1. Future Directions and Development of DCB Systems
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. J Am Coll Cardiol Intv 2012;5:1001–12

4. Drug Coated Balloons – Future Innovation
Coating and balloon technology
Crystalline vs. amorphous coating
Balloon surface
Dedicated balloon platforms for different vascular territories and indications
Nanotechnology
DCB and dissections
Scoring balloon
DCA + DCB
DCB + bioabsorbable stents
Alternative drugs
Clinical evidence
RCT in different indications and for different types of DCB
No class effect
‘DEBonly’ concept

5. DCB - Mode of action
Scheller, Heart 2007; 93: Scheller, Circulation 2004; 110: Speck, Circ Cardiovasc Interv 2012; 5:

6. Crystalline vs. amorphous paclitaxel on DCB
Additive is an independent determinant of efficacy in animal models, despite the same dose of drug on balloon surface
Restenosis quantified by late lumen loss at 1 month, normalized by restenosis of plain balloon angioplasty control; i.e., calculated by 1 - [(Late Loss of Control) – (Late Loss of Drug Coated Balloon Formulation)]/(Late Loss of Control).
Slide adapted from Juan Granada 2013 6

7. Cosmetic improvements at the expense of efficacy?
Alexander Rübben, from the Internet

8. Not all DCB are created equal
“When presenting our first preclinical data on DCB about 10 years ago, people said it would never work in humans. Today, the greatest threat to this technology is bad clinical science. As mentioned in the ESC/EACTS guidelines for coronary revascularization, one cannot assume a class effect for DCB.
Therefore, clinical evidence includes adequately powered RCTs in different indications for each type of DCB.”
Cremers, Clin Res Cardiol 2009; 98: 325–330. SCAAR, Bondesson, EuroIntervention 2012; 8: Scheller, Cardiovasc Revasc Med. 2012; 13: 257-9

9. Submitted

10. Drug Coated AngioSculpt
May be able to deliver drug more effectively with a scoring element
Better acute luminal results with AngioSculpt compared to POBA
Lower rate of dissection with AngioSculpt compared to POBA
No slippage or “geographic miss” with AngioSculpt
May be able to avoid adjunctive stenting
All of the above may allow a drug-coated AngioSculpt to provide “stand alone” therapy for a wide range of coronary and peripheral arterial lesions with a significantly lower restenosis rate than POBA or allow the use of BMS rather than DES
AngioSculpt (coated)
AngioSculpt (bare)
In-Stent Restenosis (ISR)
Non-slip (avoid “geographic miss”)
Less tissue “recoil”
More optimal re-expansion of original stent, improved initial lumen gain

11. Cardiovascular Revascularization Medicine 13 (2012) 219–223

12. Werner, LINC 2012

13. EuroIntervention 2011; 7: K17-22

14. Clin Res Cardiol. 2012. Circ Cardiovasc Interv. 2011; 4: 447-55

15. DCB + BMS ! geographical mismatch
! partikels between stent struts and vessel wall
=> (spot-)stent, DCB postdilatation
Clin Res Cardiol 2010; 99: 165–174. EuroIntervention 2011; 7: K Hamm AHA Heart 2011; 97:

16. DCB only DCB are not a replacement for DES.
New platform for local drug delivery without the need for stent implantation.
Predilatation
Preparation of the lesion, identification of risk for dissections
Final size (de-novo) or 0.5 mm smaller (ISR)
Acceptable result, not stent-like
Provisional BMS
Spot-stenting for dissections type C-F
DCB
Balloon-Artery ratio
Nominal pressure, 30 seconds
EuroIntervention 2011; 7: K125-8

17. Coronary de-novo - DCBonly
J Am Coll Cardiol 2012; 60: J Am Coll Cardiol. 2012; 60:

18. DCBonly BIF - 54 year old male, unstable angina
initial
Predilatation, Carina shift
SQP 3.0/15
SQP 3.0/20
Final result
6 months

19. New age of vascular therapy: Leaving nothing behind
New technologies to avoid permanent implants in vascular therapies
DCB
Bioabsorbable Stents
published
Coronary
> 4,300 (paclitaxel iopromide)
> 440* (Absorb + AMS)
Peripheral
> 800
> 70
ongoing
> 3,500 (paclitaxel iopromide)
> 1,000
> 4,500 (paclitaxel urea) ?
Clinical Evidence: # of pts in RCT and large registries. *no RCT, simple lesions
TCT EuroIntervention 2011; 7: K7. Submitted for publication.