Clinical outcome and its predictors in 1560 patients with critical leg ischaemia

Objective: to assess the predictivity of clinical variables in patients wit h chronic critical leg ischaemia (CLI). Design: observational prospective cohort study. Methods: the i.c.a.i. (ischemia critica degli arti inferiori) trial databas e was used to assess the impact of patients' history, cardiovascular risk, manifestations of the disease and specific invasive and pharmacological int erventions on mortality, amputation rate and persistence of CLI. Results: of 1560 patients, 298 died within one year; at six months 187 were amputees and 746 still suffered front CLI. Prior major vascular events dou bled the risk of dying within one year. Previous revascularisation was asso ciated with a lower mortality, but also with a higher probability of amputa tion. Among cardiovascular risk factors, only diabetes affected prognosis, in terms of increased mortality and lower probability of recovery front CLI . Patients with tissue loss had a higher amputation rate and less probabili ty gf recovery. Ankle pressure was predictive of mortality and amputation o nly when unmeasurable. Patients requiring revascularisation had better chan ces of recovering from CLI, but not of longer term survival or limb salvage compared to those in whom surgery was deemed unnecessary. Antiplatelet dru gs caused resolution of CLI and decreased the amputation rate by about 1/3, while the advantage of the test treatment (alprostadil-alpha-cyclodextrine ) was confined to CLI resolution only: Conclusions: this study documents the high mortality and heterogeneity of p atients with CLI. It provides stratification criteria for reliably estimati ng the achievable benefit in routine practice and for clinical trials.