Abstract 58: Rates Of Postoperative Stroke, Cardiac Complication And Mortality In Patients Undergoing Intracranial Stent Placement As Part Of A Clinical Trial Versus Those Treated Outside A Clinical Trial
Background: The pre-maturely discontinued Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial demonstrated lack of benefit of intracranial stent placement due to high rates of immediate post procedure complications. The rates of complications were higher than those reported previously raising the question whether such results were representative of intracranial stent placement in actual routine practice.
Objective: To ascertain and compare the rate of outcomes between patients who underwent intracranial stent placement within and outside clinical trials.
Materials/Methods: Using the Nationwide Inpatient Sample (NIS) from 2008 to 2010, patients with cerebral ischemic events who underwent intracranial stent placement were identified using ICD-9 diagnosis and procedure codes. Patients were divided into those who received intracranial stent placement as part of the clinical trial and those who were treated outside any trial. The postoperative mortality, stroke and cardiac complications were primary endpoints.
Results: A total of 3447 patient underwent intracranial stent placement, 223 patients (6.5%) were enrolled in a clinical trial. Patients who received intracranial stent placement as part of the clinical trial were significantly younger (65±10 versus 68±13 years, p=0.008). Both groups did not differ in terms of gender, race and ethnicity and medical co-morbidities. Mean length of stay was longer in patients treated outside a clinical trial (9.1±11 versus 5.1±4, p<0.0001). The rate of composite endpoint of postoperative mortality (9.6% versus 4.5%), postoperative stroke (4.6% versus 0%), and cardiac complications (1% versus 0%) was significantly higher in patients treated with intracranial stent placement outside clinical trial compared with those treated within clinical trials (14.2% versus 4.5%, p = 0.04).
Conclusions: Patients who undergo intracranial stent placement outside a clinical trial have higher rates of postoperative stroke, cardiac complication and mortality. Such results support those of the SAMMPRIS trial and the need for restricting these procedures to selected patients and specialized centers with high experience.
- © 2012 by American Heart Association, Inc.