TY - JOUR
T1 - Safety and Efficacy of Switching From Either Unfractionated Heparin or Enoxaparin to Bivalirudin in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Managed With an Invasive Strategy. Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial
AU - White, Harvey D.
AU - Chew, Derek P.
AU - Hoekstra, James W.
AU - Miller, Chadwick D.
AU - Pollack, Charles V.
AU - Feit, Frederick
AU - Lincoff, A. Michael
AU - Bertrand, Michel
AU - Pocock, Stuart
AU - Ware, James
AU - Ohman, E. Magnus
AU - Mehran, Roxana
AU - Stone, Gregg W.
N1 - Funding Information:
Dr. White has received consulting fees and lecture fees from The Medicines Company and Sanofi-Aventis and grant support from The Medicines Company, Sanofi-Aventis, Proctor & Gamble, Schering-Plough, Eli Lilly & Co., Alexion, Merck, Neuron Pharmaceuticals, GlaxoSmithKline, Pfizer, Roche, Fournier Laboratories, and Johnson & Johnson. Dr. Chew is on the Speakers' Bureau for Sanofi-Aventis and Commonwealth Serum Laboratory Biotherapeutics, Australia. Dr. Hoekstra is on the Speakers' Bureau for Bristol-Myers Squibb, Sanofi-Aventis, and Schering-Plough, and is a consultant for The Medicines Company, Sanofi-Aventis, and Schering-Plough. Dr. Pollack is a consultant for The Medicines Company, Sanofi-Aventis, Schering-Plough, and Bristol-Myers Squibb; he is also on the Speakers' Bureau for Sanofi-Aventis and Schering-Plough and receives direct research support from GlaxoSmithKline. Dr. Feit is a consultant to The Medicines Company and has stock in Johnson & Johnson, Millennium Pharmaceuticals, and The Medicines Company. Dr. Lincoff has received grant support from The Medicines Company. Dr. Bertrand is on the Advisory Board of Nycomed in Europe. Dr. Pocock has received consulting fees from The Medicines Company. Dr. Ware is a consultant to The Medicines Company, Biogen, InfraReDx, and Schering-Plough. Dr. Ohman has received consulting fees from The Medicines Company, Sanofi-Aventis, Liposcience, Inovise Medical, Response Biomedical, and Savacor, has equity interests in Medtronic and Savacor, has received lecture fees from Schering-Plough, Bristol-Myers Squibb, and Datascope, and has received grant support from Schering-Plough, Bristol-Myers Squibb, and Berlex. Dr. Mehran has received lecture fees from The Medicines Company, Cordis, and Boston Scientific. Dr. Stone has received consulting fees from The Medicines Company.
PY - 2008/5/6
Y1 - 2008/5/6
N2 - Objectives: The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to bivalirudin monotherapy. Background: Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to bivalirudin monotherapy. Methods: We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or bivalirudin monotherapy. Results: Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to bivalirudin. Patients switching to bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p < 0.01), and improved net clinical outcomes (9.2% vs. 11.9%, p < 0.01) than those on consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy who were administered bivalirudin (n = 1,427) had similar rates of ischemia (6.2% vs. 5.5%, p = 0.47), less major bleeding (2.5% vs. 4.9%, p < 0.001), and similar net clinical outcomes (8.0% vs. 9.4%, p = 0.17) compared with naive patients administered UFH/ENOX plus a GP IIb/IIIa inhibitor (n = 1,462). Conclusions: Switching from UFH/ENOX to bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
AB - Objectives: The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to bivalirudin monotherapy. Background: Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to bivalirudin monotherapy. Methods: We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or bivalirudin monotherapy. Results: Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to bivalirudin. Patients switching to bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p < 0.01), and improved net clinical outcomes (9.2% vs. 11.9%, p < 0.01) than those on consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy who were administered bivalirudin (n = 1,427) had similar rates of ischemia (6.2% vs. 5.5%, p = 0.47), less major bleeding (2.5% vs. 4.9%, p < 0.001), and similar net clinical outcomes (8.0% vs. 9.4%, p = 0.17) compared with naive patients administered UFH/ENOX plus a GP IIb/IIIa inhibitor (n = 1,462). Conclusions: Switching from UFH/ENOX to bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
UR - http://www.scopus.com/inward/record.url?scp=43049084442&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2007.12.052
DO - 10.1016/j.jacc.2007.12.052
M3 - Article
C2 - 18452778
AN - SCOPUS:43049084442
SN - 0735-1097
VL - 51
SP - 1734
EP - 1741
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 18
ER -