Purpose: To investigate the bleeding complications associated with endovascular therapy (EVT) for peripheral artery disease (PAD) and develop a dedicated peripheral bleeding score (PBS). Materials and Methods: This prospective, single-center study enrolled 530 patients (mean age 67.6±9.8 years; 396 men) undergoing endovascular procedures between August 2016 and July 2018 for chronic PAD. Primary endpoints were the incidence of 30-day bleeding complications [minor and major (prolonging hospitalization, causing permanent sequelae, or resulting in death)], the identification of factors associated with bleeding events, and the development of a dedicated PBS based on univariate and multivariate analysis. Hazard ratios (HR) and 95% confidence intervals (CI) are reported. The HAS-BLED score was compared with the PBS. Results: The overall peripheral bleeding complication rate was 3.8% (20/530), of which 3.2% (17/530) were major and included 4 (0.7%) active retroperitoneal bleeding events and 13 (2.4%) pseudoaneurysms. The annualized incidences of overall bleeding and major bleeding complications were 1.9% and 1.6%, respectively. Multivariable regression analysis identified age ≥75 as a correlate of significantly increased bleeding risk (HR 3.32, 95% CI 1.12 to 9.80, p<0.02). Male gender (HR 0.193, 95% CI 0.49 to 0.75, p<0.001) and statin therapy (HR 0.245, 95% CI 0.08 to 0.71, p=0.01) were correlated with a significantly decreased bleeding risk. Based on the regression analysis findings an 8-point PBS was developed, demonstrating 75.0% sensitivity and 78.4% specificity in detecting bleeding complications. The HAS-BLED score failed to identify 30-day bleeding events. Conclusion: The annualized incidence of bleeding complications associated with peripheral EVT was low. Advanced age and female sex were correlated with increased bleeding risk. The PBS demonstrated satisfactory statistical performance and could be considered for inclusion in the preprocedural endovascular checklist to help optimize intra- and postprocedural care.
Keywords: HAS-BLED score; access site; age; bleeding complications; endovascular interventions; female sex; gender; peripheral artery disease; peripheral bleeding score; pseudoaneurysm; retroperitoneal bleeding; statins.