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Vascular & Interventional Radiology Unit Department of Radiological Sciences

N EW TECHNOLOGIES: Wires, balloons, drug-eluting devices, ect . Fabrizio Fanelli . Vascular & Interventional Radiology Unit Department of Radiological Sciences “ Sapienza” – University of Rome. Below The Knee Arteries. Small vessels Long lesions Occlusions > stenoses

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Vascular & Interventional Radiology Unit Department of Radiological Sciences

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  1. NEW TECHNOLOGIES: Wires, balloons, drug-eluting devices, ect. Fabrizio Fanelli Vascular & InterventionalRadiologyUnit DepartmentofRadiologicalSciences “Sapienza” – UniversityofRome

  2. Below The KneeArteries • Small vessels • Long lesions • Occlusions > stenoses • More vessels • Calcifications L. Graziani – Eur J VascEndovascSurg 2007

  3. CLI : MeanLengthTreatedlesions 5% ATG 63±61 mm 55% FEM-POP 116±113 mm 185±121 mm 96% BTK R.Ferraresi - oralpresentation CICE 2012

  4. 1) F. Liistro- oralpresentationTCT 2012 4) K. Katsanos- oralpresentationCIRSE 2011 2) A. Schmidt – JACC 2011 5) M. Bosiers – J VascSurg 2012 3) F. Fanelli - oralpresentationCIRSE2012 6) A. Rastan – EuropeanHeart Journal 2011

  5. …. New Technologies ….

  6. Micro-puncture set • Guidewires • Micro-guidewires • Introducers • Supportcatheters • Low profile balloon catheters • Atherectomydevices • Drugelutingballoons (DEB) • Bare metal stents • Drugelutingstents (DES)

  7. Micro-puncture set • Guidewires • Micro-guidewires • Introducers • Supportcatheters • Low profile balloon catheters • Atherectomydevices • Drugelutingballoons (DEB) • Bare metal stents • Drugelutingstents (DES)

  8. DrugElutingBalloons • In.PactAmphirion– Medtronic/Invatec • Advance LP 18 PTX – Cook • Freeway II/Dior – Eurocor • Elutax – AachenMedical

  9. DEB BTK LeipzigRegistry IN.PACT™Amphirion in real world BTK complexlesions A. Schmidt – JACC 2011

  10. vs historical PTA cohort(A.Schmidt - Cath. and Cardiovasc. Interventions 2010) DEB BTK LeipzigRegistry (1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain

  11. vs historical PTA cohort(A.Schmidt - Cath. and Cardiovasc. Interventions 2010) DEB BTK LeipzigRegistry (1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain

  12. DEBATE BTK • Investigator initiated, single center Study • Randomized (1:1) DEB vs. standard PTA • Primary Endpoint: 12-month Angiographic • Binary (>50%) Restenosis Rate • Secondary Endpoints: TLR and Reocclusion CLI + Diabetes 150 (Tibial) Lesions Random(1:1) DEB (75 lesions) Std PTA (75 lesions) • Key Inclusions • RC 4-5-6 and Diabetes • Stenosis / occlusions >40 mm in at least 1 tibial vessel with distal run-off • Key Exclusions • Allergy to Paclitaxel • Contraindication for combined antiplatelet treatment • Life expectancy <1 year Aspirin + Clopidogrel (1 month) 12-month Angiographic and Clinical follow-up 24-month Duplex and Clinical follow-up F. Liistro- oralpresentationTCT 2012

  13. DEBELLUM DrugEluting Balloon EvaluationforLowerLimbmUltileveltreatMent • Investigator initiated, single center Study • Randomized (1:1) DEB vs. standard PTA • Primary Endpoint: 6-month LLL • Secondary Endpoints: TLR, Primary Patency, Fontaine change, MAE at 6 and 12 months • Key Inclusions • Fontaine Stage IIb, III, IV • SFA, popliteal and BTK lesions either isolated or concomitant • De-novo lesions • Stenosis or occlusions 3 - 30 cm F. Fanelli - oralpresentationCIRSE2012

  14. 12-mos TLR analysis per lesion

  15. DEBELLUM- 12 mos F.U.

  16. ProspectiveRandomizedMulticenter Trial • 50 pts. • RC: 4-6 • >50% calcifiedstenosis • popliteal, tibial and peronealaa.

  17. SecondaryEndpoints

  18. 1) F. Liistro- oralpresentationTCT 2012 2) A. Schmidt – JACC 2011 3) F. Fanelli - oralpresentationCIRSE2012

  19. WhataboutStent… ?

  20. 1) F. Liistro- oralpresentationTCT 2012 4) K. Katsanos- oralpresentationCIRSE 2011 2) A. Schmidt – JACC 2011 5) M. Bosiers – J VascSurg 2012 3) F. Fanelli - oralpresentationCIRSE2012 6) A. Rastan – EuropeanHeart Journal 2011

  21. 1) F. Liistro- oralpresentationTCT 2012 4) K. Katsanos- oralpresentationCIRSE 2011 2) A. Schmidt – JACC 2011 5) M. Bosiers – J VascSurg 2012 3) F. Fanelli - oralpresentationCIRSE2012 6) A. Rastan – EuropeanHeart Journal 2011

  22. JVIR 2009; 20(9):1141-1150 Everolimus-elutingstent vs. bare metal stent 103 pts. CLI Angioplasty + Bailoutstenting

  23. HR: 4.8, CI 2.9-7.9 p<0.001 HR: 2.5, CI 1.3-5.0 p=0.006 D. Siablis – JVIR 2009; 20(9):1141-1150

  24. Xcience-Prime Xcience-Prime

  25. Conclusions • DEB patency rate similarto DES butwith the advantageof • “nothingleftbehind”. • Efficacyof DEB in verycalcifiedarteriesstill under evaluation • Combined treatment withatherectomymustbevalidated.

  26. The Future … BioabsorbableStent • Adaptiontoflexion, extension • •OvercomeStentfractures • •PositiveRemodelling • •Might act as a transporter (Gen-Therapy) • •Surgeon’s friend

  27. ABSORB Study Poly-L-lactide + Everolimus 30 pts. 5-y F.U. - No cardiacdeath - No thrombosis - MACE: 3.4 % - LLL 0.27 mm

  28. fabrizio.fanelli@uniroma1.it

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