AUTHOR=Peng Xiaoping , Li Zhenyong , Li Dunheng , Li Zhongyin , Lu Zhaohua , Luo Caidong , Ji Zheng 

TITLE=Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.821322

DOI=10.3389/fcvm.2022.821322

ISSN=2297-055X

ABSTRACT=Background: This 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 high bleeding risk patients (the elderly, or complicated with diabetes mellitus or renal function impairment) undergoing PCI with bivalirudin as anticoagulant.
Methods: A total of 1226 patients with high bleeding risk who received PCI with bivalirudin as 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 hours post bivalirudin administration; subsequently, patients were followed up at the 30th day with the safety data collected as well.
Results: AEs 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 ADRs 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; administration of bivalirudin preoperatively or intraoperatively (P=0.013, OR=5.097) was independently associated with higher bleeding risk.
Conclusion: Bivalirudin presents favorable safety profile regarding ADRs, thrombocytopenia and bleeding in Chinese patients with high bleeding risk undergoing PCI.