Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

The authors' affiliations are listed in the Appendix.
New England Journal of Medicine (Impact Factor: 55.87). 02/2013; 368(10). DOI: 10.1056/NEJMoa1214300
Source: PubMed


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.

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).

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).

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; number, NCT00359424.).

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Available from: Michael D Hill, Jun 10, 2015
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    • "Those studies, with different protocols and objectives, were not aligned with the current endovascular techniques and required many protocols adjustments to improve recruitment and equipoise issues [8] [20] [22]. Consequently, these trials incited some misunderstanding within the medical community concerning the utility of the mechanical thrombectomy in AIS treatment [16] [20] [31]. These trials used the old and first generation device technology or intra-arterial pharmacological thrombolysis and failed to consecutively recruit properly selected patients [6] [32] [36]. "
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    ABSTRACT: Acute ischemic stroke is a morbid and disabling medical condition with a significant social and economic impact throughout the world. Intravenous thrombolysis (IVT) has been the first line treatment for patients presenting up to 4.5hours after symptom onset for many years. Endovascular stroke treatment has been used successfully as rescue therapy after failed IVT; in patients with contraindications to rtPA or presenting outside the 4.5-hour window. The effectiveness of IVT is high for distal thrombi but significantly lower for proximal occlusions. Endovascular treatment has been revolutionized by the evolution from intra-arterial thrombolysis and first generation mechanical devices to the current generation of stent retrievers and aspiration systems with large bore catheters. These devices have been associated with excellent revascularization, improved clinical outcomes, shorter procedure times and reduced device and procedure related complications. We report the current literature, clinical standards and perspectives on mechanical thrombectomy in acute ischemic stroke. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
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    • "This is further supported by the poor outcomes associated with non-interventional strategies in large vessel occlusion strokes, as discussed above. Even though direct comparison cannot be made, the rates of favorable outcomes in our study are well above those in published trials on intra-arterial therapy, such as the reported rate of 40.8% in the IMS III trial [9] and 30.4% the SYNTHESIS Trial [20]. A possible drawback of the study would be the small number of patients and the resultant heterogeneous location of the occluded vessels. "
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    • "Cependant, si le traitement combiné TIV puis geste endovasculaire (bridging therapy) permet un taux de recanalisation important, aucun essai randomisé n'a montré à ce jour sa supériorité par rapport à la TIV seule concernant le handicap à long terme [34] [35]. Les analyses de sous-groupes de l'essai IMS-3 suggèrent que les essais évaluant ce traitement combiné devront concerner préférentiellement des patients présentant un déficit neurologique sévère, une occlusion artérielle proximale et pris en charge très rapidement [34]. L'identification, dès l'arrivée à l'hôpital, des patients présentant des facteurs cliniques et radiologiques de mauvais pronostic fonctionnel malgré la TIV, possiblement dans le cadre d'un score dédié, pourrait être utile pour sélectionner les meilleurs candidats à l'évaluation de ce traitement combiné [7] [8]. "
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