Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management - One-year results from the ACUITY trial


Stone, GW; Ware, JH; Bertrand, ME; Lincoff, AM; Moses, JW; Ohman, EM; White, HD; Feit, F; Colombo, A; McLaurin, BT; Cox, DA; Manoukian, SV; Fahy, M; Clayton, TC; Mehran, R; Pocock, SJ; (2007) Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management - One-year results from the ACUITY trial. JAMA, 298 (21). pp. 2497-2506. ISSN 0098-7484 DOI: https://doi.org/10.1001/jama.298.21.2497

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Abstract

Context At 30-day follow-up, patients with moderate-and high-risk acute coronary syndromes (ACS) undergoing early invasive treatment in the ACUITY trial with bivalirudin monotherapy vs heparin plus glycoprotein ( GP) IIb/IIIa inhibitors had noninferior rates of adverse ischemic events with reduced rates of major bleeding. Deferred upstream use of GP IIb/IIIa inhibitors for selective administration to patients undergoing percutaneous coronary intervention (PCI) resulted in a significant reduction in major bleeding, although a small increase in composite ischemia could not be excluded. Objective To determine 1-year ischemic outcomes for patients in the ACUITY trial. Design, Setting, and Patients A prospective, randomized, open-label trial with 1-year clinical follow-up at 450 academic and community-based institutions in 17 countries. A total of 13 819 patients with moderate- and high-risk ACS undergoing invasive treatment were enrolled between August 23, 2003, and December 5, 2005. Interventions Patients were assigned to 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 GP IIb/IIIa administration and 4602 were deferred to selective GP IIb/IIIa inhibitor administration. Main Outcome Measure Composite ischemia ( death, myocardial infarction, or unplanned revascularization for ischemia) at 1 year. Results Composite ischemia at 1 year occurred in 15.4% of patients assigned to heparin plus GP IIb/IIIa inhibitors and 16.0% assigned to bivalirudin plus GP IIb/ IIIa inhibitors ( compared with heparin plus GP IIb/ IIIa inhibitors, HR, 1.05; 95% Cl, 0.951.16; P=.35), and 16.2% assigned to bivalirudin monotherapy (HR, 1.06; 95% Cl, 0.95-1.17; P=.29). Mortality at 1 year occurred in an estimated 3.9% of patients assigned to heparin plus GP IIb/ IIIa inhibitors, 3.9% assigned to bivalirudin plus GP IIb/ IIIa inhibitors ( HR, 0.99; 95% Cl, 0.80-1.22; P=.92), and 3.8% assigned to bivalirudin monotherapy ( HR, 0.96; 95% Cl, 0.77-1.18; P=.67). Composite ischemia occurred in 16.3% of patients assigned to deferred use compared with 15.2% of patients assigned to upstream administration ( HR, 1.08; 95% Cl, 0.97-1.20; P=.15). Conclusions At 1 year, no statistically significant difference in rates of composite ischemia or mortality among patients with moderate- and high-risk ACS undergoing invasive treatment with the 3 therapies was found. There was no statistically significant difference in the rates of composite ischemia between patients receiving routine upstream administration of GP IIb/ IIIa inhibitors vs deferring their use for patients undergoing PCI. Trial Registration clinicaltrials. gov Identifier: NCT00093158.

Item Type: Article
Keywords: Acute Coronary Syndrome, drug therapy, therapy, Aged, Angioplasty, Transluminal, Percutaneous Coronary, Anticoagulants, therapeutic use, Drug Therapy, Combination, Female, Fibrinolytic Agents, therapeutic use, Heparin, therapeutic use, Hirudins, Humans, Kaplan-Meiers Estimate, Male, Middle Aged, Myocardial Ischemia, epidemiology, Peptide Fragments, therapeutic use, Platelet Aggregation Inhibitors, therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex, antagonists & inhibitors, Recombinant Proteins, therapeutic use, Treatment Outcome
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
Research Centre: Centre for Global Non-Communicable Diseases (NCDs)
PubMed ID: 18056903
Web of Science ID: 251361900015
URI: http://researchonline.lshtm.ac.uk/id/eprint/7861

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