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A Myth Debunked: the Results of SYNTHESIS Expansion and IMS III

Korean Society of Interventional Neuroradiology
Publication Date
DOI: 10.5469/neuroint.2013.8.1.1
  • Editorial
  • Medicine


In February 2013, the results of two key clinical trials assessing the clinical efficacy of endovascular manage- ment in acute ischemic stroke were presented at the annual meeting of the International Stroke Conference (ISC) in Honolulu. The trials, SYNTHESIS expansion and IMS-III, had received great attention from many neurologists and neurointerventionalists, as they were multicenter, randomized, controlled trials comparing clinical results of endovascular approach versus standard intravenous (IV) recombinant tissue plasminogen activator (tPA) alone. Although it had already been demonstrated that endovascular treatment had higher recanalization rates than standard medical care (IV tPA), clinical outcomes of the two methods had not yet been compared directly. The SYNTHESIS expansion trial, led by Alfonso Ciccone (Carlo Poma Hospital, Mantua, Italy), randomly assigned 362 acute ischemic stroke patients within 4.5 hours of symptom onset to receive IV tPA or intraarterial endovascular treatment, including intraar- terial thrombolysis with tPA, mechanical clot disrup- tion or retrieval, or a combination of these interven- tions. This study was initiated under the hypothesis that “the disadvantage of endovascular treatment in terms of time spent may be offset by more effective recanal- ization achieved with endovascular therapy.” This hypothesis was supported by the preliminary results of the SYNTHESIS study. The primary outcome of survival (free from disabil- ity, modified Rankin score (mRS) 1) was assessed at 3 months. 30.4% of 181 patients given endovascular therapy and 34.8% of 181 patients given tPA were free of disability (mRS 1). This result demonstrated that intraarterial intervention was not superior to standard medical care for patients with acute ischemic stroke. In addition, there were no between-group differences in mortality at 90 days (14.4% in the endovascular group versus 9.9% in the IV tPA group, p = 0.22) or sympto- matic intracranial hemorrhage within 7 days (6% in ea

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