Pierre-Alexandre Vent1, Adrien Kaladji2, Jean-Michel Davaine1, Béatrice Guyomarch3, Philippe Chaillou1, Alain Costargent1, Thibaut Quillard4, Yann Gouëffic5. 1. Department of Vascular Surgery, CHU (University Hospital Centre) Nantes, l'institut du thorax, service de chirurgie vasculaire (Institut du Thorax), Nantes, France. 2. Department of Cardiothoracic and Vascular Surgery, CHU de Rennes, Rennes, France. 3. CHU Nantes, l'institut du thorax, centre d'investigation clinique (Clinical Investigation Centre), Nantes, France; Inserm UMR1087, l'institut du thorax, Nantes, France; CNRS, UMR 6291, Nantes, France; Université de Nantes, Nantes, France. 4. Laboratory of Bone Resorption Physiopathology, Inserm UMR-957, Nantes, France. 5. Department of Vascular Surgery, CHU (University Hospital Centre) Nantes, l'institut du thorax, service de chirurgie vasculaire (Institut du Thorax), Nantes, France; Université de Nantes, Nantes, France; Laboratory of Bone Resorption Physiopathology, Inserm UMR-957, Nantes, France. Electronic address: yann.goueffic@chu-nantes.fr.
Abstract
BACKGROUND: The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES). METHODS: In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18 months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias. RESULTS: In total, 110 limbs were treated (STELLA: n = 62; STELLA PTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLA PTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency. CONCLUSIONS: Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.
BACKGROUND: The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES). METHODS: In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18 months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias. RESULTS: In total, 110 limbs were treated (STELLA: n = 62; STELLAPTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLAPTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency. CONCLUSIONS:Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.