Abstract
BackgroundSubgroup analyses from randomized controlled trials (RCT) of carotid endarterectomy (CEA) for both symptomatic and asymptomatic carotid stenosis suggest less benefit in women compared to men, due partly to higher age-independent peri-operative risk. However, a meta-analysis of case series and databases focussing on CEA-related gender differences has never been investigated.MethodsA systematic review of all available publications (including case series, databases and RCTs) reporting data on the association between sex and procedural risk of stroke and/or death following CEA from 1980 to 2015 was investigated. Pooled Peto odds ratios of the procedural risk of stroke and/or death were obtained by Mantel-Haenszel random-effects meta-analysis. The I2 statistic was used as a measure of heterogeneity. Potential publication bias was assessed with the Egger test and represented graphically with Begg funnel plots of the natural log of the OR versus its standard error. Additional sensitivity analyses were undertaken to evaluate the potential effect of key assumptions and study-level factors on the overall results. Meta-regression models were formed to explore potential heterogeneity as a result of potential risk factors or confounders on outcomes. A tria sequential analysis (TSA) was performed with the aim to maintain an over- all 5 % risk of type I error, being the standard in most meta- analyses and systematic reviews.Results58 articles reported combined stroke and mortality rates within 30 days of treatment. In the unselected overall meta-analysis, the incidence of stroke and death in the male and female groups differed significantly (Peto OR, 1,162; 95 % CI, 1.067-1.266; P = .001), revealing a worse outcome for female patients. Moderate heterogeneity among the studies was identified (I2 = 36 %), and the possibility of publication bias was low (P = .03). In sensitivity analyses the meta-analysis of case series with gender aspects as a secondary outcome showed a significantly increased risk for 30-day stroke and death in women compared to men (Peto OR, 1.390; 95 % CI, 1.148-1.684; P = .001), In contrast, meta-analysis of databases (Peto OR, 1.025; 95 % CI, 0.958-1.097; P = .474) and case series with gender related outcomes as a primary aim (Peto OR, 1.202; 95 % CI, 0.925-1.561; P = .168) demonstrated no increase in operative risk of stroke and death in women compared to men.ConclusionsMetanalyses of case series and databases dealing with CEA reveal inconsistent results regarding gender differences related to CEA-procedure and should not be transferred into clinical practice.
Highlights
Subgroup analyses from randomized controlled trials (RCT) of carotid endarterectomy (CEA) for both symptomatic and asymptomatic carotid stenosis suggest less benefit in women compared to men, due partly to higher age-independent peri-operative risk
The subgroup analyses of NASCET (North American Symptomatic Carotid Endarterectomy Trial), ACAS (Asymptomatic Carotid Atherosclerosis Study), and ECST (European Carotid Surgery Trial) suggested that CEA may not be as efficacious in women as it is in men [5, 6] and that women might have higher risk of perioperative adverse events compared to men [1, 2]
In contrast to the results presented by Bond et al [95], we have shown that the effects of sex on the operative risk of CEA in published series from routine clinical practice are not consistent with those observed in the RCTs and even differ between cases series with gender considerations as primary aim and those with gender aspects as a secondary aim and database analyses
Summary
Subgroup analyses from randomized controlled trials (RCT) of carotid endarterectomy (CEA) for both symptomatic and asymptomatic carotid stenosis suggest less benefit in women compared to men, due partly to higher age-independent peri-operative risk. The subgroup analyses of NASCET (North American Symptomatic Carotid Endarterectomy Trial), ACAS (Asymptomatic Carotid Atherosclerosis Study), and ECST (European Carotid Surgery Trial) suggested that CEA may not be as efficacious in women as it is in men [5, 6] and that women might have higher risk of perioperative adverse events compared to men [1, 2] It has been speculated, that the lower magnitude of benefit in women was due partly to a slightly higher operative risk in women as compared to men combined with the lower natural history risk of stroke in women [5,6,7]. Rather than the risk of stroke and death, is recorded in the large-scale statewide or national reports of routinely collected data on outcome after CEA [12,13,14,15], a meta-analysis of all available publications (including case series, databases and RCTs) published during 1980–2015 that reported the perioperative risk of stroke and death following CEA by gender was performed
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