title: Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS).
abstract: OBJECTIVE
  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.affiliation: Department of Neurosurgery, State University of New York, Health Sciences Center, T-12 080, Stony Brook, NY 11794-8122, USA. fiorella.SAMMPRIS@gmail.com
authors.forename: David
authors.initials: D
authors.lastname: Fiorella
authors.forename: Colin P
authors.initials: CP
authors.lastname: Derdeyn
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lynn
authors.forename: Stanley L
authors.initials: SL
authors.lastname: Barnwell
authors.forename: Brian L
authors.initials: BL
authors.lastname: Hoh
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.forename: Mark R
authors.initials: MR
authors.lastname: Harrigan
authors.forename: Richard P
authors.initials: RP
authors.lastname: Klucznik
authors.forename: Cameron G
authors.initials: CG
authors.lastname: McDougall
authors.forename: G Lee
authors.initials: GL
authors.lastname: Pride
authors.forename: Osama O
authors.initials: OO
authors.lastname: Zaidat
authors.forename: Helmi L
authors.initials: HL
authors.lastname: Lutsep
authors.forename: Michael F
authors.initials: MF
authors.lastname: Waters
authors.forename: J Maurice
authors.initials: JM
authors.lastname: Hourihane
authors.forename: Andrei V
authors.initials: AV
authors.lastname: Alexandrov
authors.forename: David
authors.initials: D
authors.lastname: Chiu
authors.forename: Joni M
authors.initials: JM
authors.lastname: Clark
authors.forename: Mark D
authors.initials: MD
authors.lastname: Johnson
authors.forename: Michel T
authors.initials: MT
authors.lastname: Torbey
authors.forename: Zoran
authors.initials: Z
authors.lastname: Rumboldt
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Cloft
authors.forename: Tanya N
authors.initials: TN
authors.lastname: Turan
authors.forename: Bethany F
authors.initials: BF
authors.lastname: Lane
authors.forename: L Scott
authors.initials: LS
authors.lastname: Janis
authors.forename: Marc I
authors.initials: MI
authors.lastname: Chimowitz
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D003251:Constriction, Pathologic / Q000150:complications / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D059035:Perioperative Period; D012008:Recurrence; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects*; D020521:Stroke / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome