DCB for Coronary ISR Impact of Lesion Preparation Bruno Scheller

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1 DCB for Coronary ISR Impact of Lesion Preparation Bruno Scheller Klinische und Experimentelle Interventionelle Kardiologie, Universität des Saarlandes, Campus Homburg Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Homburg / Saar, Germany

2 Speaker s name: Bruno Scheller X I have the following potential conflicts of interest to report: X Research contracts (B.Braun, MDT Invatec, AngioScore) Consulting Employment in industry X Stockholder of a healthcare company (InnoRa GmbH) Owner of a healthcare company X Other(s): coinventor in several patent applications I do not have any potential conflict of interest

3 European Heart Journal doi: /eurheartj/ehu278

4 JACC Cardiovasc Interv 2012; 5:

5 Lancet. 2013; 381: 461-7

6 Am Coll Cardiol Intv 2015; epub

7 Lancet, 2015; 386:

8 Alfonso, J Am Coll Cardiol 2015; 66: 23-33

9 RIBS IV Experience of operators with DCB Learning Curve Drug loss in blood (time from insertion in guiding cath till deployment), only 3.2% cross-over Lesion preparation 50% diameter stenosis accepted in DCB group >10% of pts with restenosis just at baseline inflation pressure significantly lower in the DCB group high pressure postdilatation in EES group by protocol Acute gain RIBS V RIBS IV Paccocath ISR PEPCAD DES PEPCAD II PEPCAD China Vessel Refer. Diameter Acute Gain Bruno Scheller, Paul Ong, Franz X Kleber: Letter to the editor. J Am Coll Cardiol 2015; in press

10 Catheter Cardiovasc Interv. 2014; 83: 881-7

11 Specialty Balloons AngioSculpt Chocolate

12 Catheter Cardiovasc Interv Nov 21. doi: /ccd [Epub ahead of print]

13 Catheter Cardiovasc Interv Sep 2. doi: /ccd [Epub ahead of print]

14 ISAR DESIRE IV Byrne, TCT 2015

15 ISAR DESIRE IV Byrne, TCT 2015

16 SQP SVD Japan Atsushi FUNATSU. CCT, Kobe, Japan, 2015

17 SQP SVD Japan Atsushi FUNATSU. CCT, Kobe, Japan, 2015

18 SQP SVD Japan Atsushi FUNATSU. CCT, Kobe, Japan, 2015

19 Lancet. 2013; 381: 461-7

20 EES DCB Binary restenosis 11 % 19 % TLR 4 % 13 % TLR/restenosis 47 % 74 % There is a possibility, however, that the indication for reinterventions at follow-up would have been influenced by their perceived risk benefit. Treating recurrent ISR in patients with a double metal layer [ ] might be considered as less attractive than treating ISR after BA failure. Alfonso F. J Am Coll Cardiol 2015; 66: Alfonso F, Cuesta J. JACC Cardiovascular interventions 2015; 8:

21 JACC CI 2014; 7: Zhao TCT 2014

22 JACC: Cardiovasc Int 2015; epub ahead of print

23 JACC: Cardiovasc Int 2015; epub ahead of print

24 JACC Cardiovasc Int 2013; 6:

25 Stent thrombosis after treatment of ISR Study (pts per group) Richardt et al. (n=281) Type of ISR treatment Follow-up stent thrombosis Reference BMS- and DES-ISR ZES 1 year 2 years 2.1% 2.5% JACC Cardiovasc Int 2013;6: PACCOCATH ISR (n=54) BMS-ISR DCB (paclitaxel iopromide) 6 years 0 JACC Cardiovasc Int 2012;5: PEPCAD II (n=66) BMS-ISR DCB (paclitaxel iopromide) Habara et al. (n=25) DES-ISR DCB (paclitaxel iopromide) 3 years 0 In press 6 months 0 JACC Cardiovasc Int 2011;4: PEPCAD DES (n=72) DES-ISR DCB (paclitaxel iopromide) 6 months 1.4% (1 case, possible) J Am Coll Cardiol 2012;59: ISAR DESIRE III (n=131) DES-ISR DCB (paclitaxel iopromide) 1 year 0.7% (1 case) Lancet 2013;381:461-7 PEPCAD Japan (n=136) BMS- and DES-ISR DCB (paclitaxel iopromide) 6 months 0 Am Heart J 2013; 166: SQP Word Wide Registry (n=1,523) BMS- and DES-ISR DCB (paclitaxel iopromide) 9 months 0.1% (2 cases) J Am Coll Cardiol 2012;60: DCB overall (n=2,007) DCB (paclitaxel iopromide) 0.2 % (4 cases) JACC Cardiovasc Int 2013; 6: Comment on TCTMD.com August 14 th 2013.

26 DCB for coronary ISR lessons to learn Operator experience (drug loss in blood) Lesion preparation Impact of endpoint definition Ironically, this major advantage of DCB, namely the repeatability of the procedure, leads to a significant disadvantage in endpoints that include surrogates like TLR and not hard endpoints only. However, randomized comparisons report a long-term survival benefit for DCB in DES-ISR treatment. Bruno Scheller, Paul Ong, Franz X Kleber: Letter to the editor. J Am Coll Cardiol 2015; in press

27 DCB treatment default strategy for ISR avoids several layers of metal reduces the need for prolonged dual antiplatelet therapy repeatability of the procedure positively influences hard endpoints on long-term disadvantage in angiographic outcomes should be limited by careful lesion preparation assuring sufficient initial lumen gain. Bruno Scheller, Paul Ong, Franz X Kleber: Letter to the editor. J Am Coll Cardiol 2015; in press

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