BACKGROUND AND OBJECTIVE:Glycoprotein (GP) IIb/IIIa receptor inhibitors enhance thrombolysis in patients with acute coronary syndromes. This analysis evaluates the economic impact of abciximab, a GP IIb/IIIa inhibitor, as an adjunct to urokinase in peripheral artery occlusions of less than 6 weeks duration. STUDY DESIGN: A post-hoc economic analysis was performed using clinical data and inpatient resource utilisation derived from the prospective comparative phase II Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis (PROMPT) pilot study. Study endpoints were amputation-free survival and survival without open surgery or major amputation after 90 days, and the rate of major complications at 30 days. PERSPECTIVE: Third-party payer and the societal perspective. PATIENTS AND METHODS: Seventy patients with lower extremity thrombi were randomised (2 : 5 ratio) to urokinase plus placebo or to urokinase plus abciximab. Economically relevant data were retrospectively derived from the clinical study database from a specific evaluation of patient records and from expert opinion. RESULTS: From the viewpoint of the society, average total per-patient direct and indirect costs accruing over 3 months were more favourable for treatment with abciximab plus urokinase than for urokinase alone [9723 euros (EUR) vs EUR10 322; 2000 values], despite higher initial hospitalisation costs of the combination therapy. Abciximab plus urokinase was the dominant strategy at 3 months due to a clinically higher rate of survival without amputation or bypass surgery coupled with a lower average per-patient cost. From the perspective of the third-party payer, treatment with abciximab plus urokinase was economically also superior to urokinase alone (EUR8773 vs EUR9663). CONCLUSIONS: Based on the preliminary findings of the PROMPT trial, the use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase alone, in terms of clinical and economic outcomes. Further trials are needed to confirm these clinical and economic findings. The preliminary clinical benefits experienced by patients treated with abciximab plus urokinase in the PROMPT trial translated into cost savings in terms of reduced direct medical costs at 3 months. These cost savings more than offset the cost of abciximab. The use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase-alone in terms of clinical and economic outcomes, but further trials are needed to confirm the these clinical and economic findings.
RCT Entities:
BACKGROUND AND OBJECTIVE: Glycoprotein (GP) IIb/IIIa receptor inhibitors enhance thrombolysis in patients with acute coronary syndromes. This analysis evaluates the economic impact of abciximab, a GP IIb/IIIa inhibitor, as an adjunct to urokinase in peripheral artery occlusions of less than 6 weeks duration. STUDY DESIGN: A post-hoc economic analysis was performed using clinical data and inpatient resource utilisation derived from the prospective comparative phase II Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis (PROMPT) pilot study. Study endpoints were amputation-free survival and survival without open surgery or major amputation after 90 days, and the rate of major complications at 30 days. PERSPECTIVE: Third-party payer and the societal perspective. PATIENTS AND METHODS: Seventy patients with lower extremity thrombi were randomised (2 : 5 ratio) to urokinase plus placebo or to urokinase plus abciximab. Economically relevant data were retrospectively derived from the clinical study database from a specific evaluation of patient records and from expert opinion. RESULTS: From the viewpoint of the society, average total per-patient direct and indirect costs accruing over 3 months were more favourable for treatment with abciximab plus urokinase than for urokinase alone [9723 euros (EUR) vs EUR10 322; 2000 values], despite higher initial hospitalisation costs of the combination therapy. Abciximab plus urokinase was the dominant strategy at 3 months due to a clinically higher rate of survival without amputation or bypass surgery coupled with a lower average per-patient cost. From the perspective of the third-party payer, treatment with abciximab plus urokinase was economically also superior to urokinase alone (EUR8773 vs EUR9663). CONCLUSIONS: Based on the preliminary findings of the PROMPT trial, the use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase alone, in terms of clinical and economic outcomes. Further trials are needed to confirm these clinical and economic findings. The preliminary clinical benefits experienced by patients treated with abciximab plus urokinase in the PROMPT trial translated into cost savings in terms of reduced direct medical costs at 3 months. These cost savings more than offset the cost of abciximab. The use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase-alone in terms of clinical and economic outcomes, but further trials are needed to confirm the these clinical and economic findings.
Authors: S H Duda; G Tepe; O Luz; K Ouriel; K Dietz; U Hahn; P Pereira; P Marsalek; G Ziemer; C M Erley; C D Claussen Journal: Radiology Date: 2001-12 Impact factor: 11.105
Authors: E M Antman; R P Giugliano; C M Gibson; C H McCabe; P Coussement; N S Kleiman; A Vahanian; A A Adgey; I Menown; H J Rupprecht; R Van der Wieken; J Ducas; J Scherer; K Anderson; F Van de Werf; E Braunwald Journal: Circulation Date: 1999-06-01 Impact factor: 29.690
Authors: J M Miller; R Smalling; E M Ohman; C Bode; A Betriu; N S Kleiman; J S Schildcrout; E Bastos; E J Topol; R M Califf Journal: Am J Cardiol Date: 1999-10-01 Impact factor: 2.778