Objectives: To evaluate the effects of iloprost, in addition to surgery, on the outcome of acute lower limb ischemia (ALLI). Design: Post-hoc analysis of a randomized, double-blind, placebo-controlled study. Methods: In the context of the ILAILL (ILoprost in Acute Ischemia of Lower Limbs) study, 192 elderly patients (>70 years old) undergoing surgery for ALLI were assigned to receive perioperative iloprost (intra-arterial, intra-operative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for six hours/day for 4-7 days following surgery), or placebo (iloprost: n = 100; placebo: n = 92). Patients were followed-up for three-months following surgical revascularization. Results: The combined incidence of death and amputation (primary study end-point) was significantly reduced in patients treated with iloprost (16.0% vs 27.2% in the placebo group; hazard ratio 1.99, 95% confidence interval 1.05-3.75, p = 0.03). A statistically significant lower mortality (6.0%) was reported in patients receiving iloprost, compared to controls (15.2%) (hazard ratio 2.93, 1.11-7.71, p = 0.03). The overall incidence of death and major cardiovascular events was lower in patients receiving iloprost compared to those assigned placebo (24.0% and 35.9%, respectively), at the limits of statistical significance (relative risk 1.64, 0.97-2.79, p = 0.06). Conclusions: These results confirm the poor outcome in elderly patients with ALLI. Based on a subgroup analysis iloprost, as an adjuvant to surgery, appears to reduce the combined end-point of death and amputation.
De Donato, G., Gussoni, G., de Donato, G., Cao, P., Setacci, C., Pratesi, C., et al. (2007). Acute limb ischemia in elderly patients: can iloprost be useful as an adjuvant to surgery? Results from the ILAILL study. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 34(2), 194-198 [10.1016/j.ejvs.2007.02.002].
Acute limb ischemia in elderly patients: can iloprost be useful as an adjuvant to surgery? Results from the ILAILL study
De Donato, G.;Setacci, C.;BALDI, IRENE;
2007-01-01
Abstract
Objectives: To evaluate the effects of iloprost, in addition to surgery, on the outcome of acute lower limb ischemia (ALLI). Design: Post-hoc analysis of a randomized, double-blind, placebo-controlled study. Methods: In the context of the ILAILL (ILoprost in Acute Ischemia of Lower Limbs) study, 192 elderly patients (>70 years old) undergoing surgery for ALLI were assigned to receive perioperative iloprost (intra-arterial, intra-operative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for six hours/day for 4-7 days following surgery), or placebo (iloprost: n = 100; placebo: n = 92). Patients were followed-up for three-months following surgical revascularization. Results: The combined incidence of death and amputation (primary study end-point) was significantly reduced in patients treated with iloprost (16.0% vs 27.2% in the placebo group; hazard ratio 1.99, 95% confidence interval 1.05-3.75, p = 0.03). A statistically significant lower mortality (6.0%) was reported in patients receiving iloprost, compared to controls (15.2%) (hazard ratio 2.93, 1.11-7.71, p = 0.03). The overall incidence of death and major cardiovascular events was lower in patients receiving iloprost compared to those assigned placebo (24.0% and 35.9%, respectively), at the limits of statistical significance (relative risk 1.64, 0.97-2.79, p = 0.06). Conclusions: These results confirm the poor outcome in elderly patients with ALLI. Based on a subgroup analysis iloprost, as an adjuvant to surgery, appears to reduce the combined end-point of death and amputation.File | Dimensione | Formato | |
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https://hdl.handle.net/11365/6863
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