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ACUITY
Acute Catheterization and Urgent Intervention Triage Strategy
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Author(s) |
(a) Stone GW, Bertrand M, Colombo A, Dangas G, Farkouh ME, Feit F, Lansky AJ, Lincoff AM, Mehran R, Moses JW, Ohman M, White HD
(b) Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht H-J, Hoekstra J, Mehran R, Ohman EM |
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Title(s) |
(a) Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: Study design and rationale
(b) Bivalirudin for patients with acute coronary syndromes |
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Reference(s) |
(a) Am Heart J 2004;148:764–75
(b) N Engl J Med 2006;355:2203–16 |
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Disease |
Acute coronary syndromes |
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Purpose |
To evaluate the role of thrombin-specific anticoagulation therapy with bivalirudin in moderate and high-risk patients with acute coronary syndromes undergoing an early invasive strategy |
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Study design |
Randomised, open |
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Follow-up |
30 days |
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Patients |
13,819 patients (4603 heparin plus a GP IIb/IIIa inhibitor, 4604 bivalirudin plus a GP IIb/IIIa inhibitor, 4612 bivalirudin alone), mean age 63 years, with moderate and high-risk acute coronary syndromes |
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Treatment regimen |
Unfractionated heparin or enoxaparin plus a GP IIb/IIIa inhibitor, or bivalirudin plus a GP IIb/IIIa inhibitor, or bivalirudin alone |
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Results |
Bivalirudin plus a GP IIb/IIIa inhibitor, as compared to heparin plus a GP IIb/IIIa inhibitor, was associated with non-inferior rates of the composite ischaemia endpoint (7.7% vs 7.3%; relative risk 1.07; 95% CI 0.92–1.23; p = 0.007), major bleeding (5.3% vs 5.7%; relative risk 0.93; 95% CI 0.78–1.10; p < 0.001), and the net clinical outcome (11.8% vs 11.7%; relative risk 1.01; 95% CI 0.90–1.12; p < 0.001). Bivalirudin alone, as compared to heparin plus a GP IIb/IIIa inhibitor, was associated with a non-inferior rate of the composite ischaemia endpoint (7.8% vs 7.3%; relative risk 1.08; 95% CI 0.93–1.24; p = 0.32), significantly reduced major bleeding (3.0% vs 5.7%; relative risk 0.53; 95% CI 0.43–0.65; p < 0.001) and the net clinical outcome (10.1% vs 11.7%; relative risk 0.86; 95% CI 0.77–0.97; p = 0.02) |
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Comments |
This study has been the basis for a number of publications. A selection of references:
Age
– Lopes RD et al, J Am Coll Cardiol 2009;53:1021–30
Arterial access site
– Hamon M et al, EuroIntervention 2009;5:115–20
Bivalirudin during PCI
– Stone GW et al, Lancet 2007;369:907–19
Chronic kidney disease
– Mehran R et al, J Am Coll Cardiol Interv 2009;2:748–57
Early stent thrombosis
– Aoki J et al, Circulation 2009;119:687–98
Gender
– Lansky AL et al, Am J Cardiol 2009;103:1196–203
Initial presentation to the emergency department
– Miller CD et al, Acad Emerg Med 2009;16:717–25
Major bleeding and mortality
– Manoukian SV et al, J Am Coll Cardiol 2007;49:1362–8
Optimal use of GP IIb/IIIa inhibitors
– Stone GW et al, JAMA 2007;297:591–602
1-year ischaemic outcomes
– Stone GW et al, JAMA 2007;298:2497–506
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