Comparative Effectiveness Study of Drug-Eluting and Bare-Metal Peripheral Artery Stents in Endovascular Femoropopliteal Artery Revascularization.

Objectives. Paclitaxel drug-eluting stents [DES] have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents [BMS] in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization [TLR], target-vessel revascularization [TVR], and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. Methods. The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease [XLPAD] registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score [PS]-matched datasets [174 for each]. Results. This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P=.02] and matched data [HR. 0.50 95% CI, 0.27-0.91; P=.02]. The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort [HR, 0.57; 95% CI, 0.33-0.98; P=.04). Mortality rate in the DES group [5%] was significantly higher than the BMS group in both unmatched [2%; P=.04] and matched groups [1%; P=.046] at 1 year. Conclusions. Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.