The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting.
BACKGROUND
The use of carotid artery stenting with embolic protection has been practiced for over a decade in the United States, and increasingly so since carotid stenting received FDA approval in 2004. While there have been attempts at establishing predictors of outcomes in carotid artery stenting, they have generally been limited to single center experiences and/or multicenter retrospective surveys. This report examines predictors of outcomes in carotid stenting in the earliest and largest prospective multicenter neurologist-adjudicated experience in the United States post device approval.


METHODS
The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry conducted to assess outcomes of carotid artery stenting (CAS) in the noninvestigational setting following device approval for high surgical risk patients (symptomatic with > or =50% stenosis; asymptomatic > or =80% stenosis). A neurologist examined the patients before the procedure, at 24 hr and 30-days post-procedure. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30-days post-procedure. Strokes and neurological events suspected to be strokes were adjudicated by an independent Clinical Events Adjudication Committee (CEAC) using prespecified definitions. Logistic regression analysis was performed to determine clinical, procedural, and anatomic predictors of endpoint outcomes.


RESULTS
Three thousand five hundred patients were enrolled at 144 sites by 353 physicians of varying specialty backgrounds and CAS experience. The 30-day primary endpoint event rate of death, stroke and MI was 6.3% [95% CI: 5.5-7.1%], and the rate of major stroke and death 2.9% [95% CI: 2.4-3.5]. Predictors of adverse outcomes included age, symptomatic patients, predilation prior to embolic protection device placement, time from symptoms to CAS procedure, and the use of multiple stents.


CONCLUSIONS
In general, carotid stenting is performed safely in patients with severe stenosis at high surgical risk, with best outcomes in younger asymptomatic patients. However, there are certain patient and procedural characteristics that are associated with poorer outcomes. In these patients, the risk of stenting should be considered vis-à-vis both the anticipated benefit as well as the alternative surgical and medical options.
Gray
William A
WA
Columbia University Medical Center, 161 Ft. Washington Avenue, Fifth Floor, New York, NY 10032, USA. wg2131@columbia.edu
Yadav
Jay S
JS
Verta
Patrick
P
Scicli
Andrea
A
Fairman
Ronald
R
Wholey
Mark
M
Hopkins
L Nelson
LN
Atkinson
Richard
R
Raabe
Rod
R
Barnwell
Stanley
S
Green
Richard
R
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery*; D004106:Dilatation / Q000009:adverse effects; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation; D009203:Myocardial Infarction / Q000209:etiology* / Q000401:mortality; D016017:Odds Ratio; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology