Occurrence and Risk Factors of Adverse Drug Reactions in Patients Receiving Bivalirudin as Anticoagulant During Percutaneous Coronary Intervention: A Prospective, Multi-Center, Intensive Monitoring Study
Bivalirudin 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 populat...
Saved in:
Published in | Frontiers in cardiovascular medicine Vol. 8; p. 781632 |
---|---|
Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Switzerland
Frontiers Media S.A
29.04.2022
|
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | Bivalirudin 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.
A 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.
A 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.
Bivalirudin 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. |
---|---|
Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Jianying Ma, Fudan University, China; Xianghua Fu, Second Hospital of Hebei Medical University, China These authors have contributed equally to this work Edited by: Angelo Silverio, University of Salerno, Italy This article was submitted to Structural Interventional Cardiology, a section of the journal Frontiers in Cardiovascular Medicine |
ISSN: | 2297-055X 2297-055X |
DOI: | 10.3389/fcvm.2021.781632 |