Thomas A Tomsick1, Sharon D Yeatts1, David S Liebeskind2, Janice Carrozzella3, Lydia Foster1, Mayank Goyal2, Ruediger von Kummer4, Michael D Hill5, Andrew M Demchuk6, Tudor Jovin4, Bernard Yan7, Osama O Zaidat8, Wouter Schonewille9, Stefan Engelter10, Renee Martin11, Pooja Khatri2, Judith Spilker12, Yuko Y Palesch12, Joseph P Broderick2. 1. Department of Radiology, University of Cincinnati Academic Health Center, University Hospital 234 Goodman St, Cincinnati, Ohio, USA. 2. Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA. 3. UCLA Stroke Center, 924 Westwood Blvd, Los Angeles, California, USA. 4. Department of Radiology and Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada. 5. Department of Neuroradiology, Dresden University Stroke Center, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany. 6. Calgary Stroke Program, Department of Clinical Neurosciences/Medicine/Community Health Sciences, Hotchkiss Brain Institute, University of Calgary, Rm 1242A, Foothills Hospital, Calgary, Alberta, Canada. 7. The Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 8. Division of Neurosciences, Comprehensive Stroke Centre, Royal Melbourne Hospital, Parkville, Victoria, Australia. 9. Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA. 10. St Antonius Hospital Nieuwegein, Koekoekslaan 1, Nieuwegein 3435 CM 53226, Netherlands. 11. University Hospital Basel, Petersgraben 4, Basel, Switzerland. 12. Department of Neurology, University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.
Abstract
BACKGROUND: Interventional Management of Stroke III did not show that combining IV recombinant tissue plasminogen activator (rt-PA) with endovascular therapies (EVTs) is better than IV rt-PA alone. OBJECTIVE: To report efficacy and safety results for EVT of intracranial internal carotid artery (ICA) and middle cerebral artery trunk (M1) occlusion. METHODS: Five revascularization methods for persistent occlusions after IV rt-PA treatment were evaluated for prespecified primary and secondary endpoints, after accounting for differences in key baselines variables using propensity scores. Revascularization was scored using the arterial occlusive lesion (AOL) and the modified Thrombolysis in Cerebral Ischemia (mTICI) scores. RESULTS: EVT of 200 subjects with intracranial ICA orM1 occlusion resulted in 81.5% AOL 2-3 recanalization, in addition to 76% mTICI 2-3 and 42.5% mTICI 2b-3 reperfusion. Adverse events included symptomatic intracranial hemorrhage (SICH) (8.0%), vessel perforations (1.5%), and new emboli (14.9%). EVT techniques used were standard microcatheter n=51; EKOS n=14; Merci n=77; Penumbra n=39; Solitaire n=4; multiple n=15. Good clinical outcome was associated with both TICI 2-3 and TICI 2b-3 reperfusion. Neither modified Rankin scale (mRS) 0-2 (28.5%), nor 90-day mortality (28.5%), nor asymptomatic ICH (36.0%) differed among revascularization methods after propensity score adjustment for subjects with intracranial ICA or M1 occlusion. CONCLUSIONS: Good clinical outcome was associated with good reperfusion for ICA and M1 occlusion. No significant differences in efficacy or safety among revascularization methods were demonstrated after adjustment. Lack of high-quality reperfusion, adverse events, and prolonged time to treatment contributed to lower-than-expected mRS 0-2 outcomes and study futility compared with IV rt-PA. TRIAL REGISTRATION NUMBER: NCT00359424. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
BACKGROUND: Interventional Management of Stroke III did not show that combining IV recombinant tissue plasminogen activator (rt-PA) with endovascular therapies (EVTs) is better than IV rt-PA alone. OBJECTIVE: To report efficacy and safety results for EVT of intracranial internal carotid artery (ICA) and middle cerebral artery trunk (M1) occlusion. METHODS: Five revascularization methods for persistent occlusions after IV rt-PA treatment were evaluated for prespecified primary and secondary endpoints, after accounting for differences in key baselines variables using propensity scores. Revascularization was scored using the arterial occlusive lesion (AOL) and the modified Thrombolysis in Cerebral Ischemia (mTICI) scores. RESULTS:EVT of 200 subjects with intracranial ICA or M1 occlusion resulted in 81.5% AOL 2-3 recanalization, in addition to 76% mTICI 2-3 and 42.5% mTICI 2b-3 reperfusion. Adverse events included symptomatic intracranial hemorrhage (SICH) (8.0%), vessel perforations (1.5%), and new emboli (14.9%). EVT techniques used were standard microcatheter n=51; EKOS n=14; Merci n=77; Penumbra n=39; Solitaire n=4; multiple n=15. Good clinical outcome was associated with both TICI 2-3 and TICI 2b-3 reperfusion. Neither modified Rankin scale (mRS) 0-2 (28.5%), nor 90-day mortality (28.5%), nor asymptomatic ICH (36.0%) differed among revascularization methods after propensity score adjustment for subjects with intracranial ICA or M1 occlusion. CONCLUSIONS: Good clinical outcome was associated with good reperfusion for ICA and M1 occlusion. No significant differences in efficacy or safety among revascularization methods were demonstrated after adjustment. Lack of high-quality reperfusion, adverse events, and prolonged time to treatment contributed to lower-than-expected mRS 0-2 outcomes and study futility compared with IV rt-PA. TRIAL REGISTRATION NUMBER: NCT00359424. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Ameer E Hassan; Mahmoud Dibas; Amrou Sarraj; Sherief Ghozy; Amr Ehab El-Qushayri; Adam A Dmytriw; Wondwossen G Tekle Journal: Neuroradiol J Date: 2021-08-31