Emergency PCI in the GTA:
From Myth to Reality
Introduction:
Dr. Vlad Dzavik
The York-Simcoe Regional Primary PCI Program Dr. Warren Cantor
The UofT Hospitals initiative
Dr. Vlad Dzavik
Current Emergency PCI Status and initiatives
at St. Michael’s
Dr. Neil Fam
at Sunnybrook
Dr. Dennis Ko
at UHN
Dr. Chris Overgaard
EMS Initiatives
Alan Craig
Prehospital fibrinolysis or direct transport for primary PCI in acute STEMI
(PREDESTINY): A proposal for a randomized controlled trial
Background
Dr. Shaun Goodman
Protocol
Dr. Laurie Morrison
Discussion
1
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
2
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
3
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
Keeley et al. Lancet 2003; 361:13–20
4
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
Metanalysis of 23 Trials
5
University of Toronto
Keeley
City-wide Cardiology Rounds
et al. Lancet
2003;29,361:13–20
November
2007
D2B TIME AND MORTALITY
NRMI REGISTRY
McNamarra et al. JACC Vol. 47, No. 11, 2006
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
6
NRMI 2-4: PCI-related delay where PCI and
Thrombolysis mortality rates are equal
7
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
bradley et al. www.nejm.org november 30, 200
11
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
bradley et al. www.nejm.org november 30, 2006
12
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
Number of Strategies and Door-toBalloon Time
bradley et al. www.nejm.org november 30, 2006 13
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
Regional Primary PCI
Southlake Regional Health Centre
Warren J. Cantor, MD, FRCPC
Physician Director, Regional Primary PCI
Program
Assistant Professor of Medicine, Univ. of Toronto
9803mo01,
Regional Cardiac Care Program at SRHC
1998 – MOH designated former York County
Hospital to be an Advanced Regional Cardiac
Centre for York Region, Simcoe County & Muskoka
to provide PCI, cardiac surgery & PPM
Redevelopment in 2002, $170 million capital
expansion
1st PCI Nov 2003
Serve 11 hospitals, over 1 Million residents served
York Region & Simcoe County are the fastest
growing areas in Canada
9803mo01,
PCI Volumes at SRHC
9803mo01,
Regional Cardiac Care Program
at Southlake Regional Health Centre
One of the major goals is to
provide best management for
all STEMI patients within our
region
9803mo01,
Primary PCI vs. Thrombolysis
Short-term outcomes
PTCA
Thrombolytic
Therapy
Frequency (%)
23 trials
n=7,739
Long-term outcomes
Death
Death,
excluding
SHOCK
MI
Recurrent
Ischemia
Stroke
Hemorr.
Stroke
Major
Bleed
Death / MI
/ Stroke
9803mo01,
—Keeley EC, Lancet 2003
Percentage of patients with events
Door-to-Balloon Time
In-Hospital Mortality
10
Goal: Door-to-Balloon
Time ≤ 90 minutes
8
6
p=0.51
4
4.2
p=0.08
5.1
P<0.001
6.7
NRMI-2
P<0.001
P<0.001
8.5
7.9
27,080
pts
4.6
2
0
n=2230 n=5734 n=6616 n=4461 n=2627 n=5412
0-60
61-90 91-120 121-150 151-180 >180
Door-to-Balloon Time (minutes)
9803mo01,
Cannon CP, et al. JAMA 2000
2004 ACC/AHA Guideline Considerations
Fibrinolysis generally
preferred


Early presentation (≤ 3h
from sx onset and delay
to invasive strategy)
Invasive strategy not an
option (cath lab not
available, no vasc
access, lack of skilled
PCI lab)
Delay to Invasive
Strategy med contact to
balloon >90

ACC/AHA STEMI Guidelines 2004, Figure 3
Primary PCI generally
preferred
Skilled PCI lab available
(med contact to balloon <
90 min)

High risk STEMI
(cardiogenic shock, Killip
class ≥3)



Contraindication to lysis
Late presentation (>3 hrs)

Diagnosis in doubt
6 Proven Strategies to Reduce Door-to-Balloon Times
1) Having emerg physicians activate the cath lab
2) Having a single call to a central page operator activate cath
lab
3) Having the emergency dept activate the cath lab while the
patient is en route to the hospital
4) Expecting staff to arrive in the cath lab within 20 minutes
after being paged (vs. >30 minutes)
5) Having an attending cardiologist always on site
6) Having staff in the emerg dept and the cath lab use realtime data feedback
9803mo01,
Bradley EH, N Engl J Med 2006
6 Proven Strategies to Reduce Door-to-Balloon Times
Having emerg physicians activate the cath lab
Having a single call to a central page operator activate cath
lab
Having the emergency dept activate the cath lab while the
patient is en route to the hospital
Expecting staff to arrive in the cath lab within 20 minutes
after being paged (vs. >30 minutes)
Having an attending cardiologist always on site
Having staff in the emerg dept and the cath lab use realtime data feedback
9803mo01,
Bradley EH, N Engl J Med 2006
How our PPCI program was implemented
Identified by Division & senior hospital
administration as priority for hospital & region
EMS & base hospital directors invited to join
committee which met regularly to plan
implementation
“Mock” run-in done to assess paramedic ECG
interpretation, patient volume, impact on beds
Start with late-presenters to minimize impact of
any potential treatment delays related to
transfers
9803mo01,
Primary PCI - SRHC Emerg Dept
Started 24/7 Primary PCI March 1/06
Approx 60 pts / yr (5 pts / month)
Median Door-to-Balloon Time: 85 min
Emerg MD calls ‘Code STEMI’, directly activates cath
lab
STEMI nurse gets patient up to cath lab quickly
Immediate feedback to ED after each case
Feb /08- EMS will bypass SRHC emerg dept
9803mo01,
Primary PCI – Simcoe EMS
Jan/07- STEMI pts in Simcoe County ambulances
brought directly to SRHC for primary PCI (Late
presenters or contraindications to lysis) if within 45
min to SRHC
Paramedics directly activate cath lab, STEMI nurse
meets EMS at front door & accompanies to cath lab
16 patients, Median Time from EMS arrival at scene
to 1st Inflation: 95 minutes
Median 53 min from ECG to arrival in cath lab
Only 1 incorrect ECG interpretation (paced rhythm)
9803mo01,
9803mo01,
Distances to SRHC
RVH: 58 km
Stevenson: 51 km
9803mo01,
Primary PCI – RVH Emerg dept
Feb/07- STEMI pts in RVH Emerg Dept (“walk-ins”)
transferred to SRCH for primary PCI (Late presenters
or contraindications to lysis)
Transfer time from RVH to cath lab: 46 min
Time from ECG to ED departure remains too long
Developing strategies to minimize delays (eg.
abciximab pretreatment eliminated- FINESSE)
9803mo01,
RVH STEMI
Algorithm
History & ECG consistent with ST-elevation MI *
Does patient have cardiogenic shock OR
Absolute contraindications to thrombolysis? *
YES
NO
Did symptoms start > 3 hours (and < 12 hours) ago?
NO
YES
Call EMS- “Code STEMI, Code 4”
Anticipate arrival at SRHC within 60 minutes of diagnostic ECG?
NO
YES
Call Southlake Dispatch
905-895-4521 ext 7777
“Code STEMI - RVH”
ASA 160 mg po
Clopidogrel 600 mg po
Heparin 70 U/kg ( 7000 U)
bolus
Send for 1o PCI
Consider Thrombolysis
+ TRANSFER-AMI if eligible
* If diagnostic uncertainty or relative
contraindications to thrombolysis, page
interventional cardiologist on-call
905-895-4521 ext 2216
Transfer for Rescue PCI if
9803mo01,
required
Prehospital vs. Emerg Dept
Treatment times much quicker when STEMI
diagnosed pre-hospital
“Walk-In” patients often have more atypical, milder
symptoms
ED pts face additional delay of waiting for
ambulance
Physicians tend to slow down the process
 Less protocol-driven
 Initially reluctant to activate cath lab without
discussing case with another MD first
 Many different Emerg MD’s, each seeing only
few STEMI’s per year
9803mo01,
Regional Primary PCI Program- Principles
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
9803mo01,
Regional Primary PCI Program- Principles
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
9803mo01,
Code STEMI “Hotline”
Ext 7777 answered immediately by hospital
operator 24/7
Only 3 questions asked: EMS vs. ED, location,
ETA
Cath lab staff, interventionalist, STEMI nurse
paged simultanously
9803mo01,
Regional Primary PCI Program- Principles
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
9803mo01,
Southlake – 5th Floor
PCI Lab
CCU
STEMI beds
Duration
of stay
< 24 hrs
Working Model
STEMI Beds
Pre-PCI preparation
Post-PCI high-risk
Virtual bed
PCI Unit
Repatriation Unit
STEMI Nurse
PCI Unit
Elevators
Cardiology Ward
•
•
•
•
•
•
•
Bed status is never checked prior to activating cath lab for primary PCI
Repatriation
Stable patients routinely repatriated within 24
hrs of PCI
Formal repatriation agreement developed with
RVH, MSH, OSMH, YCH
Includes patients who were brought by EMS,
never seen in community hospital
9803mo01,
Lessons learned
The fewer physicians involved in decisionmaking the better
Gradual implementation in steps works best
Need complete ‘buy-in’ from hospital
administration, EMS, community hospitals
Start with late presenters until ‘well-greased’
system in place for consistent rapid transfers
Keep protocol as simple as possible
9803mo01,
Future Directions
ECG Transmission
Prehospital Thrombolysis (Predestiny)
Pharmacoinvasive Strategy (Transfer-AMI)
9803mo01,
‘High Risk’ ST Elevation MI within 12 hours of symptom onset
N=1200
TNK + Heparin / Enoxaparin + Clopidogrel
Community
Hospital
Emergency
Department
Urgent Transfer to
PCI Centre
Standard Treatment
Assess chest pain, ST resolution
at 60-90 minutes
Failed Reperfusion
PCI Centre
Cath Lab
Cath / PCI within 6 hrs
“Pharmacoinvasive
Strategy”
Cath and Rescue
PCI  GP IIb/IIIa
Inhibitor
Successful Reperfusion
Elective Cath
 PCI
> 24 hrs later
Primary Endpoint: 30-day death / re-MI / CHF / severe recurrent ischemia/ shock
Secondary Endpoints: Major bleeding, 90-minute ST resolution, ECG- and Echo-derived infarct size / extent
9803mo01,
Cantor WJ. Am Heart J, In Press
1044 pts
9803mo01,
Primary PCI
Other strategies
9803mo01,
ACUTE MI PCI
University of Toronto Hospital
Initiatives
42
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
IMPROVING ACUTE MI CARE
PHASE ONE
• The three University of Toronto Interventional Cardiology
Programs, St. Michael’s Hospital, Sunnybrook Health
Sciences Centre and the University Health Network, have
agreed in principle to improve and optimize existing
emergent interventional services by joining forces and thus
providing a ‘guaranteed accept’ 24/7 service for patients in
the region requiring interventional care for failed
thrombolysis, very high risk patients in cardiogenic shock
or advanced Killip class, and those with contraindications to
thrombolytic therapy. This service, agreed to and signed off
on by the Administration of each of the three hospitals, St.
Michael’s Hospital, Sunnybrook Hospital and the University
Health Network, will apply the following principles: 43
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
PHASE ONE
A single contact number to reach emergent interventional care
administered by CritiCall
A call schedule involving the three programs will be made
available to Criticall
The interventional cardiologist on call will be the contact at the
receiving interventional cardiology centre
There will be a NO REJECT policy, as is currently the case with
trauma and in some centres organ transplants.
In the case that the primary interventional on-call team is already
in the midst of an emergent procedure, the second on-call centre
will be contacted by CritiCall to accept a new patient.
Patients transferred from community hospitals who are deemed
stable following the interventional procedure will be transferred
back to that hospital within 24 hours of the procedure and could
be transferred as soon as the procedure is done and acute
vascular access site care has been completed.
44
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
RECOMMENDED TARGETS
•
•
•
•
Door-to-ECG
<10 minutes
ECG-to-ER Decision <10 minutes
Decision-to- Cath Lab <20 minutes
Cath Lab-to-Balloon <30 minutes
45
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
PHASE 2
In the second phase, the University interventional cardiology programs will
implement the elements necessary to establish a timely and efficient 24/7
program for primary PCI for patients arriving by ambulance or walking into
their own institutions. The ideal call-to-arrival time of CCL staff of <30 minutes
must be implemented in this phase by the means most achievable in each
individual centre. The possible options that can be implemented include the
following:
An evening shift that would extend to 11 pm or midnight
Ensuring that at least one of the on-call nurses for a particular night
lives within a 30 minute radius of the hospital
Ensuring that all interventional cardiologists and fellows can be in the
hospital within 30 minutes.
Cross-training of CICU nurses to help begin an emergent procedure until
the arrival of the CCL on call nurses and possibly to assist during the
entire procedure
46
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
PHASE 3
In the third phase the University of Toronto
interventional cardiology collaboration will
implement a strategy of performing primary PCI for
eligible patients presenting to GTA hospitals or
identified by EMS in the pre-hospital phase.
Implementation timelines
Phase 1 is to be implemented by July 1, 2007
Phase 2 is to be implemented by April 1, 2008
Phase 3 is to be implemented by July 1, 2008
47
University of Toronto
City-wide Cardiology Rounds
November 29, 2007
STEMI Initiatives
Dennis T. Ko MD MSc FRCPC
Interventional Cardiologist, Sunnybrook Health Sciences Centre
Scientist, Institute for Clinical Evaluative Sciences
University of Toronto
TCT October 23, 2007
Enhancing the effectiveness of health care
for Ontarians through research
48
Objectives
• Discuss local STEMI initiative at Sunnybrook
Health Sciences Centre
• Discuss ongoing national initiatives and
opportunities
PCI versus Fibrinolysis with Fibrin-Specific
Agents: Is Timing (Almost) Everything?
Absolute Risk Difference in Death (%)
10 −
13 RCTs
N = 5494
P = 0.04
5−
Favors PCI
0−
Favors
-5 −
┬
30
┬
40
┬
50
┬
┬
60
70
fibrinolysis
┬
80
PCI-Related Time Delay (minutes)
Nallamothu and Bates. Am J Cardiol 2003;92:824.
Recommendation for reperfusion therapy
• Minimize delay to reperfusion
 Door
to needle: <30 minutes
 Door to balloon: <90 minutes
• Not “Median”, but all patients should be
treated within the recommended timeframe
EFFECT STUDY (99-01)
Reperfusion Therapy
100
Percent
80
60
40
75%
59%
20
0
All STEMI
patients
*Ideal as per GRACE Registry criteria
Ideal* STEMI
patients
EFFECT STUDY (99-01)
Door-to-Needle time for thrombolytic therapy
60
50
40
Median 40
Time in
Minutes 30
40
46
Benchmark < 30
Minutes
20
10
Average = 40 min
Teaching
Comm
Small
6/41 hospital corps met benchmark
Sunnybrook STEMI Initiative
Improve the Quality of Care and
Outcomes of STEMI at Sunnybrook
Health Sciences Centre
Characteristics of Good STEMI hospitals
1.
Commitment to goal
“This is a part of the culture of the organization in that time to
reperfusion needs to be excellent” (VP, Cardiology)
2.
Visible Senior Management
“Holding people accountable. I think that’s the role of administration…”
(Medical Director, ER)
3.
Innovative, Standardized Protocols
“All of us got together and came up with the steps to get a patient from the ED
to the cath lab. We broke it into 8-9 steps. At each step, we allowed a
certain # of minutes, and we lived up to it.” (Cardiologist)
Bradley EH, et al. Circ 2006; 113:1079-85
Characteristics of Good STEMI hospitals
4.
Resilience to challenges with flexibility in refining
protocols
“It’s a continual thing…even though we refine the process…things change…and
we have to refine how we’re doing things…” (Cath Lab Nurse)
5.
Collaborative, interdisciplinary teams
“I feel like when I talk to somebody, they respect my opinion, so if I call the
cardiologist and say this person is having an anterior MI, they believe me.
They don’t try to talk me out of it…” (ER physician)
6.
Data/QI feedback
“It helped the ED staff that the cardiologist would come back from the cath lab
with a picture of the open artery, so the staff felt like --- this is what we’ve
done!” And the cardiologist would say the patient is doing great, you guys
did a great job!” (VP, ER)
Bradley EH, et al. Circ 2006; 113:1079-85
Before Initiative
• Median door to balloon – 90 min
• % of D2B within 90 min – 54%
• Median time to needle – 56 min
• % within 30 min – 16%
After initiative
• 38 STEMI March 1, 2007 to November 2007 (14
received fibronolysis, 22 primary PCI)
• Median door to balloon – 63 min (IQR 49-77)
• % within 90 min – 82 % (daytime 90%)
• Median door to needle – 40 min (IQR 15– 53)
• % within 30 min – 36%
D2B time pre and post initiative
Ongoing initiatives
• Canadian Cardiovascular Research Team
(CCORT) Survey

National survey on primary PCI services across Canada
• Enhanced Feedback for Effective Treatment
(EFFECT II) 2004-2005
• D2B Alliance/Canadian D2B
“This is where we show that we are not just about research
-- in QI we are not just about measurement -- but that we
can lead meaningful change by supporting hospitals and
clinicians. This is the idea.”
-- Harlan Krumholz, MD
Sunnybrook Team
• Cardiology (Harindra Wijeysundera, Claudia Bucci,
Chris Morgan, Eric Cohen)
• ER (Jeff Tyberg, Paul Hawkings, Michael Schull,
nurses)
• Cath lab team (nurses, interventional cardiologists)
STEMI TREATMENT ALGORITHM
STEMI or new LBBB < 12
hours duration
Diagnosis uncertain?
Y
N
Hemodynamically
unstable?
CCU resident to
decide activation of
cath lab
Y
N
1. ER MD ACTIVATES CATH LAB DIRECTLY:
“CODE STEMI”
-0800h-1700h: page PCI coordinator 685-9388
-Evenings / weekends: call CCU 5809
2. ER MD NOTIFIES CCU RESIDENT
3. GIVE MEDICATIONS
-ASA 160 mg
-Clopidogrel 300mg (75mg if >75 years old)
-Heparin 60IU/kg bolus (no drip), max 4000IU
No anticipated delay to
PCI:
-Add Reopro 0.25mg/kg
bolus (no drip)
Anticipated delay to PCI
> 90 minutes:
-Do NOT give Reopro
-Assess for possible
thrombolysis
Heart Attack Response Team
• ER MD activates cath lab: Code STEMI
• CCU resident sees pt in ER
• CCU RN turns on cath lab equipment, then
proceeds to ER
• CCU resident, CCU RN, ER RN (HART)
immediately transfer pt to cath lab
• Interventional fellow scrubs, preps pt, table
• Case starts when cath lab RN, tech arrive
24-7 Primary PCI
• Prompt feedback to all caregivers: CQI
• Data collection: Time intervals, Outcomes
• STEMI committee
University Health Network:
Emergency PCI Status and
Initiatives
Dr. Christopher Overgaard
Interventional Cardiology
UHN Median ER Door to Balloon Times
April 06 - October 07
140
140
124
28
120
Time (minutes)
29
100
80
60
40
86
Scrub to
Balloon
7
Rx +
Transfer
46
1st ECG
5
20
0
10
28
Pt setup
TGH
n=9
10
72
}
53%
}
58%
91
13
11
MSH
TWH
n=20
n=13
}
65%
69
Fastest Door to Balloon Time - 53 minutes
60
Time (minutes)
50
18
40
5
30
20
29
10
0
4
Door to Balloon Times
With or Without Prior CCU Consultation
120
Time (minutes)
101
100
77
80
60
40
50
35
20
0
CCU +ve
CCU -ve
UHN Primary PCI Initiatives
• Single TGH/MSH + TWH triage number to call
• Standardized ER STEMI protocols with time codes;
improved ER communication
• Concurrent activation of CCU with cath lab to avoid
time delays
• MD (cath lab fellow + CCU team member) to assist
with patient transfer
• MD and nursing committee working on cath lab
efficiency protocols (eg. increasing involvement of
staff and fellow with patient setup)
Primary Angioplasty vs. Thrombolysis for Acute MI
Quantitative Review of 23 Randomized Trials (N=7739)
Short term outcomes
25
Long term outcomes
% of Patients
50
p<0.0001
PTCA
21
Thrombolysis
20
p<0.0001
40
15
10
39
30
p=0.032
p=0.0003 p<0.0001
6.8
9
5
6.8
6
7
Death
reMI
p<0.0001
5.3
0.05 1.1
2.5
0
20
Recurrent
Ischemia
ICH
10
22
p=0.0053
6.2 8.7
p<0.0001
10
4.8
0
Major
Bleed
Death
reMI
Recurrent
Ischemia
Keeley et al Lancet 2003;361:13-20
Transport of Patients for Primary PCI
Study
N Transported
Time Between
Distance
Death During Randomization and
Range (km)
Transport
Balloon
DANAMI-2
599
3-150
0
90 min*
PRAGUE-1
101
5-74
0
80 min**
PRAGUE-2
429
5-120
2
97 min**
Vermeer et al
75
25-50
0
85 min**
AIR-PAMI
71
10-69
0
155 min**
CAPTIM
421
1-100
0
82 min**
Total
1656
1-150
2 (0.1%)
ASSENT-3+
1639
13 (0.8%)
>50% of pts <90
min†
EMIP
5469
60 (1.1%)
* Median ** Mean
† Without
AIR-PAMI
Primary Angioplasty vs. Thrombolysis for Acute MI
5 Randomized Trials With On-Site Lysis or After Emergent Transfer for Primary PTCA
20
% of Patients
PTCA (n=1466)
Thrombolysis (n=1443)
Mean 39 minute delay
p<0.0001
15
10
p=0.057
p<0.0001
5
p=0.049
p=0.25
0
Death
Reinfarction Total stroke
ICH
Death, reMI
or stroke
Keeley et al Lancet 2003;361:13-20
Randomized Trials of Prehospital Thrombolysis
Study
N
Odds Ratio & 95% Cl
Pre (%) Hosp (%)
MITI
360
5.7
8.6
EMIP
5,469
9.1
10.4
GREAT
311
6.8
11.5
Roth et al
116
5.6
6.8
Schofer et al
78
2.5
5.3
Castaigne et al
100
5.3
7.0
8.6
10.2
Overall
6,434
0.83 (0.70-0.98)
0.02 0.05 0.1 0.2
Time to lysis:
104 vs. 162 min (p=0.007)
0.5 1
2
5 10
Favours Prehospital Lysis Hospital Lysis
Morrison et al JAMA 2000; 283:2686-92
Pre-Hospital Fibrinolysis vs. Primary PCI
% of Patients
12
10
Primary PCI (n=421)
Pre-hospital Lysis (n=419)
p=0.29
8
6
4
8.2
p=0.61
6.2
p=0.13
4.8
3.8
2
3.7
1.7
0
Death
re-MI
p=0.12
0
1
Stroke
Composite
30-Day Outomes
Bonnefoy et al for the Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial
Infarction (CAPTIM) Investigators Lancet 2002;360:825-29
Pre-Hospital Fibrinolysis vs. Primary PCI
p
Thrombolysis
PCI
n=419
n=421
Death
3.8
4.8
0.61
re-MI
3.7
1.7
0.13
Disabling Stroke
1.0
0.0
0.12
Composite
8.2
6.2
0.29
Hemorrhagic Stroke
0.5
0.0
0.50
Severe Hemorrhage
0.5
2.0
0.06
Recurrent Ischemia
7.2
4.0
0.09
Cardiogenic Shock
2.5
4.9
0.09
Pre-Hospital Shock
0.0
2.1
0.004
Primary Endpoints
Secondary Endpoints
Bonnefoy et al for the Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial
Infarction (CAPTIM) Investigators Lancet 2002;360:825-29
Impact of Time to Treatment on Mortality After
Prehospital Fibrinolysis vs. Primary PCI
<2 Hours
 2 Hours
% of Patients
N=460
% of Patients
8
N=374
8
Prehospital Lysis
6
p=0.058
Primary PCI
6
5.7
p=0.47
p=0.007
4
4
3.7
3.6
2
5.9
2
2.2
p=1.0
0
0
Death
* From randomization to
admission
0
0.5
Cardiogenic
Death
Cardiogenic
Shock*
Shock*
Steg et al for the CAPTIM Investigators Circulation 2003;108:2851-56
0
Studies of Direct Transportation from Scene to PCI Centers
First Author
(Year)
Study Design
Provider of
ECG and
ECG location
Treatment
Control
Mortality
30 day Composite
Outcome§
Door-to-balloon or drug
interval (minutes)
Median (25th-75th
percentiles)
Treatment
Control
Treatment
Control
Treatment
Control
Le May (2006)
Before and after
study
Paramedic
On-scene
Prehospital
ECG and
Primary PCI
Historical controls
In-hospital
fibrinolysis and
primary PCI
1.9%
n = 108
8.9%
n = 225
N/A
N/A
63
(36-83)
41
(30-58)
Armstrong (2006)
RCT
Paramedic
On-scene
Primary PCI
TNK and
enoxaparin; mix of
inhospital and
prehospital
1%
n = 100
4%
n = 100
23%1
n = 100
25%1
n = 100
176
(140-280)
113
(74-179)
van ‘t Hof (2005,
2006)
Retrospective
Cohort
Nurse
On-scene
Prehospital
ECG and
primary PCI
Transfer to PCI from
Community hospital
1%
n=209
3.2%
n=258
2% 2
n=209
4% 2
n=258
*177
(144-237)
*208
(175-264)
Terkelson (2005)
Prospective
Cohort
Physician
On-scene
Prehospital
ECG and
Primary PCI
Transfer to PCI from
Community hospital
11%†
n = 55
0%
n = 21
N/A
N/A
21
(17-31)
30
(26-38)
Clemmensen
(2005)
Prospective
Cohort
Ambulance
Personnel
On-scene
Prehospital
ECG and
Bypass for
PCI
Historical controls
(DANAMI-2)
In-hospital
Fibrinolysis
N/A
N/A
N/A
N/A
40
94
Bonnefoy (2002)
RCT
Physician
On-scene
Prehospital
ECG and
Bypass for
Primary PCI
Prehospital
fibrinolysisaccelerated tPA
4.8%
n = 421
3.8%
n = 419
6.2% 3
n = 421
8.2% 3
n = 419
190
(149-255)
130
(95-180)
*Symptom onset-to-balloon §Composite Outcomes: 1 death, reMI, refractory ischemia, CHF, cardiogenic shock or major ventricular arrhythmia; 2 death, reMI or stroke; 3 death, reMI, disabling stroke
Rationale for a Trial Comparing
Pre-hospital Fibrinolysis vs.
Direct Transport for Primary PCI

Among patients with STEMI diagnosed
by paramedics in the pre-hospital
setting


Insufficient high quality evidence to
recommend pre-hospital bypass and
direct transport to a PCI center for primary
PCI
Lack of clinical trial data comparing prehospital fibrinolysis vs. direct transport
for primary PCI
Prehospital Perspective
Contributing to
STEMI care and Science
Laurie J. Morrison
Declaration of Conflict of Interest
Aventis
HAS Solutions
Hewlett Packard
Hoffman La Roche
• Interdev
• Panasonic
• Zoll Medical Inc.
Prehospital Fibrinolysis or Direct Transport for Primary
Percutaneous Coronary Intervention in Acute STElevation Myocardial Infarction - PREDESTINY: A
Randomized Controlled Trial
PREDESTINY Investigators
Prehospital and Transport Medicine Research Program
University of Toronto
Investigators
Rick Verbeek
Brian Schwartz
Michelle Welsford
Alan Craig
Mina Madan
Madhu Natarajan
Shaun Goodman
Neal Fam
Warren Cantor
Michael Schull
Alex Kiss
Ron Goeree
Jean-Eric Tarride
Jim Bowen
Steven Brooks
Valeria Rac
Potential Prehospital
Interventions
• What we do now?
– 3 lead ECG and drive fast
• Prehospital diagnosis of STEMI
– 12 lead ECG and advance
notification
• Prehospital intervention
– +/- Bypass to PCI site
– Prehospital fibrinolysis
ED
Steering group submitted a pilot
CIHR – RCT preliminary step
Approved
Concerns
Feasible from a prehospital perspective
Feasible from a Toronto perspective
Final submission will require data
Objective
To determine:
Safety and effectiveness
Prehospital bypass to PCI center vs.
ALS intervention – 12 lead, advance ED
notification prehospital fibrinolysis OR
BLS intervention – advance ED notification
Primary Outcome Measure
•
30-day composite of all cause
mortality and reinfarction, and stroke
defined as any new neurological
deficit lasting >24 hours.
• Survival and reinfarction rates
– 6 and 12 months
Study Population
•
–
–
•
–
–
11 geographical regions in Ontario
121,959 km2
population of 7.5M
10 EMS systems
52 receiving hospitals
within 60 minutes of ≥ 1 of 12 PCI
centres.
Where are we?
Pulling together our steering cte
EMS, medical directors each region
Provincial approval – Dec 10-11
PCI centers representatives
Acquiring baseline data estimates from
the population and from CCN
RCT application to CIHR Feb 2008
We need data to judge what we are getting
ourselves into!
Prehospital incidence
Chest pain – guessing
STEMI – even more guessing
Within 60 minutes – speculation
Reperfusion data
CCN data on those that receive PCI
Sketchy on those that received TPA or
nothing at all
Prehospital Evaluation and Economic
Analysis of Different Coronary Syndrome
Treatment Strategies – PREDICT
PREDICT Investigators
Funded by the MOHLTC
What is it?
•
–
–
–
PREDICT
observational study
comprehensive WEB based database
provide incidence numbers to all
partners
Study Design
Identify the four groups
12 lead
3 lead and transport to ED
3 lead and transport to ED within 60 mins
Bypass
of a PCI center
TPA
12 lead and transport to ED
12 lead and transport to ED within 60 mins
Bypass
of a PCI center
Show me the
data!
NEXT STEPS
• CITY-WIDE COLLABORATION
97
University of Toronto
City-wide Cardiology Rounds
November 29, 2007