Journal of Vascular and Endovascular Therapy

Editorial

Between 2015 and 2019, more than six societal guidelines came to different recommendation and conclusions given the published evidence about drug-coated devices to treat femoropopliteal and crural lesions. Showing that there is still room for discussion about drug-coated devices, especially concerning the arisen safety concerns in paclitaxel-coated devices [1-4]. Recently, Katsanos et al concluded that there is an increased risk of death following application of paclitaxelcoated balloons and stents in the femoropopliteal artery and that further investigations are urgently warranted [5]. In a second meta-analysis, the same authors concluded worse outcomes including amputation-free survival for below the knee treatment [6].

First of all, looking back few years, paclitaxel-based drugcoated balloon (DCB) or drug-coated stent (DCS), became the preferred treatment for revascularization of femoropopliteal lesions in peripheral arterial occlusive disease, especially to avoid restenosis. This was true despite the fact that sirolimuseluting stents showed to have a more potent anti-proliferative effect than paclitaxel [7].

Today, the ongoing paclitaxel controversy illustrates that neither randomized controlled trials nor real word data can really claim to determine “reality” results [8]. International collaborations like VASCUNET (www.vascunet.org) or the International Consortium of Vascular Registries (ICVR) and the Medical Device Epidemiology Network (MDEpiNet) can help by developing a scientific framework and reaching a broad consensus among real word data specialists [8,9].

A large propensity score matched analysis of health insurance claims from Germany included some 40,000 patients to determine long-term follow-up after drug-coated devices in femoropopliteal arteries [10]. Between 2010 and December 2018, 37,914 patients and 21,546 propensity score matched patients with an index revascularization were included. A rapid adoption of drug-coated devices was shown for Germany during the study period, but the authors found no sign of increased mortality following use of drug-coated devices [10].

Another follow-up study from the same group of authors concerning below the knee treatments was most recently submitted to support the ongoing warm discussion.

Last news about drug-coated devices:

Preliminary results were published on first-in-human experience with sirolimus-eluting self-expanding stent for femoropopliteal lesions [11]. The NITIDES stent (CID, Saluggia, Italy) represents a novel drug-coating/eluting strategy, as it uses the amphilimus formulation consisting of sirolimus formulated with an amphilic carrier that is released through an abluminal reservoir technology [11].

What do we learn from those data?

The future of drug-coated devices: What to expect in the next 5 years?

The velocity of information will further increased exponentially and we will launch ideas for improvements in data driven medicine. The desire to accelerate the efficiency is central and aims to improve people`s quality of life and reduce health care costs [9].

Open question for the Vascular Community to discuss, in which cases evidence from real world data may complement evidence from the sometimes inadequate RCTs [8].

More sufficiently powered studies on the immunosuppressive drugs, on the specifications and design of the releasing catheter, and the excipient that joins the drug to the surface of the balloon or stent to the artery wall are needed.

Use of nanotechnology, paclitaxel and sirolimus in different formulations and excipients from those used up to now, for better delivery, action and prolonged maintenance of the drug in the artery wall.

More studies and research development on the dependence of the dose of the drug on the effectiveness of tissue proliferation inhibition.

The excellence of observation and the continuous evaluation of our results maintain the expectation of better care and quality of life for patients with severe extensive vascular disease.

References

1. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, et al. (2016) AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the american college of cardiology/american heart association task force on clinical practice guidelines. Circulation 135: 72-79.
2. Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, et al. (2017) ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the european society for vascular surgery (esvs): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries endorsed by: the european stroke organization (eso) the task force for the diagnosis and treatment of peripheral arterial diseases of the european society of cardiology (esc) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 39: 763-816.
3. Feldman DN, Armstrong EJ, Aronow HD, Gigliotti OS, Jaff MR, et al. (2002) SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions. Catheter Cardiovasc Interv 92: 124-140.
4. Conte MS, Bradbury AW, Kolh P, White JV, Dick F, et al. (2019) Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg 58: S1-S109.
5. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D (2018) risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 7: e011245.
6. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D (2020) risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Interv Radiol.
7. Birkmeier KA, Kastrati A, Byrne RA, Holle H, Schultz S, et al. (2011) Five-year clinical outcomes of sirolimus-eluting versus paclitaxel-eluting stents in high-risk patients. Catheter Cardiovasc Interv 77: 494-501.
8. Behrendt CA, Peters F, Mani K (2020) The swinging pendulum of evidence: Is there a reality behind results from randomized trials and real-world data? Lessons learned from the Paclitaxel debate. Eur J Vasc Endovasc Surg.
9. Ocke Reis PE, Cronenwett JL (2018) Opportunities in the international consortium of vascular registries. J Vasc Endovasc Therapy 3: 24.
10. Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, et al. (2020) Long term survival after femoropopliteal artery revascularizations with paclitaxel coated devices: A propensity score matched cohort analysis. Eur J Vasc Endovasc Surg.
11. Steiner S, Sauguet A, Langhoff R, Kahlberg A, Thieme M, et al. (2019) First-in-human experience with sirolimus-eluting self-expanding stent for femoropopliteal lesions. J Am Coll Cardiol 74: 2216-2218.