Purpose: To report the midterm (<or=1 year) angiographic and clinical outcomes of a prospective study investigating the infrapopliteal application of paclitaxel-eluting stents (PES) in patients with critical limb ischemia (CLI).
Materials and methods: Infrapopliteal angioplasty was chosen as first-line therapy in patients with unilateral or bilateral CLI and additional femoropopliteal angioplasty was performed in case of multilevel disease. Implantation of coronary PES was performed in case of a suboptimal angioplasty result (eg, elastic recoil, residual stenosis>30%, or flow-limiting dissection). Patients were followed up with regular clinical evaluation, and digital subtraction angiography was scheduled at 6 months and 1 year. Life-table analysis and Kaplan-Meier plotting of angiographic and clinical variables were performed. Cox proportional-hazards regression analysis was employed to adjust for various covariates and search for independent adverse predictors of angiographic and clinical outcome.
Results: Infrapopliteal procedures were performed in 29 patients with 32 limbs with CLI; 79.3% of the patients had diabetes and 34.5% had renal disease. A total of 62 coronary PES were deployed in 50 below-knee lesions (mean stent-implanted length, 25.51 mm+/-12.16). Technical success rate was 100%. The 1-year mortality rate was 16.9%, and the limb salvage rate was 88.5%. The 1-year angiographic in-stent primary patency rate was 30.0%, whereas the incidence of in-stent binary (>50%) restenosis was 77.4%. The 1-year incidence of clinically driven repeat interventions was 30.5%. The Cox model calculated renal disease as the only independent predictor of decreased primary patency and increased repeat intervention events. Initial occlusions also adversely affected primary patency.
Conclusions: Infrapopliteal PES achieved acceptable clinical results in CLI, even though they failed to inhibit vascular restenosis and decrease the need for repeat interventions. Renal disease and initial occlusions are adverse prognostic factors for infrapopliteal endovascular procedures.