DrugCoated Balloons vs Drug Eluting Stents Is there
Drug-Coated Balloons vs Drug. Eluting Stents – Is there a Winner? Prof. Thomas Zeller, MD Department Angiology University Heart-Center Freiburg - Bad Krozingen , Germany
Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: • • • Honoraria received from: Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp. , Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, Tri. Reme, Veryan, Shockwave, Biotronik, B. Braun Consulted for: Boston Scientific Corp. , Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, Veryan Common stock: QT Medical
Worldwide Available DCBs Selected Products Some DCBs have demonstrated promising results at 1 - and 2 -years in randomized trials Longer-term data for commercially available DCBs are limited Bard Medtronic Spectranetics Boston Scientific Biotronik Braun i. Vascular Cook Aachen Resonance Biosensors Cardionovum Lutonix IN. PACT 1. Tepe G. et al. , Circulation. 2015. 2. Laird et al. , J Am Coll Cardiol. 2015. 3. Rosenfield et al. , N Engl J Med. 2015. 4. Laurich C. LEVENT II 2 Year Results, SVS 2015. 5. Krishnan, P. et al. , Circulation. 2017 6. Schroeder, H. et al. , Circulation. 2017. 7. Brodmann M, ILLUMENATE EU RCT 2 Year Results VIVA 2017 8. Schneider, P. IN. PACT SFA 4 Year Results, VIVA 2017
DCB FIH/Proof of Concept Evidence Poor Average Best Tepe G, et al. N Engl J Med. 2008; 14; 358(7): 689 -699. Werk M, et al. Circulation. 2008; 118(13): 1358 -1365. Scheinert D, et al. JACC Cardiovasc Interv. 2014; 7(1): 10 -19. Scheinert D, et al. J Endovasc Ther. 2015; 22(1): 14 -21. Werk M, et al. Circ Cardiovasc Interv. 2012; 5(6): 831 -840. D. Scheinert. Presented at: Leipzig Interventional Course 2013; January 23 -26, 2013; Leipzig, Germany. Schroeder H, et al. Catheter Cardiovasc Interv. 2015; 86(2): 278 -286. Albrecht T. Presented at: Leipzig Interventional Course 2016; January 26 -29, 2016; Leipzig, Germany. Guo W. Presented at: Leipzig Interventional Course 2016; January 26 -29, 2016; Leipzig, Germany. 5
IN. PACT SFA Trial Primary Patency 1 Results Through 3 Years 1. Freedom from core laboratory-assessed restenosis (duplex ultrasound PSVR ≤ 2. 4) or clinicallydriven target lesion revascularization through 36 months (adjudicated by a Clinical Events Committee blinded to the assigned treatment) 2. Number at risk represents the number of evaluable subjects at the beginning of the 30 -day window prior to each follow-up interval Schneider P, et al. 2018; 11: e 005891 Circulation CI
Evidence from Early DCB Trials Long-term Freedom from TLR Significant and sustained TLR reduction up to 5 years FEMPAC 2 Y THUNDER 5 Y
DCB vs DES 5 -Year Freedom from TLR 5 -year Freedom from TLR Zilver PTX vs Standard Care 83. 1% 67. 6% Log-rank p < 0. 01 Laird J. VIVA 2018 Dake M. VIVA 2015
5 -year Freedom from TLR Provisional Zilver PTX vs BMS 84. 9% Provisional Zilver PTX p = 0. 06 log-rank 71. 6% Provisional BMS Dake M. VIVA 2015
INPACT SFA RCT 5 -Year Follow-up Laird J. VIVA 2018 10
5 -year Primary Patency (PSVR < 2. 0) Zilver PTX vs Standard Care 66. 4% Zilver PTX P < 0. 01 log-rank 43. 4% Optimal PTA + BMS Dake M. VIVA 2015
5 -year Primary Patency (PSVR < 2. 0) Zilver PTX vs Standard Care 66. 4% Zilver PTX 43. 4% Optimal PTA + BMS Dake M. VIVA 2015
1. Number at risk represents the number of evaluable subjects at the beginning of the each 60 -day window TEPE G, CIRSE 2018
1. Number at risk represents the number of evaluable subjects at the beginning of the each 60 -day window TEPE G, CIRSE 2018
DCB “Real-World” Registries Global registries include real-world patients and lesions Lutonix IN. PACT 1. Thieme M, et al. (2017). JACC Cardiovasc Interv. 2. Bard Lutonix Instructions for Use BAW 1387400 r 3, Section 10. 5. Moderate to severe 3. 4. 5. 6. calcification reported; amputations not reported (NR). Presented by Scheinert D, PCR Paris, France 2015. Presented by Tepe G, CX London, UK 2016. Presented by Brodmann M, VIVA Las Vegas, USA 2015. Presented by Jaff M, VIVA Las Vegas, USA 2016. 7. Presented by Zeller T, LINC Leipzig, Germany 2017. Moderate to severe calcification reported.
DCB “Real-World” Registries Similar outcomes despite potential differences in populations and lesions, as well as reliance on provisional stenting 1. Thieme M, et al. (2017). JACC Cardiovasc Interv. 2. Bard Lutonix Instructions for Use BAW 1387400 r 3, Section 10. 5. Moderate to severe calcification reported; amputations not reported (NR). 3. Presented by Scheinert D, PCR Paris, France 2015. 4. Presented by Tepe G, CX London, UK 2016. 5. Presented by Brodmann M, VIVA Las Vegas, USA 2015. 6. Presented by Jaff M, VIVA Las Vegas, USA 2016; 7. Presented by Zeller T, LINC Leipzig, Germany 2017. Moderate to severe calcification reported.
IN. PACT Global Study Stented vs Non-Stented Analysis Freedom from CD-TLR Through 2 Years 1 1. Number at risk represents the number of evaluable subjects at the beginning of each 60 -day window Zeller T. Charing Cross 2018
REAL PTX Study Steiner et al. JACC 2018
Steiner et al. JACC 2018
Steiner et al. JACC 2018
Steiner et al. JACC 2018
Conclusions REAL PTX • At 1 year, Zilver PTX and DCB did perform equally • Even if the study was not sufficiently powerded 3 -year data tend to favor Zilver PTX vs DCB – Particularly in longer lesions – Particularly compared to plain DCB lesions • Newer Generation DES (ELUVIA) may even more outperform DCB
Gray TCT 2018 Müller-Hülsbeck CIRSE 2018
Gray TCT 2018 Müller-Hülsbeck CIRSE 2018
Gray TCT 2018 Müller-Hülsbeck CIRSE 2018
Gray TCT 2018 Müller-Hülsbeck CIRSE 2018
Treatment Algorithm in TASC A & B Femoropopliteal Lesions (no to moderate calcium) Predilatation of the SFA-lesion with an undersized balloon (Usual treatment path before DCB) In case of severe dissection / recoil DES or Supera Good result DCB according to the RVD + 1 mm Atherectomy & DCB Additional BMS on indication
Treatment Algorithm in TASC A & B Femoropopliteal Lesions (severe calcium) Predilatation of the SFA-lesion with a regular-sized balloon (Usual treatment path before DCB) In case of suboptimal result DES or Supera Good result DCB according to the RVD + 1 mm Dedicated calcium stent on indication
Treatment Algorithm in TASC C & D Femoropopliteal Lesions Predilatation of the SFA-lesion with a standard balloon (Usual treatment path before DCB) In case of severe dissection / recoil DES / Supera / Viabahn Good result DCB according to the RVD + 1 mm Additional BMS on indication
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