PMID- 29205487
OWN - NLM
STAT- MEDLINE
DCOM- 20180827
LR  - 20190401
IS  - 1540-8183 (Electronic)
IS  - 0896-4327 (Print)
IS  - 0896-4327 (Linking)
VI  - 31
IP  - 2
DP  - 2018 Apr
TI  - The impact of unfractionated heparin or bivalirudin on patients with stable 
      coronary artery disease undergoing percutaneous coronary intervention.
PG  - 177-184
LID - 10.1111/joic.12462 [doi]
AB  - OBJECTIVES: To compare bleeding and clinical events of patients with stable 
      angina or silent ischemia undergoing percutaneous coronary intervention (PCI) 
      treated with unfractionated heparin (UFH) or bivalirudin. BACKGROUND: Few direct 
      comparisons between UFH monotherapy versus bivalirudin exist for patients with 
      stable ischemic heart disease undergoing PCI. METHODS: A prospective, 
      investigator-initiated, single-center, single-blinded, randomized trial of UFH 
      versus bivalirudin was conducted. The primary endpoint was all bleeding (major 
      and minor) from index-hospitalization to 30 days post discharge. Secondary 
      endpoints included major adverse cerebral and cardiovascular events (MACCE) and 
      net adverse clinical events (NACE). RESULTS: Two-hundred-sixty patients were 
      randomized for treatment with either UFH (n = 123) (47%) or bivalirudin (n = 137) 
      (53%) There were no significant differences in baseline clinical and angiographic 
      characteristics between the two groups. Primary endpoint was similar in both 
      groups (10.9% with bivalirudin vs 7.3% with UFH [P = 0.31]). Major bleeding rates 
      were 5.8% and 2.4%, respectively (P = 0.17). There was a higher MACCE (3.5% vs 
      0%, P = 0.03) and NACE (8.8% vs 2.4%, P = 0.03) rate with bivalirudin compared to 
      UFH, respectively. Bivalirudin had increased odds of NACE (OR = 3.65, 95% CI: 
      1.00-13.3.6). Death and stent thrombosis rates were low and similar in both 
      groups. Radial access was associated with fewer bleeding events compared to 
      femoral access but not statistically significant (P = 0.29). CONCLUSIONS: Among 
      patients with stable angina or silent ischemia, there was no difference between 
      UFH and bivalirudin in bleeding rates up to 30-days post-PCI. MACCE and NACE were 
      higher among the bivalirudin group. Radial access was associated with a 
      numerically lower rate of bleeding compared with femoral access.
CI  - (c) 2017, Wiley Periodicals, Inc.
FAU - Lima, Fabio V
AU  - Lima FV
AUID- ORCID: 0000-0002-1579-7329
AD  - Department of Medicine, Brown University Rhode Island Hospital, Providence, Rhode 
      Island.
FAU - Gruberg, Luis
AU  - Gruberg L
AD  - Department of Cardiology, Hofstra Northwell School of Medicine, Northwell Health, 
      Southside Hospital, Bay Shore, New York.
FAU - Aslam, Usman
AU  - Aslam U
AD  - Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
AD  - New York Institute of Technology, College of Osteopathic Medicine, Old Westbury, 
      New York.
FAU - Ramgadoo, Melissa
AU  - Ramgadoo M
AD  - Department of Medicine, Division of Cardiovascular Diseases, Stony Brook 
      University Medical Center, Stony Brook, New York.
FAU - Clase, Kydanis
AU  - Clase K
AD  - Department of Surgery, Division of Cardiothoracic Surgery, Columbia University 
      Medical Center, New York, New York.
FAU - Trevisan, Alessandra
AU  - Trevisan A
AD  - Department of Medicine, Division of Cardiovascular Diseases, Stony Brook 
      University Medical Center, Stony Brook, New York.
AD  - Graduate Program in Public Health, Stony Brook University, Stony Brook, New York.
FAU - Jeremias, Allen
AU  - Jeremias A
AD  - Department of Medicine, Division of Cardiology, St. Francis Hospital, The Heart 
      Hospital, Roslyn, New York.
LA  - eng
GR  - M01 RR010710/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20171204
PL  - United States
TA  - J Interv Cardiol
JT  - Journal of interventional cardiology
JID - 8907826
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
CIN - J Interv Cardiol. 2018 Apr;31(2):185-187. PMID: 29644753
MH  - Aged
MH  - Anticoagulants/administration & dosage/adverse effects
MH  - *Coronary Artery Disease/diagnosis/drug therapy/surgery
MH  - Drug Monitoring
MH  - Female
MH  - *Hemorrhage/chemically induced/prevention & control
MH  - Heparin/administration & dosage/adverse effects
MH  - *Hirudins/administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Myocardial Ischemia/diagnosis/etiology
MH  - *Peptide Fragments/administration & dosage/adverse effects
MH  - *Percutaneous Coronary Intervention/adverse effects/methods
MH  - Prospective Studies
MH  - Recombinant Proteins/administration & dosage/adverse effects
MH  - *Thrombosis/diagnosis/etiology
MH  - Treatment Outcome
PMC - PMC5897148
MID - NIHMS913355
OTO - NOTNLM
OT  - bivalirudin
OT  - percutaneous coronary intervention
OT  - stable angina
OT  - unfractionated heparin
COIS- Author Disclosure: The Authors have no conflicts of interest to disclose.
EDAT- 2017/12/06 06:00
MHDA- 2018/08/28 06:00
PMCR- 2019/04/01
CRDT- 2017/12/06 06:00
PHST- 2017/08/09 00:00 [received]
PHST- 2017/09/24 00:00 [revised]
PHST- 2017/10/03 00:00 [accepted]
PHST- 2017/12/06 06:00 [pubmed]
PHST- 2018/08/28 06:00 [medline]
PHST- 2017/12/06 06:00 [entrez]
PHST- 2019/04/01 00:00 [pmc-release]
AID - 10.1111/joic.12462 [doi]
PST - ppublish
SO  - J Interv Cardiol. 2018 Apr;31(2):177-184. doi: 10.1111/joic.12462. Epub 2017 Dec 
      4.