Is it possible to improve outcome in patients undergoing surgery for acute limb ischemia? Can iloprost, a prostacyclin analogue, be helpful?

Acute limb ischaemia (ALI) is a serious medical emergency leading to high rate of complications, being not only limb- but even life-threatening, often in spite of early successful revascularization. Concomitant underlying diseases, the metabolic derangement that seems a result of the acute insult and a possible reperfusion injury following revascularization may account for this severe prognosis. Only anticoagulation, fasciotomy and perioperative supportive treatment are established strategies in ALI patients. Possible benefit from chronic therapies active on vascular and cardiac side has been suggested. Moreover, several categories of compounds, potentially acting on pathophysiological mechanisms of ischemia-reperfusion syndrome, have been tested in experimental models, but none of them has as yet been proven effective in clinical studies. Prostanoids are drugs traditionally utilized in critical chronic limb ischaemia, and their pharmacological properties support a potential usefulness as adjuvant treatment in ALI. In a pilot double-blind placebo-controlled study it has been evaluated the effect of perioperative iloprost, a synthetic prostacyclin analogue, in 30 patients with ALI undergoing Fogarty's thromboembolectomy. The encouraging results of iloprost in this study (lower incidence of major clinical events, more evident metabolic improvement by means of transcutaneous tensiometry--statistically significant reduction in TcpCO2--suggested the opportunity of performing a larger, multicenter trial (ILAILL). In comparison with the pilot study, ILAILL included patients undergoing various types of surgical revascularization, and a longer period of experimental treatment and post-operative follow-up. Preliminary data from this study confirm the high morbidity and mortality of ALI (overall incidence of major events, 29%). Results of ILAILL trial, as for comparison of effects between iloprost and control group, will be available at the beginning of 2005.

RCT Entities:   Population Interventions Outcomes