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

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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)717-725
Number of pages9
JournalAcademic Emergency Medicine
Volume16
Issue number8
DOIs
StatePublished - Aug 2009

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Hospital Emergency Service
Enoxaparin
Odds Ratio
Confidence Intervals
Safety
Hemorrhage
Triage
Acute Coronary Syndrome
Ischemia
Catheterization
Platelet Glycoprotein GPIIb-IIIa Complex
Coronary Artery Bypass
bivalirudin
Biomarkers
Transplants

Keywords

  • Acute coronary syndrome
  • Emergency care
  • Treatment

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Miller, C. D., Blomkalns, A. L., Gersh, B. J., Pollack, C. V., Brogan, G. X., Diercks, D. B., ... Hoekstra, J. W. (2009). Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department. Academic Emergency Medicine, 16(8), 717-725. https://doi.org/10.1111/j.1553-2712.2009.00417.x

Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department. / Miller, Chadwick D.; Blomkalns, Andra L.; Gersh, Bernard J.; Pollack, Charles V.; Brogan, Gerard X.; Diercks, Deborah B.; Peacock, W. Frank; Stone, Gregg W.; Hollander, Judd E.; Manoukian, Steven V.; Hoekstra, James W.

In: Academic Emergency Medicine, Vol. 16, No. 8, 08.2009, p. 717-725.

Research output: Contribution to journalArticle

Miller, CD, Blomkalns, AL, Gersh, BJ, Pollack, CV, Brogan, GX, Diercks, DB, Peacock, WF, Stone, GW, Hollander, JE, Manoukian, SV & Hoekstra, JW 2009, 'Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department', Academic Emergency Medicine, vol. 16, no. 8, pp. 717-725. https://doi.org/10.1111/j.1553-2712.2009.00417.x
Miller, Chadwick D. ; Blomkalns, Andra L. ; Gersh, Bernard J. ; Pollack, Charles V. ; Brogan, Gerard X. ; Diercks, Deborah B. ; Peacock, W. Frank ; Stone, Gregg W. ; Hollander, Judd E. ; Manoukian, Steven V. ; Hoekstra, James W. / Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department. In: Academic Emergency Medicine. 2009 ; Vol. 16, No. 8. pp. 717-725.
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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.",
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AU - Blomkalns, Andra L.

AU - Gersh, Bernard J.

AU - Pollack, Charles V.

AU - Brogan, Gerard X.

AU - Diercks, Deborah B.

AU - Peacock, W. Frank

AU - Stone, Gregg W.

AU - Hollander, Judd E.

AU - Manoukian, Steven V.

AU - Hoekstra, James W.

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N2 - 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.

AB - 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.

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KW - Emergency care

KW - Treatment

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