BACKGROUND:Sonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic stroke patients. AIMS: In preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial. METHODS: We analyzed the data from all randomized acute ischemic stroke patients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4-5) and functional independence (modified Rankin Scale 0-1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset. RESULTS: Of 126 patients, a total of 85 acute ischemic stroke patients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14-20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00). CONCLUSIONS: Our results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.
RCT Entities:
BACKGROUND: Sonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic strokepatients. AIMS: In preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial. METHODS: We analyzed the data from all randomized acute ischemic strokepatients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4-5) and functional independence (modified Rankin Scale 0-1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset. RESULTS: Of 126 patients, a total of 85 acute ischemic strokepatients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14-20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00). CONCLUSIONS: Our results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.
Authors: Thilo Hölscher; James V Dunford; Felix Schlachetzki; Sandra Boy; Thomas Hemmen; Brett C Meyer; John Serra; Jeff Powers; Arne Voie Journal: Am J Emerg Med Date: 2013-02-12 Impact factor: 2.469
Authors: Prakash R Paliwal; Aftab Ahmad; Liang Shen; Leonard L L Yeo; Pei Kee Loh; Kay W P Ng; Vincent F Chong; Benjamin K C Ong; N Venketasubramanian; Arvind K Sinha; Hock L Teoh; Girish Bathla; Bernard P L Chan; Vijay K Sharma Journal: Cerebrovasc Dis Date: 2012-03-28 Impact factor: 2.762
Authors: Andrei V Alexandrov; Kristian Barlinn; Roger Strong; Anne W Alexandrov; Jaroslaw Aronowski Journal: Transl Stroke Res Date: 2011-04-21 Impact factor: 6.829
Authors: Werner Hacke; Markku Kaste; Erich Bluhmki; Miroslav Brozman; Antoni Dávalos; Donata Guidetti; Vincent Larrue; Kennedy R Lees; Zakaria Medeghri; Thomas Machnig; Dietmar Schneider; Rüdiger von Kummer; Nils Wahlgren; Danilo Toni Journal: N Engl J Med Date: 2008-09-25 Impact factor: 91.245
Authors: Joseph P Broderick; Yuko Y Palesch; Andrew M Demchuk; Sharon D Yeatts; Pooja Khatri; Michael D Hill; Edward C Jauch; Tudor G Jovin; Bernard Yan; Frank L Silver; Rüdiger von Kummer; Carlos A Molina; Bart M Demaerschalk; Ronald Budzik; Wayne M Clark; Osama O Zaidat; Tim W Malisch; Mayank Goyal; Wouter J Schonewille; Mikael Mazighi; Stefan T Engelter; Craig Anderson; Judith Spilker; Janice Carrozzella; Karla J Ryckborst; L Scott Janis; Renée H Martin; Lydia D Foster; Thomas A Tomsick Journal: N Engl J Med Date: 2013-02-07 Impact factor: 91.245
Authors: Georgios Tsivgoulis; Jürgen Eggers; Marc Ribo; Fabienne Perren; Maher Saqqur; Marta Rubiera; Theodoros N Sergentanis; Konstantinos Vadikolias; Vincent Larrue; Carlos A Molina; Andrei V Alexandrov Journal: Stroke Date: 2009-12-31 Impact factor: 7.914
Authors: Peter Sandercock; Joanna M Wardlaw; Richard I Lindley; Martin Dennis; Geoff Cohen; Gordon Murray; Karen Innes; Graham Venables; Anna Czlonkowska; Adam Kobayashi; Stefano Ricci; Veronica Murray; Eivind Berge; Karsten Bruins Slot; Graeme J Hankey; Manuel Correia; Andre Peeters; Karl Matz; Phillippe Lyrer; Gord Gubitz; Stephen J Phillips; Antonio Arauz Journal: Lancet Date: 2012-05-23 Impact factor: 79.321
Authors: Eivind Berge; William Whiteley; Heinrich Audebert; Gian Marco De Marchis; Ana Catarina Fonseca; Chiara Padiglioni; Natalia Pérez de la Ossa; Daniel Strbian; Georgios Tsivgoulis; Guillaume Turc Journal: Eur Stroke J Date: 2021-02-19
Authors: Andrei V Alexandrov; Georgios Tsivgoulis; Martin Köhrmann; Aristeidis H Katsanos; Lauri Soinne; Andrew D Barreto; Travis Rothlisberger; Vijay K Sharma; Robert Mikulik; Keith W Muir; Christopher R Levi; Carlos A Molina; Maher Saqqur; Dimitris Mavridis; Theodora Psaltopoulou; Milan R Vosko; Jochen B Fiebach; Pitchaiah Mandava; Thomas A Kent; Anne W Alexandrov; Peter D Schellinger Journal: Ther Adv Neurol Disord Date: 2019-07-12 Impact factor: 6.570