Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department.
OBJECTIVE
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.
Miller
Chadwick D
CD
Department of Emergency Medicine, Wake Forest University School of Medicine, Winston-Salem, NC. cmiller@wfubmc.edu
Blomkalns
Andra L
AL
Gersh
Bernard J
BJ
Pollack
Charles V
CV
Brogan
Gerard X
GX
Diercks
Deborah B
DB
Peacock
W Frank
WF
Stone
Gregg W
GW
Hollander
Judd E
JE
Manoukian
Steven V
SV
Hoekstra
James W
JW
D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D015897:Comorbidity; D004636:Emergency Service, Hospital; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome; D014218:Triage
D000925:Anticoagulants; D017984:Enoxaparin; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin