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Short- and Long-Term Results of Abciximab Versus Aspirin in Conjunction with Thrombolysis for Patients with Peripheral Occlusive Arterial Disease and Arterial Thrombosis

Clinic for Internal Medicine I, Chemnitz Clinic, Chemnitz, Dresden, Germany.

Wilhelm Kirch, MD

Institute of Clinical Pharmacology, Dresden, Germany.

Reiner Koch, PhD

Institute for Medical Informatics and Biometrics of Dresden University, Dresden, Germany.

Axel Müller, MD

Clinic for Internal Medicine I, Chemnitz Clinic, Chemnitz, Dresden, Germany.

Grit Hellner, MD

Clinic for Internal Medicine I, Chemnitz Clinic, Chemnitz, Dresden, Germany.

Lutz Forkmann, MD

Clinic for Internal Medicine I, Chemnitz Clinic, Chemnitz, Dresden, Germany.

Acute peripheral occlusive arterial disease is an important cause of morbidity and mortality, particularly among older persons. Catheter-directed thrombolytic therapy is the treatment of choice but has limitations: long lytic times, occlusions refractory to throm bolysis, and a high rate of restenosis. We conducted a pilot study to evaluate the use of the platelet GP IIb/IIIa receptor antagonist abciximab versus aspirin in conjunction with thrombolysis in patients with acute peripheral occlusive arterial disease associated with arterial thrombosis.

A total of 84 patients were randomized into two equal groups to receive 5 mg recom binant tissue plasminogen activator intravenously and 500 IU heparin/hour along with either 500 mg acetylsalicylic acid or a bolus of 0.25 mg/kg abciximab followed by 10 µg/min abciximab over 12 hours (heparin reduced to 250 IU/hour). Primary efficacy criteria included the number of rehospitalizations, reinterventions, and amputations during the following 6 months. Secondary endpoints were the changes in the Fontaine stage, Bollinger index (vessel occlusion), ankle-to-brachial ratios, distance to claudication after 6 months, and the duration of the initial local lysis treatment.

Adjunctive use of abciximab reduced the rates of rehospitalization, reinterventions, and amputations versus results with the use of aspirin (10 vs 14 occurrences, respec tively ; 9 vs 11; 3 vs 5; when summed, intergroup difference p < 0.05). Secondary periph eral occlusive arterial disease variables became highly significant versus aspirin (p < 0.001 or greater) at 3 and 6 months after treatment. The duration of lysis was markedly shorter upon addition of abciximab versus aspirin (75 vs 110 min; p < 0.001). No major bleeding complications or embolisms occurred. These preliminary results indicate that abciximab may have a useful role when used adjunctively with a thrombolytic agent in older persons with acute peripheral occlusive arterial disease and arterial thrombosis.

Angiology, Vol. 51, No. 11, 913-923 (2000)
DOI: 10.1177/000331970005101104


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