BACKGROUND: Thrombolytic agents have been used to treat arterial occlusion for almost 40 years. Recently, an investigation of the costs associated with two treatment options for acute peripheral arterial occlusions, thrombolysis and surgical intervention, was completed. The availability of hospital cost data for patients enrolled in the thrombolytic and operative treatment groups provided a basis with which to accurately assess the financial impact of the different treatment strategies, both from a purely financial standpoint and in relation to outcome. METHODS: The patient base was composed of 114 patients with acute limb ischemia of less than 7 days' duration. The patients were randomly assigned to receive urokinase (n = 57) or to undergo an operation (n = 57) as the initial therapeutic intervention. Patients in the thrombolytic group underwent standard intraarterial diagnostic arteriography, and patients with embolic events, in whom complete lysis of all embolic and propagated thrombotic material was achieved, were subsequently treated with heparin and long-term warfarin (Coumadin) therapy. The economic analysis was undertaken after the completion of the trial. Statistical comparisons between groups were made with the Student t test for continuous, normally distributed data. Mortality and limb salvage rates were calculated from Kaplan-Meier curves, appropriate for the censored nature of the data. RESULTS: The total treatment costs did not differ significantly between the two treatment groups ($22,171 +/- $4,959 in the thrombolytic group and $19,775 +/- $5,253 in the operative group). The total hospital charges were similar between the two groups. Overall, the total charges were remarkably similar between the two treatment groups, averaging $40,823 +/- $8,764 in the thrombolytic group and $41,930 +/- $10,398 in the operative group. CONCLUSIONS: An economic analysis of the data confirmed that the total economic impact of thrombolysis approximated that of initial operative therapy. The improved clinical outcome in patients treated with thrombolysis suggests that this modality may be appropriate as the initial therapeutic intervention in the select group of patients seen within the first few hours of an acute peripheral arterial occlusive event.
RCT Entities:
BACKGROUND: Thrombolytic agents have been used to treat arterial occlusion for almost 40 years. Recently, an investigation of the costs associated with two treatment options for acute peripheral arterial occlusions, thrombolysis and surgical intervention, was completed. The availability of hospital cost data for patients enrolled in the thrombolytic and operative treatment groups provided a basis with which to accurately assess the financial impact of the different treatment strategies, both from a purely financial standpoint and in relation to outcome. METHODS: The patient base was composed of 114 patients with acute limb ischemia of less than 7 days' duration. The patients were randomly assigned to receive urokinase (n = 57) or to undergo an operation (n = 57) as the initial therapeutic intervention. Patients in the thrombolytic group underwent standard intraarterial diagnostic arteriography, and patients with embolic events, in whom complete lysis of all embolic and propagated thrombotic material was achieved, were subsequently treated with heparin and long-term warfarin (Coumadin) therapy. The economic analysis was undertaken after the completion of the trial. Statistical comparisons between groups were made with the Student t test for continuous, normally distributed data. Mortality and limb salvage rates were calculated from Kaplan-Meier curves, appropriate for the censored nature of the data. RESULTS: The total treatment costs did not differ significantly between the two treatment groups ($22,171 +/- $4,959 in the thrombolytic group and $19,775 +/- $5,253 in the operative group). The total hospital charges were similar between the two groups. Overall, the total charges were remarkably similar between the two treatment groups, averaging $40,823 +/- $8,764 in the thrombolytic group and $41,930 +/- $10,398 in the operative group. CONCLUSIONS: An economic analysis of the data confirmed that the total economic impact of thrombolysis approximated that of initial operative therapy. The improved clinical outcome in patients treated with thrombolysis suggests that this modality may be appropriate as the initial therapeutic intervention in the select group of patients seen within the first few hours of an acute peripheral arterial occlusive event.
Authors: Stephan H Duda; Gunnar Tepe; Mohan Bala; Oliver Luz; Gerhard Ziemer; Kenneth Ouriel; Benjamin Pusich; Jakub Wiskirchen; Claus D Claussen; Kurt Banz Journal: Pharmacoeconomics Date: 2002 Impact factor: 4.981