Update on management of Acute ischemic stroke. · UPDATE ON MANAGEMENT OF ACUTE ISCHEMIC STROKE....
Transcript of Update on management of Acute ischemic stroke. · UPDATE ON MANAGEMENT OF ACUTE ISCHEMIC STROKE....
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UPDATE ON
MANAGEMENT OF ACUTE
ISCHEMIC STROKE.Himanshu Chokhawala, MD
Vascular Neurology fellow,
Ochsner Clinic Foundation.
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No Conflict of interest
No Discosures!
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Objectives
• Extending window for thrombectomy to 24 hours
• Treating WAKE – UP stroke.
• When to NOT administer IV – tPA in Acute Ischemic stroke
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DAWN and DEFUSE III trial
• Thrombectomy benefitted in carefully selected patients
• Window for treatment of AIS extended to 24 hours
• Time is just another factor in decision for treatment options
• TIME = BRAIN NOW COLLATERALS = BRAIN
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Copyright © 2017 Stryker NP001713 v1.0 | Slide 5 of 29
DAWN™ TrialDWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo® Retriever
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Purpose of the DAWN Trial?
Compare the benefit of treatment
with the Trevo® Retriever + medical
management vs. medical
management alone within 6-24
hours after last seen well (TSLW).
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Design
Unblinded open label randomized multicenter international clinical
trial
Funding
Stryker Neurosciences
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Population
Inclusion criteria:
• Age >= 18
• Acute ischemic stroke
• Failed IV t-PA or treatment with IV t-PA contraindicated
• Last known to be normal 6-24 hours previously
• Baseline modified Rankin Scale (mRS) of 0 or 1
• Occlusion of ICA and/or (M1 MCA)
• Mismatch between severity of clinical deficit and infarct volume
• Group A: > 80 yrs, NIHSS 10+, infarct volume < 21 ml
• Group B: < 80 yrs, NIHSS 10+, infarct volume < 31 ml
• Group C: < 80 yrs, NIHSS 20+, infarct volume 31-51 ml
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Exclusion criteria:
Clinical
• Pregnancy, major hemorrhage, prior thrombectomy use
• Seizures at stroke onset
• Sustained hypertension (systolic >185 or diastolic >110)
Imaging
• Intracranial hemorrhage
• Infarct > 1/3rd MCA territory at baseline
• Cerebral vasculitis
• carotid dissection, high grade stenosis,
• Intracranial stenting in treatment area from pre-existing intervention
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Demographics
Treatment arm N=107
Control arm N=99
Age (years) (mean) 69.4 + 14.1 70.7 + 13.2
80 or over (%) 23% 29%
NIHSS, baseline (median, [IQR]) 17 [13-21] 17 [14-21]
NIHSS 10-20 (%) 73% 73%
Sex, male (%) 39% 52%
IV-tPA administered 5% 13%
Nogueira R.G. et. al., NEJM 2017
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Medical history
Treatment arm N=107
Control arm N=99
Hypertension 78% 76%
Atrial fibrillation* 40% 24%
Diabetes mellitus 24% 31%
Previous ischemic stroke or TIA 11% 11%
* p=0.01
Nogueira R.G. et. al., NEJM 2017
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Baseline clot locations – core lab adjudicated
Clot locationTreatment arm
N=107 Control arm
N=99
ICA 21% 19.2%
M1 78% 78%
M2 2% 3%
Nogueira R.G. et. al., NEJM 2017
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Workflow times and mode of stroke presentationTreatment arm
N=107 Control arm
N=99
Time last seen well to randomization –hours median [IQR]
12.2 (10.2, 16.3) 13.3 (9.4, 15.8)
Time symptoms observed to randomization – hours, median [IQR]
4.8 [3.6 – 6.2] 5.6 [3.6 – 7.8]
Time last seen well to revascularization (TICI 2b/3) –hours median [IQR]
13.6 [11.3 – 18.0] NA
Mode of stroke presentation
Wake up stroke* 63% 47%
Witnessed stroke 10% 14%
Un-witnessed stroke 27% 38%
* P=0.04
Nogueira R.G. et. al., NEJM 2017
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Primary endpoint
Nogueira R.G. et. al., NEJM 2017
48 %v/s
13 %5
mRS 0 - 2
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mRS 5 – 6
38 %v/s
70 %
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Primary endpoint
Nogueira R.G. et. al., NEJM 2017
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Primary endpoint
Nogueira R.G. et. al., NEJM 2017
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Safety outcomes
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Subgroup analyses
of the first primary
endpoint
Nogueira R.G. et. al., NEJM 2017
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Conclusions
• DAWN-eligible patients treated with Thrombectomy is associated with better clinical outcomes and with higher rates of functional independence (mRS 0-2) compared to standard medical therapy (48.6% vs 13.1%, probability of superiority >0.999, NNT = 2.8)
• Treatment effect persisted throughout 24 hours from TLKW; however, earlier treated patients do better.
• DAWN eligible patients presenting beyond 6 hours of TLSW had comparable safety profile to thrombectomy performed within 6 hours.
Nogueira R.G. et. al., NEJM 2017
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And mismatch ratio > 1.8
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IV Thrombolysis in WAKE – UP stroke
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Objective
• IV Alteplase is a standard of care for AIS within 4.5 hours of symptom onset
• Time of symptom onset in not known in 14 – 27% of strokes.
• Reasons – Wake up strokesAphasia, confusion
• MRI brain can help assist with gauging time of symptom onset
• Ischemic lesion on DWI sq with no hyperintensity on FLAIR seq predicts symptom onset 4.5 hours from imaging.
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DWIADC
FLAIRHemo / SWI
MRI brain
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Trial Design
Investigator – initiated, multicenter, randomized, double blinded, placebo
controlled clinical trial.
Inclusion criteria
• Clinical signs of Acute stroke
• Age > 18 – 80 < years old
• No known time of onset
• Last known well more than atleast 4.5 hours
• Mismatch on DWI / FLAIR lesion with GRE/ SWAN seq and MRA
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Exclusion Criteria
• MRI showed intracranial hemorrhage
• Lesion > 1/3rd of the MCA territory
• Pt getting thrombectomy
• NIHSS > 25
• Any other contraindication for tPA.
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Demographics
Treatment arm N=245
Control arm N=249
Age (years) (mean) 65.3 + 11.2 65.2 + 11.9
Sex, male (%) 65% 64.3%
Median NIHSS score 6 (4 - 9) 6(4 - 9)
Reason for unknown time of onset
Nighttime sleep 227 (89) 222 (89.2)
Day time sleep 12(4.7) 11(4.4)
Aphasia (Confusion) 15(5.9) 16(6.4)
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Treatment arm N=245
Control arm N=249
Any 84 (33) 84(34.1)
Intracranial ICA 24 (9.6) 11(4.5)
MCA stem 35 (14.1) 37(15.0)
MCA branch 32 (12.9) 36(14.6)
Others 12(4.8) 12(4.9)
Vessel Occlusion on MRA
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Medical history
Treatment arm N=254
Control arm N=249
Hypertension 135(53) 131(52)
Diabetes Mellitus 43(16.9) 39(15.7)
Atrial fibrillation 93(36) 85(34.1)
Hypercholesterolemia 30(11.8) 29(11.6)
Nogueira R.G. et. al., NEJM 2017
Hx of Ischemic stroke 37(14.6) 131(52)
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Primary Outcomes
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74
65
GROTTA BAR
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Safety Outcomes
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Conclusion
• MRI selected patients with unkown time of onset of symptoms
benefitted from IV tPA
• Availability of MRI still a restricting factor
• Thrombectomy eligible patients were excluded so benefit with IV
tPA unknown
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When NOT to give IV tPA in AIS
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PRISMS - The Potential of rtPA for Ischemic Strokes with Mild
Symptoms
Published - July 10, 2018
Journal - JAMA
Funding - Genentech Inc.
Design - Phase IIIb, Multicenter, randomized, double blinded
Clinical Trial
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Background
• Mild stroke burden (NIHSS (0-5)) > 60% of all ischemic strokes
• There is no RCT for efficacy of Alteplase in Minor non- disabling AIS.
• Large Landmark trials for tPA - NINDS, ECASS, ECASSI I , ECASS I I I, ATLANTIS, EPITHET) excluded patients with low NIHSS.
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Population
Inclusion Criteria
• Age > 18
• NIHSS 0 - 5 and neuro deficit not disabling
• Able to perform basic ADL (bathing, ambulating, toileting
hygiene and eating)
• Pt able to walk unassisted
• Treatment initiated within 3 hours of symptom onset
Exclusion Criteria
• Pre - stroke disability (mRS 2 - 6)
• Dysphagia, ICH and other standard contraindications for tPA
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Study Intervention
• Group 1 - IV Alteplase and Placebo oral ASA
• Group 2 - Placebo IV Alteplase and Oral ASA
• IV study treatment was administered within 3 hrs of symptom
onset
• Oral study treatment administered within 24 hours of symptom
onset (75% got < 3h)
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Demographics
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Medical History
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Time from symptom onset
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Baseline NIHSS
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Primary Outcome
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Safety Outcomes
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Conclusion
• MINOR + NON disabling AIS treatment with Alteplase
compared with ASA DID NOT increase the likelihood of
favorable outcome at 90 days.
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SYNOPSIS
• DAWN and DEFUSE III eligible patients benefits with
thrombectomy upto 24 hours from LKN.
• Pt with Unkown time of onset benefits with IV tPA when
eligible with MRI brain.
• Low NIHSS and non - disbaling stroke can be treated with
ASA instead of IV tPA.