Eluvia banner image

ELUVIA VS. BMS VS. DCB

SPORTS randomised controlled trial results.

SPORTS Clinical Trial Results​

SPORTS is the first investigator-sponsored, core-lab adjudicated, prospective, multi-centre, three-arm RCT comparing outcomes of DES (EluviaTM) vs. BMS (investigator choice) vs. DCB (SeQuent Please), 1:1:1, in TASC C/D lesions.1

SPORTS confirms that Eluvia is the definitive treatment for ​long complex lesions in the SFA2-11

12M Primary Patency across Eluvia Trials

The Eluvia DES has shown consistent performance of ~90% primary patency ​
at 12 months, no matter the lesion, no matter the patient. ​

The Eluvia arm in the SPORTS registry had an average lesion length of 235mm and is one of the most complex cohorts studied for the stent to date. ​

Primary endpoint: percentage diameter stenosis in lesion at 12 months1

Eluvia demonstrated statistically superior performance over BMS, whilst DCB was only non-inferior to BMS when evaluated angiographically for percent diameter stenosis and late lumen loss at 12 months.

Primary endpoint % Diameter Stenosis in Lesion

Secondary endpoint: freedom from CD-TLR at 12 months1

Eluvia also demonstrated superior patient outcomes over BMS and DCB ​as evidenced by freedom from TLR through the 12-month follow-up period.​

Secondary endpoint Freedom from CD-TLR

SPORTS randomised controlled trial details​

Eluvia DES​ (n=74)​ DCB​ (n=74)​ BMS​ (n=76)​ p-value​
Average Diameter Stenosis in Lesion​ 25.3%​ 53.7%​ 60.0%​ <0.0001​
Average Late Lumen Loss​ 0.4mm​ 1.1mm​ 2.0mm​ <0.0001​
K-M Freedom from CD-TLR ​ 94.5%​ 80.7%​ 77.4%​ 0.015​
  ELUVIA N=74 DCB N=74 BMS N=76 P-value
Average lension length 235mm 221mm 227mm 0.57
Occlusion 85% 70% 74% 0.08
Average occlusion length 179mm 175mm 151mm 0.18
Average diameter stenosis in lesion 96.80% 92.60% 94.20% 0.10
Mod-sev calcification 58.10% 71.70% 67.10% 0.36
Diabetes 23% 30% 26% -
Renal disease 8% 12% 3% -


 
References:
  1. Tepe G. SPORTS. TCT 2023, October 24, 2023, San Francisco, CA.​
  2. Imperial: Gray WA, Keirse K, Soga Y, et al; IMPERIAL investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;27;392(10157):1541–1551. Müller-Hülsbeck S, Benko A, Soga Y, 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
  3. EMINENT: Gouëffic Y, Torsello G, Zeller T, et al; EMINENT Investigators. 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.
  4. Majestic: Müller-Hülsbeck S, Charing Cross 2015. Müller-HülsbeckS, et al. Cardiovasc Intervent Radiol. 2017;40(12):1832–1838.
  5. Regal: Lansik W. Real world all comers data from the REGAL registry – 2-year results. Presented at LINC 2023.
  6. Auckland: Holden, A. Single Centre Long-Term Experience with the Boston Scientific Eluvia DES in Femoro-popliteal Artery Occlusive Disease. LINC 2020.
  7. IMPERIAL Long: Müller-Hülsbeck S, Benko A, Soga Y, 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(3):368–375. 
  8. Capsicum: Iida O, Takahara M, Soga Y, et al; CAPSICUM Investigators. 1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration. JACC Cardiovasc Interv. 2022 Mar 28;15(6):630–638. Iida LINC 2023.
  9. Desafinado: 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.
  10. Muenster: Stavroulakis K, Torsello G, Bosiers M. 2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions. JACC Cardiovasc Interv. 2021;14(6):692–701.
  11. Ultimate: Ichihashi S, Takahara M, Yamaoka T, et al. Drug eluting versus covered stent for femoropopliteal artery lesions: Results of the ultimate study. Eur J Vasc Endovasc Surg. 2022;64(4);359–366

Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.