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ISAR REACT 3A: Lower dose unfractionated heparin led to decreased bleeding vs. higher dose

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European Society of Cardiology Congress 2010

Patients who underwent percutaneous coronary intervention and were given 100 U/kg unfractionated heparin experienced a reduction in bleeding when compared with those treated with 140 U/kg unfractionated heparin, new study data indicated.

The Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3A trial consisted of patients (n=2,505) with negative biomarkers. Patients underwent PCI after clopidogrel pretreatment and received a single bolus of 100 U/kg unfractionated heparin (UFH). Researchers defined the primary endpoint as net clinical outcome, which was a quadruple endpoint of death, MI, urgent target vessel revascularization within 30 days, or in-hospital REPLACE-2 trial-defined major bleeding.

According to study results, the primary endpoint incidence was 7.3% in the lower UFH dose group vs. 8.7% in the higher UFH dose group (140 U/kg; HR=0.81; 95% CI, 0.67-1.00), whereas the incidence of major bleeding was 3.6% in the lower UFH dose group vs. 4.6% in the higher dose group (HR=0.79; 95% CI, 0.59-1.05). Furthermore, researchers found lower dose UFH met the criterion of non-inferiority vs. bivalirudin (Angiomax, The Medicines Company; P<.001).

“In biomarker negative patients undergoing PCI, a reduction in heparin dose from 140 to 100 U/kg provides net clinical benefit. The benefit was mostly driven by a reduction in bleeding,” Stefanie Schulz, MD, with the German Heart Center in Munich, and researcher on the study, said in her presentation. “The lower UHF dose also provided non-inferior net clinical outcome compared with the bivalirudin group.”

In the presentation’s discussant report, Christian Hamm, MD,with the Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany, said the message to take away from this trial is that patients should be treated with no more than 100 U/kg of UHF in elective PCI, and that smaller dosages may be equally beneficial.

Schulz S. Session 707009–707010.

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