title: Intracranial stent placement for symptomatic intracranial stenosis as part of a clinical trial versus outside a clinical trial.
abstract: OBJECTIVE
  A high rate of postprocedure complications in the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial has raised concerns whether such results are representative of intracranial stent placement in actual routine practice.
  
  
  METHODS
  Using the Nationwide Inpatient Sample from 2008 to 2010, patients with cerebral ischemic events treated with intracranial stent as part of a clinical trial or outside the trial were identified. The composite end point (postoperative stroke, cardiac complications, and mortality) was reported.
  
  
  RESULTS
  Of the 3447 patients who underwent intracranial stent placement, 223 patients (6.5%) were enrolled in a clinical trial. The rate of composite end point was higher in patients treated outside clinical trials compared with those treated within clinical trials (14.2% versus 4.5%; P=0.1). The proportion of patients discharged to home was higher in those treated in clinical trials (76.8% versus 49.6%; P=0.001).
  
  
  CONCLUSIONS
  Intracranial stent placement procedures outside a clinical trial have higher rates of postoperative stroke, cardiac complication, and mortality.
authors.affiliation: From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis.
authors.forename: Farhan
authors.initials: F
authors.lastname: Siddiq
authors.forename: Malik M
authors.initials: MM
authors.lastname: Adil
authors.forename: Kiersten
authors.initials: K
authors.lastname: Norby
authors.forename: Adnan I
authors.initials: AI
authors.lastname: Qureshi
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D003251:Constriction, Pathologic / Q000401:mortality / Q000601:surgery; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000401:mortality / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D015607:Stents; D020521:Stroke / Q000401:mortality / Q000601:surgery*; D016896:Treatment Outcome
keywords: angioplasty; stents; stroke