PMID- 35752771
OWN - NLM
STAT- MEDLINE
DCOM- 20220628
LR  - 20220716
IS  - 1471-2261 (Electronic)
IS  - 1471-2261 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Jun 25
TI  - Comprehensive safety profile evaluation of bivalirudin in Chinese ST-segment 
      elevation myocardial infarction patients receiving percutaneous coronary 
      intervention: a prospective, multicenter, intensive monitoring study.
PG  - 290
LID - 10.1186/s12872-022-02716-4 [doi]
LID - 290
AB  - BACKGROUND: This prospective, multi-center, intensive monitoring study aimed to 
      systematically assess the occurrence of adverse events (AEs) and adverse drug 
      reactions (ADRs), especially thrombocytopenia and bleeding, as well as their risk 
      factors in Chinese ST-segment elevation myocardial infraction (STEMI) patients 
      receiving bivalirudin as anticoagulant for percutaneous coronary intervention 
      (PCI). METHODS: In total, 1244 STEMI patients undergoing PCI and receiving 
      bivalirudin as anticoagulant were enrolled in the present study. Safety data were 
      collected from hospital admission to 72 h after bivalirudin administration; in 
      addition, patients were further followed up at the 30th day with safety data 
      collected at that time. RESULTS: AEs, severe AEs, ADRs and severe ADRs were 
      reported in 224 (18.0%), 15 (1.2%), 49 (3.9%) and 5 (0.4%) patients, 
      respectively. Importantly, 4 (0.3%) patients were submitted to hospitalization 
      and 6 (0.5%) patients died due to AEs, while 1 (0.1%) patient was submitted to 
      hospitalization but no (0.0%) patient died due to ADRs. Meanwhile, 
      thrombocytopenia and bleeding occurred in 24 (1.9%) and 21 (1.7%) patients, 
      respectively. Further multivariate logistic analysis identified several important 
      independent factors related to AEs, ADRs, thrombocytopenia or bleeding, which 
      included history of cardiac surgery and renal function impairment, high CRUSADE 
      risk stratification, elective operation and combination with glycoprotein 
      IIb/IIIa inhibitors. Moreover, 4 multivariate models were constructed based on 
      the above-mentioned factors, which all showed acceptable predictive value for 
      AEs, ADRs, thrombocytopenia and bleeding, respectively. CONCLUSION: Bivalirudin 
      is a well-tolerant anticoagulant in Chinese STEMI patients undergoing PCI 
      procedure.
CI  - (c) 2022. The Author(s).
FAU - Zheng, Haijun
AU  - Zheng H
AD  - Department of Cardiology, Jiaozuo People's Hospital, Jiaozuo, China.
FAU - Wang, Zhonghua
AU  - Wang Z
AD  - Department of Cardiology, Chenzhou First People's Hospital, Chenzhou, China.
FAU - Li, Qi
AU  - Li Q
AD  - Department of Cardiology, Peking University People's Hospital, Beijing, China.
FAU - Zhao, Yingxin
AU  - Zhao Y
AD  - Department of Cardiology, Beijing Institute of Heart Lung and Blood Vessel 
      Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
FAU - Liu, Yin
AU  - Liu Y
AD  - Department of Cardiology, Tianjin Chest Hospital, Tianjin, China.
FAU - Chen, Aiming
AU  - Chen A
AD  - Department of Cardiology, The First People's Hospital of Jinzhou District, 
      Dalian, China.
FAU - Deng, Jianping
AU  - Deng J
AD  - Department of Cardiology, Nanchong Central Hospital, No. 97, Renmin South Road, 
      Shunqing District, Nanchong, 637000, China. DJPDBY@163.com.
FAU - Su, Guohai
AU  - Su G
AD  - Department of Cardiology, Jinan Clinical Medical College, Jinan Central Hospital, 
      Shan-Dong University, No. 105 Jiefang Road, Jinan, 250000, Jinan, China. 
      sgh7058@126.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220625
PL  - England
TA  - BMC Cardiovasc Disord
JT  - BMC cardiovascular disorders
JID - 100968539
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Anticoagulants/adverse effects
MH  - Antithrombins/adverse effects
MH  - China/epidemiology
MH  - Hemorrhage/chemically induced
MH  - Heparin
MH  - Hirudins/adverse effects
MH  - Humans
MH  - Peptide Fragments/adverse effects
MH  - *Percutaneous Coronary Intervention/adverse effects/methods
MH  - Prospective Studies
MH  - Recombinant Proteins/adverse effects
MH  - *ST Elevation Myocardial Infarction/diagnosis/therapy
MH  - *Thrombocytopenia/chemically induced
MH  - Treatment Outcome
PMC - PMC9233771
OTO - NOTNLM
OT  - Adverse events and drug reactions
OT  - Bivalirudin
OT  - Percutaneous coronary intervention
OT  - ST-segment elevation myocardial infarction
OT  - Thrombocytopenia and bleeding
COIS- No potential conflict of interest was reported by the authors.
EDAT- 2022/06/26 06:00
MHDA- 2022/06/29 06:00
PMCR- 2022/06/25
CRDT- 2022/06/25 23:28
PHST- 2021/09/26 00:00 [received]
PHST- 2022/01/12 00:00 [accepted]
PHST- 2022/06/25 23:28 [entrez]
PHST- 2022/06/26 06:00 [pubmed]
PHST- 2022/06/29 06:00 [medline]
PHST- 2022/06/25 00:00 [pmc-release]
AID - 10.1186/s12872-022-02716-4 [pii]
AID - 2716 [pii]
AID - 10.1186/s12872-022-02716-4 [doi]
PST - epublish
SO  - BMC Cardiovasc Disord. 2022 Jun 25;22(1):290. doi: 10.1186/s12872-022-02716-4.