Document Detail


Peripheral arteries: treatment with antibodies of platelet receptors and reteplase for thrombolysis--APART trial.
MedLine Citation:
PMID:  16641342     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Gunnar Tepe; Claudius Hopfenzitz; Klaus Dietz; Jakub Wiskirchen; Stephan Heller; Kenneth Ouriel; Gerhard Ziemer; Claus D Claussen; Stephan H Duda
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2006-04-26
Journal Detail:
Title:  Radiology     Volume:  239     ISSN:  0033-8419     ISO Abbreviation:  Radiology     Publication Date:  2006 Jun 
Date Detail:
Created Date:  2006-05-22     Completed Date:  2006-06-08     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  0401260     Medline TA:  Radiology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  892-900     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) RSNA, 2006.
Affiliation:
Department of Diagnostic Radiology, University of Tübingen, Tübingen, Germany. gunnar.tepe@med.uni-tuebingen.de
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MeSH Terms
Descriptor/Qualifier:
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:
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; EC 3.4.21.68/Tissue Plasminogen Activator; EC 3.4.21.73/Urokinase-Type Plasminogen Activator; X85G7936GV/abciximab

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


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