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1. Intravenous thrombolysis for acute ischemic stroke associated to extracranial internal carotid artery occlusion: the ICARO-2 study.

Author

Paciaroni M, Agnelli G, Caso V, Pieroni A, Bovi P, Cappellari M, Zini A, Nichelli P, Inzitari D, Nesi M, Nencini P, Pezzini A, Padovani A, Tassinari T, Orlandi G, Chiti A, Gialdini G, Alberti A, Venti M, Acciarresi M, D'Amore C, Luda E, Tassi R, Martini G, Ferrarese C, Beretta S, Trentini C, Silvestrelli G, Lanari A, Previdi P, Ciccone A, Delodovici ML, Bono G, Galletti G, Marcheselli S, Del Sette M, Traverso E, Riva M, Silvestrini M, Cerqua R, Consoli D, Monaco S, and Toni D

Subjects
Administration, Intravenous, Aged, Aged, 80 and over, Brain Ischemia drug therapy, Brain Ischemia mortality, Carotid Artery Diseases complications, Carotid Artery Diseases mortality, Case-Control Studies, Cohort Studies, Female, Fibrinolytic Agents therapeutic use, Humans, Male, Middle Aged, Multicenter Studies as Topic, Outcome Assessment, Health Care methods, Stroke complications, Tissue Plasminogen Activator adverse effects, Treatment Outcome, Carotid Artery Diseases drug therapy, Stroke drug therapy, Thrombolytic Therapy adverse effects, Tissue Plasminogen Activator therapeutic use
Abstract

Background and Purposes: In a case-control study in patients with acute ischemic stroke and extracranial internal carotid artery (eICA) occlusion, thrombolytic treatment was associated with increased mortality. The aim of this cohort study was to assess the efficacy and safety of thrombolysis in patients with eICA occlusion compared to those without eICA occlusion., Methods: Consecutive patients treated with intravenous tissue-type plasminogen activator within 4.5 h from symptom onset included in the Safe Implementation of Thrombolysis in Stroke - International Stroke Thrombolysis Registry (SITS-ISTR) in 20 Italian centres were analyzed. Acute carotid occlusion was diagnosed using ultrasound examination, angio-CT scan or angio-MRI. Since the SITS-ISTR database did not plan to report the site of vessel occlusion, each participating center provided the code of the patient with eICA occlusion. Patients were divided into 2 groups, those with and those without eICA occlusion. Main outcome measures were: death, disability (modified Rankin Scale, mRS, 3-6) and any intracranial bleeding at 3 months. Multiple logistic regression analysis was performed to reveal predictors for main outcomes. The following variables of interest were included in the analysis: presence of eICA occlusion, age, gender, diabetes mellitus, hyperlipidemia, atrial fibrillation, congestive heart failure, previous stroke, current smoking, antiplatelet treatment at stroke onset, baseline NIHSS score, baseline blood glucose, cholesterol and blood pressure, history of hypertension and stroke onset to treatment time., Results: A total of 1,761 patients without eICA occlusion and 137 with eICA occlusion were included in the study. At 3 months, 42 patients were lost to follow-up (3 with eICA occlusion). Death occurred in 30 (22.4%) patients with eICA occlusion and in 175 (10.2%) patients without (p < 0.0001). Death or disability at 3 months occurred in 91 of 134 patients with eICA occlusion (67.9%) compared with 654 of 1,722 patients without eICA occlusion (37.9%, p < 0.0001). No or minimal disability at 3 months (mRS 0-1) was reported in 25 (18.7%) patients with eICA occlusion and in 829 (48.2%) patients without (p < 0.0001). Any intracranial bleeding detected by CT or MRI at posttreatment imaging was seen in 16 (11.7%) patients with eICA occlusion and in 314 (17.8%) of those without (p = 0.09). The proportion of symptomatic intracerebral hemorrhage was 5.8% for patients with eICA occlusion and 8.0% for patients without (p = 0.16). At logistic regression analysis, eICA occlusion was associated with mortality (odds ratio, OR 5.7; 95% confidence interval, CI 2.9-11.1) and mortality or disability (OR 5.0; 95% CI 2.9-8.7) at 90 days., Conclusions: This cohort study in patients with acute ischemic stroke treated with thrombolysis showed an association between eICA occlusion and adverse outcome., (Copyright © 2012 S. Karger AG, Basel.)

Published
2012
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2. Systemic thrombolysis in patients with acute ischemic stroke and Internal Carotid ARtery Occlusion: the ICARO study.

Author

Paciaroni M, Balucani C, Agnelli G, Caso V, Silvestrelli G, Grotta JC, Demchuk AM, Sohn SI, Orlandi G, Leys D, Pezzini A, Alexandrov AV, Silvestrini M, Fofi L, Barlinn K, Inzitari D, Ferrarese C, Tassi R, Tsivgoulis G, Consoli D, Baldi A, Bovi P, Luda E, Galletti G, Invernizzi P, DeLodovici ML, Corea F, Del Sette M, Monaco S, Marcheselli S, Alberti A, Venti M, Acciarresi M, D'Amore C, Macellari F, Lanari A, Previdi P, Gonzales NR, Pandurengan RK, Vahidy FS, Sline M, Bal SS, Chiti A, Gialdini G, Dumont F, Cordonnier C, Debette S, Padovani A, Cerqua R, Bodechtel U, Kepplinger J, Nesi M, Nencini P, Beretta S, Trentini C, Martini G, Piperidou C, Heliopoulos I, D'Anna S, Cappellari M, Donati E, Bono G, Traverso E, and Toni D

Subjects
Aged, Aged, 80 and over, Brain Ischemia etiology, Carotid Stenosis complications, Case-Control Studies, Female, Fibrinolytic Agents adverse effects, Humans, Male, Middle Aged, Stroke etiology, Thrombolytic Therapy adverse effects, Thrombolytic Therapy methods, Time Factors, Tissue Plasminogen Activator adverse effects, Treatment Outcome, Brain Ischemia drug therapy, Carotid Artery, Internal, Carotid Stenosis drug therapy, Fibrinolytic Agents therapeutic use, Stroke drug therapy, Tissue Plasminogen Activator therapeutic use
Abstract

Background and Purpose: The beneficial effect of intravenous thrombolytic therapy in patients with acute ischemic stroke attributable to internal carotid artery (ICA) occlusion remains unclear. The aim of this study was to evaluate the efficacy and safety of intravenous recombinant tissue-type plasminogen activator in these patients., Methods: ICARO was a case-control multicenter study on prospectively collected data. Patients with acute ischemic stroke and ICA occlusion treated with intravenous recombinant tissue-type plasminogen activator within 4.5 hours from symptom onset (cases) were compared to matched patients with acute stroke and ICA occlusion not treated with recombinant tissue-type plasminogen activator (controls). Cases and controls were matched for age, gender, and stroke severity. The efficacy outcome was disability at 90 days assessed by the modified Rankin Scale, dichotomized as favorable (score of 0-2) or unfavorable (score of 3-6). Safety outcomes were death and any intracranial bleeding., Results: Included in the analysis were 253 cases and 253 controls. Seventy-three cases (28.9%) had a favorable outcome as compared with 52 controls (20.6%; adjusted odds ratio (OR), 1.80; 95% confidence interval [CI], 1.03-3.15; P=0.037). A total of 104 patients died, 65 cases (25.7%) and 39 controls (15.4%; adjusted OR, 2.28; 95% CI, 1.36-3.22; P=0.001). There were more fatal bleedings (2.8% versus 0.4%; OR, 7.17; 95% CI, 0.87-58.71; P=0.068) in the cases than in the controls., Conclusions: In patients with stroke attributable to ICA occlusion, thrombolytic therapy results in a significant reduction in the proportion of patients dependent in activities of daily living. Increases in death and any intracranial bleeding were the trade-offs for this clinical benefit.

Published
2012
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3. Intravenous thrombolysis for acute ischemic stroke associated to extracranial internal carotid artery occlusion: the ICARO-2 study

Author

Andrea Zini, Tiziana Tassinari, Alessandro Pezzini, Domenico Consoli, Paolo Frigio Nichelli, Domenico Inzitari, Alessandro Padovani, Giorgio Silvestrelli, Giovanni Orlandi, Alberto Chiti, Serena Monaco, Mascia Nesi, Simona Marcheselli, Danilo Toni, Alessio Pieroni, Gino Gialdini, Carlo Ferrarese, Michele Venti, Alfonso Ciccone, Giampiero Galletti, Caso, M. Del Sette, Manuel Cappellari, Michele Augusto Riva, Mauro Silvestrini, Raffaella Cerqua, M. L. Delodovici, Claudia Trentini, Rossana Tassi, Elisabetta Traverso, P Bovi, Emilio Luda, Patrizia Nencini, Paolo Previdi, Giancarlo Agnelli, Maurizio Paciaroni, Giorgio Bono, Alessia Lanari, Andrea Alberti, Simone Beretta, Cataldo D'Amore, Monica Acciarresi, Giuseppe Martini, Paciaroni, M, Agnelli, G, Caso, V, Pieroni, A, Bovi, P, Cappellari, M, Zini, A, Nichelli, P, Inzitari, D, Nesi, M, Nencini, P, Pezzini, A, Padovani, A, Tassinari, T, Orlandi, G, Chiti, A, Gialdini, G, Alberti, A, Venti, M, Acciarresi, M, D'Amore, C, Luda, E, Tassi, R, Martini, G, Ferrarese, C, Beretta, S, Trentini, C, Silvestrelli, G, Lanari, A, Previdi, P, Ciccone, A, Delodovici, M, Bono, G, Galletti, G, Marcheselli, S, Del Sette, M, Traverso, E, Riva, M, Silvestrini, M, Cerqua, R, Consoli, D, Monaco, S, and Toni, D

Subjects
Carotid Artery Diseases, Male, Neurology, patent foramen ovale, medicine.medical_treatment, stroke, trombolysis ischemic, Tissue plasminogen activator, Brain Ischemia, Brain ischemia, Cohort Studies, Systemic thrombolysis, Outcome Assessment, Health Care, Occlusion, 80 and over, Acute stroke, Multicenter Studies as Topic, Thrombolytic Therapy, carotid occlusion, acute stroke, systemic thrombolysis, outcome, Stroke, Carotid occlusion, Outcome, Aged, 80 and over, Fibrinolytic Agent, Thrombolysis, Middle Aged, Administration, Intravenous, Aged, Case-Control Studies, Female, Fibrinolytic Agents, Humans, Outcome Assessment (Health Care), Tissue Plasminogen Activator, Treatment Outcome, Neurology (clinical), Cardiology and Cardiovascular Medicine, Administration, Cardiology, Internal carotid artery, Case-Control Studie, Intravenous, Human, medicine.drug, medicine.medical_specialty, Intravenous thrombolysis, education, Administration, Intravenou, Systemic thrombolysi, Carotid Artery Occlusion, Internal medicine, medicine.artery, medicine, cardiovascular diseases, Carotid Artery Disease, business.industry, medicine.disease, Acute Ischemic Stroke, Cohort Studie, business, Fibrinolytic agent
Abstract

Background and Purposes: In a case-control study in patients with acute ischemic stroke and extracranial internal carotid artery (eICA) occlusion, thrombolytic treatment was associated with increased mortality. The aim of this cohort study was to assess the efficacy and safety of thrombolysis in patients with eICA occlusion compared to those without eICA occlusion. Methods: Consecutive patients treated with intravenous tissue-type plasminogen activator within 4.5 h from symptom onset included in the Safe Implementation of Thrombolysis in Stroke – International Stroke Thrombolysis Registry (SITS-ISTR) in 20 Italian centres were analyzed. Acute carotid occlusion was diagnosed using ultrasound examination, angio-CT scan or angio-MRI. Since the SITS-ISTR database did not plan to report the site of vessel occlusion, each participating center provided the code of the patient with eICA occlusion. Patients were divided into 2 groups, those with and those without eICA occlusion. Main outcome measures were: death, disability (modified Rankin Scale, mRS, 3–6) and any intracranial bleeding at 3 months. Multiple logistic regression analysis was performed to reveal predictors for main outcomes. The following variables of interest were included in the analysis: presence of eICA occlusion, age, gender, diabetes mellitus, hyperlipidemia, atrial fibrillation, congestive heart failure, previous stroke, current smoking, antiplatelet treatment at stroke onset, baseline NIHSS score, baseline blood glucose, cholesterol and blood pressure, history of hypertension and stroke onset to treatment time. Results: A total of 1,761 patients without eICA occlusion and 137 with eICA occlusion were included in the study. At 3 months, 42 patients were lost to follow-up (3 with eICA occlusion). Death occurred in 30 (22.4%) patients with eICA occlusion and in 175 (10.2%) patients without (p < 0.0001). Death or disability at 3 months occurred in 91 of 134 patients with eICA occlusion (67.9%) compared with 654 of 1,722 patients without eICA occlusion (37.9%, p < 0.0001). No or minimal disability at 3 months (mRS 0–1) was reported in 25 (18.7%) patients with eICA occlusion and in 829 (48.2%) patients without (p < 0.0001). Any intracranial bleeding detected by CT or MRI at posttreatment imaging was seen in 16 (11.7%) patients with eICA occlusion and in 314 (17.8%) of those without (p = 0.09). The proportion of symptomatic intracerebral hemorrhage was 5.8% for patients with eICA occlusion and 8.0% for patients without (p = 0.16). At logistic regression analysis, eICA occlusion was associated with mortality (odds ratio, OR 5.7; 95% confidence interval, CI 2.9–11.1) and mortality or disability (OR 5.0; 95% CI 2.9–8.7) at 90 days. Conclusions: This cohort study in patients with acute ischemic stroke treated with thrombolysis showed an association between eICA occlusion and adverse outcome.

Published
2012

4. Systemic thrombolysis in patients with acute ischemic stroke and Internal Carotid ARtery Occlusion: the ICARO study

Author

Federica Macellari, Simone Beretta, Mauro Silvestrini, Andrew M. Demchuk, Michele Venti, Danilo Toni, Charlotte Cordonnier, Mascia Nesi, Claudia Trentini, Giovanni Orlandi, Paolo Bovi, Renganayaki Pandurengan, Alessia Lanari, Andrea Alberti, Ioannis Heliopoulos, Rossana Tassi, Simona Marcheselli, Frédéric Dumont, Antonio Baldi, Alessandro Padovani, Serena Monaco, Charitomeni Piperidou, Giuseppe Martini, James C. Grotta, Didier Leys, Elisabetta Traverso, Carlo Ferrarese, Edoardo Donati, Maurizio Paciaroni, Alessandro Pezzini, Valeria Caso, Emilio Luda, Sung Il Sohn, Giorgio Silvestrelli, Francesco Corea, Clotilde Balucani, Simerpreet Bal, Patrizia Nencini, Jessica Kepplinger, Manuel Cappellari, Farhaan S Vahidy, Monica Acciarresi, Cataldo D'Amore, Stéphanie Debette, Andrei V. Alexandrov, Ulf Bodechtel, Nicole R. Gonzales, Melvin R Sline, Paolo Previdi, Sebastiano D'Anna, Domenico Consoli, Domenico Inzitari, Gino Gialdini, Maria Luisa DeLodovici, Alberto Chiti, Massimo Del Sette, Giampiero Galletti, Giancarlo Agnelli, Paolo Invernizzi, Giorgio Bono, Georgios Tsivgoulis, Kristian Barlinn, Raffaella Cerqua, Luisa Fofi, Paciaroni, M, Balucani, C, Agnelli, G, Caso, V, Silvestrelli, G, Grotta, J, Demchuk, A, Sohn, S, Orlandi, G, Leys, D, Pezzini, A, Alexandrov, A, Silvestrini, M, Fofi, L, Barlinn, K, Inzitari, D, Ferrarese, C, Tassi, R, Tsivgoulis, G, Consoli, D, Baldi, A, Bovi, P, Luda, E, Galletti, G, Invernizzi, P, Delodovici, M, Corea, F, Del Sette, M, Monaco, S, Marcheselli, S, Alberti, A, Venti, M, Acciarresi, M, D'Amore, C, Macellari, F, Lanari, A, Previdi, P, Gonzales, N, Pandurengan, R, Vahidy, F, Sline, M, Bal, S, Chiti, A, Gialdini, G, Dumont, F, Cordonnier, C, Debette, S, Padovani, A, Cerqua, R, Bodechtel, U, Kepplinger, J, Nesi, M, Nencini, P, Beretta, S, Trentini, C, Martini, G, Piperidou, C, Heliopoulos, I, D'Anna, S, Cappellari, M, Donati, E, Bono, G, Traverso, E, and Toni, D

Subjects
Male, medicine.medical_specialty, acute stroke, carotid occlusion, outcome, thrombolysis, Time Factors, medicine.medical_treatment, acute stroke carotid occlusion outcome thrombolysis, Tissue plasminogen activator, Brain Ischemia, Fibrinolytic Agents, Modified Rankin Scale, Internal medicine, medicine.artery, Occlusion, 80 and over, medicine, Humans, Carotid Stenosis, Thrombolytic Therapy, Stroke, Aged, Advanced and Specialized Nursing, Aged, 80 and over, Case-Control Studies, Female, Middle Aged, Tissue Plasminogen Activator, Treatment Outcome, Carotid Artery, Internal, Neurology (clinical), Cardiology and Cardiovascular Medicine, business.industry, Thrombolysis, medicine.disease, Internal, Surgery, acute stroke, carotid occlusion, outcome, thrombolysis, Cardiology, Carotid Artery, Internal carotid artery, business, Plasminogen activator, Fibrinolytic agent, medicine.drug
Abstract

Background and Purpose— The beneficial effect of intravenous thrombolytic therapy in patients with acute ischemic stroke attributable to internal carotid artery (ICA) occlusion remains unclear. The aim of this study was to evaluate the efficacy and safety of intravenous recombinant tissue-type plasminogen activator in these patients. Methods— ICARO was a case-control multicenter study on prospectively collected data. Patients with acute ischemic stroke and ICA occlusion treated with intravenous recombinant tissue-type plasminogen activator within 4.5 hours from symptom onset (cases) were compared to matched patients with acute stroke and ICA occlusion not treated with recombinant tissue-type plasminogen activator (controls). Cases and controls were matched for age, gender, and stroke severity. The efficacy outcome was disability at 90 days assessed by the modified Rankin Scale, dichotomized as favorable (score of 0–2) or unfavorable (score of 3–6). Safety outcomes were death and any intracranial bleeding. Results— Included in the analysis were 253 cases and 253 controls. Seventy-three cases (28.9%) had a favorable outcome as compared with 52 controls (20.6%; adjusted odds ratio (OR), 1.80; 95% confidence interval [CI], 1.03–3.15; P =0.037). A total of 104 patients died, 65 cases (25.7%) and 39 controls (15.4%; adjusted OR, 2.28; 95% CI, 1.36–3.22; P =0.001). There were more fatal bleedings (2.8% versus 0.4%; OR, 7.17; 95% CI, 0.87–58.71; P =0.068) in the cases than in the controls. Conclusions— In patients with stroke attributable to ICA occlusion, thrombolytic therapy results in a significant reduction in the proportion of patients dependent in activities of daily living. Increases in death and any intracranial bleeding were the trade-offs for this clinical benefit.

Published
2012

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