The DAWN of a New Era for Wake-up Stroke
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1 The DAWN of a New Era for Wake-up Stroke Alan H. Yee, D.O. Stroke and Critical Care Neurology Department of Neurology University of California Davis Medical Center
2 Objectives Review Epidemiology and Natural History of Large Vessel Cerebral Occlusion Review Recent Trials for Extended Treatment Time Window for Ischemic Stroke Key Criteria for Extended Time Window for Treatment of Acute Ischemic Stroke
3 None DISCLOSURES
4 Saving Tissue at Risk Up to 24 hours
5 Saving Tissue at Risk Up to 24 hours Penumbra Infarct TIME Infarct UNABLE to remove the blood clot
6 Saving Tissue at Risk Up to 24 hours Penumbra Infarct TIME Infarct REMOVE the blood clot reperfusion
7 Saving Tissue at Risk Up to 24 hours Untreated stroke Penumbra Treated stroke Infarct TIME Infarct -Less disability -Improved recovery -Less hospital complications
8 Time is brain! 2 million cells die each minute One minute saved = 1 day of normal life BUT Each Stroke Evolves in Unique Manner NOT Solely Reliant Upon Time
9 IV tpa for Acute Ischemic Stroke
10 Cerebrovascular Anatomy Carotid Terminus Carotid Artery MCA
11 Large Vessel Occlusion Facts: Strokes Up to 46% of All Strokes Associated 6 mo. Mortality (4.5 X) and Outcome Esp. Occlusion of Basilar and Carotid T Arteries RECANALIZATION Rates from tpa Alone: Prox MCA: 30% Distal MCA: 44% IC: 6% BA: 33%
12 Large Vessel Occlusion Facts: Little Data ~13% of TIAs Etiologies: Afib, ICAD, artery-artery LVO patients present with greater disability (moderate vs mild stroke symptoms) LVO is associated with: TIA recurrent stroke in 90 days functional impairment
13 Advances in Brain Imaging: CT Perfusion Biological Approach vs Just Time New technology can identify brain tissue that is rescuable by our new treatments This technology (CTA/CTP) is readily available at our local hospitals and routinely used in the assessment of stroke patients
14 CT Angiogram Occluded RIGHT Proximal MCA Vessel
15 Acute Stroke Neuroimaging RCBV rtmax
16 Thrombectomy Trials
17
18 Stentriever Trial Summary Trial n Tx t Time (h) NIHSS: IA group Age Imaging Selection stroke to TPA Stroke to puncture 90d mrs <3 control MRCLEAN No % 19% REVASCAT Yes, CTA % 28% ESCAPE IA Yes, CTA % 29% SWIFT- PRIME Yes, CTP (some CTA) % 36% Extend IA Yes, CTP % 40% Severe Deficits Most < 4.5 hrs
19 Strongest level of evidence for Endovascular: NIHSS 6 (at least moderate disability) Favorable CT (absent large infarct on 1 st CT) Intracranial IC or Proximal MCA < 6 hrs from symptom onset
20 Acute Stroke Care Sequence tpa
21 Is There Anything We Can Do After 6 Hrs? Can we still consider Endovascular Rx? Is it Safe? Is there Data?
22 Hot Off The Press: Endovascular Rx Beyond 6 Hrs DAWN Trial (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo). NEJM Nov 11, 2017 DEFUSE 3 Trial (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3). NEJM Jan 24, 2018
23 Thrombectomy for AIS DAWN Trial
24 Thrombectomy for AIS DAWN Trial Multicenter, prospective, randomized design Industry sponsored (Stryker Neurovascular) Eligibility: Confirmed LVO (Intracranial ICA and/or M1) LKW 6-24 hrs NIHSS > 10 Clinico-radiographic Mismatch (next slide) < 1/3 MCA infarction on initial imaging
25 Group A > 80 yrs NIHSS >10 Core < 21 cc DAWN Trial Group B < 80 yrs NIHSS >10 Core < 31 cc Group C (severe) < 80 yrs NIHSS >20 Core cc tmax or MTT RCB
26 DAWN Trial Additional randomization Time: 6-12 hrs vs. > hrs Occlusion site (Intracranial ICA or M1) Only TREVO Device Rescue w/ other devices or pharm NOT allowed
27 Outcome Measures (90 days) (1) Standard mrs (0-6) (2) *Utility-weighted mrs (0-10) 0= death 10 = No symptoms Performs similarly to mrs in identifying treatment effects AND valid reflection of Patient-Centered Benefit Several Secondary Outcomes (i.e. TICI)
28 Main Results Trial stopped early (Thrombectomy superior) 206 pts (NIR = 107; Control = 99) NIHSS = 17 Infarct Core: NIR = 7.6 ml; Control = 8.9 ml LKW: NIR =~12 hrs vs. 13 hrs (control) Baseline characteristics well matched Except: Wake-up: NIR 63% vs 47% Afib: NIR 40% vs. 24% tpa: Control 13% vs. 5% (NIR)
29 DAWN Trial (Functional Independence) mrs: 49% vs. 13% (CI 21-44) Uw-mRS: 5.5 vs. 3.4 (CI 1.1-3)
30 Pre-Tx POST-Tx
31 Secondary Outcomes Thrombectomy lead to: Early Response (improvement of deficits) Less Infarct Burden
32 DAWN Trial Summary Thrombectomy within 6-24 Hrs: Earlier Recovery (24 hrs-days after procedure) Greater Meaningful Functional Independence 2-3 NIR treated = 1 Functionally Independent! Similar Functional Independence compared to NIR < 6 hrs in pooled 5-Trial analysis (46%) (Caveats: DAWN controls with lower rate (13%) functional indep vs. 26% (reasons: tpa use, older, higher NIHSS)
33 DAWN Trial Summary SAFETY: NO significant difference: Stroke or All-Cause of Death sich (6 vs 3 pts) Neurologic Deterioration at 24 hrs (14% vs. 26%) A STUDY of IMAGING Assessment!!!
34 Thrombectomy for AIS DEFUSE 3 Trial
35 Thrombectomy for AIS DEFUSE 3 Trial
36 Endovascular Thrombectomy Summary
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