Standardized application of drug-coated devices in lower extremity peripheral arterial diseases_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

 BAO Junmin

Department of Vascular Surgery, Shanghai Changhai Hospital, Shanghai 200433, P. R. China;

Corresponding?author：

BAO Junmin, Email: bao_junmin@126.com

Keywords：

lower extremity peripheral arterial disease; endovascular treatment; drug-coated device

DOI：

10.7507/1007-9424.202512009

Video：

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Drug-coated devices, including drug-coated balloons and drug-eluting stents, are effective tools to overcome restenosis after endovascular treatment of lower extremity peripheral arterial diseases. To use drug-coated devices properly, it is essential to assess the nature of the lower limb arterial lesions, which is a key factor affecting surgical success and postoperative efficacy. Based on a thorough assessment of the lesion characteristics, the most appropriate vessel preparation method can be selected, including the two main methods of balloon dilation and debulking. The purpose of vessel preparation is to fully obtain the lumen of the vessel, improve the compliance of the vascular wall and create conditions for the application of drug coated devices. Standardized application of drug-coated devices requires an understanding of the performance characteristics of different devices. Drug-coated balloons and drug-eluting stents have different clinical applications, so it is essential to strictly grasp the indications for use, reasonably combine them, and complement their respective advantages. Attention must be paid to controlling technical details during use and managing perioperative medication properly.

1.	中華醫學會外科學分會血管外科學組, 中國醫師協會血管外科醫師分會. 下肢動脈載藥器具規范化應用中國專家共識 (2025版). 中國實用外科雜志, 2025, 45(8): 855-864.
2.	包俊敏. 如何正確理解“leavetherightthingbehind”理念?. 中華血管外科雜志, 2023, 8(3): 246-252.
3.	Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol, 2015, 65(9): 931-941.
4.	Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC Ⅱ). J Vasc Surg, 2007, 45(Suppl S): S5-S7.
5.	Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg, 2019, 69(6S): 3S-125S. e40. doi: 10.1016/j.ejvs.2019.05.006.
6.	Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv, 2014, 83(6): E212-E220.
7.	Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol, 2014, 37(4): 898-907.
8.	Roberts D, Niazi K, Miller W, et al. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca⁺⁺ trial. Catheter Cardiovasc Interv, 2014, 84(2): 236-244.
9.	Lanzer P, Hannan FM, Lanzer JD, et al. Medial arterial calcification: JACC state-of-the-art review. J Am Coll Cardiol, 2021, 78(11): 1145-1165.
10.	中華醫學會外科學分會血管外科學組, 中國醫師協會血管外科醫師分會. 下肢動脈疾病腔內減容規范化應用中國專家共識 (2024版). 中國實用外科雜志, 2024, 44(12): 1328-1338.
11.	包俊敏. 下肢動脈硬化閉塞癥腔內治療技術新進展與評價. 中國實用外科雜志, 2018, 38(12): 1436-1439.
12.	Miki K, Fujii K, Kawasaki D, et al. Intravascular ultrasound-derived stent dimensions as predictors of angiographic restenosis following nitinol stent implantation in the superficial femoral artery. J Endovasc Ther, 2016, 23(3): 424-432.
13.	Adams G, Shammas N, Mangalmurti S, et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the disrupt PAD Ⅲ study. J Endovasc Ther, 2020, 27(3): 473-480.
14.	Chandra V, Lansky AJ, Sayfo S, et al. Thirty-day outcomes from the Disrupt PAD BTK Ⅱ study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg, 2025, 81(3): 710-719. e2.
15.	Iida O, Nanto S, Uematsu M, et al. Influence of stent fracture on the long-term patency in the femoro-popliteal artery: experience of 4 years. JACC Cardiovasc Interv, 2009, 2(7): 665-671.
16.	Deloose K, Bosiers M, Peeters P, et al. Combining the passeo-18 lux drug-coated balloon and the pulsar-18 bare metal stent: 12- and 24-month outcomes of the BIOLUX 4EVER investigator-initiated trial. J Endovasc Ther, 2020, 27(6): 936-945.
17.	Stahlberg E, Allmendinger AC, Anton S, et al. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for revascularization of complex femoro-popliteal lesions. Cardiovasc Interv Ther, 2021, 36(3): 338-346.
18.	Giannopoulos S, Secemsky EA, Schneider PA, et al. Concomitant drug-coated balloon angioplasty with bail-out use of eluvia drug-eluting stent: is there any downside to a double dose of paclitaxel?. J Invasive Cardiol, 2022, 34(6): E469-E476.
19.	Iida O, Takahara M, Soga Y, et al. Three-year clinical course after fluoropolymer-based drug-eluting stent implantation for femoropopliteal lesions. Vasc Med, 2024, 29(2): 182-188.
20.	Kum S, Ipema J, Huizing E, et al. Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia. Vasc Med, 2021, 26(3): 267-272.
21.	Miki K, Tanaka T, Yanaka K, et al. Influence of self-expanding paclitaxel-eluting stent sizing on neointimal hyperplasia in superficial femoral artery lesions. Circ J, 2020, 84(10): 1854-1861.
22.	Falkenberg M, James S, Andersson M, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet, 2025, 406(10508): 1103-1114.
23.	Nordanstig J, James S, Andersson M, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet, 2025, 406(10508): 1115-1127.
24.	Katsanos K, Spiliopoulos S, Kitrou P, et al. 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, 2018, 7(24): e011245. doi: 10.1161/JAHA.118.011245.
25.	Behrendt CA, Sedrakyan A, Peters F, et al. Editor’s choice - long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg, 2020, 59(4): 587-596.
26.	Kim JM, Yeh RW, Song Y, et al. Drug-coated vs non-drug-coated devices for femoropopliteal artery interventions: long-term outcomes of the SAFE-PAD study. Eur Heart J, 2025 Sep 25: ehaf721. doi: 10.1093/eurheartj/ehaf721.

1. 中華醫學會外科學分會血管外科學組, 中國醫師協會血管外科醫師分會. 下肢動脈載藥器具規范化應用中國專家共識 (2025版). 中國實用外科雜志, 2025, 45(8): 855-864.
2. 包俊敏. 如何正確理解“leavetherightthingbehind”理念?. 中華血管外科雜志, 2023, 8(3): 246-252.
3. Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol, 2015, 65(9): 931-941.
4. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC Ⅱ). J Vasc Surg, 2007, 45(Suppl S): S5-S7.
5. Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg, 2019, 69(6S): 3S-125S. e40. doi: 10.1016/j.ejvs.2019.05.006.
6. Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv, 2014, 83(6): E212-E220.
7. Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol, 2014, 37(4): 898-907.
8. Roberts D, Niazi K, Miller W, et al. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca⁺⁺ trial. Catheter Cardiovasc Interv, 2014, 84(2): 236-244.
9. Lanzer P, Hannan FM, Lanzer JD, et al. Medial arterial calcification: JACC state-of-the-art review. J Am Coll Cardiol, 2021, 78(11): 1145-1165.
10. 中華醫學會外科學分會血管外科學組, 中國醫師協會血管外科醫師分會. 下肢動脈疾病腔內減容規范化應用中國專家共識 (2024版). 中國實用外科雜志, 2024, 44(12): 1328-1338.
11. 包俊敏. 下肢動脈硬化閉塞癥腔內治療技術新進展與評價. 中國實用外科雜志, 2018, 38(12): 1436-1439.
12. Miki K, Fujii K, Kawasaki D, et al. Intravascular ultrasound-derived stent dimensions as predictors of angiographic restenosis following nitinol stent implantation in the superficial femoral artery. J Endovasc Ther, 2016, 23(3): 424-432.
13. Adams G, Shammas N, Mangalmurti S, et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the disrupt PAD Ⅲ study. J Endovasc Ther, 2020, 27(3): 473-480.
14. Chandra V, Lansky AJ, Sayfo S, et al. Thirty-day outcomes from the Disrupt PAD BTK Ⅱ study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg, 2025, 81(3): 710-719. e2.
15. Iida O, Nanto S, Uematsu M, et al. Influence of stent fracture on the long-term patency in the femoro-popliteal artery: experience of 4 years. JACC Cardiovasc Interv, 2009, 2(7): 665-671.
16. Deloose K, Bosiers M, Peeters P, et al. Combining the passeo-18 lux drug-coated balloon and the pulsar-18 bare metal stent: 12- and 24-month outcomes of the BIOLUX 4EVER investigator-initiated trial. J Endovasc Ther, 2020, 27(6): 936-945.
17. Stahlberg E, Allmendinger AC, Anton S, et al. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for revascularization of complex femoro-popliteal lesions. Cardiovasc Interv Ther, 2021, 36(3): 338-346.
18. Giannopoulos S, Secemsky EA, Schneider PA, et al. Concomitant drug-coated balloon angioplasty with bail-out use of eluvia drug-eluting stent: is there any downside to a double dose of paclitaxel?. J Invasive Cardiol, 2022, 34(6): E469-E476.
19. Iida O, Takahara M, Soga Y, et al. Three-year clinical course after fluoropolymer-based drug-eluting stent implantation for femoropopliteal lesions. Vasc Med, 2024, 29(2): 182-188.
20. Kum S, Ipema J, Huizing E, et al. Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia. Vasc Med, 2021, 26(3): 267-272.
21. Miki K, Tanaka T, Yanaka K, et al. Influence of self-expanding paclitaxel-eluting stent sizing on neointimal hyperplasia in superficial femoral artery lesions. Circ J, 2020, 84(10): 1854-1861.
22. Falkenberg M, James S, Andersson M, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet, 2025, 406(10508): 1103-1114.
23. Nordanstig J, James S, Andersson M, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet, 2025, 406(10508): 1115-1127.
24. Katsanos K, Spiliopoulos S, Kitrou P, et al. 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, 2018, 7(24): e011245. doi: 10.1161/JAHA.118.011245.
25. Behrendt CA, Sedrakyan A, Peters F, et al. Editor’s choice - long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg, 2020, 59(4): 587-596.
26. Kim JM, Yeh RW, Song Y, et al. Drug-coated vs non-drug-coated devices for femoropopliteal artery interventions: long-term outcomes of the SAFE-PAD study. Eur Heart J, 2025 Sep 25: ehaf721. doi: 10.1093/eurheartj/ehaf721.

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