Safety of Paclitaxel-Eluting Stents in Below-the-Knee Arteries for Critical Limb Ischemia Treatment: the Devil is in the
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COMMENTARY
COMMENTARY
Safety of Paclitaxel-Eluting Stents in Below-the-Knee Arteries for Critical Limb Ischemia Treatment: the Devil is in the Details Konstantinos Katsanos1
•
Stavros Spiliopoulos2
Received: 4 September 2020 / Accepted: 10 September 2020 Ó Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
Konijn et al. have reported the long-term 10-year safety outcomes with the use of paclitaxel-eluting stents (TAXUS) in below-the-knee arteries for critical limb ischemia treatment [1]. The report expands on previously published results from the multicenter randomized PADI trial that have shown promising results with improved patency and most importantly significantly reduced risk of amputation with bail-out use of the TAXUS paclitaxeleluting stents in the infrapopliteal arteries. The work has been driven by our recently published meta-analyses documenting increased long-term risk of all-cause mortality with paclitaxel-coated balloons and stents in the femoropopliteal segment [2], and increased short-term risk of death or amputation in the infrapopliteal segment [3]. We certainly commend the authors on releasing their long-term results in view of the ongoing paclitaxel debate and we take the opportunity to highlight some key elements with regards to the design and the paclitaxel payload of the TAXUS stent compared to the ZILVER-PTX stent in the femoropopliteal artery and also to the rest of the paclitaxelcoated balloons approved for above or below knee applications (Table 1). First, the TAXUS stent that was used in the PADI trial incorporates a triblock copolymer topcoat that allows for
& Konstantinos Katsanos [email protected] Stavros Spiliopoulos [email protected] 1
Interventional Radiology, Patras University Hospital, 26504 Rio, Greece
2
Interventional Radiology, Attikon University Hospital, 12462 Athens, Greece
sustained controlled elution of the anti-proliferative drug paclitaxel. On the contrary, the ZILVER-PTX stent is plainly coated with amorphous paclitaxel without any polymer or other agent or excipient to control drug transfer. On the other hand, paclitaxel-coated balloons universally incorporate a certain type of excipient to facilitate drug transfer to the vessel wall. Second, total paclitaxel payload is similar between the TAXUS and the ZILVER-PTX stent, but an order of a magnitude lower compared to paclitaxelcoated balloons. In addition, total dose delivered may vary significantly according to lesion length treated, e.g., from an average 0.3 mg in the PADI trial to as much as 4.9 mg in the IN.PACT BTK randomized trial. Of note, we have recently reported evidence of significantly worse long-term amputation-free survival in case of the IN.PACT BTK study [4]. Third, the pharmacokinetics of paclitaxel-coated balloons and stents follow complex nonlinear functions and are typically associated with long-lasting tissue residence with often unknown local and downstream effects. It has been el
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