMI 283
TIMI 11
APRICOT2
90 mins
3 mos
3.5 days
57
47 ? Plt0.001
22 ? P0.26
Occluded Infarct-Related Artery ()
32
30
36 ? Plt0.001
25
18.4
11.7
TPA
SK
ASA
Placebo
ASA
ASA Clopidogrel
1. TIMI Study Group. N Engl J Med.
1985312932-936. 2. Meijer A, et al.
Circulation. 1993871524-1530. 3. Sabatine MS,
et al. N Engl J Med. 20053521179-1189.
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CLARITY-TIMI 28 Trial Summary and Conclusion

• In patients with STEMI ?75 yrs, receiving a
  standard fibrinolytic regimen, a loading dose of
  300 mg of clopidogrel followed by 75 mg daily
  resulted in

• 36 reduction in the odds of an occluded
  infarct-related artery, or death/MI by angio
  (NNT16)
• Highly consistent benefit across all major
  subgroups
• 20 reduction in CV death, MI, or recurrent
  ischemia leading to urgent revasc through 30 days
  (NNT36)
• No excess in TIMI major or minor bleeding
  (including in those undergoing CABG) or in ICH

Conclusion Clopidogrel offers an effective,
simple, inexpensive, and safe means by which to
improve infarct-related artery patency and reduce
ischemic complications (Sabatine MS, et al. N
Engl J Med. 20053521179-1189).
Sabatine M. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla.
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COMMIT/CCS-2 Study Design

• Treatment Clopidogrel 75 mg daily vs placebo
• (aspirin 162 mg daily in both groups)
• Inclusion Suspected acute MI (ST change or
  LBBB) within 24 h of symptom onset
• Exclusion Primary PCI or high risk of bleeding
• 1? Outcomes Death and death, re-MI, or stroke up
  to 4 weeks in hospital (or prior discharge)

Mean treatment and follow-up 16 days
COMMIT ClOpidogrel Metoprolol in Myocardial
Infarction Trial. Chen Z. Presented at 54th
Annual Scientific Session of the American College
of Cardiology March 9, 2005 Orlando, Fla.
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COMMIT Effect of Clopidogrel on Death, Re-MI,
or Stroke
Placebo ASA 2311 events (10.1)
Clopidogrel ASA 2125 events (9.3)
9 (SE3) relative risk reduction (2P0.002)
Chen Z. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla.
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COMMIT Effect of Clopidogrel on Death in
Hospital
Placebo ASA 1846 deaths (8.1)
Clopidogrel ASA 1728 deaths (7.5)
7 6 5 4 3 2 1 0
7 (SE3) relative risk reduction (2P0.03)
Mortality ()
0 7 14 21 28
Days since randomization (up to 28 days)
Chen Z. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla.
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COMMIT Major Bleed in Hospital

• Type Clopidogrel
  Placebo
  
  
  (n22,958) (n22,891)
• Cerebral
• Fatal 39 40
• Nonfatal 16 15
• Noncerebral
• Fatal 36 37
• Nonfatal 46 36
• Any major bleed 134 124
• (0.58)
  (0.54)

Chen Z. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla.
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COMMIT Conclusions

• Adding 75 mg daily clopidogrel to aspirin in
  acute MI prevents 10 major vascular events per
  1000 treated
• No excess of cerebral, fatal, or transfused
  bleeds (even with fibrinolytic therapy
  and in older people)
• Every million MI patients treated for 2 weeks
  would avoid 5000 deaths and 5000 nonfatal events

Chen Z. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 9, 2005 Orlando, Fla.
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Milestones in the Evolution of Thrombolysis in
Myocardial Infarction

• Mortality
• 1988 ISIS-2 SK 25 ?
• ASA 23 ?
• 1993 GUSTO-1 TPA 14 ?
• 2005 COMMIT/ Clopidogrel 7 ? CCS-2

Cannon CP. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 9, 2005 Orlando, Fla.
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Clopidogrel in STEMI

• Evidence from 2 large trials in 50,000 patients
• Benefit in opening infarct-related artery, and
  in reducing mortality and morbidity
• No excess in major bleeding
• Low cost

A new addition to treatment of STEMI
Cannon CP. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 9, 2005 Orlando, Fla.
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Clopidogrel Across Spectrum of CAD
UA/NSTEMI
PCI
Long-term 2o (1o) Prevention
CAPRIE Lancet 1996
High-Risk Vascular Disease
MI/Stroke/PAD
PCI
NSTEMI / UA
1 Year
1 Year
1-3 Years
Up to 3.5 years(ongoing)
Benefit
Benefit
Benefit
Cannon CP. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 9, 2005 Orlando, Fla.
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Clopidogrel for High Atherothrombotic Risk and
Ischemic Stabilization, Management, and
Avoidance (CHARISMA) Study Design
N15,600
Clopidogrel75 mg once daily (n7600)
Aspirin 75162 mg once daily
Double-blind treatment up to 1040 primary
efficacy events
Aspirin 75162 mg once daily
Placebo 1 tab once daily (n7600)
1-month visit
3-month visit
Primary end point Combination of CV death,
stroke, or MI
42nd monthor final visit
R randomization.
Bhatt DL, Topol EJ. Am Heart J. 2004148263-268.
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Women's Health Study Low-Dose Aspirin in
Primary Prevention Trial
39,876 initially healthy women, aged ?45
yrs Randomized, blinded, factorial
Placebo n19,942

• Low-Dose Aspirin
• 100 mg on alternate days
• n19,934

• End points (mean, 10.1 yrs)
• Combined end point of nonfatal MI, nonfatal
  stroke, or total cardiovascular death
• Incidence of total malignant neoplasms of
  epithelial cell origin

No history of coronary heart disease,
cerebrovascular disease, cancer (except
nonmelanoma skin cancer), or other major chronic
illness no history of side effects to any of the
study medications not taking aspirin or
nonsteroidal anti-inflammatory medications
(NSAIDs) more than once a week (or were willing
to forgo their use during the trial) not taking
anticoagulants or corticosteroids and not taking
individual supplements of vitamin A, E, or
beta-carotene more than once a week.
Ridker PM. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 7, 2005 Orlando, Fla. Ridker PM, et al. N
Engl J Med. 20053521293-1304.
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Women's Health Study Low-Dose Aspirin in
Primary Prevention Trial
Primary Composite End Point Major Cardiovascular
Events Relative Risk RR 0.91 95 CI,
0.80-1.03 P0.13
Composite Components
Death from CV Causes P0.68
Stroke P0.04
MI P0.83
300
600
266
522
477
250
500
221
198
193
200
400
150
300
126
120
100
200
50
100
0
0
Aspirin
Placebo

• Baseline characteristics were well matched
  between the two treatment groups.
• Among the individual components of the composite
  end point, there was no difference in MI or
  death from cardiovascular causes, but total
  stroke was lower in the aspirin group.

Ridker PM. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 7, 2005 Orlando, Fla. Ridker PM, et al. N
Engl J Med. 20053521293-1304.
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ARMYDA-2 Trial
255 patients with stable coronary artery disease
or nonST-elevation ACS prior to PCI Excluding
those with primary intervention for AMI, baseline
levels CK-MB gt upper normal limit,
contraindications to antithrombotic/antiplatelet
therapy, high-risk bleeding, CABG in past 3 mos,
or clopidogrel treatment within 10 days of
randomization 23 female mean age, 64 years 13
received GP IIb/IIIa inhibitors and 20 received
drug-eluting stents
Standard Loading Dose of Clopidogrel 300 mg
Pre-PCI n129
High Loading Dose of Clopidogrel 600 mg Pre-PCI
n126

• Primary End Point Composite of death, MI, or
  target vessel revascularization (TVR) at 30 days
• Secondary End Point Postprocedural biomarker
  increase gt upper limit of normal (CK-MB gt2 times
  upper limit of normal), peak CK-MB, troponin I,
  and myoglobin postprocedure, occurrence of any
  vascular/hemorrhagic complication

ARMYDA-2 Antiplatelet Therapy for Reduction of
Myocardial Damage During Angioplasty. Di Sciascio
G. Presented at 54th Annual Scientific Session
of the American Collegeof Cardiology March 6,
2005 Orlando, Fla. Patti G, et al. Circulation.
2005111.
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ARMYDA-2 Trial Primary End Point
Primary composite of death, MI, and target vessel
revascularization P0.041
14

• Primary composite end point was significantly
  lower in the high-dose clopidogrel group at 30
  days
• One TVR in the high-dose group
• No deaths in either arm

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12
10
8
6
4
4
2
0
High Dose
Standard Dose
Di Sciascio G. Presented at 54th Annual
Scientific Session of the American Collegeof
Cardiology March 6, 2005 Orlando, Fla. Patti
G, et al. Circulation. 2005111.
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Pioglitazone Trial
50 nondiabetic patients undergoing PCI in de novo
lesions Study arms had equivalent baseline
fasting blood glucose, fasting insulin, HbA1c,
and lipid levels
Pioglitazone 30 mg/OD n25

• Placebo
• n25

• End Points
• Primary Neointimal volume measured (with IVUS)
  within the stented segment at 6 months
• Secondary Total plaque volume, minimum lumen
  diameter, and percent stenosis at 6 months

Marx N. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 9, 2005 Orlando, Fla.
27
Pioglitazone Trial Primary End Point
Neointimal volume by intravascular ultrasound at
6 months P lt0.05
4
The primary end point of neointimal volume within
the stented segment at 6 months was significantly
lower in the pioglitazone group compared with
placebo
3.1
3
2.3
mm3/mm stented area
2
1
0
Pioglitazone
Placebo
Marx N. Presented at 54th Annual Scientific
Session of the American Collegeof Cardiology
March 9, 2005 Orlando, Fla.
28
TNT Trial
10,003 patients with stable coronary heart
disease Aged 35-75 years, LDL between 130 and
250 mg/dL, triglyceride 600 mg/dL 19 female,
mean aged 60.3 years All received atorvastatin 10
mg during 8-week open-label run-in period
Atorvastatin 80 mg n4,995
Atorvastatin 10 mg n5,006
Primary Endpoint Major cardiovascular event
defined as coronary heart death (CHD) , nonfatal
M, resuscitated cardiac arrest, and fatal or
nonfatal stroke at a mean follow-up of 4.9
years. Secondary Endpoint Major coronary events,
cerebrovascular events, hospitalization for
congestive heart failure (CHF), all-cause
mortality, peripheral artery disease, any
cardiovascular event, any coronary event
LaRosa JC. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
29
TNT Trial Primary End Point
Primary Composite of CHD death, nonfatal MI,
resuscitated cardiac arrest, and fatal or
nonfatal stroke Hazard Ratio HR0.78 Plt0.001

• The primary composite end point of CHD death,
  nonfatal MI, resuscitated cardiac arrest, and
  fatal or nonfatal stroke was lower in the
  high-dose atorvastatin 80 mg group at a mean
  follow-up of 4.9 years.

LaRosa JC. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
30
RIO-Europe Trial
1,507 patients with body mass index (BMI) 30
kg/m2, or BMI gt27 kg/m2 with dyslipidemia or
hypertension, and stable weight during the prior
three months Randomized, Blinded, Parallel

• Placebo
• n305

• Rimonabant
• A selective cannabinoid type 1 receptor
  antagonist
• 5 mg
• n603

• Rimonabant
• A selective cannabinoid type 1 receptor
  antagonist
• 20 mg
• n599

Treatment for 2 Years

• End Points
• Primary Absolute change in weight from baseline
  to one year.
• Secondary Weight loss relative to baseline
  weight (5 and 10), waist circumference, and
  change in metabolic parameter.

Van Gaal L. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
31
RIO-Europe Trial
Weight Loss at 1 Year
Weight Loss at 2 Years Intent-to-Treat Analysis
Weight Loss at 2 Years Patients who completed
study duration
Plt0.001
Plt0.001
P0.038
P0.0002
20 mg
5 mg
Placebo
20 mg
Placebo
20 mg
Placebo
5 mg
5 mg

• Weight loss at one year was greater in the
  rimonabant 20 mg group and the rimonabant 5 mg
  group than in the placebo group.
• The weight loss results were maintained at 2
  years, in an intent-to-treat analysis.
• Among patients who completed the duration of the
  study, the weight loss at 2 years was even
  larger.
• Mild side effects were higher in the 20 mg
  rimonabant group, including nausea, diarrhea, and
  dizziness, but were mostly mild and transient.

Van Gaal L. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
32
RIO-Europe Trial
Loss of 5 Initial Body Weight at 1 Year
Loss of 10 Initial Body Weight at 1 Year
Loss of 10 Initial Body Weight at 2 Years
Plt0.001
Plt0.001
P0.002
20 mg
5 mg
Placebo
20 mg
20 mg
5 mg
Placebo
Placebo

• Loss of 5 of initial body weight at 1 year was
  more frequent in both rimonabant arms compared
  with placebo, and similar results were reported
  for loss of 10 of initial body weight at 1 year
  and 2 years.
• Waist circumference reduction at 1 year was
  greater in the rimonabant arms (8.5 cm for 20 mg
  and 5.3 cm for 5 mg) than placebo (4.5 cm
  Plt0.001 and P0.002, respectively).
• At 2 years, results were similar in the cohort of
  patients who completed the study (reduction of
  7.5 cm in the 20 mg group, 5.3 cm in the 5 mg
  group, and 3.4 cm in the placebo group).

Van Gaal L. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
33
RIO-Europe Trial
High Density Lipoprotein (HDL) Increase at 1 Year
Triglycerides Reduction at 1 Year
Metabolic Syndrome in 20 mg Group Plt0.001 vs
Placebo
Plt0.001
Plt0.001
20 mg
Placebo
5 mg
20 mg
5 mg
Placebo
Baseline
1 Yr
2 Yrs

• Metabolic syndrome was reduced in the 20 mg
  rimonabant group at two years compared to
  placebo.
• At one year, high-density lipoprotein (HDL)
  increased in the 20 mg rimonabant group versus
  placebo, and triglycerides were reduced.
• Increases in HDL and reductions in triglycerides
  were maintained at 2 years. Both of these
  improvements were shown to be independent of
  weight loss.
• Additionally, insulin response on oral glucose
  tolerance test at 1 year was improved in the 20
  mg rimonabant group vs placebo (reduction
  compared to baseline of 11.0 µU/ml vs 2.3 µU/ml,
  P0.019).

Van Gaal L. Presented at 54th Annual Scientific
Session of the American College of Cardiology
March 7, 2005 Orlando, Fla.
34
Featured Institution Christiana Care Health
Services Newark, Delaware
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Christiana Care Health Services Newark, Delaware
36
Heart Alert Administrative Team

• Dr Charles Reese, Chair, Emergency Department
• Dr Ehsanur Rahman, Interim Cardiology, Section
  Chief
• Dr James Hopkins, Director, CCL
• Karen Toulson, RN, MS Manager, ED
• Pat Wessell, RN, Manager, Interventional Lab
• Lynne Bittner, RN, BSN, Angela DiSabatino, RN,
  MS, Jacqueline Laucirica, RN, BSN Cardiovascular
  Research
• Margie Krough, RN, Cardiac PI

37
CCHS in 1999 Seeking the Best Practice for AMI

• GOAL To provide appropriate reperfusion therapy
  to acute myocardial infarction patients in an
  efficient and timely manner.
• National Benchmark
• National Registry of Myocardial Infarctions 4
  NRMI 4 - (186,452 patients)
• Door to Needle lt 30 minutes
• Door to Balloon lt 90 minutes

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Current Knowledge

• Rapid achievement of reperfusion of the
  infarct-artery reduces mortality and morbidity
• Small differences in time to achieving
  reperfusion make clinically important differences
• Thrombolytics were the Gold Standard of therapy
  for AMI (offered reduction in mortality of 25-30
  versus placebo)

39
More Data Emerges.

• 1997 meta-analysis of 10 randomized trials showed
  MARKED superiority of primary angioplasty versus
  thrombolytic therapy
• 30 day mortality 34 reduction
• Combo of death or reinfarction 42 reduction
• Total stroke 65 reduction
• ICH 94 reduction
• BUT MUST BE EXPERT CENTERS WITH HIGH VOLUMES AND
  EXPERIENCED OPERATORS

40
Looked at CCHS Data and Trends

• 4/98 - 9/98
• 17 patients with Primary PTCA
• Door to dilatation (median minutes) 125
• Door to dilatation ?90 Min 30
• Total AMI patients 168
• lytic use 27
• Primary PTCA 10

41
Some Inherent Problems

• Disagreement of benefit of primary PTCA over
  lytics
• Not all cardiologists can perform 1 PTCA
• System front-loaded to allow DFES to identify
  AMI and treat with lytics prior to cardiologist
  consult
• CCL normal operating hrs M-F 0630-1930
• No formalized mechanism for alert to ED from the
  paramedics in the field of impending AMI patients
• No clear expectation for ED or CCL staff on
  facilitating rapid move of patient within system
  for treatment

42
Research Offers a Road Map

• AMI trial using Primary PTCA and/or Stent
• CADILLAC (Controlled Abciximab and Device
  Investigation to Lower Late Angioplasty
  Combinations)
• Operating hours 06 - 1800 M-F only
• 2/98-7/98 14 pts - Door to Balloon 104 Min
• 8/98-10/98 7 pts - Door to Balloon 99 Min
• 11/98-2/99 11 pts - Door to Balloon 88 Min

43
Benefits From CADILLIAC

• Education/improved awareness of need for rapid
  decision making, streamlined ED procedures
  necessary prior to transport
• CCL staff readiness
• Cardiologist acceptance and flexibility
• Research staff availability to assess process and
  data collect, problem solve on site, urge and
  assist in transport

44
CCHS Decides to Move Forward

• Develop a policy and procedure to allow for
  timely and effective treatment of all AMI
  patients - either thrombolytic therapy or 1 PCI
• Provide capability for 1 PCI 24/7 within the
  national benchmark timelines
• Ongoing concurrent data collection to ensure
  process is effective
• Frequent review of system and clinical outcomes

45
The Heart Alert Team

• New Castle County Paramedics
• Emergency Department Staff Wilmington and
  Christiana Hospitals
• Cardiologists
• Cardiac Catheterization Lab Staff
• Coronary Intensive Care Unit Staff
• Coronary Stepdown Units (2D, 2C, 2B)
• Cardiovascular Research Staff

46
Successful Trauma Program Used as Model for
Heart Alert/Code

• Heart Alert Patient identified as a potential
  acute heart attack
• Heart Code Patient requiring emergency
  angioplasty/stent treatment in the cardiac cath
  lab
• Alert/Code to be called overhead to alert all
  staff that AMI being treated in the ED

47
Paradigm Shift

• Pre-lytics Cardiologists rule the scene
• Age of Lytics Empower DFES to take the reins to
  achieve the necessary timelines for treatment
• Primary PCI Decision back in cardiologists
  court
• With Caveat 10 minute default to Lytics

48
Ready to Roll

• Orientation for all members of the Team
• Mock (Practice) Heart Alert/Heart Code
• Kick off May 1999
• Data collected on daily basis for all Heart
  Alerts
• Monthly case review meetings
• Reporting of stats for Cardiac Report Card

49
Mock Code
50
The Four Ds
51
Reasons for Delays

• Door to Data (EKG) Incorrect Triage
• Door to Decision Non-diagnostic EKG,
  MD non/slow answer, Patient hemodynamics
• Door to Dilatation (Balloon) O2, CXR, Paperwork,
  CCL staff delays, hemodynamics, overwhelming clot
  burden (Angiojet Dilatation Open Artery)

52
Comparison of PCI Medians by Year
53
Current CCHS Stats

• 2091 Heart Alerts have been called
• gt1500 became Heart Codes
• Median arrival to balloon time ranges from 75-90
  minutes monthly
• 63 of all Heart Codes receive treatment within
  the 90 minute best-practice target
• This timeliness places CCHS in the 98th
  percentile of large interventional hospitals
  nationwide for time to primary angioplasty

54
How Can We Continue to Improve?? Equal Value for
Inpatients

• Algorithm adjusted to allow insertion of
  inpatients
• Process remained as identical as possible in
  order to provide consistency and promote
  expediency
• Medical Residents consulted for their role

• Chest pain suspected to be AMI occurs
• Resident contacts cardiologist on call for Heart
  Alerts
• If decision made to go to CCL Heart Code called
• MICN nurses respond to facilitate transport and
  medication administration enroute to CCL

55
Our Referring In-System Hospital Wilmington
Hospital?

• Original protocol Lytics only unless absolute
  contraindication
• NEJM 08/21/03 article A strategy for
  reperfusion involving the transfer of patients to
  an invasive center for primary PCI is superior to
  on-site fibrinolysis, provided that the transfer
  takes lt120 minutes
• 20 Heart Alerts have been called
• 10 became Heart Codes
• Median door to balloon time 144 minutes
• 43 met the 120 minute target

56
Data Requests

• CPR prehospital ??? Risk stratify for PCI
• Prehospital interventional heart code team
  activation based on paramedic ECG interpretation
  significantly reduces the time to reperfusion for
  patients with acute myocardial infarction
• Operating vs non-operating hours
• Mean door to balloon time during business hours
  was 69 minutes
• Mean door to balloon time during off-hours was
  107 minutes
• These differences are significant. (Plt0.0000)

57
Research Analyses

• Interventional vs non-Interventionalist first
  call
• Heart Alerts that do not progress to Heart Codes
• Volumes over time (impact of competition)
• Appropriate MD referral for on-call Heart Alerts
• Gender differences

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59
Thank You!

• www.ChristianaCare.org
• The new clinical care and education initiative
  will
• add 216 beds, including 186 universal
  inpatient beds and 30 short-stay beds
• Add operating rooms, catheterization labs and
  emergency exam rooms
• Expand Christiana Care's cardiovascular program

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Q A
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Polling Question 2
If you participated in a previous teleconference,
how much progress have you made since
then? (Please refer to the checklists on the
next 3 slides.)

• 1) We are currently on the same item
• 2) We have since moved to the next checkbox on
  the checklist
• 3) We have progressed by more than one item on
  the checklist
• 4) ACS pathways are up-to-date and regularly
  followed

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Progress ChecklistImmediate Goals
63
Progress ChecklistShort-term Goals/Activities
64
Progress ChecklistLong-term Goals/Activities
65
Concluding RemarksChristopher P. Cannon, MD