| Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. | |
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MedLine Citation:
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PMID: 11419425 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 344 ISSN: 0028-4793 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2001 Jun |
Date Detail:
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Created Date: 2001-06-07 Completed Date: 2001-06-28 Revised Date: 2013-05-24 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1888-94 Citation Subset: AIM; IM |
Affiliation:
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Department of Cardiology, Cleveland Clinic Foundation, OH 44195, USA. topole@ccf.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Balloon, Coronary* Antibodies, Monoclonal / adverse effects, therapeutic use* Combined Modality Therapy Coronary Disease / drug therapy*, mortality, therapy Double-Blind Method Drug Therapy, Combination Female Hemorrhage / chemically induced Humans Immunoglobulin Fab Fragments / adverse effects, therapeutic use* Male Middle Aged Myocardial Infarction / prevention & control* Platelet Aggregation Inhibitors / adverse effects, therapeutic use* Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors* Stents Thrombocytopenia / chemically induced Tyrosine / adverse effects, analogs & derivatives*, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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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 |
| Comments/Corrections | |
Comment In:
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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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