Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion

The ICARO study

Maurizio Paciaroni, Clotilde Balucani, Giancarlo Agnelli, Valeria Caso, Giorgio Silvestrelli, James C. Grotta, Andrew M. Demchuk, Sung Il Sohn, Giovanni Orlandi, Didier Leys, Alessandro Pezzini, Andrei Alexandrov, Mauro Silvestrini, Luisa Fofi, Kristian Barlinn, Domenico Inzitari, Carlo Ferrarese, Rossana Tassi, Georgios Tsivgoulis, Domenico Consoli & 44 others Antonio Baldi, Paolo Bovi, Emilio Luda, Giampiero Galletti, Paolo Invernizzi, Maria Luisa Delodovici, Francesco Corea, Massimo Del Sette, Serena Monaco, Simona Marcheselli, Andrea Alberti, Michele Venti, Monica Acciarresi, Cataldo D'Amore, Federica MacEllari, Alessia Lanari, Paolo Previdi, Nicole R. Gonzales, Renganayaki K. Pandurengan, Farhaan S. Vahidy, Melvin Sline, Simerpreet S. Bal, Alberto Chiti, Gino Gialdini, Frederic Dumont, Charlotte Cordonnier, Stéphanie Debette, Alessandro Padovani, Raffaella Cerqua, Ulf Bodechtel, Jessica Kepplinger, Mascia Nesi, Patrizia Nencini, Simone Beretta, Claudia Trentini, Giuseppe Martini, Charitomeni Piperidou, Ioannis Heliopoulos, Sebastiano D'Anna, Manuel Cappellari, Edoardo Donati, Giorgio Bono, Elisabetta Traverso, Danilo Toni

Research output: Contribution to journalArticle

56 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)125-130
Number of pages6
JournalStroke
Volume43
Issue number1
DOIs
StatePublished - Jan 1 2012

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Internal Carotid Artery
Stroke
Tissue Plasminogen Activator
Thrombolytic Therapy
Odds Ratio
Confidence Intervals
Hemorrhage
Safety
Activities of Daily Living
Multicenter Studies
Case-Control Studies

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Paciaroni, M., Balucani, C., Agnelli, G., Caso, V., Silvestrelli, G., Grotta, J. C., ... Toni, D. (2012). Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion: The ICARO study. Stroke, 43(1), 125-130. https://doi.org/10.1161/STROKEAHA.111.630624

Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion : The ICARO study. / Paciaroni, Maurizio; Balucani, Clotilde; Agnelli, Giancarlo; Caso, Valeria; Silvestrelli, Giorgio; Grotta, James C.; Demchuk, Andrew M.; Sohn, Sung Il; Orlandi, Giovanni; Leys, Didier; Pezzini, Alessandro; Alexandrov, Andrei; Silvestrini, Mauro; Fofi, Luisa; Barlinn, Kristian; Inzitari, Domenico; Ferrarese, Carlo; Tassi, Rossana; Tsivgoulis, Georgios; Consoli, Domenico; Baldi, Antonio; Bovi, Paolo; Luda, Emilio; Galletti, Giampiero; Invernizzi, Paolo; Delodovici, Maria Luisa; Corea, Francesco; Del Sette, Massimo; Monaco, Serena; Marcheselli, Simona; Alberti, Andrea; Venti, Michele; Acciarresi, Monica; D'Amore, Cataldo; MacEllari, Federica; Lanari, Alessia; Previdi, Paolo; Gonzales, Nicole R.; Pandurengan, Renganayaki K.; Vahidy, Farhaan S.; Sline, Melvin; Bal, Simerpreet S.; Chiti, Alberto; Gialdini, Gino; Dumont, Frederic; Cordonnier, Charlotte; Debette, Stéphanie; Padovani, Alessandro; Cerqua, Raffaella; Bodechtel, Ulf; Kepplinger, Jessica; Nesi, Mascia; Nencini, Patrizia; Beretta, Simone; Trentini, Claudia; Martini, Giuseppe; Piperidou, Charitomeni; Heliopoulos, Ioannis; D'Anna, Sebastiano; Cappellari, Manuel; Donati, Edoardo; Bono, Giorgio; Traverso, Elisabetta; Toni, Danilo.

In: Stroke, Vol. 43, No. 1, 01.01.2012, p. 125-130.

Research output: Contribution to journalArticle

Paciaroni, M, Balucani, C, Agnelli, G, Caso, V, Silvestrelli, G, Grotta, JC, Demchuk, AM, Sohn, SI, 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, 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 & Toni, D 2012, 'Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion: The ICARO study', Stroke, vol. 43, no. 1, pp. 125-130. https://doi.org/10.1161/STROKEAHA.111.630624
Paciaroni, Maurizio ; Balucani, Clotilde ; Agnelli, Giancarlo ; Caso, Valeria ; Silvestrelli, Giorgio ; Grotta, James C. ; Demchuk, Andrew M. ; Sohn, Sung Il ; Orlandi, Giovanni ; Leys, Didier ; Pezzini, Alessandro ; Alexandrov, Andrei ; Silvestrini, Mauro ; Fofi, Luisa ; Barlinn, Kristian ; Inzitari, Domenico ; Ferrarese, Carlo ; Tassi, Rossana ; Tsivgoulis, Georgios ; Consoli, Domenico ; Baldi, Antonio ; Bovi, Paolo ; Luda, Emilio ; Galletti, Giampiero ; Invernizzi, Paolo ; Delodovici, Maria Luisa ; Corea, Francesco ; Del Sette, Massimo ; Monaco, Serena ; Marcheselli, Simona ; Alberti, Andrea ; Venti, Michele ; Acciarresi, Monica ; D'Amore, Cataldo ; MacEllari, Federica ; Lanari, Alessia ; Previdi, Paolo ; Gonzales, Nicole R. ; Pandurengan, Renganayaki K. ; Vahidy, Farhaan S. ; Sline, Melvin ; Bal, Simerpreet S. ; Chiti, Alberto ; Gialdini, Gino ; Dumont, Frederic ; Cordonnier, Charlotte ; Debette, Stéphanie ; Padovani, Alessandro ; Cerqua, Raffaella ; Bodechtel, Ulf ; Kepplinger, Jessica ; Nesi, Mascia ; Nencini, Patrizia ; Beretta, Simone ; Trentini, Claudia ; Martini, Giuseppe ; Piperidou, Charitomeni ; Heliopoulos, Ioannis ; D'Anna, Sebastiano ; Cappellari, Manuel ; Donati, Edoardo ; Bono, Giorgio ; Traverso, Elisabetta ; Toni, Danilo. / Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion : The ICARO study. In: Stroke. 2012 ; Vol. 43, No. 1. pp. 125-130.
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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.",
author = "Maurizio Paciaroni and Clotilde Balucani and Giancarlo Agnelli and Valeria Caso and Giorgio Silvestrelli and Grotta, {James C.} and Demchuk, {Andrew M.} and Sohn, {Sung Il} and Giovanni Orlandi and Didier Leys and Alessandro Pezzini and Andrei Alexandrov and Mauro Silvestrini and Luisa Fofi and Kristian Barlinn and Domenico Inzitari and Carlo Ferrarese and Rossana Tassi and Georgios Tsivgoulis and Domenico Consoli and Antonio Baldi and Paolo Bovi and Emilio Luda and Giampiero Galletti and Paolo Invernizzi and Delodovici, {Maria Luisa} and Francesco Corea and {Del Sette}, Massimo and Serena Monaco and Simona Marcheselli and Andrea Alberti and Michele Venti and Monica Acciarresi and Cataldo D'Amore and Federica MacEllari and Alessia Lanari and Paolo Previdi and Gonzales, {Nicole R.} and Pandurengan, {Renganayaki K.} and Vahidy, {Farhaan S.} and Melvin Sline and Bal, {Simerpreet S.} and Alberto Chiti and Gino Gialdini and Frederic Dumont and Charlotte Cordonnier and St{\'e}phanie Debette and Alessandro Padovani and Raffaella Cerqua and Ulf Bodechtel and Jessica Kepplinger and Mascia Nesi and Patrizia Nencini and Simone Beretta and Claudia Trentini and Giuseppe Martini and Charitomeni Piperidou and Ioannis Heliopoulos and Sebastiano D'Anna and Manuel Cappellari and Edoardo Donati and Giorgio Bono and Elisabetta Traverso and Danilo Toni",
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month = "1",
day = "1",
doi = "10.1161/STROKEAHA.111.630624",
language = "English (US)",
volume = "43",
pages = "125--130",
journal = "Stroke",
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TY - JOUR

T1 - Systemic thrombolysis in patients with acute ischemic stroke and internal carotid artery occlusion

T2 - The ICARO study

AU - Paciaroni, Maurizio

AU - Balucani, Clotilde

AU - Agnelli, Giancarlo

AU - Caso, Valeria

AU - Silvestrelli, Giorgio

AU - Grotta, James C.

AU - Demchuk, Andrew M.

AU - Sohn, Sung Il

AU - Orlandi, Giovanni

AU - Leys, Didier

AU - Pezzini, Alessandro

AU - Alexandrov, Andrei

AU - Silvestrini, Mauro

AU - Fofi, Luisa

AU - Barlinn, Kristian

AU - Inzitari, Domenico

AU - Ferrarese, Carlo

AU - Tassi, Rossana

AU - Tsivgoulis, Georgios

AU - Consoli, Domenico

AU - Baldi, Antonio

AU - Bovi, Paolo

AU - Luda, Emilio

AU - Galletti, Giampiero

AU - Invernizzi, Paolo

AU - Delodovici, Maria Luisa

AU - Corea, Francesco

AU - Del Sette, Massimo

AU - Monaco, Serena

AU - Marcheselli, Simona

AU - Alberti, Andrea

AU - Venti, Michele

AU - Acciarresi, Monica

AU - D'Amore, Cataldo

AU - MacEllari, Federica

AU - Lanari, Alessia

AU - Previdi, Paolo

AU - Gonzales, Nicole R.

AU - Pandurengan, Renganayaki K.

AU - Vahidy, Farhaan S.

AU - Sline, Melvin

AU - Bal, Simerpreet S.

AU - Chiti, Alberto

AU - Gialdini, Gino

AU - Dumont, Frederic

AU - Cordonnier, Charlotte

AU - Debette, Stéphanie

AU - Padovani, Alessandro

AU - Cerqua, Raffaella

AU - Bodechtel, Ulf

AU - Kepplinger, Jessica

AU - Nesi, Mascia

AU - Nencini, Patrizia

AU - Beretta, Simone

AU - Trentini, Claudia

AU - Martini, Giuseppe

AU - Piperidou, Charitomeni

AU - Heliopoulos, Ioannis

AU - D'Anna, Sebastiano

AU - Cappellari, Manuel

AU - Donati, Edoardo

AU - Bono, Giorgio

AU - Traverso, Elisabetta

AU - Toni, Danilo

PY - 2012/1/1

Y1 - 2012/1/1

N2 - 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.

AB - 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.

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