Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department.

Abstract

OBJECTIVES:

The objective was to assess the safety and efficacy of bivalirudin monotherapy in patients with high-risk acute coronary syndrome (ACS) presenting to the emergency department (ED).

METHODS:

Data from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial were used to conduct a post hoc subgroup analysis of high-risk ACS patients (cardiac biomarker elevation or ST-segment deviation) who initially presented to the ED. The ACUITY trial randomized patients to receive heparin (unfractionated [UFH] or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Endpoints included composite ischemia, major bleeding (not coronary artery bypass graft (CABG) related), and net clinical outcome (major bleeding plus composite ischemia).

RESULTS:

Of 13,819 participants in the ACUITY trial, 6,441 presented initially to the ED, met high-risk criteria, and were included in the primary analysis. Bivalirudin alone when compared to heparin plus GPI, after adjusting for covariates, was associated with an improvement in net clinical outcome (12.3% vs. 14.3%, adjusted odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.66 to 0.99), similar composite ischemia (9.3% vs. 9.1%, adjusted OR = 0.98, 95% CI = 0.77 to 1.24), and less major bleeding (4.0% vs. 6.8%, adjusted OR = 0.57, 95% CI = 0.42 to 0.75). Bivalirudin plus GPI when compared to heparin plus GPI had similar net clinical outcome (13.8% vs. 14.3%, adjusted OR = 0.91, 95% CI = 0.75 to 1.11), composite ischemia (8.8% vs. 9.1%, adjusted OR = 0.87, 95% CI = 0.69 to 1.11), and major bleeding (6.8% vs. 6.8%, adjusted OR = 1.01, 95% CI = 0.79 to 1.30).

CONCLUSIONS:

Bivalirudin monotherapy decreases major bleeding while providing similar protection from ischemic events compared to heparin plus GPI in patients with high-risk ACS admitted through the ED.

• Authors: Chadwick D Miller, Andra L Blomkalns, Bernard J Gersh, Charles V Pollack, Gerard X Brogan, Deborah B Diercks, W Frank Peacock, Gregg W Stone, Judd E Hollander, Steven V Manoukian, James W Hoekstra, ACUITY Investigators
• Journal: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine (Acad Emerg Med) Vol. 16 Issue 8 Pg. 717-25 (Aug 2009) ISSN: 1553-2712 [Electronic] United States
• PMID: 19673711 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticoagulants
• Enoxaparin
• Hirudins
• Peptide Fragments
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Acute Coronary Syndrome (drug therapy)
• Aged
• Anticoagulants (therapeutic use)
• Chi-Square Distribution
• Comorbidity
• Emergency Service, Hospital
• Enoxaparin (therapeutic use)
• Female
• Heparin (therapeutic use)
• Hirudins
• Humans
• Logistic Models
• Male
• Middle Aged
• Peptide Fragments (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Treatment Outcome
• Triage