title: Endovascular therapy after intravenous t-PA versus t-PA alone for stroke.
abstract: BACKGROUND
  Endovascular therapy is increasingly used after the administration of intravenous tissue plasminogen activator (t-PA) for patients with moderate-to-severe acute ischemic stroke, but whether a combined approach is more effective than intravenous t-PA alone is uncertain.
  
  
  METHODS
  We randomly assigned eligible patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2:1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days (scores range from 0 to 6, with higher scores indicating greater disability).
  
  
  RESULTS
  The study was stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone). The proportion of participants with a modified Rankin score of 2 or less at 90 days did not differ significantly according to treatment (40.8% with endovascular therapy and 38.7% with intravenous t-PA; absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], -6.1 to 9.1, with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8-19, indicating moderately severe stroke, or ≥20, indicating severe stroke]), nor were there significant differences for the predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, -4.4 to 18.1) and those with a score of 19 or lower (-1.0 percentage point; 95% CI, -10.8 to 8.8). Findings in the endovascular-therapy and intravenous t-PA groups were similar for mortality at 90 days (19.1% and 21.6%, respectively; P=0.52) and the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; P=0.83).
  
  
  CONCLUSIONS
  The trial showed similar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00359424.).
authors: Department of Neurology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH 45267-0525, USA. joseph.broderick@uc.edu.
authors: Joseph P
authors: JP
authors: Broderick
authors: Yuko Y
authors: YY
authors: Palesch
authors: Andrew M
authors: AM
authors: Demchuk
authors: Sharon D
authors: SD
authors: Yeatts
authors: Pooja
authors: P
authors: Khatri
authors: Michael D
authors: MD
authors: Hill
authors: Edward C
authors: EC
authors: Jauch
authors: Tudor G
authors: TG
authors: Jovin
authors: Bernard
authors: B
authors: Yan
authors: Frank L
authors: FL
authors: Silver
authors: Rüdiger
authors: R
authors: von Kummer
authors: Carlos A
authors: CA
authors: Molina
authors: Bart M
authors: BM
authors: Demaerschalk
authors: Ronald
authors: R
authors: Budzik
authors: Wayne M
authors: WM
authors: Clark
authors: Osama O
authors: OO
authors: Zaidat
authors: Tim W
authors: TW
authors: Malisch
authors: Mayank
authors: M
authors: Goyal
authors: Wouter J
authors: WJ
authors: Schonewille
authors: Mikael
authors: M
authors: Mazighi
authors: Stefan T
authors: ST
authors: Engelter
authors: Craig
authors: C
authors: Anderson
authors: Judith
authors: J
authors: Spilker
authors: Janice
authors: J
authors: Carrozzella
authors: Karla J
authors: KJ
authors: Ryckborst
authors: L Scott
authors: LS
authors: Janis
authors: Renée H
authors: RH
authors: Martin
authors: Lydia D
authors: LD
authors: Foster
authors: Thomas A
authors: TA
authors: Tomsick
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002533:Cerebral Angiography; D002543:Cerebral Hemorrhage / Q000209:etiology; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017131:Thrombectomy / Q000295:instrumentation; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
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