What Are the Fundamental Technology Aspects and Limitations

Disclosures Bruno Scheller, MD Travel support/speakers honoraria: B. Braun Melsungen AG, Germany Medtentia International

Paclitaxel Binding to Hydrophobic Sites within Arterial Tissue Ex vivo perfusion of calf carotid

X-ray Contrast Media for Local Drug Delivery Paclitaxel Iopromide (Ultravist ®) Invest Radiol 2002;

initial 12 days Saline control 3 min Iopromide Paclitaxel J Am Coll Cardiol 2003;

Alfonso F. , Scheller B. Euro. Intervention 2017; 13: 680 -695

Paclitaxel content of coronary arteries of pigs after a single treatment with a paclitaxel

Paclitaxel Persistance in the Vessel Wall In. Pact SFA Laird, J Am Coll Cardiol.

Surface versus Intramural Paclitaxel Concentration Over Time Crystalline versus Amorphous Coatings Crystaline Coating Paclitaxel

J Endovasc Ther. 2016 Jan 28. pii: 1526602815626557. [Epub ahead of print]

difference in lumen area at 6 months [mm²] 200 150 100 50 0 -50

Proc Natl Acad Sci USA. 2004; 101: 9463 -7

Circ Cardiovasc Interv. 2016; 9: e 003543. DOI: 10. 1161/CIRCINTERVENTIONS. 115. 003543

What Are the Fundamental Technology Aspects and Limitations of DCB Technology? • Paclitaxel preferred

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What Are the Fundamental Technology Aspects and Limitations of DCB Technology? Bruno Scheller Clinical and Experimental Interventional Cardiology University of Saarland, Homburg/Saar, Germany

Disclosures Bruno Scheller, MD Travel support/speakers honoraria: B. Braun Melsungen AG, Germany Medtentia International Ltd Oy, Finland Stockholder: Inno. Ra Gmb. H, Germany

Lancet 2017; 390: 781– 92

Paclitaxel Binding to Hydrophobic Sites within Arterial Tissue Ex vivo perfusion of calf carotid arteries, transmural distribution protein binding serum proteins raise paclitaxel levels in solution, but hinder distribution through tissues Creel, Circ Res 2000; 86: 879 -884 Lovich, J Pharm Sci 2001; 90: 1324 -1335

X-ray Contrast Media for Local Drug Delivery Paclitaxel Iopromide (Ultravist ®) Invest Radiol 2002; 37: 29 -34, Eur Heart J 2003; 24: 1462 -7, J Am Coll Cardiol 2003; 42: 1415 -20

initial 12 days Saline control 3 min Iopromide Paclitaxel J Am Coll Cardiol 2003; 42: 1415 -20

Alfonso F. , Scheller B. Euro. Intervention 2017; 13: 680 -695

Circulation 2004; 110: 810 -4

Invest Radiol. 2011; 46: 255 -63

Paclitaxel content of coronary arteries of pigs after a single treatment with a paclitaxel coated balloon; half-life 1. 7 months Circ Cardiovasc Interv 2012; 5: 392 -400

Paclitaxel Persistance in the Vessel Wall In. Pact SFA Laird, J Am Coll Cardiol. 2015; 66: 2329 -38 LEVANT II Ravish Sachar, TCT 2015 Gongora. JACC Cardiovasc Interv. 2015; 8: 1115 -23

Surface versus Intramural Paclitaxel Concentration Over Time Crystalline versus Amorphous Coatings Crystaline Coating Paclitaxel Concentration (ng/mg) Surface 1000 Amorphous Coating Paclitaxel Concentration (ng/mg) 1000 Vessel Surface Vessel 100 10 100 1 0. 10 10 1 hour 24 hours Crystalline Coating 7 days 28 days Hybrid Coating 0. 01 1 hour 24 hours Amorphous Coating 7 days Nano-Spheres Coating from Juan Granada 2013 28 days

J Endovasc Ther. 2016 Jan 28. pii: 1526602815626557. [Epub ahead of print]

difference in lumen area at 6 months [mm²] 200 150 100 50 0 -50 184 -36, 9 -0, 4 Grade A/B -100 Control -47, 3 Grade C/D/E Pac balloon J Endovasc Ther. 2013; 20: 792 -800

Zeller, VIVA 2014

Circulation 2010; 121: 2672 -80

Proc Natl Acad Sci USA. 2004; 101: 9463 -7

Circ Cardiovasc Interv. 2016; 9: e 003543. DOI: 10. 1161/CIRCINTERVENTIONS. 115. 003543

What Are the Fundamental Technology Aspects and Limitations of DCB Technology? • Paclitaxel preferred drug, limus tbd. • Excipient mandatory • Impact of coating procedure (amorphous vs crystalline) • Optimal dose unclear • Lesion preparation (optimal lumen gain, calcification, …) • No negative impact of high-grade dissections