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ACUITY at 1 year
The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial showed that in patients with moderate- and high-risk acute coronary syndromes undergoing early invasive treatment, bivalirudin monotherapy gave non-inferior rates of adverse ischaemic events and decreased rates of major bleeding when compared with heparin plus glycoprotein IIb/IIIa (GP IIb/IIIa) inhibition. ACUITY enrolled 13 819 patients from 450 academic and community-based institutions in 17 countries. Patients were assigned to receive either heparin plus GP IIb/IIIa inhibitors (n = 4603), bivalirudin plus GP IIb/IIIa inhibitors (n = 4604), or bivalirudin monotherapy (n = 4612). Of these patients, 4605 were assigned to routine upstream administration of GP IIb/IIIa inhibitors, and 4602 were deferred to selective administration. The main outcome measure was a composite of death, myocardial infarction, or unplanned revascularisation for ischaemia at 1 year.
At 1 year, 15.4% of patients given heparin plus GP IIb/IIIa inhibitors had one of the composite ischaemic end points, compared with 16.0% of those assigned to bivalirudin plus GPIIb/IIIa inhibitors (p = 0.35) and 16.2% assigned to bivalirudin monotherapy (p = 0.29). Mortality rates in the same treatment groups were 3.9%, 3.9% and 3.8%, respectively. Composite ischaemia occurred in 16.3% of patients assigned to deferred use compared with 15.2% of patients assigned to upstream administration (p = 0.15).
Although not statistically significant, the trend towards lower mortality at 1 year is reassuring given the numerically higher 30-day event rate in the original trial. Bleeding at 30 days was a significant predictor of mortality, therefore the reduced rates in the bivalirudin group may have levelled the mortality outcomes at 1 year. Combined with the recent HORIZONS trial, which showed a reduction in mortality at 30 days in patients with ST-elevation acute coronary syndrome receiving bivalirudin, it now at least appears to be a serious alternative to heparin and GP II6/IIIa inhibitors.
Stone GW, Ware JH, Bertrand ME. Antithrombotic strategies in patients …