Thrombectomy with the preset stent-retriever. Insights from the ARTESp* trial
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1 Thrombectomy with the preset stent-retriever Insights from the ARTESp* trial Wiebke Kurre, MD Klinikum Stuttgart - Germany * Acute Recanalization of Thrombo-Embolic Ischemic Stroke with preset (ARTESp) trial
2 I, Wiebke Kurre, have a consulting agreement with phenox, the manufacturer of the preset stent-retriever.
3 ESCAPE SWIFT-PRIME REVASCAT THERAPY MR CLEAN SWIFT-PRIME REVASCAT THRACE ESCAPE THERAPY ESCAPE Extend-IA Extend-IA Randomized trials favour endovascular treatment for acute ischemic stroke!
4 preset stent-retriever
5 preset design
6 Design effect
7 Study purpose I Efficacy and safety of the preset stent-retriever has already been shown in retrospective single center studies [1-2]. 1 st Purpose: To evaluate safety and efficacy of the preset stent-retriever for the treatment of acute ischemic stroke caused by proximal intracranial vessel occlusion in a prospective multicenter study 1) Kurre W, et al. Clinical experience with the preset stent retriever for the treatment of acute ischemic stroke-a review of 271 consecutive cases. Neuroradiology ) Schwaiger BJ, et al. The preset stent retriever for endovascular treatment of stroke caused by mca occlusion: Safety and clinical outcome. Clinical Neuroradiology. 2014
8 Study purpose II Thrombectomy is only provided at endovascular stroke centers and access may be limited for patients from remote areas. 2 nd Purpose: To assess the impact of patient transfer on the outcome after thrombectomy.
9 Design prospective, observational ClinicalTrials.gov identifier NCT Sponsor: phenox GmbH, Bochum, Germany Four centers in Germany Institut für Klinische Radiologie, Universitätsklinikum Münster Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes, Homburg Neuroradiologische Klinik, Klinikum Stuttgart, Stuttgart Institut für Diagnostische und Interventionelle Neurororadiologie, Klinikum rechts der Isar, Technische Universität München, Munich Imaging Corelab Prof. Stephan Felber, MD; Gemeinschaftsklinikum Mittelrhein, Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Koblenz
10 Endpoints Primary endpoint Good clinical outcome (mrs 0-2) at 90 days Secondary endpoints Very good clinical outcome (mrs 0-1) at 90 days Influence of time/transfer status on outcome at 90 days Recanalization success (TICI 2b/3) Safety endpoints Stroke related death Symptomatic intracranial hemorrhage ( NIHSS >4)
11 Inclusion criteria Age years Groin puncture within 6 hours from stroke onset TICI <2 of at least one proximal intracranial vessel in the anterior or posterior circulation. NIHSS 8 Patients consent (or legal representative) Exclusion criteria Pregnancy Demarcated ischemic area or hemorrhage on initial CT scan Rapid clinical improvement NIHSS>30 Anticoagulation with INR > 3.0 Thrombocytes <30,000 Glucose level <50mg/dL Live expectancy <90 Tage
12 Patients Screened N= 115 Screening Failures Subject disposition N= 12 Consent withdrawn Study Population Contributed to Analysis N= 3 N= 100 Completed 90-day mrs N= 89 Lost to Follow Up N= 4 Death N= 7
13 Baseline Characteristics all patients (n=100) excluding prestroke mrs >1 Transfer Patients (n=52) Direct admission (n=39) significance age - years median (range) 72 (20-90) 72 (31-90) 72 (20-85) p=0,351 female sex - % (n/n) 54 (54%) 53,8% (28/52) 53,8% (21/39) p=1,000 NIHSS score at admission median (n; range) 15 (99; 5-29) 15 (6-29) 14 (5-27) p=0,223 medical history atrial fibrillation - % (n/n) 56,1% (55/98) 58,8% (30/51) 51,3% (20/39) p=0,476 diabetes - % (n/n) 17,2% (17/99) 13,7% (7/51) 15,4% (6/39) p=0,824 former stroke - % (n/n) 15% (12/80) 18,2% (8/44) 9,7% (3/31) p=0,305 prestroke mrs - % (n/n) 0 83% (83) 92,3% (48/52) 89,7% (35/39) p=0, % (91) 100,0% (52/52) 100,0% (39/39) p=na % (96) NA NA p=na >2 4% (4) NA NA p=na preprocedure iv lysis - % (n/n) 62% (62) 65,4% (34/52) 59,0% (23/39) p=0,532 general anesthesia - % (n/n) 88% (88) 90,4% (47/52) 82,1% (32/39) p=0,245 occlusion site - % (n/n) MCA 81% (81) 80,8% (42/52) 82,1% (32/39) p=0,877 ICA 15% (15) 17,3% (9/52) 12,8% (5/39) p=0,557 BA 8% (8) 5,8% (3/52) 10,3% (4/39) p=0,456 PCA 3% (3) 3,8% (2/52) 2,6% (1/39) p=1,000 ACA 1% (1) 0,0% (0/52) 2,6% (1/39) p=0,429
14 Device related Complications Complication n (= % ) Action Outcome Intracranial Vasospasm Contrast extravasation Emboli to new territory Emboli to same territory 3 3 intra-arterial nimodipine/glyeroltrinitrate 2 2 lowering of blood pressure, self limiting 2 1 thrombectomy 1 no treatment 4 1 i.a. fibrinolysis 1 thrombectomy 2 no treatment No sequelae No sequelae 1 small infarct without clinical deterioration 1 clinical deterioration
15 Technical / Clinical Outcome all patients (n=100) excluding prestroke mrs >1 Transfer patients (n=52) direct admission (n=39) significance final TICI 2b-3 only preset % (n/n vessels) 86,2% (94/109) 91,2% (52/57) 86,0% (37/43) p=0,412 final TICI 2b-3 overall % (n/n vessels) 88,1% (96/109) 91,2% (52/57) 88,4% (38/43) p=0,637 passages until final TICI median (n vessels; range) 1 (109; 1-6) 1 (57; 1-6) 1 (43; 1-5) p=0,817 hemorrhage post parenchymal - % (n) 4% (4) 1,9% (1) 6,4% (3) p=0,339 subarachnoid - % (n) 10% (10) 7,5% (4) 12,8% (6) p=0,385 symptomatic - % (n) 1% (1) 1,9% (1) 0% (0) p=1,000 NIHSS at 24h median (n; range) 5 (99; 0-42) 6 (51; 0-42) 3 (39; 0-26) p=0,014 NIHSS at discharge = 0 % (n/n) 24,5% (23/94) 17% (8/47) 35,9% (14/39) p=0,046 mrs after 90 days; % (n/n) 0 24% (23/96) 16,3% (8/49) 39,5% (15/38) p=0, ,2% (52/96) 49% (24/49) 71,1% (27/38) p=0, ,5% (60/96) 59,2% (29/49) 76,3% (29/38) p=0, ,2% (29/96) 34,7% (17/49) 21,1% (8/38) p=0, ,3% (7/96) 6,1% (3/49) 2,6% (1/38) p=0,629
16 Kaplan-Meier curve: Reperfusion from stroke onset Stroke onset to reperfusion in minutes
17 Time analysis direct vs. transfer patients Time from stroke onset in minutes - Onset to admission 62 vs. 182 min (p<0.001) - Admission to groin puncture 45 vs. 77 min (p<0.001) - Groin puncture to recanalization 43 vs. 40 min (p=0.772) Onset to recanalization 289 vs. 188 min (p<0.001)
18 Probability % Regression analysis outcome 30% Time from stroke onset to reperfusion (minutes)
19 Conclusion Study purpose I Thrombectomy with preset stent-retriever is safe and effective. Study purpose II Very good outcome was highly dependet on time to reperfusion. Due to significant delay in time to reperfusion, functional outcome of transferred patients was inferior compared to directly admitted patients.
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