Background and Research Objectives: Complex antiplatelet and antithrombotic regimens used in conjunction with percutaneous coronary intervention may increase the risk of vascular complications. The purpose of this study was to examine predictors of vascular complications following sheath removal for percutaneous coronary intervention.
Subjects and Methods: This prospective cohort study enrolled 413 patients during a 7-month period. Data elements were collected by chart abstraction. Practice variable included pharmacological agents and method and duration of sheath removal procedure. Patient outcomes included hematoma formation, bleeding occurrence, pseudoaneurysm prevalence, incidence of arteriovenous fistula formation, and thrombosis.
Results and Conclusions: Of the 413 patients, 68 (16.5%) had a complication. Sixty-four (15.5%) developed hematomas ranging in size from 1 to 5 cm (n = 35, 8.5%) to greater than 5 cm (n = 29, 7.0%), 6 experienced bleeding (1.5%), 4 (1%) had arteriovenous fistulas, and 3 (0.7%) developed pseudoaneurysms. There were no significant differences for complications using manual, C-clamp, or arterial vascular closure device. Patients with a higher systolic blood pressure (135 vs 129; df = 410, P = .025) and of older age (66 vs 63; df = 411, P = .016) were significantly more likely to have complications. Clinically significant major vascular complications were low. Arterial closure devices, mechanical C-clamp, and manual compression all provide low and comparable complication risks following sheath removal in the era of antiplatelet and antithrombotic therapies. Patients who are older and those with elevated blood pressure should have their femoral access site closely monitored and be observed for vascular complications.