Abstract

Background: Although percutaneous transluminal angioplasty (PTA) is considered as an effective treatment strategy in patients (pts) with critical limb ischemia (CLI), below-the-knee (BTK) lesions with CLI is particularly challenging. This study sought to compare the 12-month outcomes following stenting versus standard plain old balloon angioplasty (POBA) alone in BTK lesions. Method: This study consisted of 339 consecutive lower extremity arterial disease pts (394 limbs, 1026 lesions included 716 BTK lesions) with BTK lesions from Sep 2004 to Dec 2013. All the enrolled pts were treated by stenting (bare metal stents, primary or provisional, 78 limbs in 73 pts) or POBA (316 limbs in 266 pts) with PTA. Procedural success, complications and clinical outcomes were compared between the two groups up to 12 months. To adjust potential confounders, a propensity score matched (PSM) analysis was performed using the logistic regression model. Results: After PSM analysis, 2 propensity-matched groups (56 pairs in pts, n= 112; 61 pairs in limbs, n=122, C-statistic=0.808) were generated, and the baseline & angiographic characteristics of the two groups were balanced. Procedural success, complication incidences were similar between the two groups. Six to 9-month CT or angiographic follow-up, there were similar incidence of binary restenosis, primary, and secondary patency. At 12 months, there were similar incidence of individual hard endpoints including mortality, myocardial infarction, limb salvage, and any extremity amputations except the target lesion and extremity revascularization. Repeat PTA incidence was higher in the stenting group than POBA group (table). Conclusion: Although the repeat PTA risk was increased with BTK stenting, other major individual clinical outcomes and limb salvage rates were similar between the POBA and stenting for the BTK lesions.

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