Study design and population: Periprocedural bleeding complications occurring within the first 30 days following an endovascular intervention for chronic PAD were recorded in this prospective, single-center study. Bleeding events included retroperitoneal hemorrhage, pseudoaneurysm, vessel perforation, access site hematoma >5cm or requiring surgical treatment, intracranial hemorrhage, or gastrointestinal bleeding. Symptomatic adult patients with PAD were eligible if they met criteria for EVT in our department; suffered from stenosis or occlusion in the lower or upper limb, carotid, or visceral arteries; and gave informed consent for study participation. Over a 2-year period (August 2016-July 2018), 530 patients were enrolled after having undergone 530 consecutive procedures including angioplasty ± stenting for stenotic or occlusive lesions in the lower and upper limb arteries and the carotid and visceral arteries. Comorbidities were typical of a PAD cohort (Table 1).
Endovascular Interventions and Follow-up: Arterial access was obtained using ultrasound guidance. Following sheath placement, an intra-arterial bolus of heparin (70 U/kg body weight) was administrated to achieve an activated clotting time of 200-250 seconds. The use of a closure device was left to the discretion of the physician. All patients were hospitalized for at least 24h and monitored with groin inspection and vital signs every 30min for the first 2h and every 2h thereafter. Full blood analysis and imaging were implemented only if deemed necessary and always in cases in which a bleeding event was suspected. Patients were followed during hospitalization and at 1month after the procedure during a regular clinical visit. If a patient missed the 1-month visit, a study coordinator collected the information via a telephone interview.
HAS-BLED score and creation of newly-proposed PBS: The HAS-BLED score consists of 9 variables each scoring 1 point(uncontrolled periprocedural hypertension; abnormal liver function; abnormal renal function; previous stroke; prior major bleeding or predisposition to bleeding; labile INR; age >65 years; drugs and alcohol).[8] The newly-proposed PBS score was produced by assigning 1 point for covariates with a p≥0.05 and
Study outcomes: The study’s primary outcome measures were (1) the incidence of bleeding complications occurring during or within the first month following the intervention, (2) the identification of factors associated with periprocedural bleeding events, and (3) the development of a dedicated PBS based on identified risk factors in order to recognize patients at high bleeding risk. The study’s secondary outcomes were the assessment of bleeding-related mortality, the evaluation of the bleeding risk profile using the HAS-BLED score, and a comparison of the HAS-BLED score’s clinical utility in predicting bleeding events with the newly-proposed PBS. Major and minor complications were classified according to the Society of Interventional Radiology international guidelines.[9]
Statistical Analysis: Continuous variables are reported as mean±standard deviation, while categorical variables are reported as absolute frequencies (percentage). Normality assumptions were evaluated and accordingly, parametric or non-parametric criteria were applied. Group proportions were compared with the chi-square test or the Fisher exact test. Univariate logistic regression analysis was performed using predefined independent variables: sex, BMI, hostile abdomen [covering the common femoral artery (CFA) access site], antiplatelet therapy, statin therapy, antegrade or retrograde access, site of arterial access, hypertension, coronary disease, smoking habit, renal impairment, stroke/transient ischemic attack, HAS-BLED score, sheath size, critical limb ischemia, and the use of a closure device for hemostasis. Only variables achieving p