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Real World Data on Stent Thrombosis: The Spanish ESTROFA registry

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. The author has no conflicts of interest to disclose.

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Real World Data on Stent Thrombosis: The Spanish ESTROFA registry

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  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

  3. Main investigator: Dr. Jose Mª de la Torre HernandezSantander Felipe HernandezH. 12 de octubre Madrid Marcelo San MartinH. MeixoeiroVigo Iñigo LozanoH. Central AsturiasOviedo Josefina MauriH. G. Trias i PujolBadalona Armando Perez de PradoH. de LeonLeon Jose M. VazquezH. CanalejoLa Coruña Juan SanchisH. C. de ValenciaValencia Jose M. HernandezH. V. de la VictoriaMalaga J. R. RumorosoH. GaldacanoBilbao Jose A. DiarteH. M. ServetZaragoza Juan M. Ruiz NodarH. G. de AlicanteAlicante Javier RodriguezH. C. de SalamancaSalamanca J.R. Lopez MinguezH. I. CristinaBadajoz Eduardo PinarH. V. de la ArrixacaMurcia F. AlfonsoH. C. de MadridMadrid Jose M. de la TorreH. M. de ValdecillaSantander

  4. DES Usage in Spain Use of DES in Spain has grown (5% in 2002 to 52% in 2005) over time and across centers

  5. 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.

  6. 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

  7. 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)

  8. ESTROFA: Preliminary Results (15 Centers) * Vey late: Median 11,4 months; range 6-46 months

  9. ESTROFA: DES thrombosis treatment and outcomes Treatment and 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

  10. ESTROFA: outcomes for Late vs non-Late events Acute/SubacuteLate N=96N=66 Death11 (11,4%)10 (15%)ns In hospital7 (7,3%)7 (10,6%) In follow up4 (4,5%)3 (5%) Re-Thrombosis5 (5,2%)3 (4,5%)ns

  11. Risk factors for DES Thrombosis No thrombosisThrombosis N=13338N=162p value Age (yrs)63 1160120,006 Males77%75%0,8 Diabetes29%30%0,8 HBP46%47%0,8 Renal failure3%5%0,2 LVEF, %54 1150 110,02 ACS58%80%<0,0001 STEMI 12%38%<0,0001 LAD lesion50%71%<0,0001 Total occlusion11%20%0,0005 Restenosis9%13%0,1 Bifurcation (2 stents)3%6%0.14 Stent length (mm)19 72510<0,0001 Stent diameter (mm)2,86 0,32,83 0,40,5 Abciximab15%27%<0,001

  12. ESTROFA: antiplatelet therapy at the time of thrombosis • <6 months>6 months • N=111N=51 • ASA+Clopidogrel76 (68%)2 (4%) • ASA13 (12%)35 (68%) • -Early dual disc.122 • Clopidogrel10 (9%)2 (4%) • -Early dual disc.101 • Coumadin01 (2%) • Nothing12 (11%)11 (21,5%) • Early dual disc.122 • Disc. of ASA-9 • Early stop dual tx30,6%10% • Stop mono Tx-- -- 17,6% Time to thrombosis after non-early stop of Clopidogrel: -median 155 days -range (32-1280 days)

  13. Differential characteristics in ACUTE-SUBACUTE vs LATE events Acute/SubacuteLatep N=96N=66 Age61 ±1258 ±130,09 Females31%15%0,03 Diabetes38%20%0,02 Renal insuf.8%0%0,04 EF53 ±1149 ±110,07 LAD70%77%0,4 ACS85%76%0,2 STEMI35%41%0,5 Stent length26 ±1223 ± 110,06 Stent diameter2,78 ±0,32,9 ±0,40,05 Stent subexpansion by angio.23%9%0,03 Cypher30% Taxus10%

  14. Differential characteristics in ACUTE-SUBACUTE vs LATE vs VERY LATE Ac/Subac.LateVery Late <1m1-6m>6m n=96n=15n=51 Age61 ±1263 ±1256,5 ±12* Males69%74%88%* Diabetes38%40%14%* Renal insuf.8%0%0%* EF53 ±1148 ±1452 ±10 ACS85%86%73% STEMI35%40%41% LAD70%73%78,4% Stent length26 ±1225 ±1022 ±12* Stent diameter2,78 ±0,32,85 ±0,42,92 ±0,4* Stent subexp by angio.23%0%12% * p<0,05 for comparison Ac/Sub. vs Very late

  15. ESTROFA: Independent predictors for Acute and Sub-acute stent thrombosis OR (CI 95%)p value ACS2,7 (1,4-5)0,002 STEMI4 (2,8-6)0,0001 Renal insuf.4,7 (1,7-13)0,002 Female sex2 (1,25-3)0,008 LAD2,1 (1,3-3,4)0,002 Stent Length (per mm )1,08 (1,06-1,1)0,0001 Vessel 2,5mm1,7 (1,07-2,7)0,03

  16. ESTROFA: Independent predictors for Late stent thrombosis OR (CI 95%)p value STEMI7,5 (4-14)0,0001 LAD3,9 (2,1-7,2)0,0001 Stent length1,06 (1,02-1,08)0,004

  17. ESTROFA: Independent predictors for Very Late stent thrombosis OR (CI 95%)p value STEMI6,2 (3-13)0,0001 LAD3,5 (1,8-7)0,0003

  18. TOTAL 13500 pts LAD Rest 6750 (50%)6750 Thrombosis rates Total1,7%0,68% Acute-subacute0,9%0,5% Late (1-6m)0,22%0% Very late (>6m)0,6%0,18%

  19. TOTAL 13500 pts STEMI Rest 1620 (12%)11880 Thrombosis rates Total3,8%0,8% Acute-subacute2,1%0,5% Late (1-6m)0,4%0,06% Very late (>6m)1,3%0,25%

  20. TOTAL 13500 pts STEMI-LAD Rest 800 (6%)12700 Thrombosis rates Total5,6%0,9% Acute-subacute2,75%0,58% Late (1-6m)0,75%0,07% Very late (>6m)2,1%0,26%

  21. 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.

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