Peripheral drug-eluting stents have transformed the treatment of peripheral arterial disease by reducing restenosis rates and the need for repeat interventions. However, the emergence of a possible signal of increased long-term mortality associated with paclitaxel-coated devices has generated controversy. In this editorial, the authors review the available evidence and propose practical recommendations for the current use of these technologies in patients with femoropopliteal disease.
The primary objective of the study was to analyze the balance between efficacy and safety of paclitaxel-eluting stents, while the secondary objective was to identify the clinical scenarios in which their use might be most appropriate. The summarized evidence includes multiple randomized studies and meta-analyses, including a contemporary meta-analysis of 34 randomized trials involving more than 7,400 patients treated for femoropopliteal disease.
Paclitaxel-coated devices demonstrated an approximate 40% to 60% reduction in restenosis and target lesion revascularization rates compared with conventional angioplasty, with particularly evident benefits in long femoropopliteal lesions, in-stent restenosis, and complex anatomies. In addition, paclitaxel-eluting stents showed sustained patency up to 5 years of follow-up.
However, the most recent meta-analysis identified a small but statistically significant increase in all-cause mortality associated with these devices. The risk was more evident between 18 and 24 months after the procedure and tended to attenuate toward 5 years. The absolute magnitude of the effect was small, with an estimated loss of approximately one month of survival at 5 years.
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More recent analyses suggest that the potential increase in mortality may not be uniform across all paclitaxel-coated devices, but rather related to specific devices or drug doses, although this finding remains a matter of debate.
Paclitaxel-Eluting Stents: Benefits in Complex Femoropopliteal Lesions
In summary, current evidence supports the selective — but not routine — use of paclitaxel-eluting technologies, particularly in complex femoropopliteal lesions and in-stent restenosis, where their benefits in terms of patency and reduction of repeat interventions appear to outweigh the remaining uncertainties regarding their long-term safety.
Original Title: What Are the Indications for Drug Eluting Technology in Peripheral Artery Disease Management?
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