ISC 2014 Meeting Disclosures Endovascular and Neuroprotection •IA t-PA is not labeled for clinical use •NIH • U10NS086494 - PI, NorCal-RCC • U10 NS058931 – NETT • DSMB HCRI, NIH, Stryker and Covidien Wade S. Smith, MD, PhD UCSF Department of Neurology FAST-Mag Audience Inquiry • Double blind, placebo controlled trial of IV 1. None of the clot retriever devices have been shown to be effective. When do the Mg given prehospital catheter jockeys take no for an answer? • 1700 patients • 8 years • J. Saver PI • 95 Coordinators and research assistants 1
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Acute Stroke Therapy SYNTHESIS Expansion • Italian Medicines Agency sponsored, randomized, • SYNTHESIS- Expansion Study prospective trial of endovascular t-PA vs. IV t-PA • IMS-III Study • MR RESCUE IV t-PA < 4.5 hr Outcome: CT No hemorrhage IA t-PA 90-Day R ASAP 1: mRS 1 Stroke February epub 2013 Ciccone et al , NEJM, epub Feb 2013 3
SYNTHESIS Expansion • Italian Medicines Agency sponsored, randomized, prospective trial of endovascular t-PA vs. IV t-PA 2.75 hr IV t-PA < 4.5 hr 181 Outcome: CT No hemorrhage IA t-PA 362 90-Day R ASAP 1: 181 mRS 1 3.75 hr Stroke Ciccone et al , NEJM, epub Feb 2013 Ciccone et al , NEJM, epub Feb 2013 MR RESCUE MR RESCUE • NIH sponsored, randomized, prospective trial of • NIH sponsored, randomized, prospective trial of endovascular vs. medical therapy selected by penumbral endovascular vs. medical therapy selected by penumbral pattern pattern Medical Therapy Medical Therapy 34 Penumbra Penumbra R R CTA/MRA +LVO CTA/MRA +LVO Present Endovascular Present Endovascular 1:1 Outcome: 1:1 Outcome: IV t-PA allowed IV t-PA allowed 34 MRP/CTP 90-Day MRP/CTP 90-Day 137 Analysis Medical Therapy Analysis Medical Therapy mRS mRS 20 Penumbra Penumbra R R Stroke Absent Stroke Absent 1:1 Endovascular 1:1 Endovascular 30 < 6 hours < 6 hours Kidwell et al , NEJM, epub Feb 2013 Kidwell et al , NEJM, epub Feb 2013 4
MR RESCUE Kidwell et al , NEJM, epub Feb 2013 Kidwell et al , NEJM, epub Feb 2013 IMS-III IMS-III • NIH sponsored, randomized, prospective trial of • NIH sponsored, randomized, prospective trial of IV t-PA vs. IV t-PA + endovascular IV t-PA vs. IV t-PA + endovascular Finish Finish 222 t-PA t-PA 656 Outcome: Outcome: R R CT No 2:1 CT No 2:1 IA t-PA 90-Day IA t-PA 90-Day hemorrhage hemorrhage EKOS t-PA EKOS t-PA mRS mRS Stroke IV t-PA Stroke IV t-PA MERCI MERCI 434 Penumbra Penumbra Solitaire Solitaire 58 study centers 6 years Broderick et al , NEJM, epub Feb 2013 Broderick et al , NEJM, epub Feb 2013 5
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 Broderick et al , NEJM, epub Feb 2013 Time to Reperfusion and Good Clinical Outcome Future Endovascular Trials Unadjusted Analysis SWIFT-PRIME IV t-PA vs. IV t-PA + Risk Ratio 95% CI p-value IV T-PA eligible Endovascular Time to Reperfusion 0.86 0.78-0.95 p=0.0045 Endovascular vs. Medical Therapy IV T-PA ineligible (every 30 minutes) DAWN Endovascular vs. Medical Every 30 minute delay in reperfusion is associated with a Therapy (image selection) 14% relative reduction in probability of good clinical outcome (mRS 0-2). 0 hr 4.5 6.0 24 All Studies: All Studies: CTA/MRA/DSA Carotid T/L and M1 +/- M2 occlusions CTA/MRA/DSA Carotid T/L and M1 +/- M2 occlusions 6
Audience Inquiry Audience Inquiry 1. None of the clot retriever devices have 1. None of the clot retriever devices have been shown to be effective. When do the been shown to be effective. When do the catheter jockeys take no for an answer? catheter jockeys take no for an answer? 2. Is tPA at 4.5 hrs standard of care even if 2. Is tPA at 4.5 hrs standard of care even if not approved by FDA? not approved by FDA? – It is off-label use; most stroke centers offer it – We suggest informed consent – >80 year age restriction should not be Audience Inquiry 1. OSA screening in stroke patients – Unclear is it is an independent risk factor – Associated with stroke – Reasonable to screen for OSA then refer if found 7
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