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Sex-related Long-term Clinical Outcomes Of Primary Paclitaxel-eluting Stents For Femoral-popliteal Occlusive Disease
Maria Penuela, MD, Akeem Bartley, MD, Tony Nguyen, DO, Yuchi Ma, MD, Paul Tenewitz, BS, Jean Bismuth, MD, Charles J. Bailey, MD.
University of South Florida, Tampa, FL, USA.
OBJECTIVES: Research on sex-based clinical outcomes with primary paclitaxel-eluting stents for femoral-popliteal occlusive disease is limited, remaining underreported and underrepresented in clinical trials. This study reports our institutional experience on the sex-related long-term clinical outcomes with primary paclitaxel-eluting stents in the treatment of femoral-popliteal occlusive disease.
METHODS: A retrospective review of our institutional database was performed from 2013 to 2019 to identify all patients who underwent paclitaxel-eluting stent placement (Zilver PTX, Cook Medical, Bloomington, IN) for femoral-popliteal occlusive disease. Analysis was focused on patients with at least five-years of clinical data post-implant. Patient demographic, clinical, and procedural-related metrics were analyzed. Primary outcome was major adverse limb events (MALE) at one-, two-, and five-years. Secondary outcomes included mortality, amputation-free survival (AFS), and limb salvage (LS). Kaplan-Meier and multivariate methods were used to estimate MALE and AFS.
RESULTS: Over the study period, 252 patients with 265 treated limbs met criteria with a median age of 65 years (IQR 37,96 years). Patient sex cohorts were similar with respect to demographics and pre-operative medical comorbidities, with higher rates of hyperlipidemia (Female,64% vs Male,76%;p=0.04) and history of smoking (Female,73% vs Male,87%;p=0.006) in male patients. No significant sex-based differences were noted between indications for intervention, baseline ABI, TASC lesion, or treatment lengths. Rates of MALE were similar between sex groups (Female,40% vs Male,34%;p=0.39), with stent occlusion representing the most common adverse event in both females (N=21/38,55%) and males (N=26/56,46%). The proportion of observed MALE was highest within the first (Female,53% vs Male,46%;p=0.55) and second years (Female,71% vs Male,63%;p=0.39) post-implant. Survival at five-years was similar between cohorts (Female,82% vs Male,83%; p=1.0). Major limb amputation occurred in equal frequency (Female,N=9 vs Male,N=16;p=0.91), with AFS equivalent at one- (Female,88% vs Male,89%;p=0.72), two- (Female,81% vs Male,87%;p=0.26), and five-years (Female,74% vs Male,75%;p=0.76). Patient sex was not linked to overall mortality (OR:0.99;95%CI:0.51-1.91;p=0.974), MALE (OR:0.77;95%CI:0.46-1.31;p=0.338), or AFS (OR:0.99;95%CI:0.55-1.79;p=0.974). Treatment length was not associated with MALE (OR:1.00; 95% CI: 0.99-1.00; p=0.779) or AFS (OR 1.00; 95% CI: 0.99-1.00; p=0.701).
CONCLUSIONS: Our real-world experience demonstrates equivalent sex-based long-term clinical outcomes with use of primary paclitaxel-eluting stents in the treatment of femoral-popliteal occlusive disease. Observed rates of MALE, AFS, and overall survival are similar between female and male sex, demonstrating a safety and efficacy of primary paclitaxel-eluting stents in female patients.
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