Ongoing Acute Stroke Studies 10/5/2015
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1 Ongoing Acute Stroke Studies 10/5/2015 Wade S. Smith, MD, PhD Director UCSF Neurovascular Service Daryl R. Gress Professor of Neurocritical Care and Stroke
2 Disclosures NIH U10 NS (PI) NorCal RCC U10 NS (Co-PI) NETT Stock ownership: Ornim Consultant DSMB: Covidien (SWIFT-Prime), Stryker (DAWN, ATLAS) Wade S. Smith, MD, PhD Director UCSF Neurovascular Service Daryl R. Gress Professor of Neurocritical Care and Stroke
3 Stroke Timeline years injury 12 hr days years PFO DEFUSE-3 TMS Contraint LAAO DAWN ESUS impact-24 MISTIE-3 Stem Cell SPRINT POINT SHINE ATACH-2 Tele Rehab
4 STAIR 2013 Workgroup Consensus on New AIS Trials IV t-pa vs. IV t-pa + Endovascular Endovascular vs. Medical Therapy IV T-PA eligible IV T-PA ineligible Endovascular vs. Medical Therapy (image selection) 0 hr All Studies: CTA/MRA/DSA Carotid T/L and M1 +/- M2 occlusions
5 SWIFT PRIME: Infarct Prediction using RAPID RAPID ischemic core and hypoperfusion volumes predicted infarct size Baseline core predicts infarct volume in reperfusers Baseline hypoperfusion predicts infarct in non-reperfusers Malignant profile predicts infarct growth despite reperfusion Albers GW, et al. In press, Annals of Neurology
6 DEFUSE 2: Response to reperfusion is not time-dependent in patients with salvageable tissue Treatment <6 hours Treatment >6 hours Lansberg and Cereda, et al. Neurology; Aug
7 DEFUSE 2: Response to reperfusion is not time-dependent in patients with salvageable tissue Treatment <6 hours Treatment >6 hours Lansberg and Cereda, et al. Neurology; Aug
8 Khatri et al
9 DEFUSE 3: Premise Infarct growth is highly variable Many patients have salvageable tissue beyond 6 hours Advanced CT/MR imaging can identify these patients These patients will benefit from modern endovascular therapies 9
10 45 sites (StrokeNet), PROBE, 6-16 hour large vessel AIS (M1/ICA), best medical therapy vs. thrombectomy (IV t-pa not allowed) Stroke LSN 0 hr 6 16 R 1:1 Best Medical Therapy Embolectomy (510-K cleared) Outcome: Ordinal mrs at 90 day (of subgroups remaining at end of trial) MRA/CTA ICA or M1 DWI/PWI or CTP mismatch (RAPID software) Adaptive stratified: NIHSS, core volume, NIHSS, time, site
11 DAWN (Jovin/Noguiera PIs) 50 sites, PROBE, 6-24 hour large vessel AIS (M1/ICA), best medical therapy vs. thrombectomy (IV t-pa not allowed) Stroke LSN Best Medical Therapy 0 hr 6 24 R 1:1 Embolectomy (TREVO) Outcome: Mean weighted mrs at 90 day MRA/CTA ICA or M1 DWI/PWI or CTP mismatch (RAPID software)
12 DAWN - Weighted Rankin Scale mrs Weight Rivero-Arias, O., et al., Mapping the modified Rankin scale (mrs) measurement into the generic EuroQol (EQ- 5D) health outcome. Medical decision making, (3): p Hong, K.-S. and J.L. Saver, Quantifying the Value of Stroke Disability Outcomes WHO Global Burden of Disease Project Disability Weights for Each Level of the Modified Rankin Scale. Stroke, (12): p
13 DEFUSE-3/DAWN Comparisons PARAMETER DAWN (N=500) DEFUSE-3 (N=476) Imaging MRI (DWI) or CTP RAPID MRI (DWI) or CTP RAPID Main Inclusion Age: 18 (no upper age limit) NIHSS: hours from TLSW Age Baseline NIHSS 6 and < hours LSW Infarct < 1/3 MCA Core < 70 ml Target Mismatch 0-20 cc core infarct and NIHSS 10 (and age 80 years old) 0-30 cc core infarct and NIHSS 10 (and age < 80 years old) 31 cc to < 50 cc core infarct and NIHSS 20 (and age < 80 years old) Mismatch ratio > 1.8 Mismatch volume > 15 ml 1 Outcome Mean weighted mrs at 90 days Ordinal mrs by subgroup Start 10/2014 (est 4 years) 1/2016 (est years)
14 ImpACT-24 Background SPG Increase collateral blood flow Promising effect Ischemic Stroke System (ISS) Slide from Yoram Solberg, BrainsGate
15 ImpACT-24 International 50 centers 560 pts currently enrolled planned (adaptive design) Est completion 2 years.
16 SHINE (K. Johnston PI) 62 sites, AIS with diabetes < 12 hours, randomized, blinded outcome, standard SQ insulin SS vs. IV insulin infusion Stroke LSN SQ Insulin BG < hr 12 R 1:1 Insulin gtt BG Outcome: mrs at 90 day (adjusted for NIHSS) Brain Imaging Ischemic Stroke
17 MISTIE-3 (Hanley PI) 77 sites, spontaneous ICH, randomized to minimally invasive surgery with t-pa vs. best medical therapy Stroke LSN Best Medical Therapy 0 hr 24 R 1:1 MIS + t-pa Outcome: mrs at 180 day CT: clot > 30 cc, GCS 14 or a NIHSS 6
18 Without MED Med application in Acute ischemic stroke With MED start Drug Never Reaches End 4cm clot model start Drug Reaches End in Minutes 4cm clot model Drug never reaches end, infusion over 2 hours.. (90-min Time Lapse) Drug reaches end in <15min (90-min Time Lapse) The Result Substantially Accelerated Drug Delivery 2014 Pulse Therapeutics, Inc. 18
19 Pre and Post MED Images Pulse Therapeutics, Inc. - CONFIDENTIAL 19
20 Stroke Timeline years injury 12 hr days years PFO DEFUSE-3 TMS Contraint LAAO DAWN ESUS impact-24 MISTIE-3 Stem Cell SPRINT POINT SHINE ATACH-2 Tele Rehab
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