PMID- 35172721
OWN - NLM
STAT- MEDLINE
DCOM- 20220307
LR  - 20220307
IS  - 1471-2261 (Electronic)
IS  - 1471-2261 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Feb 17
TI  - Safety profile of bivalirudin in Chinese female patients undergoing percutaneous 
      coronary intervention: a multi-center study.
PG  - 58
LID - 10.1186/s12872-022-02474-3 [doi]
LID - 58
AB  - BACKGROUND: The present study aimed to comprehensively investigate the occurrence 
      and risk factors of adverse events (AEs) or adverse drug reactions (ADRs) 
      (especially for thrombocytopenia and bleeding) in Chinese female patients 
      receiving bivalirudin during percutaneous coronary intervention (PCI). METHODS: A 
      total of 918 female patients from 27 Chinese medical centers took bivalirudin as 
      anticoagulant for PCI were enrolled in this prospective, multi-center, intensive 
      monitoring study. Safety data (AEs, ADRs, thrombocytopenia and bleeding) were 
      collected from admission to 72 h post bivalirudin administration; then, patients 
      were followed up at the 30(th) day with the safety data collected as well. 
      RESULTS: One hundred and twenty (13.1%) patients occurred AEs, among which 7 
      (0.8%) cases experienced severe AEs, and 2 (0.2%) cases died. Besides, 40 (4.4%) 
      patients occurred bivalirudin-related ADRs, in which 3 (0.3%) cases experienced 
      severe ADRs, but 0 (0.0%) cases died. It was of note that 27 (2.9%) and 13 (1.4%) 
      patients experienced thrombocytopenia and bleeding, respectively. Subsequent 
      multivariate analyses observed that: clinical presentation of spontaneous 
      coronary artery dissection (SCAD) (odds ratio (OR) = 3.191, P = 0.004), CRUSADE 
      high risk (OR = 2.075, P = 0.031), multiple culprit vessel (OR = 2.328, 
      P = 0.019) independently correlated with higher risk of bivalirudin-related ADRs; 
      clinical presentation of SCAD (OR = 4.388, P = 0.002) and multiple culprit vessel 
      (OR = 2.974, P = 0.010) independently linked with raised thrombocytopenia risk; 
      history of diabetes mellitus (OR = 5.227, P = 0.007) and CRUSADE high risk 
      (OR = 4.475, P = 0.016) were independent factor related to elevated bleeding 
      risk. CONCLUSION: Bivalirudin is well tolerated with low ADRs, thrombocytopenia 
      and bleeding incidences in Chinese female patients undergoing PCI.
CI  - (c) 2022. The Author(s).
FAU - Wu, Fan
AU  - Wu F
AD  - Department of Cardiovascular Medicine II, Xuchang Central Hospital, 30 Huatuo 
      Road, Xuchang, 461001, Henan Province, China.
FAU - Liu, Xueying
AU  - Liu X
AD  - Department of Cardiology, The First Hospital of Zhangjiakou, No.6 Chapel Lane, 
      Xinhua Front Street, Qiaoxi District, Zhangjiakou, 075061, Hunan, China.
FAU - Ran, Huazhong
AU  - Ran H
AD  - Department of Cardio-Thoracic Surgery, ZhouKou Center Hospistal of Henan 
      Province, East Section of Renmin Road, Zhoukou, 466699, Henan, China.
FAU - Tang, Qiwei
AU  - Tang Q
AD  - Department of Cardiology, The First Affiliated Hospital of Henan University, 357 
      Ximen Dajie, Kaifeng, 475004, Henan, China.
FAU - Zhong, Cheng
AU  - Zhong C
AD  - Department of Cardiovascular Medicine, Zhejiang Lvcheng Cardiovascular Hospital, 
      409 Gudun Road, Wenxin Street, Xihu District, Hangzhou, 310011, Zhejiang, China.
FAU - Wu, Yanqing
AU  - Wu Y
AD  - Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang 
      University, 1 Minde Road, Donghu District, Nanchang, 330006, China. 
      quyanjie490429890@163.com.
FAU - Xiao, Jun
AU  - Xiao J
AD  - Department of Cardiovascular Medicine, Chongqing University Central Hospital, No. 
      1 Jiankang Road, Yuzhong District, Chongqing, 400014, China. 
      qiaoji3208262@163.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220217
PL  - England
TA  - BMC Cardiovasc Disord
JT  - BMC cardiovascular disorders
JID - 100968539
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Antithrombins/adverse effects/*therapeutic use
MH  - China
MH  - Coronary Artery Disease/diagnosis/epidemiology/*therapy
MH  - Female
MH  - Hemorrhage/chemically induced/epidemiology
MH  - Hirudins/adverse effects
MH  - Humans
MH  - Incidence
MH  - Middle Aged
MH  - Peptide Fragments/adverse effects/*therapeutic use
MH  - *Percutaneous Coronary Intervention/adverse effects
MH  - Prospective Studies
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Risk Assessment
MH  - Risk Factors
MH  - Sex Factors
MH  - Thrombocytopenia/chemically induced/epidemiology
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC8851799
OTO - NOTNLM
OT  - Adverse events and adverse drug reactions
OT  - Bivalirudin
OT  - Female
OT  - Percutaneous coronary intervention
OT  - Thrombocytopenia and bleeding
COIS- The authors declare that they have no competing interests.
EDAT- 2022/02/18 06:00
MHDA- 2022/03/08 06:00
PMCR- 2022/02/17
CRDT- 2022/02/17 05:28
PHST- 2021/08/11 00:00 [received]
PHST- 2022/01/12 00:00 [accepted]
PHST- 2022/02/17 05:28 [entrez]
PHST- 2022/02/18 06:00 [pubmed]
PHST- 2022/03/08 06:00 [medline]
PHST- 2022/02/17 00:00 [pmc-release]
AID - 10.1186/s12872-022-02474-3 [pii]
AID - 2474 [pii]
AID - 10.1186/s12872-022-02474-3 [doi]
PST - epublish
SO  - BMC Cardiovasc Disord. 2022 Feb 17;22(1):58. doi: 10.1186/s12872-022-02474-3.