Document Detail


Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS).
MedLine Citation:
PMID:  22984008     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND PURPOSE: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial.
METHODS: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm.
RESULTS: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P ≤ 0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P ≤ 0.05) with ischemic events.
CONCLUSIONS: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. Clinical Trial Registration Information- URL: http://clinicaltrials.gov. Unique Identifier: NCT00576693.
Authors:
David Fiorella; Colin P Derdeyn; Michael J Lynn; Stanley L Barnwell; Brian L Hoh; Elad I Levy; Mark R Harrigan; Richard P Klucznik; Cameron G McDougall; G Lee Pride; Osama O Zaidat; Helmi L Lutsep; Michael F Waters; J Maurice Hourihane; Andrei V Alexandrov; David Chiu; Joni M Clark; Mark D Johnson; Michel T Torbey; Zoran Rumboldt; Harry J Cloft; Tanya N Turan; Bethany F Lane; L Scott Janis; Marc I Chimowitz;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-09-13
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  43     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-09-25     Completed Date:  2013-01-17     Revised Date:  2014-04-08    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2682-8     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00576693
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty / adverse effects*,  instrumentation,  methods
Constriction, Pathologic / complications,  surgery*
Female
Follow-Up Studies
Humans
Incidence
Male
Middle Aged
Multivariate Analysis
Perioperative Period*
Recurrence
Risk Factors
Stents / adverse effects*
Stroke / epidemiology*,  etiology,  prevention & control*
Time Factors
Treatment Outcome
Grant Support
ID/Acronym/Agency:
K23 NS069668/NS/NINDS NIH HHS; U01 NS058728/NS/NINDS NIH HHS; U01NS058728/NS/NINDS NIH HHS; UL1 TR000064/TR/NCATS NIH HHS; UL1RR024131/RR/NCRR NIH HHS; UL1RR029882/RR/NCRR NIH HHS; UL1RR029889/RR/NCRR NIH HHS; UL1RR029890/RR/NCRR NIH HHS
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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