The long-term outcomes associated with bivalirudin monotherapy adjunctive to early intervention in patients with acute coronary syndromes (ACS) are unknown.OBJECTIVE
To assess the 1-year outcomes associated with three different antithrombotic strategies in patients undergoing early intervention for ACS.DESIGN
The ACUITY trial was an international, prospective, randomized study. Patients were eligible for inclusion if they were aged 18 years or older, had symptoms of unstable angina during the 24 h before enrollment, and met one or more of the following criteria: known coronary artery disease, ST-segment depression or transient elevation of 1 mm or more, elevation in troponin I or T or in creatine kinase MB, or presence of any of the other Thrombolysis In Myocardial Infarction risk factors. Patients were excluded if they had major bleeding, acute ST-segment elevation or shock, renal dysfunction, or thrombo cytopenia.INTERVENTION
Patients were randomly assigned to one of three antithrombotic strategies: open-label bivalirudin monotherapy, bivalirudin plus glycoprotein IIb/IIIa inhibitors (GPIs), or heparin (unfractionated or enoxaparin) plus GPIs (control group). Patients receiving GPIs underwent secondary randomization to either deferred selective glycoprotein inhibition in the catheterization laboratory, or routine GPI use immediately after randomization. Treatment type (CABG surgery, percutaneous coronary intervention, or optimal medical therapy) was determined after coronary angiography, which took place within 72 h of randomization.OUTCOME MEASURE
The primary end point was composite ischemia (myocardial infarction, revascularization, or death from any cause).RESULTS
Between 23 August 2003 and 5 December 2005, 13,819 patients were enrolled in the trial. There were 4,612 patients in the bivalirudin monotherapy group, 4,604 patients received bivalirudin plus GPIs, and 4,603 received heparin plus GPIs. In the secondary randomization, 4,605 patients were assigned to the routine GPI group and 4,602 to the deferred selective GPI group. The baseline patient demographics and clinical characteristics were comparable across the treatment groups. At 1-year follow-up, there was no significant difference in the incidence of composite ischemia between the three groups (bivalirudin 16.2% vs control 15.4%, hazard ratio [HR] 1.06, 95% CI 0.95-1.17, P = 0.29; bivalirudin + GPIs 16.0% vs control 15.4%, HR 1.05, 95% CI 0.95-1.16, P = 0.35). There were also no significant differences in mortality between the treatment groups (524 deaths in the entire study population); (bivalirudin 3.8% vs control 3.9%, HR 0.96, 95% CI 0.77-1.18, P = 0.67; bivali-rudin + GPIs 3.9% vs control 3.9%, HR 0.99, 95% CI 0.80-1.22, P = 0.92). Deferred selective GPI use did not statistically alter the 1-year incidence of composite ischemia (16.3% vs 15.2%; P = 0.15) or mortality (4.0% vs 3.8%; P = 0.66) when compared with routine use.CONCLUSION
The incidence of composite ischemia is unaffected by the choice of adjunctive antithrombotic regimen (bivalirudin vs heparin) in patients undergoing early intervention for ACS.