The ICAI Study Group*
No effective pharmacologic intervention is available for critical leg ischemia, a severe clinical condition associated with high morbidity and mortality.
To assess the safety and efficacy of prostaglandin E1 in improving the prognosis and quality of life in patients with critical leg ischemia.
Multicenter, centrally randomized, controlled, open-label trial.
56 vascular surgery and angiology departments of the Italian National Health Service.
1560 patients with chronic critical leg ischemia.
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-α-cyclodextrine (n = 771) or no prostaglandin E1 (n = 789) during their hospital stay. The treatment period lasted for up to 28 days.
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.
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.
Short-term treatment with alprostadil-α-cyclodextrine provides patients with critical leg ischemia clinical benefit that is apparent in the short term but decreases over time.
*For members of the ICAI (Ischemia Cronica Critica degli Arti Inferiori) Study Group, see the Appendix.
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The ICAI Study Group*. Prostanoids for Chronic Critical Leg Ischemia: A Randomized, Controlled, Open-Label Trial with Prostaglandin E1. Ann Intern Med. 1999;130:412-421. doi: 10.7326/0003-4819-130-5-199903020-00005
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Published: Ann Intern Med. 1999;130(5):412-421.
Hospital Medicine, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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