Document Detail

Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization.
MedLine Citation:
PMID:  11419425     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In the setting of percutaneous coronary revascularization, agents in the class known as platelet glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of death or nonfatal myocardial infarction at 30 days. We assessed whether there are differences in safety or efficacy between two such inhibitors, tirofiban and abciximab.
METHODS: Using a double-blind, double-dummy design at 149 hospitals in 18 countries, we randomly assigned patients to receive either tirofiban or abciximab before undergoing percutaneous coronary revascularization with the intent to perform stenting. The primary end point was a composite of death, nonfatal myocardial infarction, or urgent target-vessel revascularization at 30 days. The trial was designed and statistically powered to demonstrate the noninferiority of tirofiban as compared with abciximab.
RESULTS: The primary end point occurred more frequently among the 2398 patients in the tirofiban group than among the 2411 patients in the abciximab group (7.6 percent vs. 6.0 percent; hazard ratio, 1.26; one-sided 95 percent confidence interval of 1.51, demonstrating lack of equivalence, and two-sided 95 percent confidence interval of 1.01 to 1.57, demonstrating the superiority of abciximab over tirofiban; P=0.038). The magnitude and the direction of the effect were similar for each component of the composite end point (hazard ratio for death, 1.21; hazard ratio for myocardial infarction, 1.27; and hazard ratio for urgent target-vessel revascularization, 1.26), and the difference in the incidence of myocardial infarction between the tirofiban group and the abciximab group was significant (6.9 percent and 5.4 percent, respectively; P=0.04). The relative benefit of abciximab was consistent regardless of age, sex, the presence or absence of diabetes, or the presence or absence of pretreatment with clopidogrel. There were no significant differences in the rates of major bleeding complications or transfusions, but tirofiban was associated with a lower rate of minor bleeding episodes and thrombocytopenia.
CONCLUSIONS: Although the trial was intended to assess the noninferiority of tirofiban as compared with abciximab, the findings demonstrated that tirofiban offered less protection from major ischemic events than did abciximab.
E J Topol; D J Moliterno; H C Herrmann; E R Powers; C L Grines; D J Cohen; E A Cohen; M Bertrand; F J Neumann; G W Stone; P M DiBattiste; L Demopoulos;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  344     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2001 Jun 
Date Detail:
Created Date:  2001-06-07     Completed Date:  2001-06-28     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1888-94     Citation Subset:  AIM; IM    
Department of Cardiology, Cleveland Clinic Foundation, OH 44195, USA.
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MeSH Terms
Angioplasty, Balloon, Coronary*
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Combined Modality Therapy
Coronary Disease / drug therapy*,  mortality,  therapy
Double-Blind Method
Drug Therapy, Combination
Hemorrhage / chemically induced
Immunoglobulin Fab Fragments / adverse effects,  therapeutic use*
Middle Aged
Myocardial Infarction / prevention & control*
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
Thrombocytopenia / chemically induced
Tyrosine / adverse effects,  analogs & derivatives*,  therapeutic use*
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Immunoglobulin Fab Fragments; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 144494-65-5/tirofiban; 55520-40-6/Tyrosine; X85G7936GV/abciximab
Comment In:
N Engl J Med. 2001 Jun 21;344(25):1939-42   [PMID:  11419433 ]
N Engl J Med. 2001 Jun 21;344(25):1937-9   [PMID:  11419432 ]
ACP J Club. 2002 Jan-Feb;136(1):5   [PMID:  11829546 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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