Document Detail


Prognostic modeling of individual patient risk and mortality impact of ischemic and hemorrhagic complications: assessment from the Acute Catheterization and Urgent Intervention Triage Strategy trial.
MedLine Citation:
PMID:  20026777     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Both ischemic and hemorrhagic complications increase mortality rate in acute coronary syndromes. Their frequency and relative importance vary according to individual patient risk profiles. We sought to develop prognostic models for the risk of myocardial infarction (MI) and major bleeding to assess their impact on risk of death and to examine the manner in which alternative antithrombotic regimens affect these risks in individual patients. METHODS AND RESULTS: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial randomized 13 819 patients with acute coronary syndrome to heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. By logistic regression, there were 5 independent predictors of MI within 30 days (n=705; 5.1%) and 8 independent predictors of major bleeding (n=645; 4.7%), only 2 of which were common to both event types. In a covariate-adjusted, time-updated Cox regression model, both MI and major bleeding significantly affected subsequent mortality rate (hazard ratios, 2.7 and 2.9, respectively; both P<0.001). Treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor was associated with a nonsignificant 8% increase in MI and a highly significant 50% decrease in major bleeding. Given the individual patient risk profiles and the fact that bivalirudin prevented approximately 6 major bleeds for each MI that might occur from its use, the estimated reduction in bleeding was greater than the estimated increase in MI by bivalirudin alone rather than heparin plus a glycoprotein IIb/IIIa inhibitor for nearly all patients. CONCLUSIONS: Consideration of the individual patient risk profile for MI and major bleeding and the relative treatment effects of alternative pharmacotherapies permits personalized decision making to optimize therapy of patients with acute coronary syndrome. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00093158.
Authors:
Stuart J Pocock; Roxana Mehran; Tim C Clayton; Eugenia Nikolsky; Helen Parise; Martin Fahy; Alexandra J Lansky; Michel E Bertrand; A Michael Lincoff; Jeffrey W Moses; E Magnus Ohman; Harvey D White; Gregg W Stone
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-12-21
Journal Detail:
Title:  Circulation     Volume:  121     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-01-05     Completed Date:  2010-01-28     Revised Date:  2010-09-24    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  43-51     Citation Subset:  AIM; IM    
Affiliation:
Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Stuart.Pocock@lshtm.ac.uk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00093158
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / drug therapy,  mortality
Aged
Aged, 80 and over
Female
Fibrinolytic Agents / adverse effects*
Hemorrhage / chemically induced*,  mortality*
Heparin / adverse effects
Hirudins / adverse effects
Humans
Logistic Models
Male
Middle Aged
Multivariate Analysis
Myocardial Infarction / mortality
Myocardial Ischemia / drug therapy*,  mortality*
Peptide Fragments / adverse effects
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
Predictive Value of Tests
Prognosis
Randomized Controlled Trials as Topic / statistics & numerical data
Recombinant Proteins / adverse effects
Retrospective Studies
Risk Factors
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; 0/Hirudins; 0/Peptide Fragments; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin
Comments/Corrections
Comment In:
Circulation. 2010 Sep 21;122(12):e461; author reply e462-3   [PMID:  20855666 ]
Circulation. 2010 Jan 5;121(1):5-7   [PMID:  20026787 ]

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