1) The document discusses data from the CIBELES trial which compared drug-eluting stents (DES) for the treatment of chronic total occlusions (CTOs). 2) The trial found a low incidence of clinically defined stent thrombosis (ST) of 1.97% after CTO recanalization with DES, similar to rates seen in other conditions. 3) However, systematic angiographic follow-up revealed unrecognized reocclusions in some patients, suggesting the true ST incidence may be greater than clinically apparent.

1. Drug-eluting stent thrombosis in the
treatment of CTOs: Data from the
CIBELES trial.
Javier Goicolea
University Hospital Puerta de Hierro; Madrid

2. ST with 1st Generation DES
Daemen J; Lancet 2007; 369: 667–78

3. Newer Generation DES
Sarno G, JACC 2014

4. Multivariate Predictors of Stent Thrombosis
Acute-subacute ST
ACS 2.6 1.3-4.9 0.0027
STEMI 6.9 4-12 0.0001
Renal failure 3.1 3.1 1.05-9.2 0.038
Diabetes 1.75 1.04-2.95 0.035
Stent length 1.08 1.06-1.1 0.0001
LAD 2.2 1.4-3.7 0.0011
Late ST
STEMI 5.2 5.5-7.6 0.0001
LAD 3.03 2.07 4.4
Stent length 1.07 1.05-1.09 0.0001
JM De la Torre et al; J. Am. Coll. Cardiol. 2008;51;986-990

5. Holmes Jr et al. JACC 56, 2010:1357–65

6. Predictors of Stent Thrombosis in CTOs
Lesion characteristics
– Lesion/stent length
– Vessel/stent diameter
– Complex lesions (bifurcation lesions, chronic
total occlusions)
– Saphenous vein graft target lesion
– Stasis
Procedural factors
– Inadequate stent expansion/sizing
– Incomplete stent apposition
– Stent deployment in necrotic core
– Residual edge dissection
CTO PCI is an almost ideal niche for stent thrombosis

7. Stent Thrombosis in CTOs
Particular Features/Considerations
Lesion Features
• Long and complex lesions
• Procedural Factors
Proximal/Distal dissections
• Multiple overlapping stents
• Uncertainty regarding true luminal diameter
Patient Related (Dx)
• Viability
• Collateral Circulation

8. CIBELES Trial
R Moreno et al. EuroIntervention 2010;6:112-116
• 207 patients
• 13 centers (Spain+Portugal)
• Sponsor: Spanish Society of Cardiology

9. CIBELES Trial; Angiographic FU
ISLL
R Moreno; Circ Cardiovasc Interv. 2013;6:21-28.

10. CIBELES Trial; Clinical FU
R Moreno; Circ Cardiovasc Interv. 2013;6:21-28.

11. CIBELES Trial
MACE and Stent type

12. CIBELES FU; Clinical Events

13. CIBELES Trial; MACE and ST
• + 1 pt with possible ST (sudden death >30d after) in the EES group
• Total incidence -Definite, Probable, Possible- (n=4,1.97%)

14. CIBELES Trial; ST predictors
Univariate
• Single vessel disease: (3.3 vs 0%, p=0.049)
• LAD location: (3.5 vs 0%, p=0.037)
• Post procedure MLD: (1.3±0.6 vs 2.6±0.5, p<0.001)
• Type of Stent (EES vs SES): 3 vs 0%, p=0.074
Multivariate
• Post procedure MLD

15. CIBELES Trial; Angiographic FU
Restenosis
207 randomized
CTOs
101 SES
97
106 EES
103
181
(90% Eligible)
Angio FU
2 Failures
1 Death
2 Failures
2 Deaths

16. Angiographic FU
10.8%
3.2%
9.1%
1.1%
0
4
8
12
RE ReOcc
SES
EES
%
Reocclussions are considered after excluding definite or probable ST

17. Conclusions
• Clinically defined (ARC criteria) ST is a rare
event after CTO recanalization with DES.
• The global rate of ST considering definite,
probable or possible ST is 2%, similar to that
observed in other conditions.
• However unrecognized reocclussions are
observed in a systematic angiographic FU
suggesting that in these patients true ST
incidence may be greater.