WC is a frequent complication of IB for CLI, associated with increased risk for major amputation, mortality, and greater RU. Further detailed investigation into the link between female gender and oral anticoagulation use with WC may help identify causes of WC and perhaps prevent or lessen their occurrence.

Objectives Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Though well-studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized-control trials (RCT) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCT and analyzes whether these studies adequately represent our diverse patient population. Methods We conducted a retrospective review of US-based RCT from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population. Results Seventy-seven studies were reviewed and 52 met our inclusion criteria. Of these, only 85% reported gender and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 subjects), multi-center, government-funded trials (P<0.001 for all). Women are disproportionately under-represented in RCT for all procedure categories (AAR: 9.0% vs 21.5%, CR: 30.0% vs 42.9%, LER: 22.4% vs 41.3%) while minorities are underrepresented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) while they are over represented in LER studies (26.0% vs 21.8%, P<.001 for all). Conclusions Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCT, particularly in small, non-government funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCT may yield more broadly applicable results.

Meta-analysis of trials to date shows CAS is associated with higher 30-day risk of stroke/death compared with CEA. Thus, for the patient at average surgical risk, the role of CAS is unproven, especially for symptomatic patients. And for the patient at high surgical risk, the role of any intervention is uncertain in the setting of competing comorbidities. The results of ongoing clinical trials in this area will likely provide additional evidence to support treatment choices for carotid artery stenosis.