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Published online before print October 9, 2001, 10.1148/radiol.2213010400

(Radiology 2001;221:689.)

A more recent version of this article appeared on December 1, 2001
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© RSNA, 2001

Vascular and Interventional Radiology

Peripheral Artery Occlusion: Treatment with Abciximab plus Urokinase versus with Urokinase Alone— A Randomized Pilot Trial (the PROMPT Study)1

Stephan H. Duda, MD, Gunnar Tepe, MD, Oliver Luz, MD, Kenneth Ouriel, MD, Klaus Dietz, PhD, Ulrich Hahn, MD, Philippe Pereira, MD, Parvaneh Marsalek, MD, Gerhard Ziemer, MD, Christiane M. Erley, MD and Claus D. Claussen, MD

1 From the Dept of Diagnostic Radiology (S.H.D., G.T., O.L., U.H., P.P., C.D.C.); Div of Thoracic, Cardiac, and Vascular Surgery (G.Z.); Dept of Medical Biometry (K.D.); and Dept of Internal Medicine III (C.M.E.), Univ of Tübingen, Eberhard-Karls-Univ, Hoppe-Seyler-Strasse 3, 72076 Tübingen, Germany; Dept of Vascular Surgery, The Cleveland Clinic Foundation, Ohio (K.O.); and Eli Lilly and Company, Bad Homburg, Germany (P.M.). Received Feb 1, 2001; revision requested Mar 26; revision received Apr 25; accepted May 25. Supported by a grant from Centocor, Malvern, Pa, and Lilly Deutschland, Bad Homburg, Germany. Address correspondence to S.H.D. (e-mail: stephan.duda@med.uni-tuebingen.de).

PURPOSE: To evaluate the combination of a platelet glycoprotein IIb/IIIa complex receptor inhibitor and urokinase for treatment of recent (<=6 weeks) arterial occlusion of the legs.

MATERIALS AND METHODS: Seventy patients with lower extremity arterial occlusion of less than 6 weeks duration were randomly separated into two treatment groups: urokinase plus abciximab or urokinase plus placebo. Primary end points were the rate of major complications at 30 days after randomization and the rates of amputation-free survival and survival without open surgery or major amputation at follow-up of 90 days. Two readers unaware of the patients’ treatment group assignments analyzed digital subtraction angiograms as they related to the study end points, with a final consensus reading.

RESULTS: Thrombolysis relative to clot length was faster in the urokinase-plus-abciximab group (odds ratio, 0.52; 95% CI: 0.35, 0.76; P < .001). There were no procedure-related deaths or intracranial hemorrhages, but the rate of nonfatal major bleeding was higher with urokinase plus abciximab (four of 50 patients) than with urokinase alone (none of 20 patients; P = .32). At 90 days, amputation-free survival was 96% (48 of 50 patients) in the urokinase-plus-abciximab group compared with 80% (16 of 20 patients) in the urokinase alone group. The hazard ratio for the two Kaplan-Meier curves was 0.42 (95% CI: 0.16, 0.96; P = .04).

CONCLUSION: In patients with lower extremity arterial occlusion who were undergoing urokinase thrombolysis, adjunctive abciximab treatment resulted in faster thrombus dissolution and improved amputation-free survival, despite an increase in major bleeding.

Index terms: Arteries, stenosis or obstruction, 92.721 • Extremities, angiography, 92.1222 • Extremities, thrombosis, 92.721 • Thrombolysis, 92.1265, 92.1274 • Urokinase




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