Aneurysmal degeneration of fluoropolymer-coated paclitaxel-eluting stent in the superficial femoral artery: a rising concern

Abstract

Background Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia; Boston Scientific, Marlborough, MA, USA) placement, aneurysmal degeneration after drug-eluting stent (Eluvia) placement has raised clinical concerns. Here, we report a case with progressive aneurysm formation on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery atheromatous plaque. Case presentation A 79-year-old woman with right leg intermittent claudication at 100 m distance was referred to our hospital. Pre-procedural angiography showed long-segment severe stenosis from the middle-to-distal part of the right superficial femoral artery, and a 7 mm wide drug-eluting stent (Eluvia) was placed. 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 superficial femoral artery in-stent restenosis. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed femoral artery enlargement with a maximum vessel diameter of 10.0 mm at the distal edge of the stent. Intermittent claudication on the right side recurred again 50 months after drug-eluting stent (Eluvia). Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Peri-stent contrast staining was found at the distal part of the drug-eluting stent (Eluvia) site. Intravascular ultrasound showed a further enlargement of maximum vessel diameter to 12.0 mm at the distal edge of the stent. Conclusions We report a case with progressive aneurysm degeneration on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery stenosis.

Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon

“…As the prolonged paclitaxel elution might lead to a focal reaction with vessel wall degeneration at the level of the stent (‘Halo’), this segment was evaluated by Duplex ultrasound. According to the literature [ 4 , 7 , 8 ], the Halo sign was defined as an increase in the diameter of the treated segment of ≥ 50% compared to the non-treated vessel segment with or without blood flow between the stent and the vessel wall. Secondary outcomes included clinical improvement, defined as a decrease in Rutherford classification by one or more categories compared to baseline.…”

“…On the contrary, pragmatic cohorts showed promising results with the use of the polymer-coated Eluvia DES (Boston Scientific, Marlborough, MA, USA) for challenging lesions [ 4 ], while randomized evidence revealed superior primary patency vs bare metal stent at 1 year [ 5 ] and vs. polymer-free drug-coated stent at 2 years [ 6 ]. Nonetheless, it remains unknown if the observed ‘halo’ sign, which is frequently observed following the deployment of the Eluvia scaffold, has an impact on the long-term performance of this platform [ 4 , 7 , 8 ]. It is hypothesized that prolonged paclitaxel elution might lead to a vessel wall degeneration with malapposition of the stent and late thrombosis, as observed in the coronaries [ 4 ].…”

Cardiovascular Complications Related to Lower Limb Revascularization and Drug-Delivering Technology in Peripheral Arterial Disease

“…Some cohort study and meta-analysis report the high incidence of MACE in CLTI patients after revascularization by DCB and DES. The complication such as aneurysmal degeneration in patients with ET are reported [27][28][29][30][31]. Therefore, the MACE related to DCB, and DES is still debatable [30,32].…”

“…The risk of local complication for drug delivering technology in CLTI patients are not well identified. The further study is required to concluded about the local complication of DCB and DES in PAD [28][29][30]78].…”

“…Recently, the novel technology developed the antiproliferative agent -coated and -eluting device which can deliver the drugs to the vessel wall to limit the neointimal growth within de novo vascular system and stent [21][22][23][24][25][26]. However, some literatures report the MACE, aneurysmal degeneration, vascular fibrinoid necrosis, small vessel inflammation, and budget impact after drug technology device including drug coated balloon (DCB) and drug eluting stent (DES) in patients with ET [27][28][29][30][31]. The longterm MACE after DCB and DES device usage in patients with CLTI is still controversy [30,32,33].…”