Abstract 4589: Anti-thrombotic Strategies in Patients with Elevated Biomarkers Undergoing PCI: Results from the ACUITY Trial
Background: Among patients with non ST-segment elevation acute coronary syndromes (ACS), those with biomarker elevation represent a high-risk cohort. The optimal anticoagulation strategy during PCI in this group remains controversial. We therefore examined the clinical outcomes among biomarker positive patients in the ACUITY trial who underwent PCI.
Methods: In ACUITY 13,819 patients with ACS were randomized to bivalirudin alone vs. bivalirudin plus glycoprotein IIb/IIIa inhibitor (GPI) vs. heparin plus GPI among; 7,789 patients underwent PCI, of whom 4,687 were biomarker (troponin and/or CKMB) positive. The primary endpoints at 30 days were composite ischemia (death, MI, or unplanned TVR for ischemia), major bleeding not related to CABG, and net adverse clinical events (NACE; composite ischemia or major bleeding).
Results: Of the biomarker positive patients undergoing PCI, 1,611 were randomized to bivalirudin alone, 1,532 to heparin plus GPI, and 1,544 to bivalirudin plus GPI. The groups were well balanced for age, gender, and major co-morbidities such as diabetes, hypertension, hyperlipidemia, prior MI, renal insufficiency and TIMI risk score (p ≥ 0.1 for all). 30-day and 1 year outcomes are shown. Among the patients pre-treated with a thienopyridine, bivalirudin compared to heparin plus GPI resulted in reduced major bleeding (3.9% vs. 6.8%, p=0.003) and comparable rates of composite ischemia (8.4% vs. 8.1%, p=0.73) and NACE (11.5% vs. 13.1%, p=0.17).
Conclusions: In biomarker positive ACS patients undergoing PCI, bivalirudin alone suppresses adverse ischemic events to a similar extent as does heparin plus GPI while decreasing major bleeding complications.