Drano vs. MR CLEAN Review of New Endovascular Therapy for Acute Ischemic Stroke Patients
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1 Drano vs. MR CLEAN Review of New Endovascular Therapy for Acute Ischemic Stroke Patients Peter Panagos, MD, FACEP, FAHA Associate Professor Emergency Medicine and Neurology Washington University School of Medicine
2 Disclosures Speaker s Bureau: Genentech Research Funding: NIH, St Luke s Hospital (KC) Consultant: AHA/ASA ACLS 2016 (Volunteer) Scientific Advisory Board: Pulse Therapeutics
3 Burden of Cerebrovascular Disease Stroke Death Rates Adults > 34 years of age, by county Data Source: National Vital Statistics System and US Census Bureau
4 The Penumbra Shrinks as Time from Onset of Ischemia Increases Oligemia: > 20 ml/100g/min Penumbra: 8 20 ml/100g/min Core: < 6-8 ml/100g/min
5 Time is Brain Time interval NNT for one Absolute risk good outcome reduction 0-90 min 5 20% Combined data from ECASS I-III, EPITHET, NINDS, ATLANTIS; Lees et al, Lancet 375: , min 9 11% min %
6 Faster Stroke Treatment is Better Treatment Patients treated within 60 mins. experience improved outcomes, including lower in-hospital mortality and reduced long-term disability GC Fonarow et al. JAMA. 2014;311(16): Saver et al. JAMA. 2013;309(23):2480-8
7 Basic Stroke Anatomy 101 Goyal M et al. N Engl J Med 2015;372:
8 IV tpa Doesn t Always Work Angiographic evaluation to identify presence and location of clot and effect of agent in 93 patients IV t-pa ( mg/kg) given 0-6 hours Angiographic Findings 26% (12/46) complete or partial lysis in M1, M2 9% (2 of 23) lysis in ICA Similar data by del Zoppo (Ann Neurol 1992) and Tomsick (AJNR 1996), Bhatia (Stroke 2010) Wolpert S, et al AJNR 1993; 14: 3-13.
9 Longer Clot Length = Less Chance to Work Reidel et al. Stroke 2011
10 Recent results of four trials
11 Now the Science.
12
13 MR-CLEAN Aim: To assess the effect of intra-arterial (IA) treatment on functional outcome after acute ischemic stroke (AIS) caused by a proven intracranial arterial occlusion, against a background of best medical management (with or without IV tpa) Design: multicenter, prospective randomized open, blinded endpoint (PROBE)
14 MR-CLEAN Study population: Netherlands Inclusion criteria: AIS, CTA w/ anterior circulation occlusion, age 18, NIHSS 2 Intervention: open Mechanical treatment, delivery of thrombolytic agent, or both Timeframe: IA treatment within 6 hours
15 MR-CLEAN Primary outcome: modified Rankin score (mrs) at 90 days Several clinical secondary outcomes (not covered here) Several neuro-imaging outcomes (not covered here)
16 MR-CLEAN
17 MR-CLEAN SWIFT-PRIME EXTEND-IA ESCAPE N Baseline NIHSS % with IV tpa Device Usage mrs 90d 500 patients IAT control - 17 IAT - 18 control - 87% IAT - 91% control 97% stent retriever IAT: 32.6% Control: 19.1% NNT for mrs 0-2 at 90 days sich 7 IAT: 7.7% Control: 6.4%
18
19 SWIFT-PRIME Aim: To determine if subjects experiencing an AIS due to large vessel occlusion (LVO), treated with combined IV tpa and Solitaire device within 6 hours of symptom onset, have less stroke-related disability (mrs) than subjects treated with IV tpa alone. Design: multicenter, prospective randomized open, blinded endpoint (PROBE)
20 SWIFT-PRIME Study population: United States and Europe Inclusion criteria: AIS, CTA/MRA w/ occlusion at intracranial ICA / M1 / carotid terminus, age 18-80, NIHSS 8-29, pre-stroke mrs 1 Intervention: Solitaire device (stent retriever) Timeframe: IV treatment within 4.5 hours and IA treatment within 6 hours (within 90 minutes of qualifying imaging)
21 SWIFT-PRIME Primary outcome: modified Rankin score (mrs) at 90 days Several clinical secondary outcomes (not covered here) Several neuro-imaging outcomes (not covered here)
22 SWIFT-PRIME Enrollment ended early due to MR-CLEAN (n=196)
23 MR-CLEAN SWIFT-PRIME EXTEND-IA ESCAPE N Baseline NIHSS % with IV tpa Device Usage mrs 90d 500 patients IAT control - 17 IAT - 18 control - 87% IAT - 91% control 97% stent retriever IAT: 32.6% Control: 19.1% IAT - 98 control - 17 IAT - 17 control - 100% IAT - 100% control Solitaire IAT: 60.2% Control: 35.5% NNT for mrs 0-2 at 90 days 7 4 sich IAT: 7.7% Control: 6.4% IAT: 1.0% Control: 3.1%
24
25 EXTEND-IA Rationale: To select patients with the best chance of benefit from reperfusion ( Dual Target ) with a proven major vessel occlusion and salvageable tissue with ischemic core < 70 ml (CT perfusion), treat as fast as possible, using the most effective device (stent retriever) Design: multicenter, prospective randomized open, blinded endpoint (PROBE)
26 EXTEND-IA Study population: Australia & New Zealand Inclusion criteria: AIS, CTA/MRA w/ occlusion at ICA / M1 / M2 PLUS mismatch with ischemic core < 70mL, age 18, no specified NIHSS, pre-stroke mrs 1 Intervention: Solitaire device (stent retriever) Timeframe: IV treatment within 4.5 hours and IA treatment within 6 hours
27 EXTEND-IA Primary outcomes: 24 hour MRI reperfusion 3 day NIHSS Several clinical secondary outcomes mrs at 90 days Several neuro-imaging outcomes (not covered here)
28 EXTEND-IA Enrollment ended early due to MR-CLEAN (n=70)
29 MR-CLEAN SWIFT-PRIME EXTEND-IA ESCAPE N 500 patients IAT control IAT - 98 control IAT - 35 control Baseline NIHSS - 17 IAT - 18 control - 17 IAT - 17 control - 17 IAT - 13 control % with IV tpa - 87% IAT - 91% control - 100% IAT - 100% control - 100% IAT - 100% control Device Usage 97% stent retriever Solitaire Solitaire mrs 90d IAT: 32.6% Control: 19.1% IAT: 61.1% Control: 35.5% IAT: 71% Control: 40% NNT for mrs 0-2 at 90 days sich IAT: 7.7% Control: 6.4% IAT: 1.0% Control: 3.1% IAT: 0% Control: 6%
30
31 ESCAPE Aim: to answer the question: Do I take this patient to endovascular treatment (thrombectomy)? Design: multicenter, prospective randomized open, blinded endpoint (PROBE)
32 ESCAPE Study population: Canada, US, Korea, UK & Ireland Inclusion criteria: AIS, CTA w/ occlusion at carotid terminus / M1 / 2 or more M2s PLUS moderate to good collaterals, age 18, NIHSS > 5, good functional status prior to stroke Intervention: mechanical thrombolysis (including stent retriever) Timeframe: Last-seen-well time to randomization < 12 hours and IA treatment started within 60 minutes of qualifying imaging
33 Multi-phase CTA Conventional Mid Venous Late Venous Arch to Vertex Phase Phase
34 ESCAPE Primary outcome: modified Rankin score (mrs) at 90 days Several clinical secondary outcomes (not covered here) Several neuro-imaging outcomes (not covered here)
35 ESCAPE Enrollment ended early due to MR-CLEAN (n=315)
36 MR-CLEAN SWIFT-PRIME EXTEND-IA ESCAPE N 500 patients IAT control IAT - 98 control IAT - 35 control IAT control Baseline NIHSS - 17 IAT - 18 control - 17 IAT - 17 control - 17 IAT - 13 control - 16 IAT - 17 control % with IV tpa - 87% IAT - 91% control - 100% IAT - 100% control - 100% IAT - 100% control - 73% IAT - 79% control Device Usage 97% stent retriever Solitaire Solitaire 86% stent retriever mrs 90d IAT: 32.6% Control: 19.1% IAT: 61.1% Control: 35.5% IAT: 71% Control: 40% IAT: 53% Control: 29.3% NNT for mrs 0-2 at 90 days sich IAT: 7.7% Control: 6.4% IAT: 1.0% Control: 3.1% IAT: 0% Control: 6% IAT: 3.6% Control: 2.7%
37 SUMMARY
38 MR-CLEAN SWIFT-PRIME EXTEND-IA ESCAPE Baseline NIHSS - 17 IAT - 18 control - 17 IAT - 17 control - 17 IAT - 13 control - 16 IAT - 17 control % with IV tpa Revasc Rates (TICI 2b/3 ) - 87% IAT - 91% control - 100% IAT - 100% control - 100% IAT - 100% control - 73% IAT - 79% control IAT: 58.7% IAT: 88% IAT: 86% IAT: 72.4% mrs 90d IAT: 32.6% Control: 19.1% IAT: 61.1% Control: 35.5% IAT: 71% Control: 40% IAT: 53% Control: 29.3% NNT mrs 0-2 at 90d sich IAT: 7.7% Control: 6.4% IAT: 1.0% Control: 3.1% IAT: 0% Control: 6% IAT: 3.6% Control: 2.7% Mortality at 90 days IAT: 21% Control: 22% IAT: 12.2% Control: 25.8% IAT: 9% Control: 20% IAT: 10% Control: 19%
39 Summary Slightly different inclusion/exclusion criteria Now Level I A Recommendations AHA Focused Update Statement (March 2015) All focused on minimizing time to intervention Fairly consistent results overall NNT = 3-4 for mrs 0-2 at 90 days NNT = 8 for MRS 0-2 at 90 days for IV tpa How do we implement this new evidence going forward?
40 What Does This Mean For Prehospital Care?
41 2015: All Stroke Care is Note Equal Specialty Care is Limited 91 CSC 1,200 PSC TBD ASRH Stroke Care is Comprehensive Large AIS, ICH, SAH Multi-system disease Surgical or endovascular expertise 24/7, 365 NICU Research, Education Outcomes
42 Why Doesn t EMS Just Triage the Right Patient to the Right (CSC) Hospital?
43 EMS Field Triage in Stroke: Not Exact Science Yet Often inaccurate for stroke type, size, severity Cannot predict deterioration or complications Patient preference Politics (e.g. Regional plans, CMS rules, etc ) Messaging unclear (e.g. Marketing vs. Quality)
44 Next Steps in Stroke Care Regionalization Coordination Selective Triage Track & Report Quality Adapt to Changes in Evidence
45 St Louis EMS Regional Plan Draft-Approved
46 AHA/ASA Mission: Lifeline Stroke Routing Template Draft
47 Thank You!
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