Abstract
The aim of this review is to summarize and update current research concerning the safety of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with paclitaxel (PTX) in peripheral arteries. The data from the large randomized controlled trials showed evidence of the superiority of DCBs over plain balloon angioplasty concerning efficacy.
Also, the safety parameters between the two groups did not differ. However, two meta-analyses identifying an increased late mortality risk after using PTX technologies were published only a short time ago (Katsanos et al, FDA meta-analysis).
In contradiction, a lot of following studies (meta- analyses, real-world analysis, retrospective review) published in 2019 and 2020, did not confirm any significant difference in all-cause death between PTX and no-PTX cohorts. The safety of PTX technologies still represents the most serious and controversial issue in peripheral interventions.
Until it is definitively solved further research must continue. In daily practice, recommendations for the use of PTX products include the treatment of restenosis after PTA (not of de novo lesions), the maintenance of patency of bypasses, and angioplasty for limb salvage.
In heavily calcified lesions, a prior debulking with atherectomy is suitable. Generally, the risks and benefits of the application of PTX devices should be considered in every single patient.