Safety and efficacy of low dose or no heparinization in cerebral angiography: A randomized controlled study (SELECT trial)

Abstract

INTRODUCTION: Although systemic heparinization is a widely used technique during digital subtraction angiography (DSA), heparin is associated with a variety of complications including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of microdose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases. MATERIALS AND METHODS: We conducted a prospective, single-blind, randomized controlled study on patients who ought to be experienced cerebrovascular examination and underwent DSA. Participants were randomized into three groups: regular-dose systemic heparinization, microdose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores was collected. Safety endpoints were defined as cerebral ischemic events and local complications of the puncture site. Efficacy endpoints were defined as the recovery of the patients. RESULTS: A total of 180 patients were enrolled in the study and randomized into one of three groups. Patients were on average 54.4 ± 10.6 years old and 71.6% were male. Among the three groups, there was no significant difference in the incidence of postoperative thrombotic or ischemic events (regular dose vs. microdose vs. no heparinization: 1.7% vs. 3.3% vs. 1.7%, P = 0.774). The microdose or no heparinization group; however, experienced a significantly lower rate of postoperative subcutaneous hematoma (15.0% vs. 3.3% vs. 0%, P = 0.002), as well as significantly less back pain (21.7% vs. 5.0% vs. 1.7%, P < 0.001) compared to the regular-dose heparinization group. CONCLUSIONS: Microdose heparinization or heparin-free cerebral angiography demonstrated similar safety to conventional heparinization but significantly reduced local complications of the puncture site and accelerated recovery. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06365398.