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Intravenous rt-PA: a tenth anniversary reflection.

ABSTRACT: Clinical trials with rt-PA for treating AIS began 20 years ago in 1987, and the pivotal NINDS rt-PA Stroke Study was completed and published in 1995 with FDA approval in 1996, about 10 years ago. A large number of articles emanated from that study and have established the efficacy and generalizability of this treatment.Here we summarize the background of how the NINDS trial was developed and carried out and its main findings.The NINDS rt-PA Stroke Study resulted from preclincal and pilot studies and paralleled similar studies carried out around the world. Its positive results, compared with the other trials, probably were due to the early time window for treatment and well-organized clinical and statistical centers. Many controversies have surrounded its use since its approval. As a result of the NINDS rt-PA Stroke Study, many new approaches to thrombolytic therapy are under evaluation.The results of the NINDS rt-PA Stroke Study have affected the management of patients with acute stroke worldwide.

SUBMITTER: Grotta J

PROVIDER: S-EPMC2695447 | biostudies-other | 2007

REPOSITORIES: biostudies-other

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Intravenous rt-PA: a tenth anniversary reflection.

Grotta James J Marler John J

Surgical neurology 20070101

<h4>Background</h4>Clinical trials with rt-PA for treating AIS began 20 years ago in 1987, and the pivotal NINDS rt-PA Stroke Study was completed and published in 1995 with FDA approval in 1996, about 10 years ago. A large number of articles emanated from that study and have established the efficacy and generalizability of this treatment.<h4>Methods</h4>Here we summarize the background of how the NINDS trial was developed and carried out and its main findings.<h4>Results</h4>The NINDS rt-PA Stro ...[more]

PMID: 17963915

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Project description:BackgroundEndovascular 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.MethodsWe 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).ResultsThe 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).ConclusionsThe 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.).

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Intravenous rt-PA: a tenth anniversary reflection.

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Intravenous rt-PA: a tenth anniversary reflection.

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