ACUITY: Bivalirudin in Acute Coronary Syndromes -- 1-Year Results

Luis Gruberg, MD, FACC

Disclosures

April 30, 2007

The long-term follow-up of these patients further establishes bivalirudin as the anticoagulant of choice during percutaneous coronary interventions in ACS patients.

The rationale, study design, and early follow-up results of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY)[1] trial have been reported by Medscape Cardiology (see Related Links). At the recent American College of Cardiology (ACC) 56th Annual Scientific Session meeting, the 1-year clinical results of the trial were presented and are described below.

In brief, ACUITY assessed the effect of 3 different anticoagulation strategies in a total of 13,819 moderate- to high-risk acute coronary syndrome (ACS) patients undergoing an invasive strategy. Patients were randomized to either:

  • Unfractionated heparin/enoxaparin;

  • Bivalirudin with a glycoprotein (GP) IIb/IIIa inhibitor; or

  • Bivalirudin alone.

Primary endpoint: Ischemic composite endpoint of death, myocardial infarction (MI), and unplanned revascularization for ischemia.

Presented at last year's ACC meeting, at 30-day follow-up, the combined ischemic endpoint was nearly identical in all 3 arms of the study, and there were no differences in the rate of the individual components of the composite endpoint. These results remained consistent at long-term follow-up with no significant differences in the primary composite endpoint between the 3 groups at 1-year follow-up ( Table ). There were also no differences at 1 year in the rates of MI, unplanned revascularization, or total mortality, and the rate of stent thrombosis remained low, as expected ( Table ). Of note, the rate of MI did not significantly increase between 30-day and 1-year follow-up.

Further analysis of patients who had an MI and major bleeding in the first 30 days following the procedure found that the rate of death at 1 year was 28.9% (Figure).

ACUITY: rate of death at 1 year by incidence of clinical events within 30 days of index procedure.

  1. In patients with moderate- and high-risk ACS undergoing an early invasive strategy with use of GP IIb/IIIa inhibitors, bivalirudin is an acceptable substitute for either unfractionated heparin or enoxaparin.

  2. Compared with either unfractionated heparin/enoxaparin with GP IIb/IIIa inhibitors or bivalirudin with GP IIb/IIIa inhibitors, a bivalirudin-alone strategy results in marked reduction of bleeding at 30 days and yields similar rates of mortality and composite ischemia at 1 year.

  3. The results of this study further establish the important relationship between iatrogenic bleeding complications and subsequent mortality in patients with ACS.

The long-term follow-up of these patients further establishes bivalirudin as the anticoagulant of choice during percutaneous coronary interventions in ACS patients. Its role in non-ACS patients and its economic impact will need to be assessed in further studies. A disturbing note was the very high mortality rates seen in patients who had major bleeding and an MI during the first 30 days.

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