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Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION

Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION. BY M. AKRAM KHAN MD FACC FSCAI. None. Financial Disclosure. WHY DRUG ELUTING BALLOON FOR SFA/POP DISEASE. ISSUES WITH SFA/POP RESTENOSIS. INVENTORS 1979 – Professor Speck invented contrast agent Ultravist (iopromide )

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Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION

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  1. Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION BY M. AKRAM KHAN MD FACC FSCAI

  2. None Financial Disclosure

  3. WHY DRUG ELUTING BALLOON FOR SFA/POP DISEASE

  4. ISSUES WITH SFA/POP RESTENOSIS

  5. INVENTORS 1979 – Professor Speck invented contrast agent Ultravist (iopromide) 2001 – Both Prof. Speck and Prof. Scheller introduced Ultravist / Paclitaxel Paccocath balloon Professor Ulrich Speck (scientist) Dr. Bruno Scheller (Interventional Cardiologist) History of DEB

  6. PACLITAXEL IN DEB

  7. FIRST GENERATION BALLOON Paclitaxel+Hydrophilic Spacer (iopromide) Paccocath Technology Description

  8. THUNDER TRIAL First Generation Landmark trials FEMPAC TRIAL

  9. Thunder & fempac trial 6 months results

  10. Freedom from TLR: Kaplan-Meier THUNDER FIVE YEAR OUTCOME

  11. PAC Balloon Vs. Control Follow up 18 and / or 24 Months Fempac 2 year outcome

  12. Next generation trials LEVANT-I PACIFIER Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoro popliteal Restenosis Trial for Femoro popliteal Revascularization A Randomized Multicenter Trial Evaluating Prevention of Restenosis with Paclitaxel-Coated PTA Balloon Catheters in Stenosis or Occlusion of Femoro popliteal Arteries

  13. LEVANT-I 6 months results

  14. PACIFIER – 6 months Angiographic follow up

  15. Metanalysis of deb randomized trials Conclusion: Consistent with statistically significant lower rate of restenosis in DEB Trials.

  16. Conclusion: The IN.PACT Admiral DEB achieves substantially better primary patency at 1 year compared with angioplasty. FIRST DEB VS PTA TRIAL IN USA(April 2014)IN.PACT SFA TRIAL- ONE YEAR DATA331 patients from Europe and the us received a drug-eluting balloon (DEB; n=220) or angioplasty (n=111)

  17. CURRENTLY ONGOING USA TRIALS ON DEB (ENROLLMENTS EITHER COMPLETE OR NEAR COMPLETION)

  18. DEB VS PTA FOLLOWED BY STENTING- DEBATE SFA TRIAL 12-month Restenosis and TLR (per lesion) 12-month Major Adverse Event Restenosis per lesion length Restenosis per Revasc Technique

  19. Single Center Retrospective with Propensity Score analysis IN.PACT DEB vs Zilver PTX 228 Patients Mean lesion length = 19 cm DEB provisional Stent rate = 18.3% DEB VS DESINPACT VS ZILVER PTX

  20. Deb in complex sfa disease

  21. ROLE OF DEB IN SFA/POP INTERVENTION IS PROMISING. DEB IS SUPEIOR TO PTA IN ALL CLINCAL TRIALS. RESULTS OF DEB ANGIOPLASTY ARE COMPARABLE OR BETTER THAN DES. DEB ARE EASIER TO USE. IT IS COST EFFECTIVE MODALITY FOR DE-NOVO AND RESTENOSIS LESIONS. COMPARE TO STENTS, NO ANATOMICAL LIMITATION. DEB PRESERVE FUTURE PERCUTAEOUS AND OPEN SURGERY OPTIONS. Conclusion:

  22. Thank you!!!

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