Nitinol Stent Versus Bypass in Long Femoropopliteal Lesions: 2-Year Results of a Randomized Controlled Trial

Abstract

ObjectivesThis study sought to compare patency rates and clinical outcomes of nitinol stents and primary vein bypass in long femoropopliteal lesions. BackgroundAn endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery. Nitinol stents are widely used as the standard endovascular therapy. MethodsA single-center randomized controlled trial was performed with the primary endpoints of technical success, primary and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement. ResultsA total of 110 limbs (55 per group) in 103 patients were treated. Baseline and lesion characteristics were similar, with a mean lesion length of 276 mm. Critical limb threatening ischemia was the indication for treatment in 49% of limbs in both groups. Technical success was achieved in 87% in the stent group. During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups. At 24 months, primary and secondary patency rates for the stent group were 60% and 72% versus 56% and 73% in the bypass group, respectively. Clinical improvement was significantly better in the bypass group. ConclusionsThere were no significant differences regarding patency rates, limb salvage, survival, or complications after 2 years. Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable. Mid- as well as long-term results need to be awaited.