A faster way to treat stroke

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


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


Stroke

“apoplexy” Sudden neurological

dysfunction Symptoms

• Weakness• Numbness, anesthesia• Speech impairment• Imbalance/incoordination• Visual loss


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


Ischemic stroke


Intracerebral hemorrhage


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…


http://en.wikipedia.org/wiki/Image:Smi32neuron.jpg

Stroke: What should the public know?

Signs & Symptoms of Stroke? F.A.S.TCall 9-1-1



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


14

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”



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



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


ESCAPE

20

ESCAPE trial


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)


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


ESCAPE outcomes



Guidelines were changed…


Guidelines…



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)


HERMES Collaboration 30CALGARY Stroke Program


Overall treatment effectNNT = 2.6

HERMES Collaboration 31

32

Time is Brain analysis with EVT


33

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


34

Process efficiencies matter after arrival at Endovascular Hospital


Workflow metrics direct vs transfer




https://www.youtube.com/watch?v=zlQ0E29rB3k

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


Parallel processingTeam divides: one part goes to talk to family; I go to angio



Patient starts improving


1256

NIH down to 3


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


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)


The biggest challenge



Denominator fallacy revisited


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


ESCAPE-NA-1

A pivotal Phase 3 trial Candidates for endovascular reperfusion Conducted in Canada, US, Europe, S. Korea &

Australia Enrollment has started


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


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


Thank you

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A faster way to treat stroke

Health & Medicine