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Italian Journal of Vascular and Endovascular Surgery 2004 June;11(2):93-9

Copyright © 2005 EDIZIONI MINERVA MEDICA

language: English

Iloprost as an adjuvant to surgical revascularization in acute ischemia of lower limbs

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.