Aneurysmal Degeneration of Fluoropolymer-Coated Paclitaxel-Eluting Stent in the Superficial Femoral Artery. A Rising Concern

Background: Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia™; Boston Scientific, Marlborough, MA, USA) implantation, aneurysmal degeneration after implanting Eluvia™ has raised clinical concerns. Here, we report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for a superficial femoral artery lesion. Case presentation: A 79-year-old woman with claudication in the right lower extremity decreasing her quality of life was referred to our hospital. Pre-procedural angiography showed severe stenosis from the middle-to-distal part of the right superficial femoral artery, and Eluvia™ was implanted with optimal expansion. However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months thereafter. Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal stent edge restenosis at the Eluvia™ implantation site. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed vessel enlargement with a mean vessel diameter of 7.2-9.9 mm at the distal edge of the Eluvia™ implantation site. However, intermittent claudication on the right side recurred again 50 months after Eluvia™ implantation. Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Furthermore, peri-stent contrast staining was found at the distal part of the Eluvia™ implantation site. Intravascular ultrasound showed a further enlargement of mean vessel diameter to 11.9 mm at the distal edge of the Eluvia™ stent. Moreover, enlargement of the lumen and stent malapposition were also found, suggesting exacerbated aneurysmal degeneration 50 months after Eluvia™ implantation. Conclusions: : We report a case with exacerbated aneurysmal degeneration on serial angiography and intravascular ultrasound 50 months after Eluvia™ implantation for an SFA lesion. Long-term follow-up should be mandatory for patients receiving Eluvia™ implants.