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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.

BackgroundBivalirudin is a common anticoagulant during percutaneous coronary intervention (PCI); however, since its application in China, it still lacks comprehensive evaluation of adverse events (AEs) or adverse drug reactions (ADRs) under the real-clinical setting conditions with a large-sample-size population. Therefore, this prospective, multi-center, intensive monitoring study aimed to comprehensively investigate the occurrence and risk factors of AEs and ADRs during PCI with bivalirudin as an anticoagulant.MethodsA total of 3,049 patients who underwent PCI with bivalirudin as anticoagulant from 27 Chinese medical centers were enrolled. Safety data (AEs/ADRs) were collected from hospital admission to 72 h after bivalirudin administration; then, patients were followed up at the 30th day with the safety data collected as well.ResultsA total of 414 (13.58%) patients occurred AEs, among which 31 (1.02%) cases suffered from severe AEs and 8 (0.26%) cases died due to AEs. Importantly, 118 (3.87%) patients occurred bivalirudin related ADRs, among which 7 (0.23%) cases suffered from severe ADRs while no case (0%) died due to ADRs. Of note, 7 (0.23%) patients showed new ADRs, 34 (1.12%) patients experienced bleeding, and 79 (2.59%) patients had thrombocytopenia. Furthermore, age, renal function impairment, CRUSADE high risk stratification independently correlated with total ADRs risk; CRUSADE high risk stratification, emergency operation, full dose bivalirudin independently associated with bleeding risk; age, renal function impairment independently related to thrombocytopenia risk.ConclusionBivalirudin is well-tolerated as an anticoagulant for PCI procedure; meanwhile, older age, renal function impairment, and CRUSADE high risk stratification serve as independent risk factors of bivalirudin related ADRs.