Adjunctive parenteral therapy with lipo-ecraprost, a prostaglandin E1 analog, in
patients with critical limb ischemia undergoing distal revascularization does not
improve 6-month outcomes.
Author(s): Nehler MR, Brass EP, Anthony R, Dormandy J, Jiao J, McNamara TO, Hiatt WR;
Circulase investigators.
Affiliation(s): University of Colorado Health Sciences Center and the Colorado Prevention Center,
Denver, CO 80262-0302, USA. Mark.Nehler@uchsc.edu
Publication date & source: 2007, J Vasc Surg. , 45(5):953-60; discussion 960-1
PURPOSE: In patients with critical limb ischemia (CLI), distal revascularization
remains the procedure of choice for preventing limb loss, but long-term outcomes
for pain relief, wound healing, and prevention of amputation remain suboptimal.
Prostaglandin drug therapy as an adjuvant to revascularization may improve these
outcomes. The current trial was designed to test the hypothesis that the use of
lipo-ecraprost, a lipid encapsulated prostaglandin E(1) prodrug, as an adjunctive
therapy after distal revascularization would improve amputation-free survival in
patients with CLI.
METHODS: The study was randomized, multicenter, double blind, and placebo
controlled. Patients meeting clinical and hemodynamic criteria for CLI who were
undergoing either bypass or endovascular revascularization of the below knee
popliteal or more distal arteries were randomized to receive placebo or a
60-microg dose of lipo-ecraprost administered intravenously starting
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