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Online ISSN 1827-1847
De Donato G. 1, Gussoni G. 2, De Laurentiis R. 3, De Donato M. 1, Esposito M. 1, Montemarano E. 1, De Donato G. 1
1 Vascular Surgery Unit “San Giovanni Bosco” Hospital, ASL 1 Second University of Naples, Naples, Italy
2 Scientific Department, Italfarmaco SpA, Milan, Italy
3 Pharmaceutical Service, ASL, Naples, Italy
Acute lower limb ischemia, because it may be not only limb- but even life-threatening, is a serious medical emergency associated with a high rate of complications that can often develop despite early successful treatment. In general, the immediate success rates of surgical/endovascular/thrombolytic procedures are reportedly very high, but the data from the literature are not always easy to interpret due to the diversity of treatment strategies. Acute, limb-threatening ischemia remains burdened by significant morbidity and mortality because of underlying diseases and the metabolic derangement from acute insult and possible severe reperfusion injury following successful revascularization. In patients undergoing Fogarty catheter thromboembolectomy, 30-day amputation rates of 12-35% and mortality rates of 13-25% have been estimated, while for longer follow-up (6-24 months) the incidence of amputation and mortality is reported as 13-24% and 12-52%, respectively. Other series showed 6- and 12-month major complications rates (limb loss and mortality) of 20-35% in patients with acute limb ischemia undergoing surgical revascularization. Prostanoids are drugs conventionally utilized in critical limb ischemia. Iloprost is a synthetic prostacyclin analogue with effective vasodilator, antiplatelet and antineutrophil properties; it has cytoprotective effects similar to prostacyclin and reduces reperfusion injury after prolonged ischaemia. Some authors have reported positive effects of the perioperative use of iloprost during femorodistal arterial reconstruction for critical leg ischemia; the drug has also been successfully used in some patients with acute arterial ischemia. The effect of iloprost has been evaluated in a double-blind, placebo-controlled pilot study in 30 patients who underwent Fogarty catheter thromboembolectomy for acute thromboembolic occlusion of the lower limbs. The drug was administered intra-arterially immediately after revascularization, plus by intravenous infusion at conventional doses for the following 3 days. On the basis of the encouraging results of this study (lower incidence of major amputations, more evident metabolic improvement as measured by transcutaneous oxygen and carbon dioxide pressure in the iloprost-treated group), a larger, multicentre phase III study is being conducted to further verify these results. Unlike the pilot study, this trial include patients undergoing different types of surgical revascularization and a longer period of intravenous infusion (4-7 days). The results from the study are expected in 2004.