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Abstract #98879 Published in IGR 22-4
Vein Bypass versus Nitinol Stent in Long Femoropopliteal Lesions: 4-Year Results of a Randomized Controlled Trial
Enzmann FK; Enzmann FK; Enzmann FK; Nierlich P; Nierlich P; Hölzenbein T; Aspalter M; Aspalter M; Kluckner M; Kluckner M; Hitzl W; Opperer M; Opperer M; Linni K; Linni KAnnals of surgery 2022; 0:
OBJECTIVES: The aim of this study was to compare technical success, patency rates and clinical outcomes of vein bypass (VBP) with angioplasty and nitinol stents (NS) in femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) II C and D lesions. SUMMARY BACKGROUND DATA: Guidelines widely recommend an endovascular-first strategy for long femoropopliteal lesions without sufficient data comparing it with vein bypass surgery. METHODS: A single-center prospective, randomized controlled trial (RCT) was performed, after approval of the local ethics committee, with technical success, primary and secondary patency as primary endpoints. Secondary endpoints were limb salvage, survival, complications and clinical improvement. RESULTS: Between 2016 and 2020, 218 limbs (109 per group) in 209 patients were included. Baseline and lesion characteristics were similar in both groups with a mean lesion length of 268 mm. The indication for treatment was chronic limb threatening ischemia in 53% of limbs in both groups. Technical success was feasible in 88% in the stent group. During a 4-year follow-up, primary patency, freedom from target lesion revascularizations, limb salvage, survival and complications showed no significant differences between the groups. At 48 months secondary patency for the bypass group was 73% versus 50% in the stent group (p = 0.021). Clinical improvement was significantly superior in the bypass group with 52% versus 19% reaching a Rutherford 0 category (p < 0.001). CONCLUSIONS: This is the largest RCT comparing angioplasty with NS and vein bypass in femoropopliteal TASC II C and D lesions and the first to report 4-year results. The data underline the feasibility of endovascular treatment in long lesions but also emphasize the advantages of VBP.
Department of Vascular Surgery, Medical University of Innsbruck, Austria Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University Salzburg, Austria Research and Innovation (FMTT) (biostatistics), Paracelsus Medical University Salzburg, Austria, - Department of Ophthalmology and Optometry, Paracelsus Medical University Salzburg, Austria, - Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Austria Department of Anesthesiology, Paracelsus Medical University, Salzburg, Austria.
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