PMID- 22583760
OWN - NLM
STAT- MEDLINE
DCOM- 20121204
LR  - 20220318
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 110
IP  - 4
DP  - 2012 Aug 15
TI  - Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in 
      high-risk patients undergoing percutaneous coronary intervention (from the 
      Anti-Thrombotic Strategy for Reduction of Myocardial Damage During 
      Angioplasty-Bivalirudin vs Heparin study).
PG  - 478-84
LID - 10.1016/j.amjcard.2012.04.017 [doi]
AB  - Bivalirudin, a direct thrombin inhibitor, is as effective as unfractionated 
      heparin (UFH), with decreased bleeding in patients with acute coronary syndromes 
      who undergo percutaneous coronary intervention (PCI). The aim of this study was 
      to evaluate the effectiveness of bivalirudin versus UFH in selected PCI patients 
      at high bleeding risk. Four hundred one consecutive patients who underwent PCI 
      fulfilling >/= 1 enrollment criterion (age >75 years, chronic renal failure, and 
      diabetes mellitus) were randomized to bivalirudin (bolus 0.75 mg/kg followed by 
      infusion during the procedure; n = 198) or UFH (75 IU/kg; n = 203). In the 
      overall population, 39% were aged >75 years, 22% had renal failure, 63% had 
      diabetes, and 29% had acute coronary syndromes. The primary efficacy end point 
      was the 30-day incidence of major adverse cardiac events (cardiac death, 
      myocardial infarction, stent thrombosis, or target vessel revascularization). The 
      primary safety end point was the occurrence of any bleeding or entry-site 
      complications after PCI. All patients were preloaded with clopidogrel 600 mg. 
      Glycoprotein IIb/IIIa inhibitors were used at the operators' discretion. 
      Thirty-day major adverse cardiac event rates were 11.1% in the bivalirudin group 
      and 8.9% in the UFH group (p = 0.56); the primary efficacy end point was reached 
      mainly because of periprocedural myocardial infarction; 1 patient in the 
      bivalirudin group had stent thrombosis. Occurrence of the primary safety end 
      point was 1.5% in the bivalirudin group and 9.9% in the UFH group (p = 0.0001); 
      this benefit was essentially driven by the prevention of entry-site hematomas >10 
      cm (0.5% vs 6.9%, p = 0.002). In conclusion, Anti-Thrombotic Strategy for 
      Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin 
      (ARMYDA-7 BIVALVE) indicates that bivalirudin, compared with UFH, causes 
      significantly lower bleeding and has a similar incidence of major adverse cardiac 
      events in patients with older age, diabetes mellitus, or chronic renal failure 
      who undergo PCI.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Patti, Giuseppe
AU  - Patti G
AD  - Campus Bio-Medico University of Rome, Rome, Italy. g.patti@unicampus.it
FAU - Pasceri, Vincenzo
AU  - Pasceri V
FAU - D'Antonio, Luca
AU  - D'Antonio L
FAU - D'Ambrosio, Andrea
AU  - D'Ambrosio A
FAU - Macri, Michele
AU  - Macri M
FAU - Dicuonzo, Giordano
AU  - Dicuonzo G
FAU - Colonna, Giuseppe
AU  - Colonna G
FAU - Montinaro, Antonio
AU  - Montinaro A
FAU - Di Sciascio, Germano
AU  - Di Sciascio G
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20120512
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Angioplasty, Balloon, Coronary
MH  - Antithrombins/administration & dosage/*adverse effects
MH  - Coronary Artery Disease/complications/*therapy
MH  - Diabetes Complications/therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Heart Diseases/epidemiology/etiology
MH  - Heparin/administration & dosage/*adverse effects
MH  - Hirudins/administration & dosage/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Myocardial Infarction/etiology/prevention & control
MH  - Peptide Fragments/administration & dosage/*adverse effects
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/administration & dosage/antagonists & 
      inhibitors
MH  - Postoperative Complications
MH  - Postoperative Hemorrhage/etiology/*prevention & control
MH  - Recombinant Proteins/administration & dosage/adverse effects
MH  - Renal Insufficiency/complications/therapy
MH  - Treatment Outcome
EDAT- 2012/05/16 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/05/16 06:00
PHST- 2012/02/17 00:00 [received]
PHST- 2012/04/08 00:00 [revised]
PHST- 2012/04/08 00:00 [accepted]
PHST- 2012/05/16 06:00 [entrez]
PHST- 2012/05/16 06:00 [pubmed]
PHST- 2012/12/10 06:00 [medline]
AID - S0002-9149(12)01176-9 [pii]
AID - 10.1016/j.amjcard.2012.04.017 [doi]
PST - ppublish
SO  - Am J Cardiol. 2012 Aug 15;110(4):478-84. doi: 10.1016/j.amjcard.2012.04.017. Epub 
      2012 May 12.