PMID- 21146654
OWN - NLM
STAT- MEDLINE
DCOM- 20110208
LR  - 20181201
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 160
IP  - 6
DP  - 2010 Dec
TI  - Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute 
      coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous 
      unfractionated heparin during percutaneous coronary intervention in patients with 
      non-ST-segment elevation acute coronary syndromes initially treated with 
      fondaparinux.
PG  - 1029-34, 1034.e1
LID - 10.1016/j.ahj.2010.07.037 [doi]
AB  - BACKGROUND: There is uncertainty regarding the optimal adjunctive unfractionated 
      heparin (UFH) regimen for percutaneous coronary intervention (PCI) in patients 
      with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) treated with 
      fondaparinux. OBJECTIVE: The aim of this study is to evaluate the safety of 2 
      dose regimens of adjunctive intravenous UFH during PCI in high-risk patients with 
      NSTE-ACS initially treated with fondaparinux and referred for early coronary 
      angiography. DESIGN: This is an international prospective cohort study of 
      approximately 4,000 high-risk patients presenting to hospital with unstable 
      angina or non-ST-segment elevation myocardial infarction, treated with 
      fondaparinux as initial medical therapy, and referred for early coronary 
      angiography with a view to revascularization. Within this cohort, 2,000 patients 
      undergoing PCI will be eligible for enrollment into a double-blind international 
      randomized parallel-group trial evaluating standard activated clotting time 
      (ACT)-guided doses of intravenous UFH versus a non-ACT-guided weight-adjusted low 
      dose. The standard regimen uses an 85-U/kg bolus of UFH if there is no platelet 
      glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitor or 60 U/kg if GpIIb-IIIa inhibitor 
      use is planned, with additional bolus guided by blinded ACT measurements. The 
      low-dose regimen uses a 50 U/kg UFH bolus, irrespective of planned GpIIb-IIIa 
      use. The primary outcome is the composite of peri-PCI major bleeding, minor 
      bleeding, or major vascular access site complications. The assessment of net 
      clinical benefit is a key secondary outcome: it addresses the composite of 
      peri-PCI major bleeding with death, myocardial infarction, or target vessel 
      revascularization at day 30. CONCLUSION: FUTURA/OASIS 8 will help define the 
      optimal UFH regimen as adjunct to PCI in high-risk NSTE-ACS patients treated with 
      fondaparinux.
CI  - Copyright (c) 2010 Mosby, Inc. All rights reserved.
FAU - Steg, Philippe Gabriel
AU  - Steg PG
AD  - INSERM U-698, Recherche Clinique en Atherothrombose, Universite Paris 7, Denis 
      Diderot, Hopital Bichat, Assistance Publique-Hopitaux de Paris, Paris, France. 
      gabriel.steg@bch.aphp.fr
FAU - Mehta, Shamir
AU  - Mehta S
FAU - Jolly, Sanjit
AU  - Jolly S
FAU - Xavier, Denis
AU  - Xavier D
FAU - Rupprecht, Hans-Juergen
AU  - Rupprecht HJ
FAU - Lopez-Sendon, Jose Luis
AU  - Lopez-Sendon JL
FAU - Chrolavicius, Susan
AU  - Chrolavicius S
FAU - Rao, Sunil V
AU  - Rao SV
FAU - Granger, Christopher B
AU  - Granger CB
FAU - Pogue, Janice
AU  - Pogue J
FAU - Laing, Shiona
AU  - Laing S
FAU - Yusuf, Salim
AU  - Yusuf S
LA  - eng
SI  - ClinicalTrials.gov/NCT00790907
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Anticoagulants)
RN  - 0 (Polysaccharides)
RN  - 9001-29-0 (Factor X)
RN  - 9005-49-6 (Heparin)
RN  - J177FOW5JL (Fondaparinux)
SB  - IM
MH  - Acute Coronary Syndrome/diagnostic imaging/physiopathology/*therapy
MH  - Adult
MH  - Anticoagulants/administration & dosage
MH  - Coronary Angiography
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - *Electrocardiography
MH  - Factor X
MH  - Female
MH  - Follow-Up Studies
MH  - Fondaparinux
MH  - Heparin/*administration & dosage
MH  - Humans
MH  - Injections, Intravenous
MH  - Intraoperative Period
MH  - Male
MH  - Myocardial Revascularization/*methods
MH  - Polysaccharides/*administration & dosage
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/12/15 06:00
MHDA- 2011/02/09 06:00
CRDT- 2010/12/15 06:00
PHST- 2010/06/29 00:00 [received]
PHST- 2010/07/30 00:00 [accepted]
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/02/09 06:00 [medline]
AID - S0002-8703(10)00730-1 [pii]
AID - 10.1016/j.ahj.2010.07.037 [doi]
PST - ppublish
SO  - Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.