Endovascular treatment for acute ischemic stroke
Alfonso Ciccone, Luca Valvassori, Michele Nichelatti, Annalisa Sgoifo, Michela Ponzio, Roberto Sterzi, Edoardo Boccardi, SYNTHESIS Expansion Investigators, A Ciccone, A Gatti, A Guccione, C Motto, I Santilli, R Tortorella, R Sterzi, E Ferrante, F Imbesi, R Marazzi, S Jann, A Protti, M Rizzone, P Tiraboschi, E Boccardi, L Valvassori, G Pero, L Quilici, M Piano, A Zini, F Casoni, M Cavazzuti, F Falzone, P Nichelli, S Vallone, P Carpeggiani, F Menetti, M Guidotti, N Checcarelli, F Muscia, A Martegani, G Torgano, C Mandelli, B Zecca, P Baron, A Bersano, V Branca, M Isalberti, R Papa, A Paolucci, M Magoni, A Costa, M Gamba, R Gasparotti, F Federico, M Petruzzellis, B Tartaglione, D Mezzapesa, L Chiumarulo, R De Blasi, E Agostoni, E Botto, M Longoni, V Ballarini, P Reganati, L Malfatto, D Rizzi, C Serrati, M Balestrino, C Gandolfo, L Castellan, N Mavilio, L Allegretti, M L Delodovici, F Carimati, E P Verrengia, G Bono, F Perlasca, G Craparo, A Giorgianni, C Azzini, A De Vito, M Tola, A Saletti, C Pozzessere, F Corsi, G Scifoni, S Anticoli, F R Pezzella, E Cotroneo, R Gigli, P Nencini, V Palumbo, L Pantoni, D Inzitari, S Mangiafico, M Chinaglia, M Russo, R L'Erario, P Amistà, G Malferrari, A Nucera, M L Zedde, A Dallari, G Deberti, F Falaschi, A Martignoni, F Zappoli, S Marcheselli, B Stival, P Presbitero, M L Rossi, G Belli, M Paciaroni, V Caso, G C Agnelli, M Hamam, P Bovi, E Piovan, M Sessa, F Scomazzoni, M Arnaboldi, L Tancredi, R Peroni, B Censori, M Poloni, S Lunghi, G Bonaldi, E Donati, E Magni, M Pavia, M Cobelli, E Bottacchi, G Corso, P Tosi, S Cordera, M Di Giovanni, G Giardini, T Meloni, M Cristoferi, M Natrella, L Ruiz, M L Dell'Acqua, G Rolandi, I Gallesio, A Ciccone, A Ciccone, L Valvassori, E Boccardi, R Sterzi, P Sandercock, L Candelise, G del Zoppo, M Nichelatti, M Ponzio, E Ciceri, P Doneda, C Motto, M Daolio, A Sgoifo, D Caputo, E del Zotto, E Botto, T Cantisani, Alfonso Ciccone, Luca Valvassori, Michele Nichelatti, Annalisa Sgoifo, Michela Ponzio, Roberto Sterzi, Edoardo Boccardi, SYNTHESIS Expansion Investigators, A Ciccone, A Gatti, A Guccione, C Motto, I Santilli, R Tortorella, R Sterzi, E Ferrante, F Imbesi, R Marazzi, S Jann, A Protti, M Rizzone, P Tiraboschi, E Boccardi, L Valvassori, G Pero, L Quilici, M Piano, A Zini, F Casoni, M Cavazzuti, F Falzone, P Nichelli, S Vallone, P Carpeggiani, F Menetti, M Guidotti, N Checcarelli, F Muscia, A Martegani, G Torgano, C Mandelli, B Zecca, P Baron, A Bersano, V Branca, M Isalberti, R Papa, A Paolucci, M Magoni, A Costa, M Gamba, R Gasparotti, F Federico, M Petruzzellis, B Tartaglione, D Mezzapesa, L Chiumarulo, R De Blasi, E Agostoni, E Botto, M Longoni, V Ballarini, P Reganati, L Malfatto, D Rizzi, C Serrati, M Balestrino, C Gandolfo, L Castellan, N Mavilio, L Allegretti, M L Delodovici, F Carimati, E P Verrengia, G Bono, F Perlasca, G Craparo, A Giorgianni, C Azzini, A De Vito, M Tola, A Saletti, C Pozzessere, F Corsi, G Scifoni, S Anticoli, F R Pezzella, E Cotroneo, R Gigli, P Nencini, V Palumbo, L Pantoni, D Inzitari, S Mangiafico, M Chinaglia, M Russo, R L'Erario, P Amistà, G Malferrari, A Nucera, M L Zedde, A Dallari, G Deberti, F Falaschi, A Martignoni, F Zappoli, S Marcheselli, B Stival, P Presbitero, M L Rossi, G Belli, M Paciaroni, V Caso, G C Agnelli, M Hamam, P Bovi, E Piovan, M Sessa, F Scomazzoni, M Arnaboldi, L Tancredi, R Peroni, B Censori, M Poloni, S Lunghi, G Bonaldi, E Donati, E Magni, M Pavia, M Cobelli, E Bottacchi, G Corso, P Tosi, S Cordera, M Di Giovanni, G Giardini, T Meloni, M Cristoferi, M Natrella, L Ruiz, M L Dell'Acqua, G Rolandi, I Gallesio, A Ciccone, A Ciccone, L Valvassori, E Boccardi, R Sterzi, P Sandercock, L Candelise, G del Zoppo, M Nichelatti, M Ponzio, E Ciceri, P Doneda, C Motto, M Daolio, A Sgoifo, D Caputo, E del Zotto, E Botto, T Cantisani
Abstract
Background: In patients with ischemic stroke, endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy. However, comparison of the clinical efficacy of the two approaches is needed.
Methods: We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours after onset, to endovascular therapy (intraarterial thrombolysis with recombinant tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a combination of these approaches) or intravenous t-PA. Treatments were to be given as soon as possible after randomization. The primary outcome was survival free of disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability despite symptoms, and 6 death) at 3 months.
Results: A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous t-PA. The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001). At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence interval, 0.44 to 1.14; P=0.16). Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6% of the patients in each group, and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate.
Conclusions: The results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to standard treatment with intravenous t-PA. (Funded by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.).
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Source: PubMed