1. After CTO recanalization:
which DES should be chosen?
Jean Marco
Chairman of PCR

2. After successful CTO
recanalization: which DES ?
Objective
“On which criteria could be based the
selection of DES in the light of
the best available knowledge,
local experience and constraints”

3. Which DES?
Agenda
I. Background
II. The essential from knowledge
BMS vs SES/PES
SES vs PES
SES-PES vs new generation of DES
III.Conclusion-Messages

4. Which DES?
Agenda
I. Background
II. The essential from knowledge
BMS vs SES/PES
SES vs PES
SES-PES vs new generation of DES
III.Conclusion-Messages

5. CTO lesions features
and PCI in CTO
Absence of endothelial cells
Stents exposed to deep plaque
components

6. Stent: what’s the matter?
BMS & DES: Struts feature, metal
alloys, strut thickness…
DES: Polymer coating
Permanent, biodegradable, kinetic drug
release
DES: Drug
Limus, Paclitaxel
Safety Efficacy
Stent Thrombosis (ST), MI, death Clinically-driven TLR

7. Which DES?
Agenda
I. Background
II. The essential from knowledge
BMS vs SES/PES
SES vs PES
SES-PES vs new generation of DES
III.Conclusion-Messages

8. Which DES?
Agenda
I. Background
II. The essential from knowledge
BMS vs SES/PES
SES vs PES
SES-PES vs new generation of DES
III.Decision-making and Messages

9. The essential from knowledge
RCTs:
carefully selected patients
Registries:
“all-comers” patients
Meta-analysis:
explore the efficacy & safety of DES

10. SES or PES vs BMS in CTO
Reduced risk of MACE
[RR: 0.45],(95% CI: 0.34-0.60, p< 0.001)
Reduced need for TVR
[RR: 0.40],95% CI: 0.28-0.58, p< 0.001)
Colmenarez et al. JACC 2010

11. SES or PES vs BMS in CTO
Reduced risk of restenosis
(RR: 0.25,95% CI: 0.16-0.41, p<0.001)
Reduced risk of occlusive restenosis
(RR: 0.30,95% CI: 0.18-0.49, p<0.001)
Colmenarez et al. JACC 2010

12. SES or PES vs BMS in CTO
1 stent re-occlusion event
avoided by treating
15 CTO with DES
Colmenarez et al. JACC 2010

13. SES or PES vs BMS in CTO
A higher rate
of late stent thrombosis?
[RR:2.79],95% CI: 0.98-7.97, p<0.06)
Hypothesis-generating
Colmenarez et al. JACC 2010

14. SES or PES vs BMS in CTO
Similar risk of death
(RR: 0.87,95% CI: 0.66-1.16, p= 0.88)
Similar risk of MI
(RR: 0.89,95% CI: 0.54-1.46, p=0.80)
Colmenarez et al. JACC 2010

15. SES and PES: delayed arterial
healing
BMS PES
8
6.3
6 5,7
4
2
1,1 1
0,9
0,1
0
Malapposed and Uncovered Struts Uncovered Struts Protruding Struts
Guagliumi et al. Circulation 2011

16. SES or PES vs BMS in CTO
This benefit seems to be proportional
to baseline risk of restenosis
(ie: diabetes, length of occluded
segment stented and final lumen
diameter)
Claessen et al. Am J Cardiol 2011

17. Is there any difference in safety and
efficacy profile between SES and PES?
No robust clinical relevant differences
up to 5-year follow-up
were convincly identified

18. PES vs SES in CTO
Multinational registry
KM estimated of 5-yr clinical follow-up
PES SES P
(n=208) ( n=555) value
MACE 22.5% 24.4% 0.73
Death 2.1% 6.9% 0.21
MI 6.5% 3.9% 0.49
TVR 16.2% 17.2% 0.77
Definite/probable ST 1.2% 2.1% 0.19
Mehram et al. JACC Intv 2011

19. After successful CTO
recanalization: which DES ?
Are Everolimus, Biolimus,
New-Zotarolimus ES
safer and more effective
than SE or PES in CTO?
This hypothesis still has to be
demonstrated
19

20. Meta-analysis and and “all-comers”
studies:
Everolimus Eluting Stent (EES),
Zotarolimus ES,
Biolimus ES (BES)
showed a better outcome
as compared to PES

21. EES vs SES
TLR @ 3 Years
20 (Non –inferiority)
15.5
15 12.8
10
5
0
EES SES
(N=652) (N=652)
Byrne R et al. JACC 2011

22. EES vs SES
DES Efficacy – Risk of TLR
RR (95% CI)
EES SES
ISAR-TEST 4 77/652 95/652 0.81 (0.61, 1.07)
SORT-OUT 4 20/1390 23/1384 0.87 (0.48, 1.57)
EXCELLENT 26/1079 6/364 1.46 (0.61, 3.52)
BASKET-PROVE* 29/774 33/775 0.88 (0.54, 1.43)
ESSENCE-DIABETES 1/149 4/151 0.25 (0.03, 2.24)
Long DES 7/224 5/226 1.41 (0.46, 4.38)
*
Burzotta et al. 5/75 5/75 1.00 (0.30, 3.31)
RESET 65/1597 76/1600 0.86 (0.62, 1.18)
Overall (I-squared = 0.0%, p = 0.827) 0.87 (0.73, 1.03)
* TVR .1 .2 .5 1 2 5 10
Risk ratio
N = 11,167 Favors EES Favors SES
Kalesan, Windecker

23. EES versus SES
DES Safety - Risk of Definite Stent Thrombosis
EES SES RR (95% CI)
ISAR-TEST 4 4/652 9/652 0.44 (0.14, 1.44)
SORT-OUT 4 2/1390 9/1384 0.22 (0.05, 1.02)
BASKET-PROVE 2/774 3/775 0.67 (0.11, 3.98)
RESET 5/1597 6/1600 0.83 (0.26, 2.73)
ESSENCE-DIABETES 0/149 0/151 (Excluded)
Burzotta et al. 0/75 0/75 (Excluded)
Overall (I-squared = 0.0%, p = 0.579) 0.51 (0.26, 0.99)
.1 .2 .5 1 2 5 10
Risk ratio
N = 11,167 Favors EES Favors SES
Kalesan, Windecker

24. Biodegradable polymer BES vs SES
LEADERS trial @ 4 years FU
I° End Point (cardiac death, MI, TVR)
Non-inferiority
18·7% vs 22·6%
[RR: 0·81], (95% CI: 0·66–1·00)
Windecker Lancet 2011

25. Biodegradable polymer BES vs SES
Non-inferior to SES
Hypothesis-generating
Definite ST
[RR: 0·62],( 95% CI: 0·35–1·08, p=0·09)
Very late definite ST between years 1 and 4
[RR 0·20, 95% CI 0·06–0·67, p=0·004]
Windecker Lancet 2011

26. DES selection
Differences in terms
of efficacy or safety
between EES, ZES, and BES?
No robust evidence
The overall low frequency of ST events
makes it unlikely for any of the RCTs alone
to show a significant difference
26

27. After successful CTO
recanalization: which DES ?
Conclusion
There is a low risk of late or very late
adverse events related to DES safety
27

28. After successful CTO
recanalization: which DES ?
Conclusion
All your patient’s information can and does
influence a personalized decision-making
process
28

29. After successful CTO
recanalization: which DES ?
In “high-risk” of adverse events
(diabetics, very long lesion, need to overlapping
stents, < 3mm vessel diameter)
EES, ZES, BES might be advised,
according to local regulation/constraints