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.

Abstract

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.

• Authors: Harvey D White, E Magnus Ohman, A Michael Lincoff, Michel E Bertrand, Antonio Colombo, Brent T McLaurin, David A Cox, Stuart J Pocock, James A Ware, Steven V Manoukian, Alexandra J Lansky, Roxana Mehran, Jeffrey W Moses, Gregg W Stone
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 52 Issue 10 Pg. 807-14 (Sep 02 2008) ISSN: 1558-3597 [Electronic] United States
• PMID: 18755342 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Anticoagulants
• Enoxaparin
• Fibrinolytic Agents
• Hirudins
• Peptide Fragments
• Platelet Glycoprotein GPIIb-IIIa Complex
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Acute Coronary Syndrome (drug therapy, mortality, therapy)
• Adult
• Aged
• Aged, 80 and over
• Angioplasty, Balloon, Coronary
• Anticoagulants (adverse effects, therapeutic use)
• Drug Therapy, Combination
• Enoxaparin (adverse effects, therapeutic use)
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Heparin (adverse effects, therapeutic use)
• Hirudins (adverse effects)
• Humans
• Male
• Middle Aged
• Peptide Fragments (adverse effects, therapeutic use)
• Platelet Glycoprotein GPIIb-IIIa Complex (antagonists & inhibitors)
• Recombinant Proteins (adverse effects, therapeutic use)
• Risk Factors
• Time Factors