Long-term outcomes following primary drug-eluting stenting of infrapopliteal bifurcations.

PURPOSE: To investigate the outcomes following primary deployment of drug-eluting stents (DES) for the treatment of infrapopliteal bifurcation lesions in patients suffering from critical limb ischemia (CLI).

METHODS: This was a retrospective study of a registry enrolling all patients suffering from chronic infrapopliteal artery disease and undergoing treatment of tibial bifurcation lesions with DES using 3 techniques: balloon and stent (single stent), T-shape double-stent, and culotte double-stent. The analysis included 39 CLI patients (32 men; mean age 69 ± 10 years) who underwent primary stenting of 41 infrapopliteal bifurcations. Most patients (29, 70.7%) were classified as Rutherford category 4. The mean lesion length was 31.3 ± 13.1 mm. The primary endpoints were amputation-free survival, target lesion revascularization (TLR)-free survival, angiographic 2-vessel primary patency (2VPP), and 1-vessel primary patency (1VPP). Secondary endpoints included survival and angiographic binary restenosis. A Cox regression analysis was performed to identify independent predictors influencing outcomes

RESULTS: Technical success was achieved in all cases. The mean clinical and angiographic follow-up intervals were 47.5 ± 14.8 and 17.5 ± 12.5 months, respectively. According to the Kaplan-Meier analysis, overall survival, amputation-free survival, and TLR-free survival estimates were 79.5%, 84.3%, and 58.0%, respectively, at 5 years. At 12, 24, and 36 months, the 2VPP rates were 77.2%, 47.5%, and 33.9%, and the 1VPP rates were 84.0%, 65.5%, and 54.5%, respectively. Binary restenosis rates were 26.4%, 57.3%, and 82.2% at 12, 24, and 36 months; restenotic lesions were mainly detected at the origin of the bifurcations. The regression model did not identify any independent predictors influencing outcome.

CONCLUSION: DES application for below-the-knee bifurcation lesions was safe and resulted in satisfactory long-term angiographic and clinical outcomes comparable to those reported following infrapopliteal endovascular treatment.