Effectiveness and safety of extracranial carotid stent placement: A nationwide self-controlled case-series study
Journal
Journal of the Formosan Medical Association
Journal Volume
114
Journal Issue
3
Pages
274-281
Date Issued
2015
Author(s)
Abstract
Background: Carotid angioplasty and stent (CAS) placement has emerged as an attractive revascularization strategy for patients with internal carotid artery stenosis. However, the effectiveness and safety of CAS were not fully evaluated, mainly because of methodological difficulties in finding an appropriate comparison group. Methods: Patients who underwent CAS were identified from Taiwan's National Health Insurance claims database between 2005 and 2008. The incidence rate of ischemic stroke after CAS was compared with that of the year prior to the procedure using a self-controlled case series analysis and a conditional Poisson regression model. Logistic regression was conducted to identify factors associated with poor outcome. Results: A total of 1258 patients who had undergone CAS were included, and 73 cases (5.8%) of death or ischemic stroke occurred during the index hospitalization. Within 1year after CAS, 74 patients died and 80 experienced an ischemic stroke. Of the 1184 patients who were followed for 360days, the rate ratio for ischemic stroke decreased to 0.21 (95% CI: 0.08-0.51) between 31 and 180days, and 0.10 (95% CI: 0.03-0.32) between 181 and 360days. Statin therapy was associated with a reduced risk of death or ischemic stroke in the 1st month (odds ratio of 0.53; 95% CI: 0.32-0.90). Conversely, the use of nonsteroidal anti-inflammatory agents, possibly histamine-2 receptor blockers, and CAS performed by low-volume operators were associated with a twofold increased risk. Conclusion: CAS reduced the long-term risk for ischemic stroke. Self-controlled case series analysis might be an appropriate design for evaluating device safety and effectiveness. ? 2014.
SDGs
Other Subjects
histamine H2 receptor antagonist; hydroxymethylglutaryl coenzyme A reductase inhibitor; nonsteroid antiinflammatory agent; aged; Article; brain ischemia; carotid artery stenting; computer assisted tomography; death; device safety; female; follow up; hospitalization; human; incidence; internal carotid artery occlusion; major clinical study; male; nuclear magnetic resonance imaging; outcome assessment; risk assessment; angioplasty; Carotid Artery Diseases; case control study; cerebrovascular accident; comorbidity; external carotid artery; factual database; middle aged; mortality; odds ratio; postoperative complication; public health; risk factor; statistical model; stent; surgery; Taiwan; treatment outcome; very elderly; Aged; Aged, 80 and over; Angioplasty; Carotid Artery Diseases; Carotid Artery, External; Case-Control Studies; Comorbidity; Databases, Factual; Female; Humans; Logistic Models; Male; Middle Aged; National Health Programs; Odds Ratio; Postoperative Complications; Risk Factors; Stents; Stroke; Taiwan; Treatment Outcome
Publisher
Elsevier
Type
journal article