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Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial
  1. A Ciccone1,
  2. L Valvassori2,
  3. M Ponzio3,
  4. E Ballabio4,
  5. R Gasparotti5,
  6. M Sessa6,
  7. F Scomazzoni7,
  8. P Tiraboschi1,
  9. R Sterzi1,
  10. the SYNTHESIS Investigators
  1. 1Department of Neurology, Stroke Unit, ‘Niguarda Ca' Granda’ Hospital, Milan, Italy
  2. 2Department of Neuroradiology, ‘Niguarda Ca' Granda’ Hospital, Milan, Italy
  3. 3Department of Health Sciences, Section of Epidemiology and Medical Statistics, University of Pavia, Pavia, Italy
  4. 4Neurological Clinic, ‘Policlinico’ Hospital, University of Milan, Italy
  5. 5Neuroradiology Unit, Spedali Civili, University of Brescia, Brescia, Italy
  6. 6Stroke Unit, ‘S Raffaele’ Hospital, Milan, Italy
  7. 7Neurointerventional Unit, ‘S Raffaele’ Hospital, Milan, Italy
  1. Correspondence to Dr A Ciccone, Department of Neurosciences, Stroke Unit, ‘Niguarda Ca' Granda’ Hospital, Piazza Ospedale Maggiore 3, 20164 Milano, Italy; alfonso.ciccone{at}ospedaleniguarda.it

Abstract

Objective To assess the feasibility, safety and preliminary efficacy of intra-arterial thrombolysis (IAT) compared with standard intravenous thrombolysis (IVT) for acute ischemic stroke.

Methods Eligible patients with ischemic stroke, who were devoid of contraindications, started IVT within 3 h or IAT as soon as possible within 6 h. Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial alteplase (maximum 90 mg), over 60 min into the thrombus, if necessary with mechanical clot disruption and/or retrieval. The purpose of the study was to determine the proportion of favorable outcome at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (SICH), death and other serious adverse events.

Results 54 patients (25 IAT) were enrolled. Median time from stroke onset to start to treatment was 3 h 15 min for IAT and 2 h 35 min for IVT (p<0.001). Almost twice as many patients on IAT as those on IVT survived without residual disability (12/25 vs 8/29; OR 3.2; 95% CI 0.9 to 11.4; p=0.067). SICH occurred in 2/25 patients on IAT and in 4/29 on IVT (OR 0.5; CI 0.1 to 3.3; p=0.675). Mortality at day 7 was 5/25 (IAT) compared with 4/29 (IVT) (OR 1.6; CI 0.4 to 6.7; p=0.718). There was no significant difference in the rate of other serious adverse events.

Conclusions Rapid initiation of IAT is a safe and feasible alternative to IVT in acute ischemic stroke.

Trial registration number NCT00540527.

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Footnotes

  • The SYNTHESIS co-investigators are listed in the Appendix.

  • Statistical analysis The statistical analysis was conducted by Dr Michela Ponzio, PhD, Department of Health Sciences, Section of Epidemiology and Medical Statistics, University of Pavia, Pavia, Italy.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Niguarda Ca Granda Hospital, Milan, Italy, Spedali Civili, University of Brescia, Brescia, Italy and ‘S Raffaele’ Hospital, Milan, Italy.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; not externally peer reviewed.

  • Contributors AC conceived and wrote most of this manuscript, which was checked and discussed with the other authors who approved the final version. LV prepared the parts concerning the description of intra-arterial thrombolysis. EB checked the quality of the data and helped MP who performed the statistical analysis. AC, EB and FS prepared the introduction. RG, MS, RS and PT in particular, reviewed and discussed the manuscript with AC and participated in the final version.

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