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Clinical outcome and its predictors in 1560 patients with critical leg ischaemia. Chronic Critical Leg Ischaemia
V Bertelè1, M C Roncaglioni, J Pangrazzi
1Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Insights
Predictors of outcomes in chronic critical leg ischemia (CLI) were identified. Diabetes and prior vascular events increased mortality, while antiplatelet drugs improved CLI resolution and reduced amputation rates.
Area of Science:
- Vascular Medicine
- Clinical Epidemiology
Background:
- Chronic critical leg ischemia (CLI) presents a significant challenge with high morbidity and mortality.
- Understanding predictive factors is crucial for patient management and clinical trial design.
Purpose of the Study:
- To evaluate the predictive value of clinical variables for outcomes in patients with chronic critical leg ischemia (CLI).
- To identify factors influencing mortality, amputation rates, and CLI persistence.
Main Methods:
- Analysis of the i.c.a.i. (ischemia critica degli arti inferiori) trial database, a prospective observational cohort study.
- Assessment of patient history, cardiovascular risk factors, disease manifestations, and interventions.
Main Results:
- Prior major vascular events doubled 1-year mortality risk.
- Diabetes mellitus worsened prognosis, increasing mortality and reducing CLI recovery.
- Antiplatelet agents improved CLI resolution and reduced amputation rates by approximately 33%.
Conclusions:
- Patients with CLI exhibit high mortality and heterogeneity.
- The study provides criteria for stratifying patients to estimate treatment benefits in clinical practice and trials.
Objective:
to assess the predictivity of clinical variables in patients with chronic critical leg ischaemia (CLI). Design observational prospective cohort study.
Methods:
the i.c.a.i. (ischemia critica degli arti inferiori) trial database was used to assess the impact of patients' history, cardiovascular risk, manifestations of the disease and specific invasive and pharmacological interventions 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 from CLI. Prior major vascular events doubled the risk of dying within one year. Previous revascularisation was associated with a lower mortality, but also with a higher probability of amputation. Among cardiovascular risk factors, only diabetes affected prognosis, in terms of increased mortality and lower probability of recovery from CLI. Patients with tissue loss had a higher amputation rate and less probability of recovery. Ankle pressure was predictive of mortality and amputation only when unmeasurable. Patients requiring revascularisation had better chances of recovering from CLI, but not of longer-term survival or limb salvage compared to those in whom surgery was deemed unnecessary. Antiplatelet drugs 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 patients with CLI. It provides stratification criteria for reliably estimating the achievable benefit in routine practice and for clinical trials.