Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease

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.

Download Full-text

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category

Journal of Endovascular Therapy ◽

10.1177/1526602820962972 ◽

2020 ◽

pp. 152660282096297

Author(s):

Stefanos Giannopoulos ◽

Jihad Mustapha ◽

William A. Gray ◽

Gary Ansel ◽

George Adams ◽

...

Keyword(s):

Quality Of Life ◽

Peripheral Artery Disease ◽

Survival Rates ◽

Target Lesion ◽

Major Amputation ◽

Peripheral Artery ◽

Target Vessel Revascularization ◽

Endovascular Interventions ◽

Artery Disease

Purpose: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD). Materials and Methods: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) was a prospective, observational, core laboratory–assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling. Results: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients. Conclusion: Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.

Download Full-text