This study states that Randomized controlled trials have shown that both paclitaxel drug-coated balloons (DCBs) and bare metal stents (BMSs) significantly reduce restenosis in femoropopliteal lesions compared with plain balloons (PBAs). However, the effectiveness between DCBs and BMSs has not been well-researched. Considering evidence suggesting an increased risk of mortality with paclitaxel treatment, we assessed the safety and efficacy of DCBs against alternative treatments (ie, BMSs, PBAs) in our patient population.

We performed a retrospective medical record review of femoropopliteal interventions at a single center from 2009 to 2017. The intervention, patient, and lesion characteristics and target lesion revascularization (TLR) and mortality events were recorded. Data were analyzed using Kaplan-Meier curves and Cox regression models. We found no association between paclitaxel and mortality in our patient population. Moreover, both DCBs and BMSs resulted in greater freedom from TLR but only DCBs outperformed PBAs after adjustment for covariates. Therefore, our data suggest that DCBs are safe and perform at least equally to BMSs without leaving a foreign object in the vessel.

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