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, toendovascular 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.).
RCT Entities:
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.).
Authors: A Ciccone; L Valvassori; M Ponzio; E Ballabio; R Gasparotti; M Sessa; F Scomazzoni; P Tiraboschi; R Sterzi Journal: J Neurointerv Surg Date: 2009-10-30 Impact factor: 5.836
Authors: H M Hussein; A L Georgiadis; G Vazquez; J T Miley; M Z Memon; Y M Mohammad; G A Christoforidis; N Tariq; A I Qureshi Journal: AJNR Am J Neuroradiol Date: 2010-01-14 Impact factor: 3.825
Authors: Pooja Khatri; Michael D Hill; Yuko Y Palesch; Judith Spilker; Edward C Jauch; Janice A Carrozzella; Andrew M Demchuk; Renee' Martin; Patrick Mauldin; Catherine Dillon; Karla J Ryckborst; Scott Janis; Thomas A Tomsick; Joseph P Broderick Journal: Int J Stroke Date: 2008-05 Impact factor: 5.266
Authors: Joanna M Wardlaw; Veronica Murray; Eivind Berge; Gregory del Zoppo; Peter Sandercock; Richard L Lindley; Geoff Cohen Journal: Lancet Date: 2012-05-23 Impact factor: 79.321
Authors: Jacques Sedat; Yves Chau; Lydiane Mondot; Richard Chemla; Michel Lonjon; Bernard Padovani Journal: Neuroradiology Date: 2013-11-27 Impact factor: 2.804
Authors: M A Almekhlafi; A Davalos; A Bonafe; R Chapot; J Gralla; V M Pereira; M Goyal Journal: AJNR Am J Neuroradiol Date: 2014-02-20 Impact factor: 3.825
Authors: J H Kwak; L Zhao; J K Kim; S Park; D-G Lee; J H Shim; D H Lee; J S Kim; D C Suh Journal: AJNR Am J Neuroradiol Date: 2013-10-03 Impact factor: 3.825