PMID- 28766879
OWN - NLM
STAT- MEDLINE
DCOM- 20190409
LR  - 20190409
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 91
IP  - 4
DP  - 2018 Mar 1
TI  - Bivalirudin in percutaneous coronary intervention for chronic total occlusion: A 
      single-center pilot study.
PG  - 679-685
LID - 10.1002/ccd.27181 [doi]
AB  - BACKGROUND: Bivalirudin has been reported to be an alternative to unfractionated 
      heparin (UFH) for anticoagulation during percutaneous coronary intervention (PCI) 
      and associated with less bleeding risk. However, the feasibility of bivalirudin 
      during PCI of chronic total occlusion lesions (CTO) remains unknown. OBJECTIVE: 
      To evaluate the efficacy and safety of bivalirudin versus UFH in CTO PCI. 
      METHODS: In this prospective and randomized controlled trial in single center, 
      CTO patients with high bleeding risk were randomized to treatment with 
      bivalirudin (bolus 0.75 mg/kg followed by infusion of 1.75, extra bolus 0.3 mg/kg 
      before stenting) or UFH (100 IU/kg). The primary efficacy end point was the 
      incidence of major adverse cardiac events (MACEs, composite of all-cause 
      mortality, cardiac death, stent thrombosis, periprocedural myocardial infarction, 
      or additional unplanned target lesion revascularization, or any other post-PCI 
      ischemic event) in-hospital, and at 1-year follow-up. The primary safety end 
      point was the occurrence of any bleeding or entry-site complications after PCI. 
      RESULTS: A total of 84 high bleeding risk patients undergoing PCI for CTO lesions 
      were enrolled. The baseline characteristics were similar in both treatment arms. 
      In hospital MACEs rates were 21.4% in the bivalirudin group and 14.3% in the UFH 
      group (P = 0.393). During 1-year's follow-up, end points did not significantly 
      differ between the groups either. Occurrence of the major bleeding events were 
      4.8% in the bivalirudin group and 9.5% in the UFH group (P = 0.676). No 
      entry-site complication was observed. CONCLUSION: In CTO patients at high risk 
      for bleeding undergoing PCI, our data indicates that bivalirudin appears to be at 
      least comparable in efficacy and safety to UFH. A larger clinical trial should be 
      designed to further elucidate its efficacy and safety.
CI  - (c) 2017 Wiley Periodicals, Inc.
FAU - Li, Chenguang
AU  - Li C
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Xu, Rende
AU  - Xu R
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Shen, Yi
AU  - Shen Y
AD  - Department of Geriatrics, Zhongshan Hospital, Fudan University, Shanghai, 200032, 
      China.
FAU - Dai, Yuxiang
AU  - Dai Y
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Zhang, Feng
AU  - Zhang F
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Ma, Jianying
AU  - Ma J
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Ge, Lei
AU  - Ge L
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Qian, Juying
AU  - Qian J
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
FAU - Ge, Junbo
AU  - Ge J
AUID- ORCID: 0000-0002-9360-7332
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, 200032, China.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170802
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
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  - Aged
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Antithrombins/adverse effects/*therapeutic use
MH  - China
MH  - Chronic Disease
MH  - Coronary Occlusion/diagnostic imaging/mortality/*surgery
MH  - Coronary Thrombosis/etiology/prevention & control
MH  - Feasibility Studies
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/adverse effects/*therapeutic use
MH  - Hirudins/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/adverse effects/*therapeutic use
MH  - *Percutaneous Coronary Intervention/adverse effects/mortality
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - bivalirudin
OT  - bleeding risk
OT  - coronary chronic total occlusion
OT  - percutaneous coronary intervention
EDAT- 2017/08/03 06:00
MHDA- 2019/04/10 06:00
CRDT- 2017/08/03 06:00
PHST- 2016/12/11 00:00 [received]
PHST- 2017/05/12 00:00 [revised]
PHST- 2017/06/08 00:00 [accepted]
PHST- 2017/08/03 06:00 [pubmed]
PHST- 2019/04/10 06:00 [medline]
PHST- 2017/08/03 06:00 [entrez]
AID - 10.1002/ccd.27181 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2018 Mar 1;91(4):679-685. doi: 10.1002/ccd.27181. 
      Epub 2017 Aug 2.