PMID- 37168321
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230514
IS  - 2297-055X (Print)
IS  - 2297-055X (Electronic)
IS  - 2297-055X (Linking)
VI  - 9
DP  - 2022
TI  - Bivalirudin Presents a Favorable Safety Profile Regarding Adverse Drug Reactions, 
      Thrombocytopenia, and Bleeding in Chinese Patients With High Bleeding Risk 
      Undergoing Percutaneous Coronary Intervention: A Prospective, Multi-Center, 
      Intensive Monitoring Study.
PG  - 821322
LID - 10.3389/fcvm.2022.821322 [doi]
LID - 821322
AB  - BACKGROUND: This study aimed to comprehensively explore the occurrence and risk 
      factors for adverse events (AEs) and adverse drug reactions (ADRs) (especially 
      for thrombocytopenia and bleeding) in Chinese patients with high bleeding risk 
      (older adults, or complicated with diabetes mellitus or renal function 
      impairment) undergoing percutaneous coronary intervention (PCI) with bivalirudin 
      as an anticoagulant. METHODS: A total of 1,226 patients with high bleeding risk 
      who received PCI with bivalirudin as an anticoagulant from 27 Chinese medical 
      centers were enrolled in this prospective, multi-center, intensive monitoring 
      study. AEs, ADRs, thrombocytopenia, and bleeding were collected from admission to 
      72 h post-bivalirudin administration; subsequently, patients were followed up on 
      the 30th day with the safety data collected as well. RESULTS: Adverse events were 
      observed in 198 (16.2) patients, among which severe AEs occurred in 16 (1.3%) 
      patients. Meanwhile, bivalirudin-related ADRs were reported in 66 (5.4%) 
      patients, among which 5 (0.4%) patients experienced bivalirudin-related severe 
      ADRs. Besides, thrombocytopenia and bleeding occurred in 45 (3.7%) and 19 (1.5%) 
      patients, respectively. The subsequent multivariate logistic analysis revealed 
      that age >75 years [p = 0.017, odds ratio (OR) = 1.856] and spontaneous coronary 
      artery dissection (SCAD) (p = 0.030, OR = 2.022) were independently related to 
      higher ADR risk; SCAD (p = 0.017, OR = 2.426) was independently correlated with 
      higher thrombocytopenia risk, while radial artery access (p = 0.015, OR = 0.352) 
      was independently correlated with lower thrombocytopenia risk; and the 
      administration of bivalirudin preoperatively or intraoperatively (p = 0.013, OR = 
      5.097) was independently associated with higher bleeding risk. CONCLUSION: 
      Bivalirudin presents a favorable safety profile regarding ADRs, thrombocytopenia, 
      and bleeding in Chinese patients with high bleeding risk undergoing PCI.
CI  - Copyright (c) 2022 Peng, Li, Li, Li, Lu, Luo and Ji.
FAU - Peng, Xiaoping
AU  - Peng X
AD  - Department of Cardiovascular, 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 - Li, Dunheng
AU  - Li D
AD  - Department of Cardiology, Tai'an First People's Hospital, Tai'an, China.
FAU - Li, Zhongyin
AU  - Li Z
AD  - Department of Cardiovascular, Puyang Oilfield General Hospital, Puyang, China.
FAU - Lu, Zhaohua
AU  - Lu Z
AD  - Department of Cardiology, Wuzhou People's Hospital, Wuzhou, 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 Worker's Hospital, Tangshan, China.
LA  - eng
PT  - Journal Article
DEP - 20220616
PL  - Switzerland
TA  - Front Cardiovasc Med
JT  - Frontiers in cardiovascular medicine
JID - 101653388
PMC - PMC10166107
OTO - NOTNLM
OT  - adverse events and adverse drug reactions
OT  - bivalirudin
OT  - high bleeding risk patients
OT  - percutaneous coronary intervention
OT  - thrombocytopenia and bleeding
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- 2023/05/12 01:07
MHDA- 2023/05/12 01:08
PMCR- 2022/06/16
CRDT- 2023/05/11 19:18
PHST- 2021/12/06 00:00 [received]
PHST- 2022/04/29 00:00 [accepted]
PHST- 2023/05/12 01:08 [medline]
PHST- 2023/05/12 01:07 [pubmed]
PHST- 2023/05/11 19:18 [entrez]
PHST- 2022/06/16 00:00 [pmc-release]
AID - 10.3389/fcvm.2022.821322 [doi]
PST - epublish
SO  - Front Cardiovasc Med. 2022 Jun 16;9:821322. doi: 10.3389/fcvm.2022.821322. 
      eCollection 2022.