Outcomes following sonothrombolysis in severe acute ischemic stroke

Subgroup analysis of the CLOTBUST trial

Kristian Barlinn, Georgios Tsivgoulis, Andrew D. Barreto, John Alleman, Carlos A. Molina, Robert Mikulik, Maher Saqqur, Andrew M. Demchuk, Peter D. Schellinger, George Howard, Andrei Alexandrov

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

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 72h 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.

Original languageEnglish (US)
Pages (from-to)1006-1010
Number of pages5
JournalInternational Journal of Stroke
Volume9
Issue number8
DOIs
StatePublished - Dec 1 2014

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Stroke
Tissue Plasminogen Activator
Intracranial Hemorrhages
National Institutes of Health (U.S.)
Phase III Clinical Trials
Brain Ischemia
Safety

All Science Journal Classification (ASJC) codes

  • Neurology

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Outcomes following sonothrombolysis in severe acute ischemic stroke : Subgroup analysis of the CLOTBUST trial. / Barlinn, Kristian; Tsivgoulis, Georgios; Barreto, Andrew D.; Alleman, John; Molina, Carlos A.; Mikulik, Robert; Saqqur, Maher; Demchuk, Andrew M.; Schellinger, Peter D.; Howard, George; Alexandrov, Andrei.

In: International Journal of Stroke, Vol. 9, No. 8, 01.12.2014, p. 1006-1010.

Research output: Contribution to journalArticle

Barlinn, K, Tsivgoulis, G, Barreto, AD, Alleman, J, Molina, CA, Mikulik, R, Saqqur, M, Demchuk, AM, Schellinger, PD, Howard, G & Alexandrov, A 2014, 'Outcomes following sonothrombolysis in severe acute ischemic stroke: Subgroup analysis of the CLOTBUST trial', International Journal of Stroke, vol. 9, no. 8, pp. 1006-1010. https://doi.org/10.1111/ijs.12340
Barlinn, Kristian ; Tsivgoulis, Georgios ; Barreto, Andrew D. ; Alleman, John ; Molina, Carlos A. ; Mikulik, Robert ; Saqqur, Maher ; Demchuk, Andrew M. ; Schellinger, Peter D. ; Howard, George ; Alexandrov, Andrei. / Outcomes following sonothrombolysis in severe acute ischemic stroke : Subgroup analysis of the CLOTBUST trial. In: International Journal of Stroke. 2014 ; Vol. 9, No. 8. pp. 1006-1010.
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T1 - Outcomes following sonothrombolysis in severe acute ischemic stroke

T2 - Subgroup analysis of the CLOTBUST trial

AU - Barlinn, Kristian

AU - Tsivgoulis, Georgios

AU - Barreto, Andrew D.

AU - Alleman, John

AU - Molina, Carlos A.

AU - Mikulik, Robert

AU - Saqqur, Maher

AU - Demchuk, Andrew M.

AU - Schellinger, Peter D.

AU - Howard, George

AU - Alexandrov, Andrei

PY - 2014/12/1

Y1 - 2014/12/1

N2 - 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 72h 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.

AB - 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 72h 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.

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