PMID- 25484553
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141208
LR  - 20220318
IS  - 1061-1711 (Print)
IS  - 1615-5939 (Electronic)
IS  - 1061-1711 (Linking)
VI  - 23
IP  - 4
DP  - 2014 Dec
TI  - Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary 
      Intervention in Patients at High Risk for Bleeding.
PG  - 227-32
LID - 10.1055/s-0034-1372244 [doi]
AB  - Low/medium-bleeding-risk populations undergoing percutaneous coronary 
      intervention (PCI) show significantly less bleeding with bivalirudin (BIV) than 
      with unfractionated heparin (UFH), but this has not been established for 
      high-risk patients. We performed a randomized double-blind prospective trial 
      comparing efficacy and safety of BIV versus UFH combined with dual antiplatelet 
      therapy during PCI among 100 high-risk patients with non-ST elevation myocardial 
      infarction (NSTEMI) or angina pectoris. The baseline characteristics were similar 
      in both treatment arms. A radial approach was used in 84% of patients with a 
      higher rate in the BIV group (90 vs. 78%, p < 0.05). Study end points were: major 
      and minor bleeding, port-of-entry complications, major adverse cardiac events 
      (MACE) in-hospital, and at long-term follow-up. There was one case of major 
      gastrointestinal bleeding in the BIV group and 7% minor bleeding complications in 
      both categories. Rate of periprocedural myocardial infarction (PPMI) in the BIV 
      group was twice that in the UFH group (20 vs. 10%, p < 0.16). In-hospital MACE 
      rate was higher in BIV patients as well (12 vs. 2%, p = 0.1). By univariate 
      analysis, the femoral approach was the predictor of PPMI and in-hospital MACE. In 
      a multivariate model, the independent predictor of PPMI was previous MI (odds 
      ratio, 7.7; p < 0.0158). PPMI was 49.7 times more likely with the femoral 
      approach plus BIV than the nonfemoral approach plus UFH (p < 0.0021). At 
      41.5 +/- 14 months' follow-up, end points did not significantly differ between the 
      groups. In patients at high risk for bleeding undergoing PCI, BIV was not 
      superior to UFH for bleeding complications, and early and late clinical outcomes.
FAU - Feldman, Alexander
AU  - Feldman A
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Suleiman, Khalid
AU  - Suleiman K
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Bushari, Limor
AU  - Bushari L
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Yahalom, Malka
AU  - Yahalom M
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Rozner, Ehud
AU  - Rozner E
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Freedberg, Nahum Adam
AU  - Freedberg NA
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
FAU - Turgeman, Yoav
AU  - Turgeman Y
AD  - Heart Institute, Ha'Emek Medical Center, Afula, Israel.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Int J Angiol
JT  - The International journal of angiology : official publication of the 
      International College of Angiology, Inc
JID - 9504821
PMC - PMC4244240
OTO - NOTNLM
OT  - PCI
OT  - bivalirudin
OT  - bleeding
OT  - high-risk patient
OT  - unfractionated heparin
COIS- Conflict of Interest The authors report no financial relationships or conflicts 
      of interest regarding the content herein.
EDAT- 2014/12/09 06:00
MHDA- 2014/12/09 06:01
PMCR- 2015/12/01
CRDT- 2014/12/09 06:00
PHST- 2014/12/09 06:00 [entrez]
PHST- 2014/12/09 06:00 [pubmed]
PHST- 2014/12/09 06:01 [medline]
PHST- 2015/12/01 00:00 [pmc-release]
AID - 130082 [pii]
AID - 10.1055/s-0034-1372244 [doi]
PST - ppublish
SO  - Int J Angiol. 2014 Dec;23(4):227-32. doi: 10.1055/s-0034-1372244.