1. Paclitaxel Drug-Coated Balloons for De Novo Lesions
Joshua Loh, MBBS
Washington Hospital Center
Washington, DC

2. I/we have no real or apparent conflicts of interest to report.
Joshua P. Loh, MD
I/we have no real or apparent conflicts of interest to report.

3. De Novo Indications Small vessel disease De novo lesions
Diabetes mellitus
Chronic total occlusion
Acute myocardial infarction
Bifurcation lesions

4. Limitations of DES, emergence of DCB
Late and very late stent thrombosis
Bleeding risks associated with prolonged DAPT
Reduced efficacy of DES in complex patient and lesion subsets
DCB
Homogenous antiproliferative drug delivery
Retain vessel anatomy and flow patterns
Deliverable in complex lesions
Absence of metallic stent strut / durable polymer reduces inflammation
Short-term antiproliferative drug effect promotes endothelial healing

5. DCBs in clinical trials
Some of the DCBs manufactured, paclitaxel, various coating methods, pre-mounted BMS

6. DCB for small vessel disease
Small vessel size predict restenosis
Absence of metallic stents/permanent polymer in DCB creates less inflammation
Retention of artery’s original anatomy, reducing abnormal flow patterns
Biondi-Zoccai G, et al. Percutaneous coronary intervention for small vessel coronary artery disease. Cardiovasc Revasc Med 2010;11:189 –98
Waksman R, et al. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv 2009;2:352– 8.

7. DCB for small vessel disease
PEPCAD I
6m follow-up
DEB+BMS
N=32
DEB only
N=82
Late loss (mm)
0.73 ± 0.74
0.18 ± 0.38
Restenosis
44.8%
5.5%
TLR
27.1%
4.9%
Problem of geographical mismatch (BMS longer than DCB treated segment) occurring in 77%.
Unverdorben M, et al. Clin Res Cardiol 2010;99:165–74.

8. DCB for small vessel disease
BELLO (Balloon Elution and Late Loss Optimization)
0.08 ± 0.38 mm
0.29 ± 0.38 mm
Mena diameter 2.15mm
Superiority in primary endpoints LLL
Bailout 21%
Latib A, et al. J Am Coll Cardiol. 2012;60:

9. DCB for small vessel disease
DCB-only strategy reasonable, promising
Provisional BMS

10. DCB+BMS alternative to DES?
DCB - Antiproliferative drug transfer, homogenous drug delivery
Stent - overcomes acute mechanical complications
Potential for long-term safety with reduced DAPT?

11. DCB+BMS in de novo lesions
PEPCAD III
9m follow up
DEB+BMS
Coroflex DEBlue®
(patients, n=312)
DES
Cypher®
(patients, n=305)
P value
Late lumen loss (mm)
-In segment
0.41 ± 0.51
0.16 ± 0.39
<0.001
-In stent
0.20 ± 0.52
0.11 ± 0.40
0.06
TLR
10.5%
4.7%
<0.01
Stent thrombosis
2.0
0.3
0.05
Non-inferiority not met
Safety?
Hamm CW. PEPCADIII. AHA Scientific Sessions; November 14, 2009; Orlando, FL.

12. DCB+BMS Higher late loss Inferior to best-in-class DES
ST risk, not proven to reduce DAPT duration

13. Diabetes mellitus Diabetic vessels Small calibre High plaque burden
Diffuse lesions
Advantage of homogenous delivery of DCB?
Less predilatation in DCB+BMS
Any added advantage of DCB+BMS when compared to limus-DES?
Ali RM, et al. EuroIntervention 2011;7 Suppl K:K83–92.

14. CTO Compared to a matched Taxus population Similar clinical outcomes
Non-significantly higher late loss
Wöhrle J et al.Catheter Cardiovasc Interv. 2012

15. Acute myocardial infarction
DEB-AMI
DIOR DCB
+BMS
N=50
BMS
N=51
Taxus
N=49
P value
Late loss (in-stent) (mm)
0.64 ± 0.56
0.74 ± 0.57
0.21 ± 0.32
<0.01
TLR (%)
20%
17.6%
2.0%
0.76
MACE (%)
23.5%
4.1%
0.67
Belkacemi A, et al. J Am Coll Cardiol.2012 Jun 19;59(25):
DCB+BMS no advantage compared to BMS alone
Drug uptake in ruptured plaque/high thrombus burden?
DCB only approach? High bailout stenting
(41% with Pantera Lux DCB in PAPPA Schaaf et al. TCT 2011)

16. Bifurcations DEBIUT DIOR DCB +BMS MB N=40 BMS MB N=37 DES MB P value
6m late loss (mm)
0.64 ± 0.56
0.74 ± 0.57
0.21 ± 0.32
<0.01
Proximal main branch
0.58 ± 0.65
0.60 ± 0.65
0.13 ± 0.45
0.87
Distal main branch
0.41 ± 0.60
0.49 ± 0.85
0.19 ± 0.64
0.67
Side branch
0.19 ± 0.66
0.21 ± 0.57
0.11 ± 0.43
0.92
12m MACE (%)
20%
29.7%
17.5%
0.32
Stella PR, et al. Catheter Cardiovasc Interv 2012

17. Other approaches in bifurcation
PEPCAD V (Provisional T stenting, no obligatory predilatation of SB)
Kissing DEB
(avoid predilatation, 100% procedural success)
Mathey DG, et al. EuroIntervention 2011;7 Suppl K:K61–5.
Sgueglia GA, et al. Cardiovasc Revasc Med 2011;12:280 –5.

18. DCB only vs. DCB+BMS
DCB only achieves superior late loss than DCB + BMS

19. DCB only strategy SeQuent Please World Wide Registry N=491
Valentines II trial (DIOR)
N=103
DCB only strategy tested in clinical registries
Low MACE, viable alternative to DES
Serra A. The Valentines II Trial.
Presented at CRT, 2012
Wöhrle J, et al. J Am Coll Cardiol 2012;60:

20. DCB+BMS DCB-only low risk risk increases DCB+BMS like DES?
6-12 months DAPT

21. Technical issues with DCB
Bailout stenting
Geographical miss
Bifurcations
Use with DES?
Predilatation before DCB creating “microdissections”
Differing efficacy of DCBs, no “class effect”

22. Conclusions
Current evidence suggest efficacy and safety (but limited to registries, small randomized trials)
DCB appears promising in small vessels, bifurcation side branches (technical aspects need evaluation)
Does not support superiority or equivalence to best-in-class DES
Niche role – de novo lesions not suitable or ideal for DES implantation