The ILAILL study: Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery

Gaetano de Donato, Gualberto Gussoni, Gianmarco de Donato, Giuseppe Maria Andreozzi, Erminio Bonizzoni, Antonino Mazzone, Attilio Odero, Giovanni Paroni, Carlo Setacci, Piergiorgio Settembrini, Fabrizio Veglia, Romeo Martini, Francesco Setacci, Domenico Palombo, R. de Laurentiis, G. Bianco, I. Baldi, C. Pratesi, R. Pulli, E. RomanoA. Martino, G. la Marca, H. Ebner, P. Sbraga, F. Zaraca, F. Spinelli, T. Mandolfino, F. Benedetto, D. Baccellieri, M. Ferrari, D. Adami, A. del Corso, M. Ruggieri, C. Novali, B. Mangiacotti, F. Ponzio, G. Capaldi, P. Cao, B. Parente, G. Parlani, P. Maltempi, S. Ferrero, P. Colotto, L. Nardella, S. Pastorino, G. Rauti, R. Chiesa, E. M. Marone, C. Bertoglio, A. M. Cristiani, T. Carissimi, G. Deriu, M. Antonello, F. Nessi, P. Cumbo, E. Ferrero, R. Mattassi, E. Callini, A. Ippoliti, A. Ascoli Marchetti, L. di Giulio, C. Spartera, C. Petrassi, G. Saracino, G. Biasi, P. Mingazzini, Y. Thsomba, G. Regina, G. Impedovo, A. Lillo, D. Angiletta, V. Marotta

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

SUMMARY BACKGROUND DATA: High rate of complications has been reported following revascularization for acute limb ischemia (ALI). No adjuvant pharmacologic treatment, apart from anticoagulation and standard perioperative care, has been shown clinically effective. OBJECTIVE: Aim of this study was to evaluate the effects of the prostacyclin analog iloprost as adjuvant to surgery for ALI. METHODS: A total of 300 patients were randomly assigned to receive perioperative iloprost (intra-arterial, intraoperative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for 6 hours/day for 4-7 days following surgery), or placebo. The primary endpoint was the combined incidence of death and amputation at 3-month follow-up. Secondary endpoints were the incidence of each single major complication, total event rate, symptomatology, and tolerability. RESULTS: The combined incidence of death and amputation was 19.9% in the placebo and 14.1% in the iloprost group (relative risk, 1.56; 95% confidence interval, 0.89-2.75, P = 0.12, Cox regression analysis). A statistically significant lower mortality (4.7%) was reported in patients receiving iloprost, compared with controls (10.6%; relative risk, 2.61; 95% confidence interval, 1.07-6.37, P = 0.03). The overall incidence of fatal plus major cardiovascular events was 33.1% and 22.8% in placebo and iloprost groups, respectively (relative risk, 1.61; 95% confidence interval, 1.04-2.49, P = 0.03). No serious adverse reactions occurred after iloprost administration, nor differences in the incidence of bleeding or hypotension between treatment groups. CONCLUSIONS: Although at lower levels than previously reported, our results confirm the severity of ALI. Iloprost as adjuvant to surgery significantly reduced mortality and overall major event rate. Further data are needed to support this finding, and to face a still open medical issue.

Original languageEnglish
Pages (from-to)185-193
Number of pages9
JournalAnnals of Surgery
Volume244
Issue number2
DOIs
Publication statusPublished - Aug 2006

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Iloprost
Double-Blind Method
Blood Vessels
Lower Extremity
Ischemia
Placebos
Incidence
Extremities
Confidence Intervals
Amputation
Perioperative Care
Mortality
Epoprostenol
Ambulatory Surgical Procedures
Intravenous Infusions
Hypotension
Regression Analysis
Hemorrhage
Therapeutics

ASJC Scopus subject areas

  • Surgery

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The ILAILL study : Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery. / de Donato, Gaetano; Gussoni, Gualberto; de Donato, Gianmarco; Andreozzi, Giuseppe Maria; Bonizzoni, Erminio; Mazzone, Antonino; Odero, Attilio; Paroni, Giovanni; Setacci, Carlo; Settembrini, Piergiorgio; Veglia, Fabrizio; Martini, Romeo; Setacci, Francesco; Palombo, Domenico; de Laurentiis, R.; Bianco, G.; Baldi, I.; Pratesi, C.; Pulli, R.; Romano, E.; Martino, A.; la Marca, G.; Ebner, H.; Sbraga, P.; Zaraca, F.; Spinelli, F.; Mandolfino, T.; Benedetto, F.; Baccellieri, D.; Ferrari, M.; Adami, D.; del Corso, A.; Ruggieri, M.; Novali, C.; Mangiacotti, B.; Ponzio, F.; Capaldi, G.; Cao, P.; Parente, B.; Parlani, G.; Maltempi, P.; Ferrero, S.; Colotto, P.; Nardella, L.; Pastorino, S.; Rauti, G.; Chiesa, R.; Marone, E. M.; Bertoglio, C.; Cristiani, A. M.; Carissimi, T.; Deriu, G.; Antonello, M.; Nessi, F.; Cumbo, P.; Ferrero, E.; Mattassi, R.; Callini, E.; Ippoliti, A.; Ascoli Marchetti, A.; di Giulio, L.; Spartera, C.; Petrassi, C.; Saracino, G.; Biasi, G.; Mingazzini, P.; Thsomba, Y.; Regina, G.; Impedovo, G.; Lillo, A.; Angiletta, D.; Marotta, V.

In: Annals of Surgery, Vol. 244, No. 2, 08.2006, p. 185-193.

Research output: Contribution to journalArticle

de Donato, G, Gussoni, G, de Donato, G, Andreozzi, GM, Bonizzoni, E, Mazzone, A, Odero, A, Paroni, G, Setacci, C, Settembrini, P, Veglia, F, Martini, R, Setacci, F, Palombo, D, de Laurentiis, R, Bianco, G, Baldi, I, Pratesi, C, Pulli, R, Romano, E, Martino, A, la Marca, G, Ebner, H, Sbraga, P, Zaraca, F, Spinelli, F, Mandolfino, T, Benedetto, F, Baccellieri, D, Ferrari, M, Adami, D, del Corso, A, Ruggieri, M, Novali, C, Mangiacotti, B, Ponzio, F, Capaldi, G, Cao, P, Parente, B, Parlani, G, Maltempi, P, Ferrero, S, Colotto, P, Nardella, L, Pastorino, S, Rauti, G, Chiesa, R, Marone, EM, Bertoglio, C, Cristiani, AM, Carissimi, T, Deriu, G, Antonello, M, Nessi, F, Cumbo, P, Ferrero, E, Mattassi, R, Callini, E, Ippoliti, A, Ascoli Marchetti, A, di Giulio, L, Spartera, C, Petrassi, C, Saracino, G, Biasi, G, Mingazzini, P, Thsomba, Y, Regina, G, Impedovo, G, Lillo, A, Angiletta, D & Marotta, V 2006, 'The ILAILL study: Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery', Annals of Surgery, vol. 244, no. 2, pp. 185-193. https://doi.org/10.1097/01.sla.0000217555.49001.ca
de Donato, Gaetano ; Gussoni, Gualberto ; de Donato, Gianmarco ; Andreozzi, Giuseppe Maria ; Bonizzoni, Erminio ; Mazzone, Antonino ; Odero, Attilio ; Paroni, Giovanni ; Setacci, Carlo ; Settembrini, Piergiorgio ; Veglia, Fabrizio ; Martini, Romeo ; Setacci, Francesco ; Palombo, Domenico ; de Laurentiis, R. ; Bianco, G. ; Baldi, I. ; Pratesi, C. ; Pulli, R. ; Romano, E. ; Martino, A. ; la Marca, G. ; Ebner, H. ; Sbraga, P. ; Zaraca, F. ; Spinelli, F. ; Mandolfino, T. ; Benedetto, F. ; Baccellieri, D. ; Ferrari, M. ; Adami, D. ; del Corso, A. ; Ruggieri, M. ; Novali, C. ; Mangiacotti, B. ; Ponzio, F. ; Capaldi, G. ; Cao, P. ; Parente, B. ; Parlani, G. ; Maltempi, P. ; Ferrero, S. ; Colotto, P. ; Nardella, L. ; Pastorino, S. ; Rauti, G. ; Chiesa, R. ; Marone, E. M. ; Bertoglio, C. ; Cristiani, A. M. ; Carissimi, T. ; Deriu, G. ; Antonello, M. ; Nessi, F. ; Cumbo, P. ; Ferrero, E. ; Mattassi, R. ; Callini, E. ; Ippoliti, A. ; Ascoli Marchetti, A. ; di Giulio, L. ; Spartera, C. ; Petrassi, C. ; Saracino, G. ; Biasi, G. ; Mingazzini, P. ; Thsomba, Y. ; Regina, G. ; Impedovo, G. ; Lillo, A. ; Angiletta, D. ; Marotta, V. / The ILAILL study : Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery. In: Annals of Surgery. 2006 ; Vol. 244, No. 2. pp. 185-193.
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title = "The ILAILL study: Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery",
abstract = "SUMMARY BACKGROUND DATA: High rate of complications has been reported following revascularization for acute limb ischemia (ALI). No adjuvant pharmacologic treatment, apart from anticoagulation and standard perioperative care, has been shown clinically effective. OBJECTIVE: Aim of this study was to evaluate the effects of the prostacyclin analog iloprost as adjuvant to surgery for ALI. METHODS: A total of 300 patients were randomly assigned to receive perioperative iloprost (intra-arterial, intraoperative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for 6 hours/day for 4-7 days following surgery), or placebo. The primary endpoint was the combined incidence of death and amputation at 3-month follow-up. Secondary endpoints were the incidence of each single major complication, total event rate, symptomatology, and tolerability. RESULTS: The combined incidence of death and amputation was 19.9{\%} in the placebo and 14.1{\%} in the iloprost group (relative risk, 1.56; 95{\%} confidence interval, 0.89-2.75, P = 0.12, Cox regression analysis). A statistically significant lower mortality (4.7{\%}) was reported in patients receiving iloprost, compared with controls (10.6{\%}; relative risk, 2.61; 95{\%} confidence interval, 1.07-6.37, P = 0.03). The overall incidence of fatal plus major cardiovascular events was 33.1{\%} and 22.8{\%} in placebo and iloprost groups, respectively (relative risk, 1.61; 95{\%} confidence interval, 1.04-2.49, P = 0.03). No serious adverse reactions occurred after iloprost administration, nor differences in the incidence of bleeding or hypotension between treatment groups. CONCLUSIONS: Although at lower levels than previously reported, our results confirm the severity of ALI. Iloprost as adjuvant to surgery significantly reduced mortality and overall major event rate. Further data are needed to support this finding, and to face a still open medical issue.",
author = "{de Donato}, Gaetano and Gualberto Gussoni and {de Donato}, Gianmarco and Andreozzi, {Giuseppe Maria} and Erminio Bonizzoni and Antonino Mazzone and Attilio Odero and Giovanni Paroni and Carlo Setacci and Piergiorgio Settembrini and Fabrizio Veglia and Romeo Martini and Francesco Setacci and Domenico Palombo and {de Laurentiis}, R. and G. Bianco and I. Baldi and C. Pratesi and R. Pulli and E. Romano and A. Martino and {la Marca}, G. and H. Ebner and P. Sbraga and F. Zaraca and F. Spinelli and T. Mandolfino and F. Benedetto and D. Baccellieri and M. Ferrari and D. Adami and {del Corso}, A. and M. Ruggieri and C. Novali and B. Mangiacotti and F. Ponzio and G. Capaldi and P. Cao and B. Parente and G. Parlani and P. Maltempi and S. Ferrero and P. Colotto and L. Nardella and S. Pastorino and G. Rauti and R. Chiesa and Marone, {E. M.} and C. Bertoglio and Cristiani, {A. M.} and T. Carissimi and G. Deriu and M. Antonello and F. Nessi and P. Cumbo and E. Ferrero and R. Mattassi and E. Callini and A. Ippoliti and {Ascoli Marchetti}, A. and {di Giulio}, L. and C. Spartera and C. Petrassi and G. Saracino and G. Biasi and P. Mingazzini and Y. Thsomba and G. Regina and G. Impedovo and A. Lillo and D. Angiletta and V. Marotta",
year = "2006",
month = "8",
doi = "10.1097/01.sla.0000217555.49001.ca",
language = "English",
volume = "244",
pages = "185--193",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - The ILAILL study

T2 - Iloprost as adjuvant to surgery for acute ischemia of lower limbs - A randomized, placebo-controlled, double-blind study by the Italian Society for Vascular and Endovascular Surgery

AU - de Donato, Gaetano

AU - Gussoni, Gualberto

AU - de Donato, Gianmarco

AU - Andreozzi, Giuseppe Maria

AU - Bonizzoni, Erminio

AU - Mazzone, Antonino

AU - Odero, Attilio

AU - Paroni, Giovanni

AU - Setacci, Carlo

AU - Settembrini, Piergiorgio

AU - Veglia, Fabrizio

AU - Martini, Romeo

AU - Setacci, Francesco

AU - Palombo, Domenico

AU - de Laurentiis, R.

AU - Bianco, G.

AU - Baldi, I.

AU - Pratesi, C.

AU - Pulli, R.

AU - Romano, E.

AU - Martino, A.

AU - la Marca, G.

AU - Ebner, H.

AU - Sbraga, P.

AU - Zaraca, F.

AU - Spinelli, F.

AU - Mandolfino, T.

AU - Benedetto, F.

AU - Baccellieri, D.

AU - Ferrari, M.

AU - Adami, D.

AU - del Corso, A.

AU - Ruggieri, M.

AU - Novali, C.

AU - Mangiacotti, B.

AU - Ponzio, F.

AU - Capaldi, G.

AU - Cao, P.

AU - Parente, B.

AU - Parlani, G.

AU - Maltempi, P.

AU - Ferrero, S.

AU - Colotto, P.

AU - Nardella, L.

AU - Pastorino, S.

AU - Rauti, G.

AU - Chiesa, R.

AU - Marone, E. M.

AU - Bertoglio, C.

AU - Cristiani, A. M.

AU - Carissimi, T.

AU - Deriu, G.

AU - Antonello, M.

AU - Nessi, F.

AU - Cumbo, P.

AU - Ferrero, E.

AU - Mattassi, R.

AU - Callini, E.

AU - Ippoliti, A.

AU - Ascoli Marchetti, A.

AU - di Giulio, L.

AU - Spartera, C.

AU - Petrassi, C.

AU - Saracino, G.

AU - Biasi, G.

AU - Mingazzini, P.

AU - Thsomba, Y.

AU - Regina, G.

AU - Impedovo, G.

AU - Lillo, A.

AU - Angiletta, D.

AU - Marotta, V.

PY - 2006/8

Y1 - 2006/8

N2 - SUMMARY BACKGROUND DATA: High rate of complications has been reported following revascularization for acute limb ischemia (ALI). No adjuvant pharmacologic treatment, apart from anticoagulation and standard perioperative care, has been shown clinically effective. OBJECTIVE: Aim of this study was to evaluate the effects of the prostacyclin analog iloprost as adjuvant to surgery for ALI. METHODS: A total of 300 patients were randomly assigned to receive perioperative iloprost (intra-arterial, intraoperative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for 6 hours/day for 4-7 days following surgery), or placebo. The primary endpoint was the combined incidence of death and amputation at 3-month follow-up. Secondary endpoints were the incidence of each single major complication, total event rate, symptomatology, and tolerability. RESULTS: The combined incidence of death and amputation was 19.9% in the placebo and 14.1% in the iloprost group (relative risk, 1.56; 95% confidence interval, 0.89-2.75, P = 0.12, Cox regression analysis). A statistically significant lower mortality (4.7%) was reported in patients receiving iloprost, compared with controls (10.6%; relative risk, 2.61; 95% confidence interval, 1.07-6.37, P = 0.03). The overall incidence of fatal plus major cardiovascular events was 33.1% and 22.8% in placebo and iloprost groups, respectively (relative risk, 1.61; 95% confidence interval, 1.04-2.49, P = 0.03). No serious adverse reactions occurred after iloprost administration, nor differences in the incidence of bleeding or hypotension between treatment groups. CONCLUSIONS: Although at lower levels than previously reported, our results confirm the severity of ALI. Iloprost as adjuvant to surgery significantly reduced mortality and overall major event rate. Further data are needed to support this finding, and to face a still open medical issue.

AB - SUMMARY BACKGROUND DATA: High rate of complications has been reported following revascularization for acute limb ischemia (ALI). No adjuvant pharmacologic treatment, apart from anticoagulation and standard perioperative care, has been shown clinically effective. OBJECTIVE: Aim of this study was to evaluate the effects of the prostacyclin analog iloprost as adjuvant to surgery for ALI. METHODS: A total of 300 patients were randomly assigned to receive perioperative iloprost (intra-arterial, intraoperative bolus of 3000 ng, plus intravenous infusion of 0.5-2.0 ng/kg/min for 6 hours/day for 4-7 days following surgery), or placebo. The primary endpoint was the combined incidence of death and amputation at 3-month follow-up. Secondary endpoints were the incidence of each single major complication, total event rate, symptomatology, and tolerability. RESULTS: The combined incidence of death and amputation was 19.9% in the placebo and 14.1% in the iloprost group (relative risk, 1.56; 95% confidence interval, 0.89-2.75, P = 0.12, Cox regression analysis). A statistically significant lower mortality (4.7%) was reported in patients receiving iloprost, compared with controls (10.6%; relative risk, 2.61; 95% confidence interval, 1.07-6.37, P = 0.03). The overall incidence of fatal plus major cardiovascular events was 33.1% and 22.8% in placebo and iloprost groups, respectively (relative risk, 1.61; 95% confidence interval, 1.04-2.49, P = 0.03). No serious adverse reactions occurred after iloprost administration, nor differences in the incidence of bleeding or hypotension between treatment groups. CONCLUSIONS: Although at lower levels than previously reported, our results confirm the severity of ALI. Iloprost as adjuvant to surgery significantly reduced mortality and overall major event rate. Further data are needed to support this finding, and to face a still open medical issue.

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JO - Annals of Surgery

JF - Annals of Surgery

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