| Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta3 blockade with percutaneous coronary intervention. EPIC Investigator Group. Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complication. | |
| | |
MedLine Citation:
|
PMID: 9256222 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
CONTEXT: Abciximab, a monoclonal antibody fragment against the platelet receptor alphaIIb beta3 integrin, prevents platelet aggregation. A randomized, placebo-controlled study showed that abciximab improves outcomes for patients undergoing percutaneous coronary angioplasty at 30 days and at 6 months. OBJECTIVE: To determine whether abciximab improves outcomes 3 years after coronary angioplasty. DESIGN: Double-blind, placebo-controlled, randomized trial. SETTING: A total of 56 academic and community hospitals in the United States. PATIENTS: A total of 2099 high-risk patients undergoing coronary angioplasty were randomized. Sufficient time elapsed for 2.5 years of follow-up among 2001 patients and for 3 years of follow-up among 1599 patients. INTERVENTIONS: Abciximab bolus of 0.25 mg/kg followed by infusion at 10 microg/min for 12 hours; abciximab bolus of 0.25 mg/kg followed by placebo infusion; or placebo bolus followed by placebo infusion. MAIN OUTCOMES MEASURES: The primary outcome was the composite of death, myocardial infarction, or coronary revascularization. Secondary outcomes were death, myocardial infarction, or coronary revascularization individually. Subgroups having refractory unstable angina or evolving myocardial infarction and having different elevations of creatine kinase during initial angioplasty were analyzed. RESULTS: At 3 years, composite end points occurred in 41.1% of those receiving abciximab bolus plus infusion; 47.4% of those receiving abciximab bolus only; and 47.2% of those receiving placebo only (for abciximab bolus plus infusion vs placebo, P=.009). Death occurred in 6.8%, 8.0%, and 8.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.20); myocardial infarction in 10.7%, 12.2%, and 13.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.08); and revascularization in 34.8%, 38.6%, and 40.1%, respectively (for abciximab bolus plus infusion vs placebo, P=.02). Among those with refractory unstable angina or evolving myocardial infarction, death occurred in 5.1%, 9.2%, and 12.7%, respectively (for abciximab bolus plus infusion vs placebo, P=.01). Death rates increased as periprocedural creatine kinase levels increased. CONCLUSIONS: Abciximab bolus with infusion given at the time of coronary angioplasty improves outcomes as long as 3 years after the procedure. |
| | |
Authors:
|
E J Topol; J J Ferguson; H F Weisman; J E Tcheng; S G Ellis; N S Kleiman; R J Ivanhoe; A L Wang; D P Miller; K M Anderson; R M Califf |
Publication Detail:
|
Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: JAMA : the journal of the American Medical Association Volume: 278 ISSN: 0098-7484 ISO Abbreviation: JAMA Publication Date: 1997 Aug |
Date Detail:
|
Created Date: 1997-08-21 Completed Date: 1997-08-21 Revised Date: 2006-11-15 |
Medline Journal Info:
|
Nlm Unique ID: 7501160 Medline TA: JAMA Country: UNITED STATES |
Other Details:
|
Languages: eng Pagination: 479-84 Citation Subset: AIM; IM |
Affiliation:
|
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195, USA. topole@cesmtp.ccf.org |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Angioplasty, Transluminal, Percutaneous Coronary* Antibodies, Monoclonal / administration & dosage, therapeutic use* Antigens, CD Coronary Disease / therapy* Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Humans Immunoglobulin Fab Fragments / administration & dosage, therapeutic use* Infusions, Intravenous Injections, Intravenous Integrin beta3 Male Middle Aged Multivariate Analysis Myocardial Ischemia / prevention & control* Myocardial Revascularization Platelet Aggregation Inhibitors / administration & dosage, therapeutic use* Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors* Platelet Membrane Glycoproteins Proportional Hazards Models Receptors, Vitronectin / antagonists & inhibitors Survival Analysis |
| Chemical | |
Reg. No./Substance:
|
0/Antibodies, Monoclonal; 0/Antigens, CD; 0/Immunoglobulin Fab Fragments; 0/Integrin beta3; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/Platelet Membrane Glycoproteins; 0/Receptors, Vitronectin; 143653-53-6/abciximab |
| Comments/Corrections | |
Comment In:
|
JAMA. 1997 Aug 13;278(6):518-9
[PMID:
9256229
]
JAMA. 1998 Jan 21;279(3):195-6 [PMID: 9438735 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Are surveillance endomyocardial biopsies necessary during OKT3 induction therapy?
Next Document: Severity-adjusted mortality and length of stay in teaching and nonteaching hospitals. Results of a r...