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, 23-88 years) receivedreteplase plus abciximaband 70 patients (36 men, 34 women; mean age, 68 years; range, 28-88 years) receivedurokinase 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 (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. 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. Copyright (c) RSNA, 2006.
RCT Entities:
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, 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. 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 (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. 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. Copyright (c) RSNA, 2006.