Expanded abstract
Citation
Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella
D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF,
Hoh BL, Hourihane JM, Levy EI, Alexandrov AV,
Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall
CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO,
Rumboldt Z, Cloft HJ, for the SAMMPRIS Trial Investi-
gators. N Engl J Med 2011, 365:993-1003. PubMed PMID:
21899409. his is available on www.pubmed.gov.
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
Objective: To determine whether intracranial stenting
(using the Wingspan self-expanding nitinol stent, Boston
Scientific) and intensive medical therapy is superior to
intensive medical therapy alone for preventing stroke in
recently symptomatic patients with severe intracranial
atherosclerotic stenosis.
Design: Phase III, multi-center, randomized, open label,
clinical trial.
Setting: 50 sites in the US
Subjects: 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.
Intervention: Eligible patients were randomized to receive
either aggressive medical medical management alone or
aggressive medical management plus PTAS with the use
of the Wingspan stent system.
Outcomes: he primary end point was stroke or death
within 30 days after enrollment or after a revasculari-
zation procedure for the qualifying lesion during the
follow-up period or stroke in the territory of the qualify-
ing artery beyond 30 days. Patients in the medical arm
who undergo angioplasty for recurrent TIAs (i.e. cross-
overs) and who have a stroke or death within 30 days will
also meet this endpoint.
Results
Of the 451 patients who underwent randomization, 227
were assigned to the medical management group and 224
to the PTAS group. he 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. he
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.
Commentary
Stroke is a major public health problem as it is a leading
cause of death and long-term disability in the United
States. here are approximately 795,000 incident strokes
each year, resulting in more than 140,000 deaths annually
[1]. In 2010, the cost of stroke care was estimated at $74
billion, with a mean lifetime cost of $140,000 per patient
[2]. Atherosclerotic disease of the major intracranial
arteries is a frequent cause of ischemic stroke with annual
risk as high as 24% [3]. Patients with severe intracranial © 2010 BioMed Central Ltd
Stenting versus aggressive medical therapy for
intracranial arterial stenosis: more harm than good
Muthanna Al Hasan
1,2
and Raghavan Murugan*
1,2
University of Pittsburgh Department of Critical Care Medicine: Evidence-Based Medicine Journal Club, edited by Sachin Yende
JOURNAL CLUB CRITIQUE
*Correspondence: muruganr@upmc.edu
642A Scaife Hall, 3550 Terrace Street, University of Pittsburgh, Pittsburgh, PA 15261,
USA
Full list of author information is available at the end of the article
Al Hasan and Murugan Critical Care 2012, 16:310
http://ccforum.com/content/16/3/310
© 2012 BioMed Central Ltd