Author + information
- Received February 5, 2018
- Revision received March 21, 2018
- Accepted March 27, 2018
- Published online May 21, 2018.
- Theodosios Bisdas, MD∗ (, )
- Efthymios Beropoulis, MD,
- Angeliki Argyriou, MD,
- Giovanni Torsello, MD and
- Konstantinos Stavroulakis, MD
- Clinic for Vascular Surgery, St. Franziskus Hospital and University Clinic of Muenster, Muenster, Germany
- ↵∗Address for correspondence:
Dr. Theodosios Bisdas, Clinic for Vascular Surgery, St. Franziskus Hospital and University Clinic of Muenster, Hohenzollernring 72, 48147 Muenster, Germany.
Objectives The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions.
Background The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear.
Methods Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up.
Results Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel.
Conclusions The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.
- drug-eluting stent(s)
- long femoropopliteal lesions
- paclitaxel-eluting stent(s)
- peripheral arterial disease
Dr. Bisdas is a consultant for Boston Scientific, Medtronic, Bard, and Cook Medical. Dr. Stavroulakis has received honoraria from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 5, 2018.
- Revision received March 21, 2018.
- Accepted March 27, 2018.
- 2018 American College of Cardiology Foundation
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