a faster way to treat stroke
TRANSCRIPT
A faster way to treat stroke
Drs. Michael D Hill and Mayank GoyalProfessors, Cumming School of Medicine
March 21, 2017
Welcome
Dr. Mayank Goyal• Professor of Radiology and Clinical
Neurosciences at UCalgary’s Cumming School of Medicine
• Director of Imaging and Endovascular treatment at the Calgary Stroke Program
• Passion and main research interest is acute stroke imaging, workflow and intervention (over 190 publications)
• One of the Principal Investigators in two multi-centric trials in the field: ESCAPE and SWIFT PRIME (both published in NEJM)
• He is also leading a meta-analysis (HERMES) consisting of the recent 5 positive trials published in NEJM
CALGARY Stroke Program
Welcome
Dr. Michael Hill• Professor in the Departments
of Clinical Neurosciences, Community Health Sciences, Medicine and Radiology at UCalgary's Cumming School of Medicine
• Director of the Stroke Unit for the Calgary Stroke Program, Alberta Health Services
• Research interests include stroke thrombolysis, stroke epidemiology, and surveillance and clinical trials
CALGARY Stroke Program
Outline
1. Introduction to stroke types, prevalence, etc. 2. Medical treatments for stroke3. ESCAPE trial introduction4 . ESCAPE trial results5. Endovascular treatment and technique6. Societal effect7. Conclusion
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Stroke
“apoplexy” Sudden neurological
dysfunction Symptoms
• Weakness• Numbness, anesthesia• Speech impairment• Imbalance/incoordination• Visual loss
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Stroke types
Ischemic (85%) – arterial blockage
Hemorrhagic (15%) – arterial rupture• Intra-cerebral hemorrhage (7-8%)• Sub-arachnoid hemorrhage (7-8%)
Venous sinus thrombosis (<< 1%) – vein blockage
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Ischemic stroke
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Intracerebral hemorrhage
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The neuron…
In a typical large vessel acute ischemic stroke…
1.9 million neurons 14 billion synapses 12 km of myelinated fibers
are destroyed each minute…(Saver et al, 2006) 5 min ~ 10 million neurons, 60km of wires
10 min ~ 20 million neurons, 120km of wires
15 min ~ 30 million neurons, 180 km of wires…
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Stroke: What should the public know?
Signs & Symptoms of Stroke? F.A.S.TCall 9-1-1
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Age-relatedness
12CALGARY Stroke Program
Cost avoidance
Stroke treatment
Principles A. Depends on the stroke.
• THEREFORE WE NEED A BRAIN IMAGE – CT SCAN OR MR SCAN – TO DETERIMINE IF THE STROKE IS ‘ISCHEMIC’ OR ‘HEMORRHAGIC’
B. TIME IS BRAIN. Fast process is absolutely essential for successful treatment of stroke.
C. Acute treatments D. Rehabilitation treatments
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Speed, Process and Workflow
Medical Thrombolysis
Alteplase (double chain recombinant tissue plasminogen activator or rtPA)
Thrombus / clot – dissolving agent
“drain-o for the blocked pipes in the brain”
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Stroke units prevent death
NNT = 11 (95%CI 7-25) to prevent one death
19
15
22
20
0
5
10
15
20
25
Ave
rage
Len
gth
of H
ospi
tal S
tay
(d)
0 1
0: modified Charlson Index <= 1; 1: modified Charlson Index >= 2 General neurology wards
Stroke Unit
Lessons from Cardiology:Onset to Balloon Mortality lesson
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Time to Reperfusion and good clinical outcome Observed Vs Predicted
ICAT, M1, and M2 Cases with Reperfusion with 95% confidence bands (p=0.0045)
Observed values shown as horizontal bars for every ~20 subjects
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ESCAPE
20
ESCAPE trial
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Outcomes (NNT = 4)
www.escapetrial.org 22
Clinical Intervention [n=165]
Control [n=150]
RR or cOR (CI95)
Adj RR or cOR (CI95)
mRS primary outcome (“shift analysis”) [n=311]
--- --- 2.6 (1.7-3.8) 3.1 (2.0-4.7)
mRS 0-2 at 90d [n=311]
53.0% 29.3% 1.8 (1.4-2.4) 1.7 (1.3-2.2)
EQ-VAS at 90d (median, iqr)
80 (30) 65 (30) P<0.001 (rank sum test)
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Wilson JT, et al. Stroke. 2002.33:2243-2246; Wilson JT, et al. Stroke. 2005.36:777-781; Quinn TJ, et al. Stroke. 2007.38:2257-2261.
Modified Rankin Score
0•No symptoms at all
1•Significant disability despite symptoms; able to carry out all usual duties and activities
2•Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
3•Moderate disability; requiring some help, but able to walk without assistance
4•Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
5•Severe disability; bedridden, incontinent and requiring constant nursing care and attention
6•Dead
www.escapetrial.org 24CALGARY Stroke Program
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ESCAPE outcomes
www.escapetrial.org 25
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Guidelines were changed…
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Guidelines…
www.escapetrial.org 27
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HERMES collaboration
Endovascular thrombectomy after large-vessel ischemic stroke: a meta-analysis of individual patient data from five randomized trials
Highly Effective Reperfusion evaluated in Multiple
Endovascular Stroke trials (HERMES)
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HERMES Collaboration 30CALGARY Stroke Program
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Overall treatment effectNNT = 2.6
HERMES Collaboration 31
32
Time is Brain analysis with EVT
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7.3 hour onset to groin puncture time window for EVT
7.3 hrs
2.3 2.52.9
3.44.2
5.58.6
NNTs
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Process efficiencies matter after arrival at Endovascular Hospital
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Workflow metrics direct vs transfer
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https://www.youtube.com/watch?v=zlQ0E29rB3k
From months ago
NIH 18 (severe stroke) Otherwise healthy 65 min from onset Dr. Hill and I are on call
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Parallel processingTeam divides: one part goes to talk to family; I go to angio
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Patient starts improving
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1256
NIH down to 3
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24 hour diffusion imagingNIHSS zeroDischarged home on day 3
Study design
I4. Saver J, Goyal G, Bonafe A, et al. Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV tPA alone in acute ischemic stroke. International Journal of Stroke 2015; 10.3: 439-48
Objective To compare the functional outcomes in AIS subjects treated with either IV t-PA alone or IV t-PA in combination with Solitaire device
Design Global, multi-center, prospective, randomized, open, blinded endpoint (PROBE) IDE Study
Target Vessel Intracranial ICA, M1 of MCA, and carotid terminus
Randomization 1:1IV t-PA alone vs. IV t-PA + Solitaire
Primary Endpoint 90-day global disability assessed via the blinded evaluation of modified Rankin scale (mRS)
Follow-Up 27 hours, 7-10 Days/Discharge, 30 Days, 90 Days
National PIsDrs. Jeffrey Saver, Mayank Goyal, Elad Levy and Vitor Mendes PereiraProf. Chris Diener and Alain Bonafe
The trial enrolled 196 patients between Dec 2012 and Nov 2014. Patients were equally randomized to 98 in Control and 98 in Intervention arm. Trial was officially stopped on Feb 4, 2015 due to crossing of a pre-defined
efficacy boundary.
Mayank Goyal
Cost-effectiveness of Solitaire + IV t-PA forAcute Ischemic Stroke:Results from the SWIFT PRIME Trial
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Cost Effectiveness Analysis
UCLA Stroke CenterCALGARY Stroke Program
-4 -3 -2 -1 0 1 2 3 4-$100,000
-$50,000
$0
$50,000
$100,000
Lifetime cost-effectiveness: Base case
Δ QALY
Δ Cost = - $23,203 Δ QALY = 1.74
Solitaire economically
dominant
$50,000 per QALY
Δ Co
st (S
olita
ire +
IV t-
PA)
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The biggest challenge
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Denominator fallacy revisited
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T=30min T=2 hr T=6 hr
Favo
rabl
e Im
agin
g
IV only IA/IV IV only IA/IV Medical therapy IA
Denominator fallacy revisited
Soon to be published in StrokeCALGARY Stroke Program
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ESCAPE-NA-1
A pivotal Phase 3 trial Candidates for endovascular reperfusion Conducted in Canada, US, Europe, S. Korea &
Australia Enrollment has started
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Conclusions
ESCAPE trial: work done at the University of Calgary has been responsible of change of medical practice for the whole world
Endovascular treatment of acute stroke is now the standard of care
Time is brain Getting the correct patient to the correct hospital is critical
• One of our key challenges is EDUCATION re: recognition of acute stroke
Researchers at University of Calgary continue to move the field forward and improve stroke care, education and research
CALGARY Stroke Program
Key takeaways
What can you do?• Understand the symptoms of stroke – F.A.S.T.• Call 9-1-1 immediately• Ensure that the time between the stroke and getting the
patient to hospital is minimized as much as possible
CALGARY Stroke Program
Thank you
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