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Vascular and Interventional Radiology |
1 From the Department of Diagnostic Radiology (G.T., C.H., J.W., S.H, C.D.C., S.H.D.), Department of Thoracic, Cardiac, and Vascular Surgery (G.Z.), and Department of Medical Biometry (K.D.), University of Tübingen, Eberhard-Karls-University, Hoppe-Seyler-Strasse 3, D-72076 Tübingen, Germany; and Department of Vascular Surgery, the Cleveland Clinic Foundation, Cleveland, Ohio (K.O.). From the 2003 RSNA Annual Meeting. Received April 14, 2005; revision requested June 14; revision received June 26; accepted August 1; final version accepted September 1. Address correspondence to G.T. (e-mail: gunnar.tepe{at}med.uni-tuebingen.de).
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, 2388 years) received reteplase plus abciximab and 70 patients (36 men, 34 women; mean age, 68 years; range, 2888 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 (24 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.
© RSNA, 2006
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M. Sobel and R. Verhaeghe Antithrombotic Therapy for Peripheral Artery Occlusive Disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest, June 1, 2008; 133(6_suppl): 815S - 843S. [Abstract] [Full Text] [PDF] |
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