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2 March 1999 | Volume 130 Issue 5 | Pages 412-421
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 µg of prostaglandin E1 in the form of alprostadil-
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-
*For members of the ICAI (Ischemia Cronica Critica degli Arti Inferiori) Study Group, see the Appendix.
Author and Article Information
Acknowledgments: The Group and the Study Secreteriat thank F. Clerici, A. Palumbo, and G. Sgaroni for secretarial assistance in the management of the study and help in preparing the manuscript and the G.A. Pfeiffer Memorial Library staff and J. Baggott for their helpful editorial assistance.
Grant Support: By a grant from Schwarz Pharma Italia, Milan, Italy, which also provided the experimental drug.
Requests for Reprints: V. Bertele, MD, Mario Negri Institute, via Eritrea 62, 20157 Milan, Italy; e-mail, bertele{at}irfmn.mnegri.it.
Current Author Address: ICAI Group, c/o Mario Negri Institute, via Eritrea 62, 20157 Milan, Italy. ARTICLE
Prostanoids for Chronic Critical Leg Ischemia
A Randomized, Controlled, Open-Label Trial with Prostaglandin E1
-cyclodextrine (n = 771) or no prostaglandin E1 (n = 789) during their hospital stay. The treatment period lasted for up to 28 days. -cyclodextrine provides patients with critical leg ischemia clinical benefit that is apparent in the short term but decreases over time.
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