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Online ISSN 1827-1847
SELECTED PAPERS FROM SICVE NATIONAL CONGRESS 2009
Setacci F. 1, Sirignano P. 1, Raucci A. 1, de Donato G. 1, Chisci E. 1, Galzerano G. 1, Iacoponi F. 2, Cappelli A. 1, Palasciano G. 1, Setacci C. 1
1 Department of Surgery, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy
2 Department of Biomedical Sciences, University of Siena, Siena, Italy
Aim. The aim of the study was to evaluate the safety, effectiveness and clinical outcomes of tibial endovascular revascularization. Simple percutaneous transluminal angioplasty (PTA) was compared with bail-out stenting in diabetic patients with critical limb ischemia (CLI) due to below-the-knee (BTK) occlusive arterial disease.
Methods. The study evaluated a prospective database of 81 diabetic patients admitted to our Vascular and Endovascular Surgery Unit between February 2006 and February 2008 with CLI due to BTK arterial occlusion involving two or three vessels. The revascularization strategy involved balloon angioplasty (Group A) and bail-out stenting when needed (Group B). Clinical and duplex-scan follow-up examinations were performed after 1, 3, 6 and 12 months. The variables “amputation” and “re-intervention” were evaluated by means of Kaplan-Meier curves. A P value <0.05 was considered statistically significant. Analyses were performed by using SPSS software version 13 (SPSS Inc., Chicago, IL, USA).
Results. We performed 81 BTK endovascular revascularization procedures in 81 patients. Sixty-nine (85.2%) patients were treated with PTA alone (Group A) while 12 (14.8%) patients underwent bail-out stenting (Group B). Technical success was achieved in 92.7% of Group A and 83.3% of group B patients. Primary patency, primary assisted patency and secondary patency after 1 month were 89.8%, 92.7% and 97.1%, respectively, in Group A and 75%, 83.3% and 83.3% in Group B. After 1 year, the same parameters were 60.8%, 71% and 75.3% in Group A and 58.3%, 66.6% and 75% in Group B. One-year re-intervention-free survival and major amputation-free survival rates were 62.3 and 82.6%, respectively, in Group A and 58.3 and 83.3% in Group B (P>0.05 in all cases).
Conclusions. Endovascular therapy is an appealing, safe and effective therapeutic alternative for the treatment of tibial artery lesions in diabetic patients with CLI, in that it yields a good major amputation-free survival rate, even though patency is very poor. Although collected from a limited experience, our data suggest that PTA offers a better outcome than bail-out stenting, as Kaplan-Meier analysis showed a lower re-intervention rate in group A over the first 180 days of follow-up.