Risk of Inhospital Stroke or Death Is Associated With Age But Not Sex in Patients Treated With Carotid Endarterectomy for Asymptomatic or Symptomatic Stenosis in Routine Practice: Secondary Data Analysis of the Nationwide German Statutory Quality Assurance Database From 2009 to 2014

Abstract

BackgroundGuideline recommendations on carotid endarterectomy are based predominantly on randomized, controlled trials, in which women or elderly patients are often under‐represented. This study analyzed the association of age and sex with the risk of in‐hospital stroke or death following carotid endarterectomy under routine conditions in Germany.Methods and ResultsSecondary data analysis using the Statutory German Quality Assurance Database on all carotid endarterectomy procedures (n=142 074) performed between 2009 and 2014. Primary outcome was any stroke or death until discharge; secondary outcomes were any in‐hospital stroke (alone), and death (alone). Descriptive statistics and multilevel multivariable regression analyses were applied. Patients were predominately male (68%), with mean age 71 years. Carotid stenosis was symptomatic in 40%. Primary outcome occurred in 1.8% of women and 1.9% of men. Multivariable regression analysis revealed that more‐advanced age was associated with a higher primary outcome rate (relative risk [RR] per 10‐year increase: 1.19; 95% CI, 1.14–1.24). Risk of death (alone) was associated with age (RR, 1.68; 95% CI, 1.54–1.84). Age was associated with the risk of stroke (alone; RR, 1.05; 95% CI, 1.00–1.11). Sex was not associated with primary outcome rate (1.01; 95% CI, 0.93–1.10), nor did it significantly modify the age effect.ConclusionsThis study shows that increasing age, but not sex, is associated with a higher risk of in‐hospital stroke or death following carotid endarterectomy under everyday conditions in Germany. Whereas the risk of death (alone) is significantly associated with age, the association between age and the risk of stroke (alone) can be considered of minor importance.

Risk of Stroke or Death Is Associated With the Timing of Carotid Artery Stenting for Symptomatic Carotid Stenosis: A Secondary Data Analysis of the German Statutory Quality Assurance Database

“…Controlled remote access to individual patient data was granted to our group, but we have also never had direct access to microdata. Furthermore, all applied analytic methods are described in the methods section and have been described elsewhere as well …”

“…No information on the time interval was available for 9 patients, who were therefore also excluded (N=4717). Inclusion and exclusion criteria are provided in Figure …”

“…The R extension packages gmodels , lme4 , and gam were used to calculate cross‐classified tables, chi‐squared tests, and multivariable regression analyses. The significance level for all statistical tests was set to α=0.05 …”

Risk of Stroke or Death Is Associated With the Timing of Carotid Artery Stenting for Symptomatic Carotid Stenosis: A Secondary Data Analysis of the German Statutory Quality Assurance Database

“…Furthermore, all applied analytic methods are described in the methods section and have been described elsewhere as well. [8][9][10][11][12] Legal Basis of Data Acquisition Between 2009 and 2015 the aQua Institute was commissioned and authorized by the German Federal Joint Committee (legal basis §91 German Social Security Code part 5, SGB V 11 ) to develop and implement external quality assurance in the German healthcare system pursuant to §137a SGB V. The aQua Institute was also mandated for data validation, data analysis, and publication of annual quality reports. 13 In accordance with the German Federal Joint Committee directive concerning measures of transsectoral and inpatient quality assurance, 14,15 reporting of quality assurance data is compulsory for all reconstructive procedures on the extracranial carotid bifurcation.…”

“…Conformance with German data protection laws was verified by aQua Institute staff members (T.B.). [8][9][10][11][12]…”