Stroke Treatment Beyond Traditional Time Windows. Rishi Gupta, MD, MBA
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1 Stroke Treatment Beyond Traditional Time Windows Rishi Gupta, MD, MBA Director, Stroke and Neurocritical Care Endovascular Neurosurgery Wellstar Health System
2 THE PAST
3 THE PRESENT
4 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Endorsed by the American Association of Neurological Surgeons (AANS); Congress of Neurological Surgeons (CNS); AANS/CNS Cerebrovascular Section; American Society of Neuroradiology; and Society of Vascular and Interventional Neurology Patients eligible for intravenous rtpa should receive intravenous rtpa even if intra-arterial treatments are being considered. Patients should receive endovascular therapy with a stent retriever if they meet all the following criteria a) prestroke mrs score 0 to 1, b) acute ischemic stroke receiving intravenous r-tpa within 4.5 hours of onset according to guidelines from professional medical societies, c) causative occlusion of the internal carotid artery (ICA) or proximal MCA (M1), d) age 18 years, e) NIHSS score of 6, f) ASPECTS of 6, and Class g) I treatment can be Level initiated of Evidence (groin A puncture) within 6 hours New Recommendation of symptom onset William J. Powers, Colin P. Derdeyn, José Biller, Christopher S. Coffey, Brian L. Hoh, Edward C. Jauch, Karen C. Johnston, S. Claiborne Johnston, Alexander A. Khalessi, Chelsea S. Kidwell, James F. Meschia, Bruce Ovbiagele, and Dileep R. Yavagal AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. American Heart Association Stroke Council. Stroke Published online June 29 th 2015.
5 Endovascular thrombectomy after large-vessel ischemic stroke: a meta-analysis of individual patient data from five randomised trials HERMES Collaborators Highly Effective Reperfusion evaluated in Multiple Endovascular Stroke trials (HERMES) 5
6 Overall Treatment Effect NNT = 2.6 Goyal M, et al., Lancet 2016
7 ARR 6%, NNT= 29
8 HERMES- SUBGROUP ANALYSIS AGE Goyal et. al, Lancet 2016 Ordinal (shift) analysis Dichotomized analysis by functional independence (mrs)
9 HERMES- SUBGROUP ANALYSIS stroke severity Ordinal (shift) analysis Dichotomized analysis by Functional independence (mrs)
10 Goyal et. al, Lancet 2016 HERMES- SUBGROUP ANALYSIS ASPECTS Ordinal (shift) analysis Dichotomized analysis by Functional independence (mrs)
11 Goyal et. al, Lancet 2016 HERMES- SUBGROUP ANALYSIS time to treatment Ordinal (shift) analysis Dichotomized analysis by Functional independence (mrs)
12 7.3 hour onset to groin puncture time window for EVT NNTs hrs
13 Infarct volume (both treatment groups) strongly correlates with clinical outcome SWIFT PRIME, Albers G., et al, Stroke 2015 IMS 3, Jovin T., et al, ISC 2015 (p<0.0001) P <
14 TIME IS BRAIN REVISITED Time = Brain Imaging = Time IMAGING = BRAIN!!!
15 SHOULD THERE BE A TIME WINDOW FOR ACUTE STROKE INTERVENTIONS???
16 PROGRESSIVE GROWTH OF CORE IN MCA OCCLUSION SERIAL MRI S (CORONAL SECTIONS) AT THREE LEVELS IN THE BRAIN DEPICTING THE APPARENT DIFFUSION COEFFICIENT OF WATER (ADC) (MARKED BY THE BLUE COLOUR) DEMONSTRATING THE TIME-DEPENDENT GROWTH OF THE ISCHEMIC CORE. Hossman et al., Cell Mol Neurobiol, 2006
17 Baseline DWI Volume (ml) Initial Growth Rate: Known Onset & M1 Occlusion Time between Symptom Onset and Baseline MRI (hrs) Wheeler HM, et al. Int J Stroke. 2015
18 Initial Growth Rate: Known Onset & M1 Occlusion 230 Baseline DWI Volume (ml) Time between Symptom Onset and Baseline MRI (hrs) Wheeler HM, et al. Int J Stroke. 2015
19 RELATIONSHIP BETWEEN TIME FROM ONSET TO REPERFUSION AND GOOD OUTCOMES IN DEFUSE 2 N= 46 Median baseline infarct volume = 16 cc Lansberg M. et al., Neurology 2015
20 RELATIONSHIP BETWEEN TIME FROM ONSET TO REPERFUSION AND GOOD OUTCOMES IN REVASCAT 44% favorable outcome For 30 min reduction in time 28% favorable outcome For 30 min reduction in time Ribo et al., Stroke 2016
21
22
23 WAKE UP STROKE VS WITTNESED ONSET BEYOND 8 HRS - IS THERE A DIFFERFENCE IN OUTCOMES WITH IAT? Aghaebrahim A. et al., JNIS 2015
24 SHOULD WE TREAT PATIENTS WITH LVO AND MISMATCH BEYOND 6 HOURS WITH NO TIME LIMIT???
25 88 year old woman with L M1 occlusion, TLSW 22 hours, NIHSS 21, no intervention mrs at 3 weeks: 3 Baseline MRI/MRA NIHSS 21 MCA occlusion MCA partially recanalized 4 day MRI/MRA NIHSS 11
26 88 year old woman with R M1 occlusion, TLSW 20 hours, NIHSS 17, no intervention mrs at 30 days 1 Baseline MRI/MRA Follow-up MRI/MRA at 24 hours (NIHSS 17) no infarct growth and partial recanalization
27 61 year old man with R M1 occlusion, TLSW 14 hours, NIHSS 21, no intervention 3 months mrs 4 Baseline MRI/MRA/CTP MRI/MRA at 24 hours, NIHSS 20 MRI at day 5, NIHSS 18
28 DAWN Trial: Why Do We Need to Do It?
29 DAWN STUDY OVERVIEW Title Sponsor PI Study device Control intervention (IV-tPA yes/no?) DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN) Stryker Neyrovascular Inc. Tudor Jovin, MD and Raul Nogueira, MD Trevo ProVue and Trevo XP ProVue Retrievers Best medical therapy including iv t-pa in eligible patients (which will be estimated to make up maximium 20% of total) Study population Acute stroke patients with no upper age limit presenting in the 6-24 hour time window with proximal anterior circulation occlusions (M1, ICA T) and substantial clinical/core mismatch Objective To evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.
30 Counterpoints Supporting Equipoise: Why DAWN Can Fail? Longer Time from Stroke Onset to Treatment = Better Collaterals =? Better Natural History Longer Time from Stroke Onset to Treatment =? Increased Risk of Hemorrhagic Transformation Longer Time from Stroke Onset to Treatment =? Worse Reperfusion Rates RCTs of Delayed IV Thrombolysis (including Mismatch-Based) Have Failed to Show a Benefit
31 DAWN Trial Design Prospective, randomized (1:1), multi-center, Phase II/III (feasibility/pivotal), adaptive, population enrichment, blinded endpoint, controlled trial Up to 50 sites (worldwide) 150 subjects (feasibility) up to 500 (pivotal) max Primary endpoint: Difference between the average weighted mrs at 90 days between treatment and control groups NV AA Released: Page 31 of 28
32 DAWN Trial Unique Design Elements Designed to measure effectiveness & safety in single endpoint Primary Endpoint: Weighted mrs Designed to capture health state transitions across the entire spectrum Endpoint that is a combination of both efficacy and safety Differentiates outcomes Patient-centered outcomes analysis mrs Weight Enrichment Designed to fine tune the patient population based on core infarct size Identify subgroups experiencing clinical benefit 0-50 cc 0-45 cc 0-40 cc 0-35 cc 0-30 cc NV AA Released: Page 32 of 28
33 Origin of the Utility Weighted mrs Chasnaianunkul et al., Stroke. 2015;46:
34 DAWN Clinical Trial Goal: To identify the Target Mismatch Patient in the 6-24h Window (including Wake-Up Strokes) Clinical Mismatch: NIHSS >10 + Small Infarct Proximal Occlusion: ICA-T and/or MCA-M1 Occlusion Standardized RAPID software Randomization Balanced re: CIM subgroup, time and occlusion location
35 CLINICAL EXAM (NIHSS): A GOOD ESTIMATION OF THE AT RISK TERRITORY?? Davalos et al., Neurology 2004
36 DEFUSE 3: NIH-funded, prospective, randomized, multi-center, adaptive, blinded endpoint trial Paradigm shift From time-based selection to imaging-based selection Target population Anterior circulation ischemic stroke; ICA or M1 occlusions (CTA/MRA) Salvageable tissue on CT perfusion or MR diffusion / perfusion Endovascular therapy within 6-16 hours of last known well Design 1:1 randomization; standard medical therapy vs. endovascular 45 sites
37 Neuroimaging Inclusion Criteria MRA / CTA reveals M1 segment MCA occlusion, or ICA occlusion (cervical or intracranial; with or without tandem MCA lesions) AND Target Mismatch Profile on CT perfusion or MRI (RAPID) Ischemic core volume < 70 ml Mismatch ratio > 1.8 Mismatch volume 15 ml
38
39 Conclusions Endovascular stroke therapy is a game changer for patient outcomes Patients with larger stroke syndromes regardless of time of last known normal should be screened Worse to under treat than over treat this disease Community, Hospital, EMS discussions of how to triage patients to CSC and Endovascular hospitals
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