There are limited data on bivalirudin
monotherapy in patients with non-ST-segment elevation acute coronary syndromes
(NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin
and/or creatine kinase-myocardial band
isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin
monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.
Patients and methods
We compared the net adverse clinical events [composite ischemia – (death, myocardial infarction, or unplanned ischemic revascularization) – or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy.
Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin
plus GPI, and 1626 to bivalirudin
monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P
= 0.04), all-cause death (1.3 vs. 0.5%; P
= 0.001), cardiac death (1.1 vs. 0.5%; P
= 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P
= 0.03). At 30 days, bivalirudin
monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin
monotherapy 4.1% vs. bivalirudin
plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin
monotherapy 9.2% vs. bivalirudin
plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin
monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis.
Compared with heparin plus GPI or bivalirudin
plus GPI, bivalirudin
monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.