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
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
<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
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>
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>
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
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
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
<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
A particular slide catching your eye?
Clipping is a handy way to collect important slides you want to go back to later.