BackgroundThis study aimed to comprehensively explore the occurrence and risk factors for adverse events (AEs) and adverse drug reactions (ADRs) (especially for thrombocytopenia and bleeding) in Chinese patients with high bleeding risk (older adults, or complicated with diabetes mellitus or renal function impairment) undergoing percutaneous coronary intervention (PCI) with bivalirudin as an anticoagulant.MethodsA total of 1,226 patients with high bleeding risk who received PCI with bivalirudin as an anticoagulant from 27 Chinese medical centers were enrolled in this prospective, multi-center, intensive monitoring study. AEs, ADRs, thrombocytopenia, and bleeding were collected from admission to 72 h post-bivalirudin administration; subsequently, patients were followed up on the 30th day with the safety data collected as well.ResultsAdverse events were observed in 198 (16.2) patients, among which severe AEs occurred in 16 (1.3%) patients. Meanwhile, bivalirudin-related ADRs were reported in 66 (5.4%) patients, among which 5 (0.4%) patients experienced bivalirudin-related severe ADRs. Besides, thrombocytopenia and bleeding occurred in 45 (3.7%) and 19 (1.5%) patients, respectively. The subsequent multivariate logistic analysis revealed that age >75 years [p= 0.017, odds ratio (OR) = 1.856] and spontaneous coronary artery dissection (SCAD) (p= 0.030,OR= 2.022) were independently related to higher ADR risk; SCAD (p= 0.017,OR= 2.426) was independently correlated with higher thrombocytopenia risk, while radial artery access (p= 0.015,OR= 0.352) was independently correlated with lower thrombocytopenia risk; and the administration of bivalirudin preoperatively or intraoperatively (p= 0.013,OR= 5.097) was independently associated with higher bleeding risk.ConclusionBivalirudin presents a favorable safety profile regarding ADRs, thrombocytopenia, and bleeding in Chinese patients with high bleeding risk undergoing PCI.