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
Eluvia is the definitive treatment for long complex lesions2-11
DET Graphics v2 (1024 x 520 px) - Eluvia 90% Primary Patency
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.
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.
SPORTS randomised controlled trial details
- 1-year results
- Baseline characteristics
| | 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% | - |
- Tepe G. SPORTS. TCT 2023, October 24, 2023, San Francisco, CA.
- 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
- 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.
- Majestic: Müller-Hülsbeck S, Charing Cross 2015. Müller-HülsbeckS, et al. Cardiovasc Intervent Radiol. 2017;40(12):1832–1838.
- Regal: Lansik W. Real world all comers data from the REGAL registry – 2-year results. Presented at LINC 2023.
- Auckland: Holden, A. Single Centre Long-Term Experience with the Boston Scientific Eluvia DES in Femoro-popliteal Artery Occlusive Disease. LINC 2020.
- 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.
- 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.
- 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.
- 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.
- 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
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