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Randomized Controlled Trial
Peripheral arteries: treatment with antibodies of platelet receptors and reteplase for thrombolysis--APART trial.
- Gunnar Tepe, Claudius Hopfenzitz, Klaus Dietz, Jakub Wiskirchen, Stephan Heller, Kenneth Ouriel, Gerhard Ziemer, Claus D Claussen, and Stephan H Duda.
- Department of Diagnostic Radiology, University of Tübingen, Tübingen, Germany. gunnar.tepe@med.uni-tuebingen.de
- Radiology. 2006 Jun 1; 239 (3): 892-900.
PurposeTo 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 MethodsThe 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.ResultsTherapeutic 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.ConclusionThe proposed regimen resulted in only a limited number of major complications, and the low amputation rate in both groups may be attributed to abciximab.Copyright (c) RSNA, 2006.
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