News | March 24, 2015

Study Finds Medication Superior to Stents for Narrowed Artery Within the Brain

Balloon-expandable stents found to increase risk of stroke or transient ischemic attack within one year

JAMA, intracranial arterial stenosis, balloon expandable stents, medication

March 24, 2015 — A study in the March 24/31 issue of JAMA found that using balloon-expandable stents to treat symptomatic intracranial arterial stenosis resulted in an increased risk of stroke or transient ischemic attack (TIA). The study results support the use of medical therapy (clopidogrel and aspirin) as an alternative to balloon-expandable stents.

Intracranial arterial stenosis (narrowing of an artery inside the brain) is a common cause of stroke worldwide. The recurrent stroke risk with severe symptomatic intracranial stenosis may be as high as 23 percent at 1 year, despite medical therapy, according to background information in the article.

Osama O. Zaidat, M.D., M.S., of the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, and colleagues randomly assigned 112 patients with symptomatic intracranial stenosis (narrowing of 70 percent or greater) to receive a balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). Medical therapy consisted of clopidogrel (75 mg daily) for the first 3 months after enrollment and aspirin (81-325 mg daily) for the study duration.

This international trial (VISSIT) enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled.

The 30-day safety end point of any stroke within 30 days or hard TIA within 2 to 30 days was 9.4 percent (5/53) in the medical group and 24.1 percent (14/58) in the stent group; TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Ischemic stroke was observed in three patients (5.7 percent) in the medical group and in 10 patients (17.2 percent) in the stent group. Intracranial hemorrhage occurred in five patients (8.6 percent) in the stent group and in 0 in the medical group. The 1-year outcome of stroke or hard TIA occurred in more patients in the stent group (36.2 percent) vs the medical group (15.1 percent).

Thirty-day all-cause death was 3 of 58 patients (5.2 percent) in the stent group and 0 in the medical group. A measure of disability worsened in more patients in the stent group than in the medical group.

“These findings do not support the use of a balloon-expandable stent for patients with intracranial arterial stenosis,” the authors conclude.

For more information: www.media.jamanetwork.com

Related Content

SanBio Receives $20 Million Grant for Stroke Clinical Trial
News | Stroke| July 12, 2017
July 12, 2017 — SanBio Inc.
German Workshop Highlights Possibilities of Perfusion MRI
News | Stroke| July 03, 2017
When diagnosing strokes and heart diseases or looking at tumors, perfusion magnetic resonance imaging (MRI) offers a...
Stroke History Higher in Asymptomatic Versus Symptomatic Atrial Fibrillation Patients
News | Stroke| June 28, 2017
Newly diagnosed asymptomatic atrial fibrillation patients have a higher rate of previous stroke than those with...
Analysis Shows Increased Risk of Early Stroke with New-Onset Atrial Fibrillation Post-TAVR, SCAI 2017 late-breaking clinical trial
News | Stroke| May 12, 2017
More than one-third of patients undergoing transcatheter aortic valve replacement (TAVR) were observed to have atrial...
3-D-printed Model of Stenotic Intracranial Artery Enables Vessel-Wall MRI Standardization
News | 3-D Printing| April 18, 2017
A collaboration between stroke neurologists at the Medical University of South Carolina (MUSC) and bioengineers at the...
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
hyperbaric oxygen treatment, HBOT, stroke, David Steenblock D.O.

Image courtesy of David Steenblock, D.O.

News | Stroke| April 06, 2017
David Steenblock, D.O., an osteopathic physician based in San Clemente, Calif., recently discussed his use of...
marijuana use, increased risk, stroke, heart failure, ACC 2017 study
News | Stroke| March 15, 2017
Using marijuana raises the risk of stroke and heart failure even after accounting for demographic factors, other health...
warfarin, anticoagulation therapy, atrial fibrillation patients, Duke Clinical Research Institute study, stroke
News | Antiplatelet and Anticoagulation Therapies| March 14, 2017
More than 80 percent of stroke patients with a history of atrial fibrillation either received not enough or no...
University of Alabama at Birmingham, Amplatzer PFO Occluder, first implementation
News | Structural Heart Occluders| February 15, 2017
Doctors at the University of Alabama at Birmingham have implemented the first U.S. Food and Drug Administration (FDA)-...
Overlay Init