Stenting versus Aggressive Medical Therapy  for Intracranial Arterial Stenosis
Autor: edson mitsuhiro machado shirai | Publicado: 2011-09-08T23:00:00-03:00


T h e ne w e ngl a nd j our na l &nbsp;o f me dic i ne
10.1056/nejmoa1105335  nejm.org 1
original article
Stenting versus Aggressive Medical Therapy&nbsp;
for Intracranial Arterial Stenosis
Marc I. Chimowitz, M.B., Ch.B., Michael J. Lynn, M.S., Colin P. Derdeyn, M.D.,
Tanya N. Turan, M.D., David Fiorella, M.D., Ph.D., Bethany F. Lane, R.N.,
L. Scott Janis, Ph.D., Helmi L. Lutsep, M.D., Stanley L. Barnwell, M.D., Ph.D.,
Michael F. Waters, M.D., Ph.D., Brian L. Hoh, M.D., J. Maurice Hourihane, M.D.,
Elad I. Levy, M.D., Andrei V. Alexandrov, M.D., Mark R. Harrigan, M.D.,
David Chiu, M.D., Richard P. Klucznik, M.D., Joni M. Clark, M.D.,
Cameron G. McDougall, M.D., Mark D. Johnson, M.D., G. Lee Pride, Jr., M.D.,
Michel T. Torbey, M.D., M.P.H., Osama O. Zaidat, M.D.,
Zoran Rumboldt, M.D., and Harry J. Cloft, M.D., Ph.D.,
for the SAMMPRIS Trial Investigators*
The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Chimowitz at the Medical University of South
Carolina Stroke Program, 19 Hagood Ave.,
Harborview Office Tower, Suite 501, Charleston, SC 29425, or at mchimow@musc.edu.
*The investigators in the Stenting and
Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial
Stenosis (SAMMPRIS) trial are listed in
the Supplementary Appendix, available
at NEJM.org.
This article (10.1056/NEJMoa1105335) was
published on September 7, 2011, at NEJM
.org.
N Engl J Med 2011.
Copyright © 2011 Massachusetts Medical Society.
A bs tr ac t
Background
Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is
increasingly being treated with percutaneous transluminal angioplasty and stenting
(PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial.
Methods
We randomly assigned patients who had a recent transient ischemic attack or stroke
attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to
aggressive medical management alone or aggressive medical management plus PTAS
with the use of the Wingspan stent system. The primary end point was stroke or
death within 30 days after enrollment or after a revascularization procedure for the
qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days.
Results
Enrollment was stopped after 451 patients underwent randomization, because the
30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%;
fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%;
non–stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of followup, which is ongoing, is 11.9 months. The probability of the occurrence of a primary
end-point event over time differed significantly between the two treatment groups
(P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group
and 12.2% in the medical-management group.
Conclusions
In patients with intracranial arterial stenosis, aggressive medical management was
superior to PTAS with the use of the Wingspan stent system, both because the risk
of early stroke after PTAS was high and because the risk of stroke with aggressive
medical therapy alone was lower than expected. (Funded by the National Institute of
Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.)
The New England Journal of Medicine
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&nbsp;Copyright © 2011 Massachusetts Medical Society. All rights reserved.