Nomograms used to define the short-term treatment with PGE(1) in patients with intermittent claudication and critical ischemia. The ORACL.E (Occlusion Revascularization in the Atherosclerotic Critical Limb) study group. The European study

Infusional, cyclic PGE(1) treatment is effective in patients with intermitt ent claudication and critical limb ischemia (CLI). One of the problems rela ted to chronic PGE(1) treatment in vascular diseases due to atherosclerosis is to evaluate the variations of clinical conditions due to treatment in o rder to establish the number of cycles per year or per period (in severe va scular disease reevaluation of patients should be more frequent) needed to achieve clinical improvement. In a preliminary pilot study a group of 150 p atients (mean age 67 +/- 12 years) with intermittent claudication (walking range from 0 to 500 m) and a group of 100 patients with CLI (45% with rest pain, and 55% gangrene; mean age 68 +/- 11 years) the number of PGE(1) cycl es according to the short-term protocol (STP) needed to produce significant clinical improvement was preliminarily evaluated. Considering these prelim inary observations, the investigators established a research plan useful to produce nomograms indicating the number of cycles of PGE(1)-STP per year n eeded to improve the clinical condition (both in intermittent claudication and CLI). A significant clinical improvement was arbitrarily defined as the increase of at least 35% in walking distance (on treadmill) and/or the dis appearance of signs and symptoms of critical ischemia in 6 months of treatm ent in at least 75% of the treated patients. With consideration of the resu lts obtained with the preliminary nomograms a larger validation of the nomo grams is now advisable. A cost-effectiveness analysis is also useful to def ine the efficacy of treatment on the basis of its costs. The publication of this report in two angiological journals (Angeiologie and Angiology) will open the research on nomograms to all centers willing to collaborate to the study. The data are being collected in the ORACLE.E database and will be a nalyzed within 12 months after the publication of this report.