Table_2_Occurrence and Risk Factors of Adverse Drug Reactions in Patients Receiving Bivalirudin as Anticoagulant During Percutaneous Coronary Interven.docx (17.08 kB)
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Table_2_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.docx

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posted on 29.04.2022, 05:01 authored by Ping Li, Hongyan Zhang, Caidong Luo, Zheng Ji, Zeqi Zheng, Zhenyong Li, Fan Wu, Jinlong Li, Lang Hong
Background

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.

Methods

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.

Results

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.

Conclusion

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.

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