| Peripheral arteries: treatment with antibodies of platelet receptors and reteplase for thrombolysis--APART trial. | |
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MedLine Citation:
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PMID: 16641342 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To prospectively compare the safety and efficacy of combination therapy with the glycoprotein IIb/IIIa antagonist abciximab plus the third-generation thrombolytic agent reteplase versus those of therapy with the standard thrombolytic agent urokinase plus abciximab. MATERIALS AND METHODS: The study was approved by the local ethics committee, and patient informed consent was obtained. Patients with peripheral arterial occlusions less than 60 days old (n=120) were enrolled in the study: 50 patients (32 men, 18 women; mean age, 67 years; range, 23-88 years) received reteplase plus abciximab and 70 patients (36 men, 34 women; mean age, 68 years; range, 28-88 years) received urokinase plus abciximab. Study end points were the rate of major complications at 30 days, therapeutic success, and survival without open surgery or major amputation at follow-up. Fisher exact test was used to compare treatment groups with respect to dichotomous variables, and the event-free-survival probabilities were calculated with the Kaplan-Meier method. For the comparison of the lengths of occlusions among the groups, a two-sample t test was used. RESULTS: Therapeutic success (P=.7) did not differ between the groups, whereas the time required for thrombolysis was lower in the urokinase-plus-abciximab group (P=.001). Patients who received reteplase plus abciximab tended to develop more minor complications (mainly bleeding events) (P<.001). During long-term follow-up (2-4 years), no group differences were observed. The reocclusion rate was 48% (22 of 46) in the reteplase-plus-abciximab group and 45% (29 of 64) in the urokinase-plus-abciximab group. Only two of 120 major amputations were counted in the follow-up period. CONCLUSION: The proposed regimen resulted in only a limited number of major complications, and the low amputation rate in both groups may be attributed to abciximab. |
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Authors:
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Gunnar Tepe; Claudius Hopfenzitz; Klaus Dietz; Jakub Wiskirchen; Stephan Heller; Kenneth Ouriel; Gerhard Ziemer; Claus D Claussen; Stephan H Duda |
Publication Detail:
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Type: Journal Article; Randomized Controlled Trial Date: 2006-04-26 |
Journal Detail:
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Title: Radiology Volume: 239 ISSN: 0033-8419 ISO Abbreviation: Radiology Publication Date: 2006 Jun |
Date Detail:
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Created Date: 2006-05-22 Completed Date: 2006-06-08 Revised Date: 2008-11-21 |
Medline Journal Info:
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Nlm Unique ID: 0401260 Medline TA: Radiology Country: United States |
Other Details:
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Languages: eng Pagination: 892-900 Citation Subset: AIM; IM |
Copyright Information:
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Copyright (c) RSNA, 2006. |
Affiliation:
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Department of Diagnostic Radiology, University of Tübingen, Tübingen, Germany. gunnar.tepe@med.uni-tuebingen.de |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Amputation Antibodies, Monoclonal / administration & dosage, adverse effects, therapeutic use* Arterial Occlusive Diseases / drug therapy* Drug Combinations Female Fibrinolytic Agents / administration & dosage, adverse effects, therapeutic use Follow-Up Studies Hemorrhage / chemically induced Humans Immunoglobulin Fab Fragments / administration & dosage, adverse effects, therapeutic use* Longitudinal Studies Male Middle Aged Peripheral Vascular Diseases / drug therapy* Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors* Prospective Studies Recombinant Proteins / administration & dosage, adverse effects, therapeutic use Recurrence Safety Thrombolytic Therapy* / adverse effects Time Factors Tissue Plasminogen Activator / administration & dosage, adverse effects, therapeutic use* Treatment Outcome Urokinase-Type Plasminogen Activator / administration & dosage, adverse effects, therapeutic use |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 0/Drug Combinations; 0/Fibrinolytic Agents; 0/Immunoglobulin Fab Fragments; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/Recombinant Proteins; 133652-38-7/reteplase; 143653-53-6/abciximab; EC 3.4.21.68/Tissue Plasminogen Activator; EC 3.4.21.73/Urokinase-Type Plasminogen Activator |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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