Intravenous thrombolysis State of Art. Carlos A. Molina Stroke Unit. Hospital Vall d Hebron Barcelona
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1 Intravenous thrombolysis State of Art Carlos A. Molina Stroke Unit. Hospital Vall d Hebron Barcelona
2 Independent predictors of good outcome after iv tpa Factor SE OR(95%CI) p Constant 0.467(0.69) Recanalization 1.41 (0.26) 4.11 ( ) <0.001 NIHSS score (0.4) 0.35 ( ) ASPECTS value 1.09 (0.49) 2.98 ( ) SBP (0.43) 0.32 ( ) Proximal occlusion (0.45) ) <0.001 CLOTBUST Collaborators
3 Impact of recanalization on stroke outcome Rha, Saver, Stroke 2007
4 Quantitative trends over time in reperfusion rates in active arms of recanalization trials Patel, Saver. Stroke 2013
5 480 patients with endovascular treatment & known time of reperfusion
6 Time is brain also means time is clot Muchada M et al. Stroke. 2014;45:
7 Benefit to Risk ratio in randomized acute stroke trials
8 Use of tpa in real world Patients > 80y Minor stroke Body weigth > 100 kg Without occlusion < 3h without missmatch Previous Aco, normal INR NOAC and normal coagulat?
9 Challenges in reperfusion therapy Improve access to treatment Non-phamacological reperfusion strtegies Extend therapeutic window Increase recanalization rates Shortening pre- and inhospital delays
10 Improving early access to treatment Golden hour <60 min Diamond hour < 30 min
11 Improving access and early treatment Increase awareness Telemedicine. telethrombolysis Prehospital thrombolysis Shortening DTN times
12 Potencial: Figueres consultes / any Vic Girona Palamos Vilafranca Igualada Granollers HVH Mataro H. G. Trias Badalona Hospitals amb: >100 ictus/any >40 km del centre de referència TAC disponible 24 hores
13 Potencial: >1000 consultes / any 2013 Tele-Ictus 2.0 Estació mòbil Figueres Palamos Girona Mataró Germans Trias Vic Granollers Vall d Hebron Lleida Tremp Bellvitge Igualada Manresa Vilafranca Garaf Mora
14 7 M
15 Different approaches of pre- and in-hospital stroke management Audebert H J et al. Neurology 2013;81:
16 Improving early access to treatment
17 STEMO Neurologist Paramedic Radiographer CT scan Point-of-care Lab Teleradiology
18 Prehospital Thrombolysis PHANTOM-S pilot study 152 patients treated, 23 receoved tpa STEMO CONTROL N NIHSS score 8 8 Call-to-needle time: 62 min 98 min On site-to neddle time: 48 min 91 min SICH 2(9%) 3(6%)
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20 Improving time delays in the rescue chain Improve stroke awareness in the population Optimize advanced prenotification (stroke code) Continuos EMS personnel training Telemedicine with video examination (TeleStroke) Development of rapid diagnostic algoritms Ultraound Portable CT scan Telemedicine-assisted rapid identification and direct transfer to hospital CT scan
21 Shortening Door-to-needle times From: Door-to-Needle Times for Tissue Plasminogen Activator Administration and Clinical Outcomes in Acute Ischemic Stroke Before and After a Quality Improvement Initiative JAMA. 2014;311(16): doi: /jama
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25 Distal MCA occlusion Proximal MCA occlusion No idea No occlusion No window No money
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27 Door-to-needle times before and afetr text-messaging-based quality improvement
28 Stroke WhatsApp
29 Stroke WhatsApp Improve prenotification Shorten time to evalation Improve inhospital coordination Speed up decisión making Improve training
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32 Video monitoring of stroke thrombolysis
33 CT-tPA
34 shortening Imaging to-needle times reduces Door-to-needle times for tpa ITN time is a much greater source of variability in hospital DTN times common contributor to delays in timely tpa therapy More attention is needed to determine systems changes that can decrease ITN time for patients with acute ischemic stroke.
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37 Extending window beyond 4.5h Time is brain CT-based thrombolysis Selection MRI / CTP
38 Extending window beyond 4.5h Time is brain CT-based thrombolysis Selection MRI / CTP
39 Mismatch concept Molina C, Saver J, Stroke 2005
40 DEFUSE MRI profile Target mismatch No mismatch Malignant Benign Albers et al Ann Neurol 2007
41 Desmoteplase In Acute Stroke Baseline 4h post treatment Reperfusion PWI reduction 30% or TIMI change 2 post-thrombolysis)
42 Responder rate DIAS/DEDAS & DIAS 2
43 Responder rate DIAS/DEDAS & DIAS 2 Lower NIHSS score Lower rate of TIMI 0-1
44 Responder rate DIAS/DEDAS & DIAS 2 Lower NIHSS score Lower rate of TIMI 0-1 Higher mortality
45 Focusing on vascular status
46 ECASS 4- EXTEND Iv tpa 3-9 hours Penumbra-based trial PWI> 100% DWI Ongoing. Europe and Australia Perfusi ó n (TTP)
47 WAKE-UP Age years - Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening) - MRI showing a pattern of "DWI-FLAIR-mismatch",
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49 Improving the efficacy profile of thrombolysis
50 Improving the efficacy profile of thrombolysis
51 Longer half-life 14 times more fibrin-specific More resistant to PAI-1 Tenecteplase (TNK)
52 Continuous TCD monitoring Beginning Timing Degree Molina et al ISC New Orleans 2008
53 Temporal profile of tpa- and TNK-induced recanalization Molina et al ISC New Orleans 2008
54 2h-recanalization on TCD P=0.014
55 Coordinating Centre: John Hunter Hospital, Newcastle Participating Centres: Royal Melbourne Hospital, Box Hill Hospital
56 Tenecteplase versus alteplase for acute ischaemic stroke: phase II study Hypotheses: TNK superior to tpa for early reperfusion and early neurologic improvement Summary of study design: Acute stroke onset within 6 hours with vessel occlusion + ischaemic penumbra on multimodal CT. Central randomisation: patients to receive 0.9 mg/kg tpa or TNK (0.1 mg/kg or 0.25 mg/kg). Dual primary outcomes at 24 hours 1. Extent of early reperfusion 2. Extent of early clinical improvement.
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62 Stroke Research Program Brain & Mental Health Priority Research Centre University of Newcastle
63 Stroke Research Program Brain & Mental Health Priority Research Centre University of Newcastle Objectives Test the hypothesis that patients with acute hemispheric ischaemic stroke who have a penumbra on perfusion CT or MRI within 4.5hours of symptom onset will have less disability at 3 months when treated with IV tenecteplase (TNK) compared to IV alteplase (tpa).
64 Study Design - Summary Thrombolysis eligible patient stroke onset <4.5hours NCCT/CTP/CTA or MRI (DWI/PWI/MRA) Core on DWI/CTP < 70 ml Penumbra Mismatch Ratio > 1.8 (Tmax+6s) and > 15mL Randomised to IV tpa (0.9 mg/kg) or IV TNK (0.25 mg/kg) (Randomisation stratified by presence of ICA occlusion and infarct core volume) Primary outcome = mrs 0-1 at 3 months PROBE design. Sample size 1024.
65 Stroke Research Program Brain & Mental Health Priority Research Centre University of Newcastle Study Design 1024 patients will be recruited into the trial from centres worldwide. 1 st 200 patients mandatory reperfusion substudy Mandatory perfusion imaging (CT/MR) at 24 hours Interim analysis of reperfusion and early clinical improvement (as per phase II study) TNK vs tpa
66 Stroke Research Program Brain & Mental Health Priority Research Centre University of Newcastle Study Endpoints Primary Outcome modified Rankin Scale (mrs) 0-1 at 3 months Interim Analysis after 200 patients Reperfusion at 24 hours Early clinical improvement (reduction in acute 24 hour NIHSS score) mrs 0-1 at 3 months
67 Stroke Research Program Brain & Mental Health Priority Research Centre University of Newcastle Study Endpoints Safety: Symptomatic intra-cerebral haemorrhage (sich) Death due to any cause mrs 5-6 at 3 months
68 Some (of the more athletic members) of the TASTE team
69 US-Enhanced Thrombolysis CLOTBUST Trial: Complete MCA Recanalization 27% 38% 13% 13% p=0.03 New Engl J Med 2004;351;
70 Meta-analisys of US-enhanced thrombolysis Complete recanalization Tsivgoulis, et at Stroke 2009
71 Meta-analisys of US-enhanced thrombolysis Long-term outcome Tsivgoulis, et at Stroke 2009
72 Meta-analisys of US-enhanced thrombolysis Risk of ICH Tsivgoulis, et at Stroke 2009
73 CLOTBUST-ER A Phase 3, Randomized, Placebo-Controlled, Double-Blind Trial of the Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tpa) for Emergent Revascularization (CLOTBUST-ER) in Acute Ischemic Stroke.
74 Aim to evaluate the efficacy of a novel transcranial ultrasound device and systemic tpa (Target group) compared to systemic tpa alone (Control group) in subjects with acute ischemic stroke.
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76 CLOTBUST-ER CP-01 Study <80 y <time frame for tpa NIHSS> 10 Primary end-point: mrs 0-1 N=840; 1:1
77 CLOTBUSTER CLOTBUST-ER is ongoing with active enrollment at approximately 70 sites in 14 countries worldwide. 490 of 824 planned subjects have been enrolled to date., DSMB recommended continuation of the trial as planned without modification after the first interim analysis.
78 Conclusion Need to improve early access to tpa - Telemedicine - Prehospital thrombolysis - Shortening DNT Need to extend time window for tpa Need to develop more effective thrombolytics
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