Emergency PCI in the GTA: From Myth to Reality

1
Emergency PCI in the GTAFrom 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. Michaels 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

University of Toronto City-wide Cardiology
Rounds November 29, 2007
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University of Toronto City-wide Cardiology
Rounds November 29, 2007
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University of Toronto City-wide Cardiology
Rounds November 29, 2007
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Keeley et al. Lancet 2003 3611320
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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Metanalysis of 23 Trials
Keeley et al. Lancet 2003 3611320
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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D2B TIME AND MORTALITYNRMI REGISTRY
McNamarra et al. JACC Vol. 47, No. 11, 2006
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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NRMI 2-4 PCI-related delay where PCI and
Thrombolysis mortality rates are equal
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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ER activities and door-balloon times

• Written criteria for immediate ECG in ER 99.8 min
  -5.3
• Dedicated ECG tech in ER 99.7 min -2.9
• Dedicated space in triage for immediate ECG 100
  min -3.2
• ER physician activates cath lab on weekdays 90.5
  min -15.3
• ER physician activates cath lab at night w/e
  90.2 min -14.6
• ER makes single call to central operator who
  pages PCI operator and cath lab 89.2 min -20.3
• Locating calls, no confirmation needed 90.4 min
  -11.8

bradley et al. www.nejm.org november 30, 200
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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ER activities and door-balloon times

• Interv. cardiologist first MD called after Dx of
  MI made 97.3 min -3.7
• Labs and CXR needed to activate cath lab 116.7
  min 17.6
• EMS calls in ECG result to ER 96.0 min -6.2
• ER activates cath lab with patient en route 85.4
  min vs. calling cardiologist -10.3 vs. no EMS
  ECG done -19.6
• Page to cath lab staff arriving 20 min vs. gt30
  min -20.0
• Page to interv. cardiologist 20 min 94.6 min vs.
  gt30 min -17.5
• Transport from ER to cath lab set interval after
  call 84.9 min vs. cath lab calling for patient
  -15.7 vs. other -25.6

bradley et al. www.nejm.org november 30, 2006
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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Other variables and door-to-balloon time

• An attending cardiologist is always at the
  hospital 92.6 min -8.2
• ER routinely gives data feedback to EMS 90.7 min
  -12.1

bradley et al. www.nejm.org november 30, 200
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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bradley et al. www.nejm.org november 30, 200
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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bradley et al. www.nejm.org november 30, 2006
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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Number of Strategies and Door-to-Balloon Time
bradley et al. www.nejm.org november 30, 2006
University of Toronto City-wide Cardiology
Rounds November 29, 2007
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Regional Primary PCI Southlake Regional Health
CentreWarren J. Cantor, MD, FRCPCPhysician
Director, Regional Primary PCI ProgramAssistant
Professor of Medicine, Univ. of Toronto
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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

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PCI Volumes at SRHC
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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

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Primary PCI vs. Thrombolysis
Short-term outcomes
PTCA
Thrombolytic Therapy
23 trials n7,739
Frequency ()
Long-term outcomes
Death, excluding SHOCK
Death / MI / Stroke
Death
MI
Stroke
Major Bleed
Recurrent Ischemia
Hemorr. Stroke
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Keeley EC, Lancet 2003
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NRMI-2 27,080 pts
Goal Door-to-Balloon Time 90 minutes
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Cannon CP, et al. JAMA 2000
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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
  gt90

• Primary PCI generally preferred
• Skilled PCI lab available (med contact to
  balloon lt 90 min)
• High risk STEMI (cardiogenic shock, Killip class
  3)
• Contraindication to lysis
• Late presentation (gt3 hrs)
• Diagnosis in doubt

ACC/AHA STEMI Guidelines 2004, Figure 3
21
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. gt30 minutes)
5. Having an attending cardiologist always on site
6. Having staff in the emerg dept and the cath lab
   use real-time data feedback

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Bradley EH, N Engl J Med 2006
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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. gt30 minutes)
• Having an attending cardiologist always on site
• Having staff in the emerg dept and the cath lab
  use real-time data feedback

9803mo01,
Bradley EH, N Engl J Med 2006
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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

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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

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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)

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Distances to SRHC RVH 58 km Stevenson 51 km
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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)

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RVH STEMI Algorithm
History ECG consistent with ST-elevation MI
Does patient have cardiogenic shock OR
Absolute contraindications to thrombolysis?
YES
NO
NO
Did symptoms start gt 3 hours (and lt 12 hours) ago?
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 required
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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 MDs, each seeing only few
  STEMIs per year

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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

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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

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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

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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

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Southlake 5th Floor
PCI Lab
CCU
STEMI beds
Duration of stay lt 24 hrs
PCI Unit
Elevators
Cardiology Ward
Bed status is never checked prior to activating
cath lab for primary PCI
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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

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Lessons learned

• The fewer physicians involved in decision-making
  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

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Future Directions

• ECG Transmission
• Prehospital Thrombolysis (Predestiny)
• Pharmacoinvasive Strategy (Transfer-AMI)

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High Risk ST Elevation MI within 12 hours of
symptom onset N1200
TNK Heparin / Enoxaparin Clopidogrel
Urgent Transfer to PCI Centre
Standard Treatment
Assess chest pain, ST? resolution at 60-90
minutes
Failed Reperfusion
Successful Reperfusion
Cath / PCI within 6 hrs Pharmacoinvasive Strategy

Cath and Rescue PCI GP IIb/IIIa Inhibitor
Elective Cath PCI gt 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
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Cantor WJ. Am Heart J, In Press
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1044 pts
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Primary PCI
Other strategies
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ACUTE MI PCI

• University of Toronto Hospital Initiatives

University of Toronto City-wide Cardiology
Rounds November 29, 2007
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IMPROVING ACUTE MI CAREPHASE ONE

• The three University of Toronto Interventional
  Cardiology Programs, St. Michaels 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. Michaels Hospital, Sunnybrook Hospital and
  the University Health Network, will apply the
  following principles

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University of Toronto City-wide Cardiology
Rounds November 29, 2007
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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.

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University of Toronto City-wide Cardiology
Rounds November 29, 2007
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RECOMMENDED TARGETS

• Door-to-ECG lt10 minutes
• ECG-to-ER Decision lt10 minutes
• Decision-to- Cath Lab lt20 minutes
• Cath Lab-to-Balloon lt30 minutes

University of Toronto City-wide Cardiology
Rounds November 29, 2007
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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 lt30 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

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University of Toronto City-wide Cardiology
Rounds November 29, 2007
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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

University of Toronto City-wide Cardiology
Rounds November 29, 2007
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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
49
Objectives

• Discuss local STEMI initiative at Sunnybrook
  Health Sciences Centre
• Discuss ongoing national initiatives and
  opportunities

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PCI versus Fibrinolysis with Fibrin-Specific
Agents Is Timing (Almost) Everything?
10 -
13 RCTs
N 5494
P 0.04
5 -
Favors PCI
Absolute Risk Difference in Death ()
0 -
Favors fibrinolysis
-5 -
-
-
-
-
-
-

1. 40 50
   60 70 80

PCI-Related Time Delay (minutes)
Nallamothu and Bates. Am J Cardiol 200392824.
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Recommendation for reperfusion therapy

• Minimize delay to reperfusion
• Door to needle lt30 minutes
• Door to balloon lt90 minutes
• Not Median, but all patients should be treated
  within the recommended timeframe

52
EFFECT STUDY (99-01)
Reperfusion Therapy
100
80
60
Percent
75
40
59
20
0
All STEMI patients
Ideal STEMI patients
Ideal as per GRACE Registry criteria
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EFFECT STUDY (99-01)
Door-to-Needle time for thrombolytic therapy
60
50
46
40
40
40
Median Time in Minutes
Benchmark lt 30 Minutes
30
20
10
Teaching
Comm
Small
Average 40 min 6/41 hospital corps
met benchmark
54
Sunnybrook STEMI Initiative

• Improve the Quality of Care and Outcomes of STEMI
  at Sunnybrook Health Sciences Centre

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Characteristics of Good STEMI hospitals

• Commitment to goal
• This is a part of the culture of the
  organization in that time to reperfusion needs to
  be excellent (VP, Cardiology)
• Visible Senior Management
• Holding people accountable. I think thats the
  role of administration (Medical Director, ER)
• 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 1131079-85
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Characteristics of Good STEMI hospitals

• Resilience to challenges with flexibility in
  refining protocols
• Its a continual thingeven though we refine the
  processthings changeand we have to refine how
  were doing things (Cath Lab Nurse)
• 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 dont try to talk me out of
  it (ER physician)
• 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 weve 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 1131079-85
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Before Initiative

• Median door to balloon 90 min
• of D2B within 90 min 54
• Median time to needle 56 min
• within 30 min 16

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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

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D2B time pre and post initiative
62
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

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• 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

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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)

65
STEMI TREATMENT ALGORITHM
66
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

67
24-7 Primary PCI

• Prompt feedback to all caregivers CQI
• Data collection Time intervals, Outcomes
• STEMI committee

68
University Health NetworkEmergency PCI Status
and InitiativesDr. Christopher
OvergaardInterventional Cardiology
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UHN Median ER Door to Balloon Times April 06 -
October 07
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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)

73
Primary Angioplasty vs. Thrombolysis for Acute MI
Quantitative Review of 23 Randomized Trials
(N7739)
Short term outcomes
Long term outcomes
of Patients
25
50
plt0.0001
PTCA
plt0.0001
21
Thrombolysis
20
40
39
15
30
10
20
22
p0.032
p0.0003
plt0.0001
plt0.0001
6.8
p0.0053
6.8
9
5
10
6
5.3
plt0.0001
10
8.7
7
6.2
1.1
4.8
0.05
2.5
0
0
Death
reMI
RecurrentIschemia
ICH
Major Bleed
Death
reMI
RecurrentIschemia
Keeley et al Lancet 200336113-20
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Transport of Patients for Primary PCI
Time Between Randomization and Balloon 90 min 80
min 97 min 85 min 155 min 82 min gt50
of pts lt90 min
Distance Range (km) 3-150 5-74 5-120 25-50 10-69 1
-100 1-150
Death During Transport 0 0 2 0 0 0 2 (0.1) 13
(0.8) 60 (1.1)
Study DANAMI-2 PRAGUE-1 PRAGUE-2 Vermeer et
al AIR-PAMI CAPTIM Total ASSENT-3 EMIP
N Transported 599 101 429 75 71 421 1656 1639 5469
Median Mean Without AIR-PAMI
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Thrombolysis n419 PCI n421 p
Primary Endpoints
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
Secondary Endpoints
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
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Studies of Direct Transportation from Scene to
PCI Centers
First Author (Year) Study Design Provider of ECG and ECG location Treatment Control Mortality Mortality 30 day Composite Outcome 30 day Composite Outcome Door-to-balloon or drug interval (minutes) Median (25th-75th percentiles) Door-to-balloon or drug interval (minutes) Median (25th-75th percentiles)
First Author (Year) Study Design Provider of ECG and ECG location Treatment Control 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 100 231 n 100 251 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 n209 3.2 n258 2 2 n209 4 2 n258 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 fibrinolysis- accelerated 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
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Rationale for a Trial ComparingPre-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
  pre-hospital fibrinolysis vs. direct transport
  for primary PCI

82
Prehospital Perspective Contributing to STEMI
care and Science

• Laurie J. Morrison

83
Declaration of Conflict of Interest

• Aventis
• HAS Solutions
• Hewlett Packard
• Hoffman La Roche

• Interdev
• Panasonic
• Zoll Medical Inc.

84
Prehospital Fibrinolysis or Direct Transport for
Primary Percutaneous Coronary Intervention in
Acute ST-Elevation Myocardial Infarction -
PREDESTINY A Randomized Controlled Trial

• PREDESTINY Investigators
• Prehospital and Transport Medicine Research
  Program
• University of Toronto

85
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
86
Potential Prehospital Interventions

• What we do now?
• 3 lead ECG and drive fast
• Prehospital diagnosis of STEMI
• 12 lead ECG and advance ED notification
• Prehospital intervention
• /- Bypass to PCI site
• Prehospital fibrinolysis

87
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

88
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
89
Primary Outcome Measure

• 30-day composite of all cause mortality and
  reinfarction, and stroke defined as any new
  neurological deficit lasting gt24 hours.
• Survival and reinfarction rates
• 6 and 12 months

90
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.

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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

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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

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Prehospital Evaluation and Economic Analysis of
Different Coronary Syndrome Treatment Strategies
PREDICT

• PREDICT Investigators
• Funded by the MOHLTC

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What is it?

• PREDICT
• observational study
• comprehensive WEB based database
• provide incidence numbers to all partners

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Study Design

• Identify the four groups
• 3 lead and transport to ED
• 3 lead and transport to ED within 60 mins of a
  PCI center
• 12 lead and transport to ED
• 12 lead and transport to ED within 60 mins of a
  PCI center

12 lead
Bypass
TPA
Bypass
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Show me the data!
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NEXT STEPS

• CITY-WIDE COLLABORATION

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University of Toronto City-wide Cardiology
Rounds November 29, 2007