Detailed Analysis of Periprocedural Strokes in Patients Undergoing Intracranial Stenting in Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)

• Type of Material: Article
• Authors: David Fiorella, State University of New York; Colin P. Derdeyn, Washington University in St. Louis; Michael Lynn, Emory University; Stanley L. Barnwell, Oregon Health Sciences University; Brian L. Hoh, University of Florida; Elad I. Levy, State University of New York; Mark R. Harrigan, University of Alabama Birmingham; Richard P. Klucznik, The Methodist Hospital; Cameron G. McDougall, Barrow Neurological Institute; G. Lee Pride, University of Texas Southwestern Medical Center; Osama O. Zaidat, Medical College of Wisconsin; Helmi L. Lutsep, Oregon Health Sciences University; Michael F. Waters, University of Florida; J. Maurice Hourihane, Dent Neurological Institute; Andrei V. Alexandrov, University of Alabama Birmingham; David Chiu, The Methodist Hospital; Joni M. Clark, Barrow Neurological Institute; Mark D. Johnson, University of Texas Southwestern Medical Center; Michel T. Torbey, Medical College of Wisconsin; Zoran Rumboldt, Medical University of South Carolina; Harry J. Cloft, Mayo Clinic; Tanya N. Turan, Medical University of South Carolina; Bethany F. Lane, Emory University; L. Scott Janis, National Institutes of Neurological Disease and Stroke; Marc I. Chimowitz, Medical University of South Carolina
• Language: English
• Date: 2012-10-01
• Publisher: American Heart Association
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012 American Heart Association, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1161/STROKEAHA.112.661173
• Title of Journal or Parent Work: Stroke
• ISSN: 0039-2499
• Volume: 43
• Issue: 10
• Start Page: 2682
• End Page: 2688
• Grant/Funding Information: This research is also supported by the Investigator-Sponsored Study Program of AstraZeneca that donates rosuvastatin (Crestor) to study patients.; The SAMMPRIS trial was funded by a research grant (U01 NS058728) from the US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS).; In addition, the following Clinical and Translational Science Awards, funded by the National Institutes of Health, provided local support for the evaluation of patients in the trial: Medical University of South Carolina (UL1RR029882), University of Florida (UL1RR029889), University of Cincinnati (UL1RR029890), and University of California, San Francisco (UL1RR024131).; Corporate Support: Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided study devices and supplemental funding for third party device distribution, site monitoring and study auditing.
• Keywords: THERAPY; ANGIOPLASTY; SMOKING; Science & Technology; CLOPIDOGREL; ASSOCIATION; Neurosciences & Neurology; Clinical Neurology; TRIAL; ACUTE MYOCARDIAL-INFARCTION; ARTERIAL-STENOSIS; Peripheral Vascular Disease; Life Sciences & Biomedicine; WINGSPAN STENT; intracranial stenosis; EVENTS; angioplasty and stenting; clinical trial; Cardiovascular System & Cardiology
• Research Categories: Biology, Biostatistics; Biology, Neuroscience; Health Sciences, Radiology

Abstract

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.