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 - 05/08/11
, Shamir Mehta, MD, MSc d, k, Sanjit Jolly, MD d, k, Denis Xavier, MD e, k, Hans-Juergen Rupprecht, MD f, k, Jose Luis Lopez-Sendon, MD g, k, Susan Chrolavicius, BScN d, Sunil V. Rao, MD h, k, Christopher B. Granger, MD h, k, Janice Pogue, MSc, MA i, Shiona Laing, BSc j, Salim Yusuf, FRS(C), DPhil d, kRésumé |
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.
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| RCT reg no. NCT00790907. |
Vol 160 - N° 6
P. 1029 - décembre 2010 Retour au numéro
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