title: 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.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  FUTURA/OASIS 8 will help define the optimal UFH regimen as adjunct to PCI in high-risk NSTE-ACS patients treated with fondaparinux.
authors.affiliation: INSERM U-698, Recherche Clinique en Athérothrombose, Université Paris 7, Denis Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France. gabriel.steg@bch.aphp.fr
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Shamir
authors.initials: S
authors.lastname: Mehta
authors.forename: Sanjit
authors.initials: S
authors.lastname: Jolly
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.forename: Hans-Juergen
authors.initials: HJ
authors.lastname: Rupprecht
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Lopez-Sendon
authors.forename: Susan
authors.initials: S
authors.lastname: Chrolavicius
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Shiona
authors.initials: S
authors.lastname: Laing
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage; D017023:Coronary Angiography; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005170:Factor X; D005260:Female; D005500:Follow-Up Studies; D000077425:Fondaparinux; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007275:Injections, Intravenous; D007432:Intraoperative Period; D008297:Male; D009204:Myocardial Revascularization / Q000379:methods*; D011134:Polysaccharides / Q000008:administration & dosage*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D005170:Factor X; D006493:Heparin; D000077425:Fondaparinux