A prospective epidemiological survey of the natural history of chronic leg ischaemia. Evidence of the severity of prognosis and need for large-scale clinical trials

Objective: To draw a picture of the different practices adopted for the diagnosis, specific treatment and general care of critical leg ischaemia (CLI) in the light of the recommendations of the recent Consensus Document. Design: Prospective observational study. Setting: A representative sample of vascular and general surgery, angiology, general medicine departments of the Italian National Health Service. Subjects: Patients with leg ischaemia considered as chronic and critical according to the definition and diagnostic criteria adopted in each centre. Chief outcome measures: Epidemiological profile of the standard population; prevalence of definition criteria and of diagnostic and therapeutic procedures; short and medium-term clinical outcome as well as of the general vascular morbidity and mortality. Main results: Over a 3 month period, 574 patients were recruited in 69 centres mainly on the basis of clinical findings of CLI (rest pain and~or trophic lesions). They had an adequate diagnostic assessment of their vascular lesions and a high cardiovascular risk in terms of prior morbidity and presence of risk factors. Over half of the patients underwent revascularisation and three quarters were given pharmacological treatments. At the end of the observation period, 50 patients had died (8.7%), three had had a myocardial infarction (0.5%), six a stroke (1.0%), 70 a major amputation (12.2%) and 103 had persistent CLI (17.9%). Conclusions" This survey confirms the dramatic prognosis of patients with CLI and provides an appropriate background and setting to conduct experimental clinical studies in this field.