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Acute Catheterization and Urgent Intervention Triage Strategy Timing Trial - ACUITY Timing Trial
Description:
The goal of the trial was to evaluate early emergency department adminstration of glycoprotein (GP) IIb/IIIa inhibition compared with catheterization laboratory administration of GP IIb/IIIa inhibition as needed among patients with acute coronary syndromes.
Study Design
Study Design:
Mean Follow Up: One year (30 days reported to date)
Mean Patient Age: Median age 63 years
Female: 30
Patient Populations:
Unstable angina or non ST-segment elevation MI with 10 minutes of cardiac chest pain within 24 hours, plus one of the following: troponin or CK-MB elevation, dynamic EKG changes, documented prior coronary artery disease, or all of the following four features: 1) age ≥65 years; 2) aspirin taken in prior 7 days; 3) ≥2 episodes of angina in the prior 24 hours; 4) ≥3 of the following risk factors: hypertension, hypercholesterolemia, family history or coronary artery disease, diabetes, current smoker.
Exclusions:
Anticipated inability to perform angiography within 72 hours of randomization, or indicated revascularization within the index hospitalization; acute ST elevation MI; cardiogenic shock; bleeding diathesis or history of intracerebral mass, aneurysm, arteriovenous malformation, hemorrhagic stroke, or gastrointestinal or genitourinary bleeding within the preceding 2 weeks; platelet count <100,000/mm3 at baseline or history of heparin induced thrombocytopenia; baseline INR >1.5 times control; treatment with bivalirudin, thrombolytic therapy, fondaparinux, abciximab, another GPIIb/IIIa inhibitor that cannot be discontinued, or ≥2 doses of LMWH for the current admission; calculated creatinine clearance <30 mL/min; absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications.
Primary Endpoints:
1) Composite of death, myocardial infarction, unplanned revascularization for ischemia, and major bleeding at 30 days; 2) Composite of death, myocardial infarction, and unplanned revascularization for ischemia at 30 days; 3) Major bleeding at 30 days
Drug/Procedures Used:
Patients were randomized to either GP IIb/IIIa inhibitor administration upstream prior to angiography (n=4605) or during PCI as needed (n=4602). Patients then underwent cardiac catheterization within 72 hours with either percutaneous coronary intervention (PCI), surgical revascularization, or medical management
Concomitant Medications:
Aspirin; clopidogrel at the physician discretion
Principal Findings:
Cardiac enzymes (troponin or CKMB) were elevated at baseline in 59% of patients and 35% had dynamic ST-segment changes. The management strategy following catheterization was PCI in 57% of patients, CABG in 11%, and medical therapy in 32% of patients. GP inhibitors were administered to 98% of patients in the early administration group and 56% of patients in the delayed administration group (96% of PCI patients). Angiography was performed an average of 6.2 hours after randomization. GP IIb/IIIa inhibitor was used pre-angiography in 94.2% of the upstream group and 4.6% of the delayed group.
The primary endpoint of net clinical benefit was non-inferior for upstream compared with delayed administration (11.7% each, p<0.001 for non-inferiority). The triple ischemic endpoint did not meet the criteria for non-inferiority (7.1% for upstream vs 7.9% for delayed, p=NS for non-inferiority; p=0.13 for superiority). Major bleeding was significantly lower in the delayed group (4.9% vs 6.1%, p=0.009). There was no difference in bleeding when using the TIMI major bleed criteria (1.9% vs 1.6%, p=0.20) but TIMI minor bleeding was lower in the delayed group (5.4% vs 7.1%, p<0.001). There was no difference in mortality (1.3% for upstream vs 1.5% for delayed) or MI (4.9% vs 5.0%) but unplanned revascularization for ischemia was lower in the upstream group (2.1% vs 2.8%, p=0.03 for superiority). In the cohort of patients who received PCI (n=5170), the composite ischemic endpoint was significantly lower in the upstream therapy group (8.0% vs 9.5%, p=0.05).
Interpretation:
Among patients with acute coronary syndromes, upstream therapy with a GP IIb/IIIa inhibitor was non-inferior for the net-clinical benefit endpoint compared with delayed administration of GP IIb/IIIa inhibitor therapy, but did not meet the criteria for non-inferiority for the ischemic endpoint.
References:
Stone GW, et al. Routine Upstream Initiation vs Deferred Selective Use of Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes. The ACUITY Timing Trial. JAMA. 2007;297:591-602.
Presented by Dr. Gregg W. Stone at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.
Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Cardiac Catheterization, Emergency Service, Hospital, Hypercholesterolemia, Hirudins, Platelet Membrane Glycoprotein IIb, Percutaneous Coronary Intervention, Recombinant Proteins, Peptide Fragments, Hypertension, Diabetes Mellitus, Troponin, Platelet Glycoprotein GPIIb-IIIa Complex
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