Mortality with Use of Paclitaxel-eluting Stents is Not Associated with Treatment Length or Drug-dosage: A Five-year Real-world Experience
Charles J Bailey, Christine Jokisch, Christina Tran, Chetan Dargan, Andrew Matar, Lauren Harry, Mark Asirwatham, Murray Shames
University of South Florida, Tampa, FL
INTRODUCTION: The results of a study-level meta-analysis suggested an increase in late all-cause mortality with use of paclitaxel-coated devices in femoral-popliteal endovascular interventions. Subsequent review of long-term clinical trial and patient-level data has reported no mortality difference between paclitaxel-coated and uncoated devices. This study reports a real-world experience of clinical efficacy and mortality with use of paclitaxel-eluting stents. METHODS: We conducted a single-center retrospective review of all patients who underwent femoral-popliteal arterial stent placement between 2013 and 2020. Data-analysis was focused on those who received paclitaxel-eluting stents (Zilver PTX, Cook Medical, Bloomington, IN) of native femoral-popliteal artery. Exclusion criteria included placement of only non-PTX stents, paclitaxel-coated balloon angioplasty at index procedure or within follow-up, or iliac artery paclitaxel-stent placement. Primary outcome was all-cause mortality at one-, two-, and five-years. Mortality was further examined for association with patient clinical, anatomic, and procedural factors. Secondary outcomes included one- and two-year primary, primary-assisted, and secondary patency rates. RESULTS: Over the seven-year study period 510 femoral-popliteal artery stent procedures were performed. We identified 282 patients undergoing 314 separate drug-eluting Zilver PTX stent placements. All-cause mortality across the studied timeframe was 11.7% (N=33/282). Mortality at one- and two-years was 6.7% (N=19/282), and 9.6% (27/282), respectively. Mortality for patients at five-years following Zilver PTX stent placement was 15.6% (15/96). Treatment length and paclitaxel dosage were not associated with increased mortality (p=NS). Paclitaxel-independent mortality was increased for patients with evidence of critical limb ischemia (CLI, Rutherford class 4-6), as compared to intermittent claudication (IC) at both two- (17.83% vs 6.54%, p=0.003) and five-years (34.2% vs 5.17%, p=0.0001). Analysis of two- and five-year data further noted significantly increased paclitaxel-independent mortality (p<0.05) in patients with chronic kidney disease, end-stage renal disease, prior myocardial infarction, and congestive heart failure. Observed one-year primary, primary-assisted, and secondary patency rates were 81.4%, 85.7%, and 92.2%, respectively. Two-year primary, primary-assisted, and secondary patency rates were, respectively, 76.5%, 81.4%, and 89.8%. CONCLUSIONS:Our real-world experience with paclitaxel-coated stents for femoral-popliteal occlusive disease demonstrates clinical efficacy comparable to randomized trials, without an observed increase in mortality as a function of paclitaxel stent treatment length or drug-dosage. A paclitaxel-independent mortality risk is noted in patients with critical limb ischemia (CLI) and clinical markers of severe systemic atherosclerosis.
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