Novo Ensaio Clínico permiti ampliação de janela terapêutica para tratamento endovascular do AVC isquêmico

Original Article

Thrombectomy 6 to 24 Hours after Stroke

with a Mismatch between Deficit and Infarct

R.G. Nogueira, A.P. Jadhav, D.C. Haussen, A. Bonafe, R.F. Budzik, P. Bhuva,

D.R. Yavagal, M. Ribo, C. Cognard, R.A. Hanel, C.A. Sila, A.E. Hassan, M. Millan,

E.I. Levy, P. Mitchell, M. Chen, J.D. English, Q.A. Shah, F.L. Silver, V.M. Pereira, B.P. Mehta, B.W. Baxter, M.G. Abraham, P. Cardona, E. Veznedaroglu,

F.R. Hellinger, L. Feng, J.F. Kirmani, D.K. Lopes, B.T. Jankowitz, M.R. Frankel,

V. Costalat, N.A. Vora, A.J. Yoo, A.M. Malik, A.J. Furlan, M. Rubiera, A. Aghaebrahim,

J.-M. Olivot, W.G. Tekle, R. Shields, T. Graves, R.J. Lewis, W.S. Smith,

D.S. Liebeskind, J.L. Saver, and T.G. Jovin, for the DAWN Trial Investigators*

 

ABSTRACT

 

 

BACKGROUND

The effect of endovascular thrombectomy that is performed more than 6 hours after

the onset of ischemic stroke is uncertain. Patients with a clinical deficit that is disproportionately

severe relative to the infarct volume may benefit from late thrombectomy.

METHODS

We enrolled patients with occlusion of the intracranial internal carotid artery or

proximal middle cerebral artery who had last been known to be well 6 to 24 hours

earlier and who had a mismatch between the severity of the clinical deficit and the

infarct volume, with mismatch criteria defined according to age (<80 years or ≥80

years). Patients were randomly assigned to thrombectomy plus standard care (the

thrombectomy group) or to standard care alone (the control group). The coprimary

end points were the mean score for disability on the utility-weighted modified Rankin

scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of

functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which

ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days.

RESULTS

A total of 206 patients were enrolled; 107 were assigned to the thrombectomy group

and 99 to the control group. At 31 months, enrollment in the trial was stopped because

of the results of a prespecified interim analysis. The mean score on the utility-weighted

modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared

with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95%

credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate

of functional independence at 90 days was 49% in the thrombectomy group as compared

with 13% in the control group (adjusted difference, 33 percentage points; 95%

credible interval, 24 to 44; posterior probability of superiority, >0.999). The rate of

symptomatic intracranial hemorrhage did not differ significantly between the two

groups (6% in the thrombectomy group and 3% in the control group, P = 0.50), nor did

90-day mortality (19% and 18%, respectively; P = 1.00).

CONCLUSIONS

Among patients with acute stroke who had last been known to be well 6 to 24 hours

earlier and who had a mismatch between clinical deficit and infarct, outcomes for

disability at 90 days were better with thrombectomy plus standard care than with

standard care alone. (Funded by Stryker Neurovascular; DAWN ClinicalTrials.gov

number, NCT02142283.)

The New England Journal of Medicine

Downloaded from nejm.org on November 11, 2017. For personal use only. No other uses without permission.

Copyright © 2017 Massachusetts Medical Society. All rights reserved. Th e new england journal o f medicine

n engl j med nejm.org 1

The authors’ full names, academic degrees,

and affiliations are listed in the Appendix.

Address reprint requests to Dr.

Jovin at the University of Pittsburgh Medical

Center Stroke Institute, Department

of Neurology, Presbyterian University Hospital,

200 Lothrop St., C-400, Pittsburgh,

PA 15217, or at jovintg@

upmc

.edu.

*A complete list of sites and investigators

in the DAWN trial is provided in the

Supplementary Appendix, available at

NEJM.org.

Drs. Nogueira and Jovin contributed equally

to this article.

This article was published on November

11, 2017, at NEJM.org.

DOI: 10.1056/NEJMoa1706442

Copyright © 2017 Massachusetts Medical Society.

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