The Medicines Company has announced that a sub-analysis of the ACUITY (Acute Catheterisation and Urgent Intervention Triage strategY) study, published in September in the Journal of American College of Cardiology, shows that Angiomax (bivalirudin) monotherapy provides moderate- and high-risk (unstable angina [UA]/non-ST elevation myocardial infarction) acute coronary syndrome (ACS) patients , who are undergoing percutaneous coronary intervention (PCI), with similar results from ischaemic events and death versus standard therapy (unfractionated heparin [UFH] or enoxaparin plus a glycoprotein [GP] IIb/IIIa inhibitor) as measured at one-year post-PCI.
Additionally, as previously reported in The Lancet, patients in the PCI subset of ACUITY who were treated with Angiomax experienced a 41% reduction in bleeding at 30 days compared to standard treatment.
“These findings are important as the data suggest treatment with Angiomax provides similar protection against ischaemia and death over standard therapy at one-year. Furthermore, at 30 days we saw Angiomax reduced major bleeding. Multiple studies have shown a significant association between bleeding complications in ACS and PCI with mortality,” said Dr Harvey White, Green Lane Hospital, Auckland, New Zealand, one of primary investigators and author of the study. “The data from the ACUITY sub-analysis suggest treatment with Angiomax is an attractive antithrombotic therapeutic option for patients undergoing PCI.”
The analysis of the ACUITY-PCI subset assessed the impact of treatment with Angiomax within 30 days and on 1-year outcomes in 7,789 moderate- and high-risk ACS patients undergoing PCI compared to standard therapy. In the study, patients were randomised to UFH or enoxaparin plus a GP IIb/IIIa inhibitor, Angiomax plus a GP IIb/IIIa inhibitor, or Angiomax alone. Endpoints included assessment of composite ischaemia, defined as death, myocardial infarction, or unplanned revascularisation, mortality at one-year and highlighted the impact of bleeding.