Restenosis is a significant issue and is impacted by the choice of superficial femoral artery (SFA) treatment
Restenosis remains a challenge and is highly prevalent⁷

Meta-analysis of randomised controlled trials revealed that bare metal stents (BMSs) and percutaneous transluminal angioplasty (PTA) are still widely used, despite being associated with high restenosis rates.⁸
Since the first use of PTA nearly 60 years ago, SFA disease management remains inconsistent BMS and PTA still widely used even though meta-analysis of randomised controlled trials reveal that they are associated with high restenosis rates.9-10
New-generation endovascular approaches, however, such as drug coated devices, have helped to reduce restenosis rates.10-11
Paclitaxel devices are effective and safe
Paclitaxel drug-eluting technologies (DETs) help reduce restenosis, resulting in better outcomes for patients vs BMS or plain old balloon angioplasty (POBA)¹⁰⁻¹¹
The EMINENT RCT combined with network meta-analysis of RCTs conclude that DES and DCBs respectively, result in greater primary patency versus non-drug devices.10-11
- Paclitaxel primary patency
- Paclitaxel all-cause mortality rates
Our paclitaxel DCB Ranger™and DES Eluvia™ demonstrate significantly superior primary patency versus non-DETs¹¹⁻¹²

All-cause mortality rates for paclitaxel-coated vs uncoated products¹⁰⁻¹⁴

Boston Scientific has superior DET devices for any SFA lesion, in any patient
Treat SFA lesions with the only drug eluting technology backed by 5 RCTs and included in studies that will exceed 10,000 patients in over 15 countries¹¹⁻¹⁵
Click below to read more about the relevant clinical trial:
Eluvia demonstrates consistent outcomes in complex lesions in both real world evidence and RCTs
12 month | |
Capsicum | 87.1%24 |
Imperial RCT | 91%25 |
Drug-Eluting Technologies
References
- Sachar R et al. RANGER II SFA Investigators. 1-year results from the RANGER II SFA randomized trial of the Ranger drug-coated balloon. JACC Cardiovasc Interv. 2021;10:1123–1133.
- Gouëffic Y, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: Primary results of the EMINENT randomized trial. Circulation. 2022;146:1564–1576.
- Steiner S, et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv. 2018;11:934–941.
- Steiner S, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41:2541–2552.
- Müller-Hülsbeck S, et al. Two-year efficacy and safety results from the IMPERIAL Randomized study of the Eluvia polymer-coated drug-eluting stent and the Zilver PTX polymer-free drug-coated stent. Cardiovasc Intervent Radiol. 2021;44:368–375.
- Marianne Brodmann, CIRSE 2022 Symposium: DET in complexities co-morbidities, and underserved patient populations.
- Cho S, et al. Directional atherectomy for treating in-stent restenosis of the superficial femoral artery. Vasc Specialist Int. 2020;36(3):136–143.
- Kasapis C, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(1):44–55.
- Aboyans V, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39:763–816.
- Ullah W, et al. Safety and efficacy of drug-coated balloon for peripheral artery revascularization-A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2022;99(4):1319–1326.
- Gouëffic Y, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: Primary results of the EMINENT randomized trial. Circulation. 2022;146:1564–1576.
- Sachar R, et al. RANGER II SFA Investigators. 1-year results from the RANGER II SFA randomized trial of the Ranger drug-coated balloon. JACC Cardiovasc Interv. 2021;10:1123–1133.
- Steiner S, et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv. 2018;11:934–941.
- Steiner S, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41:2541–2552.
- Müller-Hülsbeck S, et al. Two-year efficacy and safety results from the IMPERIAL Randomized study of the Eluvia polymer-coated drug-eluting stent and the Zilver PTX polymer-free drug-coated stent. Cardiovasc Intervent Radiol. 2021;44:368–375.
- Katsanos K, 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;7(24):e011245.
- Subgroup Analysis of VOYAGER PAD presented at TCT. October 2020.
- Dinh K, et al. Mortality rates after paclitaxel-coated device use in patients with occlusive femoropopliteal disease: an updated systematic review and meta-analysis of randomized controlled trials. J Endovasc Ther. 2021;28(5):755–777.
- Nordanstig J, et al. Mortality with paclitaxel-coated devices in peripheral artery disease. N Engl J Med. 2020;383(26):2538–2546.
- Secemsky EA, et al. Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among medicare beneficiaries: the SAFE-PAD study. JAMA Intern Med. 2021;181(8):1071–1080.
- Stavroulakis K, et al. 2-year outcomes of the Eluvia drug-eluting stent for the treatment of complex femoropopliteal lesions. JACC Cardiovasc Interv. 2021;14:692–701.
- Holden A. Single centre long-term experience with the Boston Scientific Eluvia DES in femoro-popliteal artery occlusive disease. Presented at Leipzig Interventional Course (LINC), Leipzig, Germany, 28–31 January 2020.
- Kum S. DES for SFA/Pop 12-month results of the DESAFINADO registry. Presented at Leipzig Interventional Course (LINC), Leipzig, Germany, 28–31 January 2020.
- Lida O, et al. 1-year outcomes of fluoropolymer-based drug-eluting stent in femoropopliteal practice: predictors of restenosis and aneurysmal degeneration. JACC Cardiovasc Interv. 2022;15:630–638.
- Gray WA, Lancet. 2018 Sep 24. pii: S0140-6736(18)32262-1
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