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Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial.

Publication ,  Journal Article
Stone, GW; White, HD; Ohman, EM; Bertrand, ME; Lincoff, AM; McLaurin, BT; Cox, DA; Pocock, SJ; Ware, JH; Feit, F; Colombo, A; Manoukian, SV ...
Published in: Lancet
March 17, 2007

BACKGROUND: The aim of this study was to assess anticoagulation with the direct thrombin inhibitor bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. METHODS: 13,819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, bivalirudin plus glycoprotein IIb/IIIa inhibitors, or bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. FINDINGS: Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received bivalirudin alone. 26 (0.3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0.16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0.32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0.1). Rates of composite ischaemia were much the same in those who received bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0.45); however, there were significantly fewer individuals who experienced major bleeding among those who received bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p<0.0001, relative risk 0.52, 95% CI 0.40-0.66), resulting in a trend towards better 30-day net clinical outcomes (303 [12%] patients vs 341 [13%] patients, p=0.057; 0.87, 0.75-1.00). INTERPRETATION: Substitution of unfractionated heparin or enoxaparin with bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.

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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

March 17, 2007

Volume

369

Issue

9565

Start / End Page

907 / 919

Location

England

Related Subject Headings

  • Treatment Outcome
  • Recombinant Proteins
  • Prospective Studies
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors
  • Peptide Fragments
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Humans
 

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Stone, G. W., White, H. D., Ohman, E. M., Bertrand, M. E., Lincoff, A. M., McLaurin, B. T., … Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators, . (2007). Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet, 369(9565), 907–919. https://doi.org/10.1016/S0140-6736(07)60450-4
Stone, Gregg W., Harvey D. White, E Magnus Ohman, Michel E. Bertrand, A Michael Lincoff, Brent T. McLaurin, David A. Cox, et al. “Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial.Lancet 369, no. 9565 (March 17, 2007): 907–19. https://doi.org/10.1016/S0140-6736(07)60450-4.
Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW, Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907–919.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

March 17, 2007

Volume

369

Issue

9565

Start / End Page

907 / 919

Location

England

Related Subject Headings

  • Treatment Outcome
  • Recombinant Proteins
  • Prospective Studies
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors
  • Peptide Fragments
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Humans