PMID- 35573935
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220519
IS  - 2297-055X (Print)
IS  - 2297-055X (Electronic)
IS  - 2297-055X (Linking)
VI  - 8
DP  - 2021
TI  - 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.
PG  - 781632
LID - 10.3389/fcvm.2021.781632 [doi]
LID - 781632
AB  - 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.
CI  - Copyright (c) 2022 Li, Zhang, Luo, Ji, Zheng, Li, Wu, Li and Hong.
FAU - Li, Ping
AU  - Li P
AD  - Department of Cardiology, The First People's Hospital of Yulin, Yulin, China.
FAU - Zhang, Hongyan
AU  - Zhang H
AD  - Department of Cardiology, Affiliated Hospital of Qilu Medical University (The 
      People's Hospital of Xin Tai City), Xintai, China.
FAU - Luo, Caidong
AU  - Luo C
AD  - Department of Cardiology, Mianyang Central Hospital, Mianyang, China.
FAU - Ji, Zheng
AU  - Ji Z
AD  - First Department of Cardiology, Tangshan Workers' Hospital, Tangshan, China.
FAU - Zheng, Zeqi
AU  - Zheng Z
AD  - Department of Cardiology, The First Affiliated Hospital of Nanchang University, 
      Nanchang, China.
FAU - Li, Zhenyong
AU  - Li Z
AD  - Department of Cardiology, Xuzhou Central Hospital, Xuzhou, China.
FAU - Wu, Fan
AU  - Wu F
AD  - Second Department of Cardiology, Xuchang Central Hospital, Xuchang, China.
FAU - Li, Jinlong
AU  - Li J
AD  - Department of Cardiology, The Affiliated Taian City Central Hospital of Qingdao 
      University, Tai'an, China.
FAU - Hong, Lang
AU  - Hong L
AD  - Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang 
      Medical College, Nanchang, China.
LA  - eng
PT  - Journal Article
DEP - 20220429
PL  - Switzerland
TA  - Front Cardiovasc Med
JT  - Frontiers in cardiovascular medicine
JID - 101653388
PMC - PMC9099409
OTO - NOTNLM
OT  - adverse drug reactions
OT  - adverse events
OT  - bivalirudin
OT  - bleeding and thrombocytopenia
OT  - percutaneous coronary intervention
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/05/17 06:00
MHDA- 2022/05/17 06:01
PMCR- 2021/01/01
CRDT- 2022/05/16 04:35
PHST- 2021/09/23 00:00 [received]
PHST- 2021/12/27 00:00 [accepted]
PHST- 2022/05/16 04:35 [entrez]
PHST- 2022/05/17 06:00 [pubmed]
PHST- 2022/05/17 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fcvm.2021.781632 [doi]
PST - epublish
SO  - Front Cardiovasc Med. 2022 Apr 29;8:781632. doi: 10.3389/fcvm.2021.781632. 
      eCollection 2021.