JAMA -- Low-Dose vs Standard-Dose Unfractionated Heparin for Percutaneous Coronary Intervention in Acute Coronary Syndromes Treated With Fondaparinux: The FUTURA/OASIS-8 Randomized Trial, August 31, 2010, The FUTURA/OASIS-8 Trial Group 0 (2010): jama.2010.1320v2

Low-Dose vs Standard-Dose Unfractionated Heparin for Percutaneous Coronary Intervention in Acute Coronary Syndromes Treated With Fondaparinux
The FUTURA/OASIS-8 Randomized Trial

The FUTURA/OASIS-8 Trial Group*


JAMA. Published online August 31, 2010. doi:10.1001/jama.2010.1320

ABSTRACT

Context
The optimal unfractionated heparin regimen for percutaneous coronary intervention (PCI) in patients with non–ST-segment elevation acute coronary syndromes treated with fondaparinux is uncertain.

Objective
To compare the safety of 2 unfractionated heparin regimens during PCI in high-risk patients with non–ST-segment elevation acute coronary syndromes initially treated with fondaparinux.

Design, Setting, and Participants
Double-blind randomized parallel-group trial in 179 hospitals in 18 countries involving 2026 patients undergoing PCI within 72 hours, nested within a cohort of 3235 high-risk patients with non–ST-segment elevation acute coronary syndromes initially treated with fondaparinux enrolled from February 2009 to March 2010.

Interventions
Patients received intravenously either low-dose unfractionated heparin, 50 U/kg, regardless of use of glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitors or standard-dose unfractionated heparin, 85 U/kg (60 U/kg with GpIIb-IIIa inhibitors), adjusted by blinded activated clotting time (ACT).

Main Outcome Measures
Composite of major bleeding, minor bleeding, or major vascular access-site complications up to 48 hours after PCI. Key secondary outcomes include composite of major bleeding at 48 hours with death, myocardial infarction, or target vessel revascularization within day 30.

Results
The primary outcome occurred in 4.7% of those in the low-dose group vs 5.8% in the standard-dose group (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.54-1.19; P = .27). The rates of major bleeding were not different but the rates of minor bleeding were lower with 0.7% in the low-dose group vs 1.7% in the standard-dose group (OR, 0.40; 95% CI, 0.16-0.97; P = .04). For the key secondary outcome, the rates for low-dose group were 5.8% vs 3.9% in the standard-dose group (OR, 1.51; 95% CI, 1.00-2.28; P = .05) and for death, myocardial infarction, or target vessel revascularization it was 4.5% for the low-dose group vs 2.9% for the standard-dose group (OR, 1.58; 95% CI, 0.98-2.53; P = .06). Catheter thrombus rates were very low (0.5% in the low-dose group and 0.1% in the standard-dose group, P = .15).

Conclusion
Low-dose compared with standard-dose unfractionated heparin did not reduce major peri-PCI bleeding and vascular access-site complications.

Trial Registration clinicaltrials.gov Identifier: NCT00790907


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JAMA -- Low-Dose vs Standard-Dose Unfractionated Heparin for Percutaneous Coronary Intervention in Acute Coronary Syndromes Treated With Fondaparinux: The FUTURA/OASIS-8 Randomized Trial, August 31, 2010, The FUTURA/OASIS-8 Trial Group 0 (2010): jama.2010.1320v2