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ACUITY 1-Year Sub-Analysis Published In Journal Of The American College Of Cardiology

Intervention Triage strategY study, published in the September 2, 2008 issue of 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 ischemic 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 Lancet1 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 ischemia and death over standard therapy at 1-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 Harvey White, MD, Green Lane Hospital, Auckland, New Zealand, Department of Cardiology, 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 randomized 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 ischemia, defined as death, myocardial infarction, or unplanned revascularization, mortality at 1-year and highlighted the impact of bleeding.

Specifically, the results of the ACUITY trial in patients undergoing PCI showed that:

- Patients treated with Angiomax experienced comparable composite ischemia (death, myocardial infarction or unplanned revascularization) and mortality at 1-year compared to patients treated with standard therapy.

-- Composite ischemia results were 19.2% bivalirudin alone, 19.4% bivalirudin plus a GP llb/llla inhibitor vs. 17.8% UFH/ enoxaparin plus a GP llb/llla inhibitor

-- Mortality results were 3.1% bivalirudin alone, 3.3% bivalirudin plus a GP llb/llla inhibitor vs. 3.2% UFH/enoxaparin plus a GP llb/llla inhibitor

- A 30-day analysis showed major bleeding occurred in 7% of the UFH/enoxaparin plus GP IIb/IIIa inhibitor group compared to 4% in the Angiomax alone group (p < 0.0001).

- Patients who experienced major bleeding significantly longer hospital stays than those who did not experience a major bleed (5.0 days vs. 3.0 days, respectively (p





ACUITY de 1 an Sub-Analiza Publicatã în Journal of The American College of Cardiology - ACUITY 1-Year Sub-Analysis Published In Journal Of The American College Of Cardiology - articole medicale engleza - startsanatate