Background: No effective pharmacologic intervention is available for critical leg ischemia, a severe clinical condition associated with high morbidity and mortality.
Objective: To assess the safety and efficacy of prostaglandin E1 in improving the prognosis and quality of life in patients with critical leg ischemia.
Design: Multicenter, centrally randomized, controlled, open-label trial.
Setting: 56 vascular surgery and angiology departments of the Italian National Health Service.
Patients: 1560 patients with chronic critical leg ischemia.
Interventions: In addition to routine treatments practiced in each center, patients were randomly assigned to receive either a daily intravenous infusion of 60 microg of prostaglandin E1 in the form of alprostadil-alpha-cyclodextrine (n = 771) or no prostaglandin E1 (n = 789) during their hospital stay. The treatment period lasted for up to 28 days.
Measurements: A combined end point consisting of death and peripheral and cardiocerebrovascular illness (major amputation or persistence of critical leg ischemia, acute myocardial infarction, or stroke) evaluated at hospital discharge and during 6 months of follow-up.
Results: The incidence of the combined outcome measure was lower in the alprostadil group than in controls at hospital discharge (493 [63.9%] patients compared with 581 [73.6%] patients; relative risk, 0.87 [95% CI, 0.81 to 0.93]; P < 0.001) but differed only modestly at 6 months (348 of 661 [52.6%] patients compared with 387 of 673 [57.5%] patients; relative risk, 0.92 [CI, 0.83 to 1.01]; P = 0.074). Most of the observed benefit was due to recovery from critical leg ischemia.
Conclusions: Short-term treatment with alprostadil-alpha-cyclodextrine provides patients with critical leg ischemia clinical benefit that is apparent in the short term but decreases over time.