PMID- 18755342 OWN - NLM STAT- MEDLINE DCOM- 20080919 LR - 20161124 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 52 IP - 10 DP - 2008 Sep 2 TI - 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. PG - 807-14 LID - 10.1016/j.jacc.2008.05.036 [doi] AB - OBJECTIVES: This study was designed to determine the impact of bivalirudin on 1-year outcomes in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated that in moderate- and high-risk ACS patients undergoing PCI, bivalirudin alone compared to unfractionated heparin (UFH) or enoxaparin plus a glycoprotein (GP) IIb/IIIa inhibitor resulted in less major bleeding and similar ischemic outcomes at 30 days. The impact of bivalirudin on 1-year outcomes in ACS patients undergoing PCI is unknown. METHODS: In the ACUITY trial, 13,819 patients were enrolled, and 7,789 (56.4%) patients had PCI. Composite ischemia (death, myocardial infarction, or unplanned revascularization) and mortality at 1 year were assessed. RESULTS: Among patients undergoing PCI, 2,561, 2,609, and 2,619 were randomized to UFH or enoxaparin plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibitor, and bivalirudin monotherapy, respectively. At 1 year, there were no differences in composite ischemia (17.8% vs. 19.4% vs. 19.2%, p = NS) or mortality (3.2% vs. 3.3% vs. 3.1%, p = NS) among the 3 groups, respectively. CONCLUSIONS: Bivalirudin compared with UFH or enoxaparin plus a GP IIb/IIIa inhibitor results in similar rates of composite ischemia and mortality at 1 year in moderate- and high-risk ACS patients undergoing PCI. FAU - White, Harvey D AU - White HD AD - Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. HarveyW@adhb.govt.nz FAU - Ohman, E Magnus AU - Ohman EM FAU - Lincoff, A Michael AU - Lincoff AM FAU - Bertrand, Michel E AU - Bertrand ME FAU - Colombo, Antonio AU - Colombo A FAU - McLaurin, Brent T AU - McLaurin BT FAU - Cox, David A AU - Cox DA FAU - Pocock, Stuart J AU - Pocock SJ FAU - Ware, James A AU - Ware JA FAU - Manoukian, Steven V AU - Manoukian SV FAU - Lansky, Alexandra J AU - Lansky AJ FAU - Mehran, Roxana AU - Mehran R FAU - Moses, Jeffrey W AU - Moses JW FAU - Stone, Gregg W AU - Stone GW LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Anticoagulants) RN - 0 (Enoxaparin) RN - 0 (Fibrinolytic Agents) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM MH - Acute Coronary Syndrome/*drug therapy/mortality/therapy MH - Adult MH - Aged MH - Aged, 80 and over MH - *Angioplasty, Balloon, Coronary MH - Anticoagulants/adverse effects/*therapeutic use MH - Drug Therapy, Combination MH - Enoxaparin/adverse effects/*therapeutic use MH - Female MH - Fibrinolytic Agents/adverse effects/*therapeutic use MH - Heparin/adverse effects/*therapeutic use MH - Hirudins/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Peptide Fragments/adverse effects/*therapeutic use MH - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors MH - Recombinant Proteins/adverse effects/therapeutic use MH - Risk Factors MH - Time Factors EDAT- 2008/08/30 09:00 MHDA- 2008/09/20 09:00 CRDT- 2008/08/30 09:00 PHST- 2007/12/12 00:00 [received] PHST- 2008/05/21 00:00 [revised] PHST- 2008/05/27 00:00 [accepted] PHST- 2008/08/30 09:00 [pubmed] PHST- 2008/09/20 09:00 [medline] PHST- 2008/08/30 09:00 [entrez] AID - S0735-1097(08)02050-0 [pii] AID - 10.1016/j.jacc.2008.05.036 [doi] PST - ppublish SO - J Am Coll Cardiol. 2008 Sep 2;52(10):807-14. doi: 10.1016/j.jacc.2008.05.036.