PMID- 20381652
OWN - NLM
STAT- MEDLINE
DCOM- 20100615
LR  - 20220318
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 105
IP  - 8
DP  - 2010 Apr 15
TI  - Comparison of bivalirudin and unfractionated heparin plus protamine in patients 
      with coronary heart disease undergoing percutaneous coronary intervention (from 
      the Antithrombotic Regimens aNd Outcome [ARNO] trial).
PG  - 1053-9
LID - 10.1016/j.amjcard.2009.12.001 [doi]
AB  - Previous studies have compared bivalirudin and unfractionated heparin (UFH) plus 
      the routine use of glycoprotein IIb/IIIa inhibitors. They have demonstrated that 
      bivalirudin can decrease bleeding complications without a significant increase in 
      ischemic complications, resulting in a better net clinical outcome, as defined by 
      the efficacy (ischemic complications) or safety (bleeding complications) end 
      point. The aim of the present study was to compare bivalirudin and UFH plus 
      protamine in patients undergoing elective percutaneous coronary intervention and 
      pretreated with clopidogrel and aspirin. We randomly assigned 850 patients with 
      stable or unstable coronary artery disease to bivalirudin or UFH followed by 
      protamine at the end of the percutaneous coronary intervention. The primary end 
      point was in-hospital major bleeding. The main secondary end points were the 
      1-month composite of death, myocardial infarction, unplanned target vessel 
      revascularization; and the 1-month net clinical outcome. The rate of major 
      bleeding (primary end point) was 0.5% in patients randomized to bivalirudin and 
      2.1% in patients randomized to UFH (p = 0.033). At 30 days, the rate of major 
      bleeding was 0.9% in the bivalirudin arm and 2.8% in the UFH arm (p = 0.043). The 
      composite of death, myocardial infarction, and target vessel revascularization 
      rate and the net clinical outcome rate was 2.8% and 6.4% (p = 0.014) and 3.3% and 
      7.8% (p = 0.004), respectively, in the bivalirudin and UFH arms. In conclusion, 
      in percutaneous coronary intervention patients pretreated with clopidogrel and 
      aspirin, bivalirudin was associated with less major bleeding and fewer ischemic 
      complications and a better net clinical outcome than UFH.
CI  - Copyright 2010 Elsevier Inc. All rights reserved.
FAU - Parodi, Guido
AU  - Parodi G
AD  - Division of Cardiology, Careggi Hospital, Florence, Italy.
FAU - Migliorini, Angela
AU  - Migliorini A
FAU - Valenti, Renato
AU  - Valenti R
FAU - Bellandi, Benedetta
AU  - Bellandi B
FAU - Signorini, Umberto
AU  - Signorini U
FAU - Moschi, Guia
AU  - Moschi G
FAU - Buonamici, Piergiovanni
AU  - Buonamici P
FAU - Cerisano, Giampaolo
AU  - Cerisano G
FAU - Antoniucci, David
AU  - Antoniucci D
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20100220
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Heparin Antagonists)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Protamines)
RN  - 0 (Recombinant Proteins)
RN  - 129480-74-6 (ITF 300)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Angioplasty, Balloon, Coronary/*methods
MH  - Anticoagulants/*administration & dosage
MH  - Antithrombins
MH  - Coronary Disease/blood/diagnosis/*therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination
MH  - Electrocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - Hemorrhage/epidemiology/prevention & control
MH  - Hemostasis/*drug effects
MH  - Heparin/administration & dosage/*analogs & derivatives
MH  - Heparin Antagonists/administration & dosage
MH  - Hirudins/*administration & dosage
MH  - Humans
MH  - Incidence
MH  - Infusions, Intravenous
MH  - Italy/epidemiology
MH  - Male
MH  - Peptide Fragments/*administration & dosage
MH  - Protamines/*administration & dosage
MH  - Recombinant Proteins/administration & dosage
MH  - Retrospective Studies
MH  - Treatment Outcome
EDAT- 2010/04/13 06:00
MHDA- 2010/06/16 06:00
CRDT- 2010/04/13 06:00
PHST- 2009/09/30 00:00 [received]
PHST- 2009/12/01 00:00 [revised]
PHST- 2009/12/01 00:00 [accepted]
PHST- 2010/04/13 06:00 [entrez]
PHST- 2010/04/13 06:00 [pubmed]
PHST- 2010/06/16 06:00 [medline]
AID - S0002-9149(09)02829-X [pii]
AID - 10.1016/j.amjcard.2009.12.001 [doi]
PST - ppublish
SO  - Am J Cardiol. 2010 Apr 15;105(8):1053-9. doi: 10.1016/j.amjcard.2009.12.001. Epub 
      2010 Feb 20.