Routine upstream initiation vs deferred selective use of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: the ACUITY Timing trial.
Publication/Presentation Date
2-14-2007
Abstract
CONTEXT: In patients with moderate- and high-risk acute coronary syndromes (ACS) who undergo an early, invasive treatment strategy, current guidelines recommend administration of platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors, either upstream to all patients prior to angiography or deferred for selective use in the catheterization laboratory just prior to angioplasty. The preferred approach is undetermined.
OBJECTIVE: To determine the optimal strategy for the use of Gp IIb/IIIa inhibitors in patients with moderate- and high-risk ACS undergoing an early, invasive treatment strategy.
DESIGN: Prospective, randomized, open-label trial with 30-day clinical follow-up.
SETTING: Four hundred fifty academic and community-based institutions in 17 countries.
PATIENTS: A total of 9207 patients with moderate- and high-risk ACS undergoing an invasive treatment strategy.
INTERVENTIONS: Patients were randomly assigned to receive either routine upstream (n=4605) or deferred selective (n=4602) Gp IIb/IIIa inhibitor administration, respectively.
MAIN OUTCOME MEASURES: The primary outcome was assessment of noninferiority of deferred Gp IIb/IIIa inhibitor use compared with upstream administration for the prevention of composite ischemic events (death, myocardial infarction, or unplanned revascularization for ischemia) at 30 days, using a 1-sided alpha level of .025. Major secondary end points included noninferiority or superiority of major bleeding and net clinical outcomes (composite ischemia or major bleeding).
RESULTS: Glycoprotein IIb/IIIa inhibitors were used more frequently (98.3% vs 55.7%, respectively) and for a significantly longer duration (median, 18.3 vs 13.1 hours; P
CONCLUSIONS: Among patients with moderate- and high-risk ACS undergoing an invasive treatment strategy, deferring the routine upstream use of Gp IIb/IIIa inhibitors for selective administration in the cardiac catheterization laboratory only to patients undergoing percutaneous coronary intervention resulted in a numerical increase in composite ischemia that, while not statistically significant, did not meet the criterion for noninferiority. This finding was offset by a significant reduction in major bleeding.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00093158.
Volume
297
Issue
6
First Page
591
Last Page
602
ISSN
1538-3598
Published In/Presented At
Stone, G. W., Bertrand, M. E., Moses, J. W., Ohman, E. M., Lincoff, A. M., Ware, J. H., Pocock, S. J., McLaurin, B. T., Cox, D. A., Jafar, M. Z., Chandna, H., Hartmann, F., Leisch, F., Strasser, R. H., Desaga, M., Stuckey, T. D., Zelman, R. B., Lieber, I. H., Cohen, D. J., Mehran, R., … ACUITY Investigators (2007). Routine upstream initiation vs deferred selective use of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: the ACUITY Timing trial. JAMA, 297(6), 591–602. https://doi.org/10.1001/jama.297.6.591
Disciplines
Medicine and Health Sciences
PubMedID
17299194
Department(s)
Department of Medicine
Document Type
Article