Evaluation of clinical outcomes after revascularization in patients with chronic limb-threatening ischemia: results from a prospective national cohort study (RIVALUTANDO)

We evaluated the outcomes of revascularization in patients with chronic limb-threateningischemia (CTLI) treated in real-world settings. This is a prospective multicenter cohortstudy with 12-month follow-up enrolling patients (n=287) with CLTI undergoing open,endovascular, or hybrid lower extremity revascularization (LER). The primary endpoint wasamputation-free survival (AFS) at 12 months. Cox proportional analysis was used todetermine independent predictors of amputation and restenosis. At 30 days, majoradverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%,respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and theprimary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis,smoking (Hazard ratio [HR] 2.2, p=0.04), renal failure (HR 2.3, p=0.03), Rutherford class (≥5)(HR 3.2, p=0.01) and below-the-knee disease (HR 2.0, p=0.05) were significant predictors of amputation; iloprost infusion (>10 vials)(HR 0.64, p=0.05) was a significant protective factor. Cilostazol administration (HR 0.77, p=0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized.Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.