The Spanish ESTROFA-2 registry Thrombosis in real practice with second generation Drug-eluting stents: Endeavor, Xience an...
<ul><li>I, Jose Mª de la Torre Hernandez, DO NOT have a financial interest/arrangement or affiliation with one or more org...
Rationale for the registry <ul><li>The experience with first generation DES ( Cypher ®  and Taxus  ® )  showed that random...
Methods <ul><li>34 centers throughout Spain   (public tertiary hospitals) </li></ul><ul><li>Data Collection: </li></ul><ul...
Participating centers F Gimeno H. C. Valladolid J A Diarte H. M. Servet, Zaragoza A Perez de Prado H. de Leon J Sanchis H....
M Larman P. Guipuzcoa  J Botas H.F. Alcorcon J A Bullones H. Carlos Haya, Malaga B Garcia H. Vall de Hebron Barcelona J Mo...
Stent Thrombosis Definition
ZES EES N=1916 N=1413 p Age (yrs) 66.8   12 65.8  12 0.01 Females 23.2% 23.7% 0.7 Diabetes 30.5% 35.2% 0.004 HBP 62% 64%...
ZES EES N=1916 N=1413 p ACS 75.5% 66.6% <0.0001 STEMI + non STEMI  49.4% 39% <0.0001 N lesions treated 1.45    0.8 1.51  ...
1 m 6 m 12 m 18 m EES Pts. at risk  1413 950 347 35 Incidence 0.5% 1.2% 1.6% -- ZES Pts. at risk  1916 1560 1004 585 Incid...
1 m 6 m 12 m 18 m EES Pts. at risk  1413 950 347 35 Incidence 0.5% 0.9% 1.4% -- ZES Pts. at risk  1916 1560 1004 585 Incid...
1 m 6 m 12 m 18 m EES Pts. at risk  1413 950 347 35 Incidence 0.3% 0.5% 0.9%   -- ZES Pts. at risk  1916 1560 1004 585 Inc...
1 m 6 m 12 m 18 m Pts. at risk 694 530 320 130 Incidence 0.7% 1.1% 1.1% 1.6% STEMI cases (73% with ZES) Definite+probable ...
1 m 6 m 12 m 18 m EES Pts. at risk  190 138 81 9 Incidence 0.7% 0.7% 0.7%   -- ZES Pts. at risk  504 392 239 121 Incidence...
No thrombosis Def. + prob.  thrombosis N=3292 N=37 p Age (yrs) 66.4   12 70  12 0.06 Females 23.4% 29.7% 0.5 Diabetes 32...
  No thrombosis Def. + prob.  thrombosis   N=3292 N=37 p ACS 71.7% 78.4% 0.5 STEMI + non STEMI  45% 48.6% 0.7 N lesions tr...
Antiplatelet therapy in definite and probable  thrombosis No late Late n=23 n=14 ASA+clopidogrel 21 10 ASA 2 Clopidogrel 1...
Definite + probable thrombosis No late  Late  N=23 N=14 p Females 17.4% 43% 0.1 Age 66.9    12 76    9.7 0.02 STEMI + no...
Univariant analysis for predictors of definite and probable   stent thrombosis HR (CI 95%) p Age 1.037 (1.008-1.06) 0.01 D...
HR (CI 95%) p LVEF 0.96 (0.94-0.99) 0.03 Stent   diameter 0.35 (0.15-0.84) 0.02 HBP 7.3 (1.7-31) 0.007 -------------------...
<ul><li>In this registry the incidence at 1 year of  definite + probable  stent thrombosis was 1.4% for everolimus-eluting...
Upcoming SlideShare
Loading in...5
×

The Spanish ESTROFA-2 registry

586

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
586
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
7
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading , let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)
  • The Spanish ESTROFA-2 registry

    1. 1. The Spanish ESTROFA-2 registry Thrombosis in real practice with second generation Drug-eluting stents: Endeavor, Xience and Promus Jose Mª de la Torre Hernandez, MD, PhD Interventional Cardiology Department Hospital Universitario Marqués de Valdecilla Santander. SPAIN Spanish Working Group Interventional Cardiology
    2. 2. <ul><li>I, Jose Mª de la Torre Hernandez, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. </li></ul>Disclosure Statement of Financial Interest
    3. 3. Rationale for the registry <ul><li>The experience with first generation DES ( Cypher ® and Taxus ® ) showed that randomized trials do not reflect the risk for late thrombosis associated with their use in real practice (frequent off-label usage,...). </li></ul><ul><li>Industry-independent, large-scale registries without exclusion criteria yielded a linearly growing rate of thrombosis with 0.4-0.6% per year. </li></ul><ul><li>Second generation DES ( Endeavor ® , Xience ® and Promus ® ) based in new platforms, polymers and drugs (Zotarolimus and Everolimus), have shown to be “safe” and effective in randomized trials but,...... </li></ul><ul><li>Again, we need registries from real practice to ascertain the risk for late thrombosis with these new DES according to current definitions. </li></ul>
    4. 4. Methods <ul><li>34 centers throughout Spain (public tertiary hospitals) </li></ul><ul><li>Data Collection: </li></ul><ul><ul><li>Web-based CRF (supported by the Spanish Working Group on Interventional Cardiology) </li></ul></ul><ul><ul><li>Detailed forms (clinical and procedural) for all patients treated with Everolimus-eluting stents (EES) or Zotarolimus-eluting stents (ZES) until April / 08. </li></ul></ul><ul><ul><li>Systematic clinical follow up of all patients in: </li></ul></ul><ul><ul><ul><li>May 2008 </li></ul></ul></ul><ul><ul><ul><li>May 2009 </li></ul></ul></ul><ul><ul><li>Detailed forms for all cases with definite, probable or possible stent thrombosis. </li></ul></ul><ul><ul><li>Adjudication process by independent-one person MD event review </li></ul></ul><ul><ul><li>According to confidential regulations in Spain. </li></ul></ul>
    5. 5. Participating centers F Gimeno H. C. Valladolid J A Diarte H. M. Servet, Zaragoza A Perez de Prado H. de Leon J Sanchis H. Clinico, Valencia R Lopez Palop H. San Juan, Alicante F Hernandez H. 12 de Octubre, Madrid JA Baz H. Meixoeiro, Vigo I Lozano H. Central Asturias J Mauri H. G. Trias i Pujol, Badalona J M Vazquez H. J. Canalejo, La Coruña J M Hernandez H. V. de la Victoria, Malaga J R Rumoroso H. Galdacano, Bilbao J M Ruiz Nodar H. G. de Alicante J Martin Moreiras H. C. de Salamanca Fernando Rivero H. La Princesa, Madrid E Pinar H. V. de la Arrixaca, Murcia Coordinator: Jose Mª De la Torre H.U.M de Valdecilla Santander
    6. 6. M Larman P. Guipuzcoa J Botas H.F. Alcorcon J A Bullones H. Carlos Haya, Malaga B Garcia H. Vall de Hebron Barcelona J Moreu H. V. De la Salud, Toledo F Alfonso H. Clinico, Madrid J Elizaga H.G. Marañon, Madrid F Bosa H. C. U. de Tenerife R Melgares H. V. de las Nieves, Granada A Gomez-Jaume H. Son Dureta, P. de Mallorca A Sanchez Recalde H. La Paz, Madrid R Trillo H. C. de S. de Compostela JL Diez H. Dr. Peset, Valencia J D Cascon H. S. M. del Rosell, Cartagena J A Fernandez H. P. de Hierro, Madrid J Jimenez H. G. Albacete J Diaz H. J. Ramon Jimenez, Huelva Participating centers
    7. 7. Stent Thrombosis Definition
    8. 8. ZES EES N=1916 N=1413 p Age (yrs) 66.8  12 65.8  12 0.01 Females 23.2% 23.7% 0.7 Diabetes 30.5% 35.2% 0.004 HBP 62% 64% 0.2 Current smoker 28.7% 30% 0.8 Hypercholesterolemia 54% 59% 0.004 Renal failure 7.9% 8.7% 0.4 LVEF, % 56.3  12 56.4  12 0.9 Previous STEMI 18.9% 19% 0.9 Previous PCI 21% 24.8% 0.01 Previous CABG 5.7% 7.5% 0.04 Clinical characteristics (N=3329)
    9. 9. ZES EES N=1916 N=1413 p ACS 75.5% 66.6% <0.0001 STEMI + non STEMI 49.4% 39% <0.0001 N lesions treated 1.45  0.8 1.51  0.8 0.03 Total stent length 34.4  22 35  22 0.4 Abciximab 31.7% 28.2% 0.03 ASA+Clopidogrel: Indefinitely 21% 15% 0.001 Def. (months) 10.9  2 11.2  1.9 0.001 2778 lesions 2133 lesions LAD lesion 45% 52% <0.0001 Total occlusion 3.2%% 4.4% 0.03 Restenosis 4.7% 7% 0.0007 Bifurcation 13.8% 16.6% 0.007 Calcified 20.1% 20.6% 0.7 Stent length (mm) 19.4  6 19.7  5.5 0.13 Stent diameter (mm) 2.99  0.4 2.98  0.4 0.3 Procedural characteristics
    10. 10. 1 m 6 m 12 m 18 m EES Pts. at risk 1413 950 347 35 Incidence 0.5% 1.2% 1.6% -- ZES Pts. at risk 1916 1560 1004 585 Incidence 1% 1.8% 1.9% 2.1% Definite+probable+possible Stent thrombosis - - - EES ZES P = 0.3
    11. 11. 1 m 6 m 12 m 18 m EES Pts. at risk 1413 950 347 35 Incidence 0.5% 0.9% 1.4% -- ZES Pts. at risk 1916 1560 1004 585 Incidence 1% 1.4% 1.5% 1.8% Definite+probable Stent thrombosis - - - EES ZES P = 0.3
    12. 12. 1 m 6 m 12 m 18 m EES Pts. at risk 1413 950 347 35 Incidence 0.3% 0.5% 0.9% -- ZES Pts. at risk 1916 1560 1004 585 Incidence 0.6% 0.9% 1% 1.2% Definite Stent thrombosis - - - EES ZES P = 0.3
    13. 13. 1 m 6 m 12 m 18 m Pts. at risk 694 530 320 130 Incidence 0.7% 1.1% 1.1% 1.6% STEMI cases (73% with ZES) Definite+probable Stent thrombosis
    14. 14. 1 m 6 m 12 m 18 m EES Pts. at risk 190 138 81 9 Incidence 0.7% 0.7% 0.7% -- ZES Pts. at risk 504 392 239 121 Incidence 0.7% 1.3% 1.3% 1.9% STEMI cases Definite+probable Stent thrombosis - - - EES ZES P=0.5
    15. 15. No thrombosis Def. + prob. thrombosis N=3292 N=37 p Age (yrs) 66.4  12 70  12 0.06 Females 23.4% 29.7% 0.5 Diabetes 32.5% 54% 0.009 HBP 63% 94% 0.0002 Current smoker 28% 15% 0.1 Hypercholesterolemia 56% 54.5% 0.9 Renal failure 8.3% 17.2% 0.1 LVEF, % 56.3  12 52.3  12.5 0.04 Previous STEMI 19% 17.6% 0.9 Previous PCI 22.6% 25.7% 0.8 Previuos CABG 6.5% 10.8% 0.5 Differential characteristics in cases with and without thrombosis
    16. 16. No thrombosis Def. + prob. thrombosis N=3292 N=37 p ACS 71.7% 78.4% 0.5 STEMI + non STEMI 45% 48.6% 0.7 N lesions treated 1.47  0.8 1.67  1 0.1 Total stent length 34.6  22 39  22 0.1 Abciximab 30% 27% 0.8 4850 lesions 61 lesions LAD lesion 48% 52.5% 0.5 Total occlusion 3.7%% 3.3% 0.8 Restenosis 5.7% 4.9% 0.9 Bifurcation 15% 21.3% 0.3 Calcified 20.3% 20.6% 0.8 Stent length (mm) 19.6  6 22  9 0.02 Stent diameter (mm) 2.99  0.4 2.8  0.4 0.001 Differential characteristics in cases with and without thrombosis
    17. 17. Antiplatelet therapy in definite and probable thrombosis No late Late n=23 n=14 ASA+clopidogrel 21 10 ASA 2 Clopidogrel 1 ASA + oral AC 1 None 2 * Early dual tx cessation 2 (8.7%) 1 (7.1%) Cessation of ASA mono-TX na 1 (7.1%) * Bleeding events
    18. 18. Definite + probable thrombosis No late Late N=23 N=14 p Females 17.4% 43% 0.1 Age 66.9  12 76  9.7 0.02 STEMI + non STEMI 34.7% 57% 0.3 ACS 65.2% 93% 0.1 LVEF 54  13 46  11 0.06 Lesions treated 1.47  0.8 2.1  1.5 0.1 Total stent length 35.5  22 43.2  25 0.3 Stent diameter 2.75  0.35 2.85  0.33 0.4 Differential characteristics in cases with late vs non-late thrombosis
    19. 19. Univariant analysis for predictors of definite and probable stent thrombosis HR (CI 95%) p Age 1.037 (1.008-1.06) 0.01 Diabetes 2.5 (1.374.5) 0.02 Renal failure 2.3 (1.007-5.2) 0 .04 LVEF 0.97 (0.94-0.99) 0.03 HBP 12 (2.9-50) 0.0006 Stent length 1.03 ( 1.009-1.08) 0.04 Stent diameter 0.48 (0.2-0.99) 0.03 ---------------------------------- ZES 1.59 (0.81-3.1) 0.2
    20. 20. HR (CI 95%) p LVEF 0.96 (0.94-0.99) 0.03 Stent diameter 0.35 (0.15-0.84) 0.02 HBP 7.3 (1.7-31) 0.007 ------------------- ZES 1.3 (0.6-2.9) 0.49 Multivariant analysis for predictors of definite and probable stent thrombosis
    21. 21. <ul><li>In this registry the incidence at 1 year of definite + probable stent thrombosis was 1.4% for everolimus-eluting stents and 1.5% for zotarolimus-eluting stents. </li></ul><ul><ul><li>This incidence results slightly lower compared to the reported with 1 st generation DES (1 yr definite thrombosis 1.2-1.7% (1-5) vs 1%) </li></ul></ul><ul><ul><li>This could be attributable to a combined effect of: drug-eluting stent, better case selection, improved implantation technique and higher antiplatelet therapy adherence </li></ul></ul><ul><li>No significant differences were found between EES and ZES. </li></ul><ul><li>Ejection fraction, hypertension and stent diameter were independent predictors for thrombosis. Stent use in myocardial infarction was not associated with a higher incidence of thrombosis. </li></ul><ul><li>A longer follow up is needed to determine the incidence of thrombosis over following years. </li></ul>Conclusions 1 Colombo A et al. JAMA 2005;293:2126-2130 4 Daemen J et al. Lancet 2007;369:667-8 2 Ong A et al. J Am Coll cardiol 2005; 45: 2088-92 5 De la Torre et al. J Am Coll Cardiol 2008;51:986-90 3 Kuchulakanti PM et al. Circulation 2006; 113 : 1108-13
    1. A particular slide catching your eye?

      Clipping is a handy way to collect important slides you want to go back to later.

    ×