Drug-coated balloons are replacing the need for nitinol stents in the superficial femoral artery.

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.