Short- and long-term results of abciximab versus aspirin in conjunction with thrombolysis for patients with peripheral occlusive arterial disease andarterial thrombosis

Acute peripheral occlusive arterial disease is an important cause of morbid ity and mortality, particularly among older persons. Catheter-directed thro mbolytic therapy is the treatment of choice but has limitations: long lytic times, occlusions refractory to thrombolysis, and a high rate of restenosi s. We conducted a pilot study to evaluate the use of the platelet: GD IIb/I IIa receptor antagonist abciximab versus aspirin in conjunction with thromb olysis in patients with acute peripheral occlusive arterial disease associa ted with arterial thrombosis. A total of 84 patients were randomized into two equal groups to receive 5 m g recombinant tissue plasminogen activator intravenously and 500 IU heparin /hour along with either 500 mg acetylsalicylic acid or a bolus of 0.25 mg/k g abciximab followed by 10 mug/min abciximab over 12 hours (heparin reduced to 250 IU/hour). Primary efficacy criteria included the number of rehospit alizations, reinterventions, and amputations during the following 6 months. Secondary endpoints were the changes in the Fontaine stage, Bollinger inde x (vessel occlusion), ankle-to-brachial ratios, distance to claudication af ter 6 months, and the duration of the initial local lysis treatment. Adjunctive use of abciximab reduced the rates of rehospitalization, reinter ventions, and amputations versus results with the use of aspirin (10 vs 14 occurrences, respectively; 9 vs 11; 3 vs 5; when summed, intergroup differe nce p < 0.05). Secondary peripheral occlusive arterial disease variables be came highly significant versus aspirin (p < 0.001 or greater) at 3 and 6 mo nths after treatment. The duration of lysis was markedly shorter upon addit ion of abciximab versus aspirin (75 vs 110 min; p < 0.001). No major bleedi ng complications or embolisms occurred. These preliminary results indicate that abciximab may have a useful role when used adjunctively with a thrombo lytic agent in older persons with acute peripheral occlusive arterial disea se and arterial thrombosis.