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Acute Catheterization and Urgent Intervention Triage Strategy Trial - PCI Subgroup: 30-Day and 1-Year Results - ACUITY PCI: 30-day and 1-Year Results
Description:
The goal of the substudy was to evaluate treatment with heparin plus glycoprotein (GP) IIb/IIIa inhibition compared with bivalirudin with or without GP IIb/IIIa inhibition among patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).
Study Design
- Randomized
Patients Screened: 13,819
Patients Enrolled: 7,789
Mean Follow Up: 1 year
Mean Patient Age: 63 years
Female: 27
Patient Populations:
Enrollment in the ACUITY trial and performance of PCI
Primary Endpoints:
- Composite of death, MI, unplanned revascularization for ischemia, and major bleeding at 30 days
- Composite of death, MI, and unplanned revascularization for ischemia at 30 days
- Major bleeding at 30 days
- Composite ischemia at 1 year
- Death at 1 year
Drug/Procedures Used:
Patients were randomized to unfractionated heparin (UFH) or enoxaparin (enox) plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibitor, or bivalirudin alone. In the last arm, GP IIb/IIIa inhibitors could be used when needed for "bailout" with suboptimal results.
In the first two arms, patients underwent a second randomization to either GP IIb/IIIa inhibitor administration upstream prior to angiography or during PCI. Patients then underwent cardiac catheterization within 72 hours. The data in the present analysis are for patients who underwent PCI (n = 7,789).
Concomitant Medications:
Patients received aspirin (300-325 mg orally, or 250-500 mg intravenously). Aspirin was continued indefinitely. At least 300 mg of clopidogrel was given within 2 hours after PCI. Clopidogrel was given for at least 1 year.
Principal Findings:
Among the PCI cohort, 65% were troponin positive at baseline. GP IIb/IIIa inhibitors were used in 9% of the bivalirudin alone group and 97% of the GP IIb/IIIa arms. Median time from admission to angiography was ~19.5 hours. Drug-eluting stents were used in 60% of patients.
The primary net clinical benefit endpoint occurred in 13.5% of the UFH/enox plus GP IIb/IIIa group, 15.1% of the bivalirudin plus GP IIb/IIIa group, and 11.7% of the bivalirudin alone group. The composite ischemic endpoint occurred in 8.2% of the UFH/enox plus GP IIb/IIIa group, 9.3% of the bivalirudin plus GP IIb/IIIa group, and 8.8% of the bivalirudin alone group. Major bleeding was lower with bivalirudin (3.5%) than the other groups (6.8% for UFH/enox plus GP IIb/IIIa; 7.5% for bivalirudin plus GP IIb/IIIa), as was the need for transfusion (1.7% for bivalirudin vs. 3.0% for UFH/enox plus GP IIb/IIIa; 3.9% for bivalirudin plus GP IIb/IIIa). There was no difference in death (0.9%, 1.1%, 1.1%, for UFH/enox plus GP IIb/IIIa, bivalirudin plus GP IIb/IIIa, and bivalirudin alone, respectively) or myocardial infarction (MI) (5.6%, 6.6%, 6.5%, respectively).
Among the subgroup of patients who were troponin positive (n = 2,949), the ischemic composite endpoint occurred in 8.1% of the UFH/enox plus GP IIb/IIIa group and 9.1% of the bivalirudin group (relative risk [RR] 1.12, 95% confidence interval [CI] 0.88-1.42). Among the subgroup of patients treated with a thienopyridine prior to PCI (n = 3,511), there was no difference in the ischemic composite endpoint (8.4% vs. 8.1%, RR 0.96, 95% CI 0.77-1.20); however, among patients not treated with a thienopyridine prior to PCI (n = 1,615), the ischemic composite endpoint occurred significantly less frequently in the UFH/enox plus GP IIb/IIIa group (7.5% vs. 10.3%, RR 1.37, 95% CI 1.00-1.88).
At 1 year, composite ischemia occurred in 17.8% of the UFH/enox plus GP IIb/IIIa group, 19.4% of the bivalirudin plus GP IIb/IIIa group, and 19.2% of the bivalirudin alone group (p = ns, between groups). All-cause mortality occurred in 3.2% of the UFH/enox plus GP IIb/IIIa group, 3.3% of the bivalirudin plus GP IIb/IIIa group, and 3.1% of the bivalirudin alone group (p = ns, between groups). MI occurred in 7.8% of the UFH/enox plus GP IIb/IIIa group, 9.1% of the bivalirudin plus GP IIb/IIIa group, and 9.3% of the bivalirudin alone group (p = 0.06, bivalirudin alone compared with heparin plus GP IIb/IIIa inhibitor).
Interpretation:
Among patients with ACS who underwent PCI in the ACUITY trial, treatment with bivalirudin alone was associated with a reduction in the net clinical benefit endpoint compared with UFH/enox plus GP IIb/IIIa inhibitors, driven by a reduction in bleeding. The composite ischemic endpoint was similar in patients treated with a thienopyridine prior to PCI, but was lower with UFH/enox plus GP IIb/IIIa inhibitors compared with bivalirudin alone in patients not treated with a thienopyridine prior to PCI.
Composite ischemia and all-cause mortality at 1 year was similar between the three groups. MI was nonsignificantly increased in the bivalirudin alone group compared with the heparin plus GP IIb/IIIa inhibitor group.
References:
White HD, Ohman EM, Lincoff AM, et al. Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention: 1-year results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. J Am Coll Cardiol 2008;52:807-14.
Stone GW, et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the ACUITY trial. Lancet 2007;369:907-19.
Presented by Dr. Gregg W. Stone at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Keywords: Myocardial Infarction, Acute Coronary Syndrome, Drug-Eluting Stents, Cardiac Catheterization, Heparin, Coronary Disease, Hirudins, Platelet Membrane Glycoprotein IIb, Percutaneous Coronary Intervention, Thienopyridines, Enoxaparin, Recombinant Proteins, Peptide Fragments, Troponin, Platelet Glycoprotein GPIIb-IIIa Complex
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