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Thomas Zeller, MD Bad Krozingen, Germany On behalf of the ETAP trial investigators

E ndovascular T reatment of A therosclerotic P opliteal Artery Lesions – Balloon Angioplasty versus primary Stenting: A prospective, multi-centre, randomised study ETAP. Thomas Zeller, MD Bad Krozingen, Germany On behalf of the ETAP trial investigators. Disclosures Advisory Board:

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Thomas Zeller, MD Bad Krozingen, Germany On behalf of the ETAP trial investigators

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  1. Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions – Balloon Angioplasty versus primary Stenting: A prospective, multi-centre, randomised study ETAP Thomas Zeller, MD Bad Krozingen, Germany On behalf of the ETAP trial investigators

  2. Disclosures Advisory Board: Medtronic-Invatec, W.L. Gore, Angioslide, Medtronic-Ardian, Covidien-ev3 Consulting Fees/Honoraria: Sanofi-Aventis, C.R. Bard, J&J Cordis, Covidien-ev3, Boston Scientific, Straub Medical, Invatec, Biotronik, Pathway Medical, W.L. Gore Research Grants: Cook, Krauth Medical, Pathway Medical, Abbott Vascular, J&J Cordis, Angioslide, Ardian, Biotronik, Invatec, InnoRa, W.L. Gore, Veryan, Covidien-ev3, Medtronic-Ardian, Medtronic-Invatec, 480 Biomedical

  3. ETAPBackground • The popliteal artery is considered as a “no-stent”-zone due to potential excessive external forces applied to the stent in the popliteal fossa • No prospective comparative controlled trials have yet investigated the performance of stents in the popliteal artery to date • The ETAP trial is the first in man trial comparing primary stenting using a contemporary nitinol stent device (Lifestent) with the current “gold standard” POBA

  4. Bend / Kink • Zone A • Compress / • Slight curve • Zone B • Fixed • Zone C • Bend / Kink • Zone D Rationale for Stent-less InterventionFemoro-popliteal Artery - Biomechanics • Lansky, A; Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004

  5. ETAPKey Features • Investigator initiated European prospective, randomized controlled multi-center trial (9 centers) • Unrestricted grant by C.R. BARD-Angiomed • Independent data management, corelab adjudication • Study Design: • 1:1 randomization POBA with provisional stenting vs. primary stenting (Lifestent) in popliteal artery disease • Patient cohort: • 246 patients • Patients with chronic PAD RCC 1-4 • No restrictions in lesion length

  6. ETAPStudy Endpoints Primary Endpoint • Restenosis rate at 12 months (duplex PSVR > 2.4) Secondary Endpoints (6,12 & 24 months) • Restenosis rate (PSVR > 2.4) • Restenosis rate (PSVR > 2.0) • Primary patency rate • Secondary patency rate • Clinically driven TLR rate • Change in RCC • Walking distance (treadmill) • ABI • MACE • Stent fractur rate at 12 and 24 months (plain X-ray)

  7. ETAPInclusion Numbers by Study Center

  8. ETAP Patient Characteristics

  9. ETAPLesion Location

  10. ETAPLesion Characteristics

  11. ETAP1-year Primary Patency [%] P < 0.05

  12. ETAPClinical Outcomes at 1-Year Follow-up -2 (-3 to -1)

  13. ETAPEvent-Free Survival (ITT)(Death, TLR, MI, amputation) P < 0.0001 (log-rank test)

  14. ETAPChange in RCC at 12 Months

  15. ETAPAbsolute Walking Distance P < 0.05

  16. ETAPInterims Analysis 1-Year Stent Fracture Rate (Corelab) *One type I & II stent fracture each

  17. ETAPSummary • ETAP is the first controlled trial investigating the performance of POBA and primary stent placement (Lifestent) in the popliteal artery • Lifestent placement in the popliteal artery is safe • Corelab adjudicated 1-year fracture rate 3.4% • Lifestent placement results in a significant higher primary patency rate as compared to POBA • In ITT analysis no significant difference in change of Rutherford categories • In ITT significant better improvement of absolute walking distance in the stent cohort

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