1. Real World Data on Stent Thrombosis: The Spanish ESTROFA registry
Jose Mª de la Torre Hernandez, MD, PhD
Interventional Cardiology Department
Hospital Universitario Marqués de Valdecilla
Santander
SPAIN

2. The author has no conflicts of interest to disclose

4. Felipe Hernandez H. 12 de octubre Madrid
Main investigator: Dr. Jose Mª de la Torre Hernandez Santander
Felipe Hernandez H. 12 de octubre Madrid
Marcelo San Martin H. Meixoeiro Vigo
Iñigo Lozano H. Central Asturias Oviedo
Josefina Mauri H. G. Trias i Pujol Badalona
Armando Perez de Prado H. de Leon Leon
Jose M. Vazquez H. Canalejo La Coruña
Juan Sanchis H. C. de Valencia Valencia
Jose M. Hernandez H. V. de la Victoria Malaga
J. R. Rumoroso H. Galdacano Bilbao
Jose A. Diarte H. M. Servet Zaragoza
Juan M. Ruiz Nodar H. G. de Alicante Alicante
Javier Rodriguez H. C. de Salamanca Salamanca
J.R. Lopez Minguez H. I. Cristina Badajoz
Eduardo Pinar H. V. de la Arrixaca Murcia
F. Alfonso H. C. de Madrid Madrid
Jose M. de la Torre H. M. de Valdecilla Santander

5. DES Usage in Spain Use of DES in Spain has grown
(5% in 2002 to 52% in 2005)
over time and across centers
2002
2003
2004
2005
2% to 30%
12% to 45%
18% to 70%
36% to 73%

6. ESTROFA: Site & Patient Selection
17 centers across Spain with 400 to 1300 PCI / year
DES use at study sites: 20% to 73%
Data Collection:
Detailed report (standardized) of every DES thrombosis since the introduction of DES in each institution, retrospective and prospective.
Detailed characterization (standardized data-base) of all the patients treated with DES and no-ST
Adjudication process by independent-one person MD event review
No funded
According to confidential regulations in Spain.

7. ESTROFA: Stent Thrombosis Definition
Angiographic documentation of complete occlusion (TIMI flow grade 0 or 1) or presence of flow limiting thrombus (TIMI flow grade 2 or 3) within or adjacent to a previously successfully implanted DES.
For cases > 1 month after procedure an associated acute coronary syndrome had to be present

8. ESTROFA: Follow-Up
Clinical follow up was obtained from the hospital registries and medical records where clinical data of the patient visits were collected
For patients who had events at another hospital, medical records and discharge summaries were requested
Clinical follow up to 4 years (median 18 months)

10. ESTROFA: Preliminary Results (15 Centers)
Overall stent thrombosis
162 (1,2%)
SES PES
1,35% %
p=0,2
Acute (< 24h)
20 (0,15%)
Subacute (1-30 days)
76 (0,56%)
Late ( 1-6 months)
Very late (> 6 months)*
15 (0,11%)
51 (0,37%)
* Vey late: Median 11,4 months; range 6-46 months

13. ESTROFA: DES thrombosis treatment and outcomes
In- hospital outcome
Outcomes
Late Follow-up (13 10 m)
82% presented as STEMI
18% presented with cardiogenic shock
7 pts died (5 cardiac: 4 sudden, 1 post-CABG)
4 re-thrombosis
3 pts underwent CABG
1 pt had a heart transplant (4 on waiting list with ICD)
6 pts had a new PCI
Thrombectomy
58 (36%)
New stent implanted
(DES 55%)
72 (44%)
Abciximab
120 (74%)
TIMI III obtained
146 (90%)
In-hospital deaths
Re- thrombosis
14 (8,6%)
4 (2,4%)

14. ESTROFA: outcomes for Late vs non-Late events
Acute/Subacute Late
N=96 N=66
Death 11 (11,4%) 10 (15%) ns
In hospital 7 (7,3%) 7 (10,6%)
In follow up 4 (4,5%) 3 (5%)
Re-Thrombosis 5 (5,2%) 3 (4,5%) ns

15. Risk factors for DES Thrombosis
No thrombosis Thrombosis
N= N=162 p value
Age (yrs) 63 12 0,006
Males 77% 75% 0,8
Diabetes 29% 30% 0,8
HBP 46% 47% 0,8
Renal failure 3% 5% 0,2
LVEF, % 54  11 0,02
ACS 58% 80% <0,0001
STEMI 12% 38% <0,0001
LAD lesion 50% 71% <0,0001
Total occlusion 11% 20% 0,0005
Restenosis 9% 13% 0,1
Bifurcation (2 stents) 3% 6% 0.14
Stent length (mm) 19 10 <0,0001
Stent diameter (mm) 2,86 0,3 2,83 0,4 0,5
Abciximab 15% 27% <0,001

16. ESTROFA: antiplatelet therapy at the time of thrombosis
<6 months >6 months
N=111 N=51
ASA+Clopidogrel 76 (68%) 2 (4%)
ASA 13 (12%) 35 (68%)
-Early dual disc
Clopidogrel 10 (9%) 2 (4%)
-Early dual disc
Coumadin (2%)
Nothing 12 (11%) 11 (21,5%)
Early dual disc
Disc. of ASA - 9
Early stop dual tx 30,6% 10%
Stop mono Tx ,6%
Time to thrombosis
after non-early stop
of Clopidogrel:
-median 155 days
-range ( days)

17. Differential characteristics in ACUTE-SUBACUTE vs LATE events
Acute/Subacute Late p
N=96 N=66
Age ± ±13 0,09
Females 31% 15% 0,03
Diabetes 38% 20% 0,02
Renal insuf. 8% 0% 0,04
EF ± ±11 0,07
LAD 70% 77% 0,4
ACS 85% 76% 0,2
STEMI 35% 41% 0,5
Stent length 26 ± ± 11 0,06
Stent diameter 2,78 ±0,3 2,9 ±0,4 0,05
Stent subexpansion by angio. 23% 9% 0,03
Cypher 30%
Taxus 10%

18. Differential characteristics in ACUTE-SUBACUTE vs LATE vs VERY LATE
Ac/Subac. Late Very Late
<1m 1-6m >6m
n=96 n=15 n=51
Age 61 ± ±12 56,5 ±12 *
Males 69% 74% 88%*
Diabetes 38% 40% 14%*
Renal insuf. 8% 0% 0%*
EF 53 ± ± ±10
ACS 85% 86% 73%
STEMI 35% 40% 41%
LAD 70% 73% 78,4%
Stent length 26 ± ± ±12*
Stent diameter 2,78 ±0,3 2,85 ±0,4 2,92 ±0,4*
Stent subexp by angio. 23% 0% 12%
* p<0,05 for comparison Ac/Sub. vs Very late

19. ESTROFA: Independent predictors for Acute and Sub-acute stent thrombosis
OR (CI 95%) p value
ACS 2,7 (1,4-5) 0,002
STEMI 4 (2,8-6) 0,0001
Renal insuf. 4,7 (1,7-13) 0,002
Female sex 2 (1,25-3) 0,008
LAD 2,1 (1,3-3,4) 0,002
Stent Length (per mm ) 1,08 (1,06-1,1) 0,0001
Vessel 2,5mm 1,7 (1,07-2,7) 0,03

20. ESTROFA: Independent predictors for Late stent thrombosis
OR (CI 95%) p value
STEMI 7,5 (4-14) 0,0001
LAD 3,9 (2,1-7,2) 0,0001
Stent length 1,06 (1,02-1,08) 0,004

21. ESTROFA: Independent predictors for Very Late stent thrombosis
OR (CI 95%) p value
STEMI 6,2 (3-13) 0,0001
LAD 3,5 (1,8-7) 0,0003

22. TOTAL 13500 pts LAD Rest 6750 (50%) 6750 Thrombosis rates
6750 (50%) 6750
Thrombosis rates
Total 1,7% 0,68%
Acute-subacute 0,9% 0,5%
Late (1-6m) 0,22% 0%
Very late (>6m) 0,6% 0,18%

23. TOTAL 13500 pts STEMI Rest 1620 (12%) 11880 Thrombosis rates
1620 (12%)
Thrombosis rates
Total 3,8% 0,8%
Acute-subacute 2,1% 0,5%
Late (1-6m) 0,4% 0,06%
Very late (>6m) 1,3% 0,25%

24. TOTAL 13500 pts STEMI-LAD Rest 800 (6%) 12700 Thrombosis rates
800 (6%)
Thrombosis rates
Total 5,6% 0,9%
Acute-subacute 2,75% 0,58%
Late (1-6m) 0,75% 0,07%
Very late (>6m) 2,1% 0,26%

25. ESTROFA Conclusions
Documented stent thrombosis was infrequent (1.2% overall) with DES
The incidence up to 6 months (~ 0.82%) seems similar to that seen with BMS
The incidence after 6 months was approximately 0.4% for both Cypher and Taxus DES, and is higher than BMS
In our experience overall ST incidence tended to be numerically, but not significantly, higher with SES compared to PES.
Main predictors of stent thrombosis < 6 months include:
-Inadequate antiplatelet therapy, STEMI, LAD, longer stent length, small stent diameter and renal failure
Of these, only the STEMI indication and LAD location were predictors of stent thrombosis after 6 months
The risk of ST is very low (0.8%) in patients without STEMI.