title: Acute limb ischemia in elderly patients: can iloprost be useful as an adjuvant to surgery? Results from the ILAILL study.
abstract: OBJECTIVE
  To evaluate the effects of iloprost, in addition to surgery, on the outcome of acute lower limb ischemia (ALLI).
  
  
  METHODS
  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.
authors: Department of Vascular Surgery, San Giovanni Bosco Hospital, II University of Naples, Italy. dedonato@unisi.it
authors: G
authors: G
authors: de Donato
authors: G
authors: G
authors: Gussoni
authors: G
authors: G
authors: de Donato
authors: P
authors: P
authors: Cao
authors: C
authors: C
authors: Setacci
authors: C
authors: C
authors: Pratesi
authors: A
authors: A
authors: Mazzone
authors: M
authors: M
authors: Ferrari
authors: F
authors: F
authors: Veglia
authors: E
authors: E
authors: Bonizzoni
authors: P
authors: P
authors: Settembrini
authors: H
authors: H
authors: Ebner
authors: A
authors: A
authors: Martino
authors: D
authors: D
authors: Palombo
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical / Q000706:statistics & numerical data; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D005121:Extremities / Q000098:blood supply*; D005260:Female; D006801:Humans; D016285:Iloprost / Q000627:therapeutic use*; D015994:Incidence; D007511:Ischemia / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures
chemical_list: D002317:Cardiovascular Agents; D016285:Iloprost