Medical therapy tops stents for averting second stroke: from the New England journal of medicine

Mary Ann Moon

Internal Medicine News. 44.16 (Oct. 1, 2011): p16. From InfoTrac Health and Medical Collection
2017.

Copyright: COPYRIGHT 2011 International Medical News Group

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Aggressive medical management was superior to intracranial stenting for preventing recurrent
stroke in patients with intracranial artery stenosis in the first randomized clinical trial to compare the
two approaches.

The main drawback of percutaneous transluminal angioplasty and stenting (PTAS) was the relatively
high rate of the combined primary end point of stroke or death within 30 days of enrollment or after
revascularization of the target artery at any time during follow-up, or an ischemic stroke in the
territory of the target artery at any time during follow-up.

The trial was halted early when an interim analysis revealed that in the PTAS group, this rate was
more than double what was observed in the medical therapy group (14.7% vs. 5.8%), Dr. Marc I.
Chimowitz of the stroke program at the Medical University of South Carolina, Charleston, and his
associates reported.

This trial, called the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing
Recurrent Stroke in Intracranial Stenosis) study, involved the self-expanding Wingspan stent system
(marketed by Stryker Neurovascular, formerly Boston Scientific Neurovascular), the only device
approved by the Food and Drug Administration for use in treating atherosclerotic intracranial arterial
stenosis. However, other similar devices are widely used "off label" in clinical practice.

"Over the past decade, intracranial PTAS has increasingly been used in the United States and other
countries," the investigators noted.

"The SAMMPRIS study results have immediate implications for clinical practice. Stroke patients with
recent symptoms and intracranial arterial blockage of 70% or greater should be treated with
aggressive medical therapy alone that follows the regimen used in this trial as closely as possible,"
Dr. Chimowitz said in a statement from the National Institute of Neurological Disorders and Stroke,
which funded the trial.

The study enrolled 451 patients at 50 medical centers who had had a transient ischemic attack or a
nondisabling stroke within the preceding 30 days, which was found on angiography to be due to
70%-99% stenosis of the diameter of a major intracranial artery.
In all, 227 subjects were randomly assigned to receive aggressive medical management alone and
224 to receive identical medical therapy plus PTAS (N. Engl. J. Med. 2011 Sept. 7
[doi:10.1056/NEJMoall05335]).

The medical management comprised daily aspirin (325 mg), daily clopidogrel (75 mg) for 90 days
after enrollment, management of primary risk factors such as hypertension and
hypercholesterolemia, and management of secondary risk factors such as diabetes, smoking, excess
body weight, and insufficient exercise using a lifestyle modification program.

The probability of the combined primary end point at the end of 1 year of follow-up also differed
significantly between the two groups (20% with PTAS and 12% with medical management).

There were five stroke-related deaths in the PTAS group (2.2%), compared with one death unrelated
to stroke in the medical management group (0.4%).

Among the 33 strokes that occurred in the PTAS group within 1 month of enrollment, 25 happened
within a day of the procedure and the other 8 took place within a week.

PTAS also led to a significantly higher rate of the secondary end point of any stroke and any major
hemorrhage (23.2%), compared with medical management (16.3%).

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Major Finding: The probability of the combined end point of recurrent stroke or death within 30
days was 14.7% with stenting, compared with only 5.8% with aggressive medical management.

Data Source: The SAMMPRIS study, a randomized clinical trial involving 451 patients who were
treated at 50 U.S. medical centers for intracranial artery stenosis following a TIA or stroke.

Disclosures: The study was funded by the National institute of Neurological Disorders and Stroke.
Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided stents and supplemental
funding. AstraZeneca provided rosuvastatin, and Walgreens Pharmacies provided other study
medications at a discount. Nationwide Better Health-INTERVENT provided a lifestyle modification
program at a discount. Dr. Chimowitz's colleagues disclosed potential conflicts of interest with
numerous companies that manufacture neurovascular devices.

Moon, Mary Ann

Source Citation (MLA 7th Edition)

Moon, Mary Ann. "Medical therapy tops stents for averting second stroke: from the New England
journal of medicine." Internal Medicine News 1 Oct. 2011: 16. InfoTrac Health and Medical Collection
2017. Web. 26 Oct. 2016.

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