| Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. The EPIC Investigation. | |
| | |
MedLine Citation:
|
PMID: 8121459 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: Platelets are believed to play a part in the ischemic complications of coronary angioplasty, such as abrupt closure of the coronary vessel during or soon after the procedure. Accordingly, we evaluated the effect of a chimeric monoclonal-antibody Fab fragment (c7E3 Fab) directed against the platelet glycoprotein IIb/IIIa receptor, in patients undergoing angioplasty who were at high risk for ischemic complications. This receptor is the final common pathway for platelet aggregation. METHODS: In a prospective, randomized, double-blind trial, 2099 patients treated at 56 centers received a bolus and an infusion of placebo, a bolus of c7E3 Fab and an infusion of placebo, or a bolus and an infusion of c7E3 Fab. They were scheduled to undergo coronary angioplasty or atherectomy in high-risk clinical situations involving severe unstable angina, evolving acute myocardial infarction, or high-risk coronary morphologic characteristics. The primary study end point consisted of any of the following: death, nonfatal myocardial infarction, unplanned surgical revascularization, unplanned repeat percutaneous procedure, unplanned implantation of a coronary stent, or insertion of an intraaortic balloon pump for refractory ischemia. The numbers of end-point events were tabulated for 30 days after randomization. RESULTS: As compared with placebo, the c7E3 Fab bolus and infusion resulted in a 35 percent reduction in the rate of the primary end point (12.8 vs. 8.3 percent, P = 0.008), whereas a 10 percent reduction was observed with the c7E3 Fab bolus alone (12.8 vs. 11.5 percent, P = 0.43). The reduction in the number of events with the c7E3 Fab bolus and infusion was consistent across the end points of unplanned revascularization procedures and nonfatal myocardial infarction. Bleeding episodes and transfusions were more frequent in the group given the c7E3 Fab bolus and infusion than in the other two groups. CONCLUSIONS: Ischemic complications of coronary angioplasty and atherectomy were reduced with a monoclonal antibody directed against the platelet IIb/IIIa glycoprotein receptor, although the risk of bleeding was increased. |
| | |
Authors:
|
- |
Related Documents
:
|
15693779 - Noninvasive evaluation of a cutting balloon entrapped in a left main coronary artery us... 10149209 - Percutaneous coronary angioscopy: methods, findings, and therapeutic implications. 17452149 - Impact of cardiac and renal dysfunction on inhospital morbidity and mortality of patien... 8241839 - Atherosclerosis and coronary heart disease. 10160069 - Cardiogenic shock: thrombolysis or angioplasty? 8141719 - The role of angioplasty in acute myocardial infarction. 8056019 - Hyposecretion of atrial natriuretic peptide due to associated right atrial infarction i... 3394829 - Quantification of regional myocardial dysfunction after acute ischemic injury. 7677539 - Complex valve operations: antegrade versus retrograde cardioplegia? |
Publication Detail:
|
Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: The New England journal of medicine Volume: 330 ISSN: 0028-4793 ISO Abbreviation: N. Engl. J. Med. Publication Date: 1994 Apr |
Date Detail:
|
Created Date: 1994-04-07 Completed Date: 1994-04-07 Revised Date: 2010-03-24 |
Medline Journal Info:
|
Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: UNITED STATES |
Other Details:
|
Languages: eng Pagination: 956-61 Citation Subset: AIM; IM |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Angioplasty, Transluminal, Percutaneous Coronary
/
adverse effects* Antibodies, Monoclonal / adverse effects, therapeutic use* Atherectomy, Coronary / adverse effects Coronary Disease / prevention & control, therapy* Coronary Thrombosis / etiology, prevention & control* Double-Blind Method Female Hemorrhage / etiology Humans Immunoglobulin Fab Fragments / adverse effects, therapeutic use* Male Middle Aged Myocardial Infarction / prevention & control, therapy Platelet Aggregation Inhibitors / adverse effects, therapeutic use* Platelet Membrane Glycoproteins / immunology* Prospective Studies Recurrence Risk Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
|
0/Antibodies, Monoclonal; 0/Immunoglobulin Fab Fragments; 0/Platelet Aggregation Inhibitors; 0/Platelet Membrane Glycoproteins; 143653-53-6/abciximab |
| Comments/Corrections | |
Comment In:
|
N Engl J Med. 1994 Apr 7;330(14):1006-7
[PMID:
8121441
]
N Engl J Med. 1998 Dec 17;339(25):1861-3 [PMID: 9867573 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Hantavirus pulmonary syndrome: a clinical description of 17 patients with a newly recognized disease...
Next Document: A subtype of diabetes mellitus associated with a mutation of mitochondrial DNA.