Key result
Perioperative iloprost fails to reduce 3-month death or amputation but cuts mortality ~56%.
Why the study?
Does perioperative iloprost reduce the combined incidence of death and amputation in patients undergoing surgery for acute limb ischemia?
RCT (n=300)
Placebo-controlled
Randomly assigned
Does perioperative iloprost reduce the combined incidence of death and amputation in patients undergoing surgery for acute limb ischemia?
Relative Risk: 1.56 (95% CI 0.89–2.75)
Absolute Event Rate: 14.1% vs 19.9%
p-value: p=0.12
Perioperative iloprost as an adjuvant to surgery for acute limb ischemia did not significantly reduce the primary composite of death and amputation, but significantly reduced mortality and overall major cardiovascular events.
Does not support routine perioperative iloprost to reduce death or amputation after acute limb ischemia surgery; leaves open a mortality benefit for confirmation.
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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Donato et al. (2006) conducted an RCT in Acute limb ischemia (ALI) (n=300). Iloprost vs. Placebo was evaluated on Combined incidence of death and amputation at 3-month follow-up (RR 1.56, 95% CI 0.89-2.75, p=0.12). Perioperative iloprost did not significantly reduce the primary composite of death and amputation at 3 months (14.1% vs 19.9%; P=0.12), though it significantly reduced mortality (4.7% vs 10.6%; P=0.03).
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