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  1. La “trasferibilita’” dei risultati clinici tra device. Il caso dello stent medicato Roberto Violini Cardiologia Interventistica AO S.Camillo Forlanini - Roma

  2. L’angioplastica coronarica RESTENOSI 30-40% solo pallone 15-20% stent < 6 % stent medicato

  3. Lo stent

  4. DES – Drug eluting stent

  5. Lots of DES ever received CE-Certificate !

  6. Transferability of data between different DES: Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  7. Transferability of data between different DES: Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  8. Restenosis after 6 Months Does a CE mark mean, a stent is safe and effective ?

  9. CE-approved DES in Europe without randomized studies ...are all Paclitaxel-eluting stents like TAXUS ?

  10. Transferability of data between different DES: NO ! Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  11. Transferability of data between different DES: Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  12. 103 randomized DES Studies in 58.356 Patients ABSOLUTE, ACTION, APPLAUSE, ASPECT, AVELLINO, BASKET, BBK, BRADES, CACTUS, CARDIA, CHINA-1, CHINA-2, CHREDIT, COMPARE, CORPAL, CORPAL-Bif-1, CORPAL-Bif-2, COSTAR-II, C-SIRIUS, Cypher/ BeStent, Cypher/Vision, DEDICATION-DES, DECODE, DELIVER-I, DESSERT, DEXA, DEXAMET, DIABETES, EAGLE, ELUTES, ENDEAVOR-II, ENDEAVOR-III, ENDEAVOR-IV, E-SIRIUS, ESTRADIOL, ETHOS-I, EUROSTAR-II, FUTURE-I, FUTURE-II, GENESIS, GENOUS-STEMI, HAAMU, HORIZONS-AMI, ISAR-DESIRE, ISAR-DIABETICS, ISAR-LM, ISAR-PEACE, ISAR-SMART-3, ISAR-TEST, ISAR-TEST-3, ISAR-TEST-4, JUPITER-II, LABEM, LEADERS, LONG-DES-II, MISSION, NOBORI-I Phase 1, NOBORI-I Phase 2, NORDIC-Bif-I, NORDIC-Bif-II, PAINT, PASSION, PATENCY, PISA-LAD, PRISON-II, PROSIT, RAPPAC, RAVEL, RIGA-LM, RRISC, REALITY, RIBS-II, SCANDSTENT, SCORE, SCORPIUS, SESAMI, SES-SMART, SEVILLA, SIRIUS, SIRIUS-Bif, SIRTAX, SISR, SORT-OUT-II, SORT-OUT-III, SOS, SPIRIT-I, SPIRIT-II, SPIRIT-III, SPIRIT-IV, STEALTH-I, STRATEGY, SYNTAX, TAXI, TAXUS-I, TAXUS-II, TAXUS-IV, TAXUS-V, TAXUS-V-ISR, TAXUS-VI, TYPHOON, ZEST, ZOOMAX-I, ZOOMAX-II Some DES were harmful, some DES were ineffective, some DES very effective

  13. Transferability of data between different DES: NO ! Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  14. Transferability of data between different DES: Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  15. Stent: Material:better deliverability, better expansion Design: better deliverability, better expansion Polymer: better drug release Drug: high efficacy without prolonged DAPT Balloon: better stent deliverability, better stent expansion Shaft: better stent deliverability Possible Improvements for DES: no study required, but inform the physicians

  16. DES Components: Stent Material Stent Design

  17. DES – Una storia vera • La multinazionale A compra la multinazionale B • Per motivi di antitrust, A rivende alcuni brevetti alla multinazionale C • A e C concordano il comarketing per il DES X • Successivamente A realizza lo stent X1 C realizza lo stent X2

  18. DES X: First in man  CE mark

  19. Changes in Stent Design Changes inStent Material Registry are enough Randomized Trial are required Stent X prodotto da A e C Stent X1 prodotto da A Stent X2 prodotto da C

  20. Transferability of data between different DES: sometimes YES sometimes NO Does a CE mark mean, a stent is safe and effective ? Are all DES the same ? (DES-1 vs. DES-2) Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b)

  21. Conclusione Al di la’ della problematica regolatoria e, per le strutture pubbliche, della normativa per gli acquisti esiste la responsabilita’ della scelta che grava sull’utilizzatore finale. Attenta valutazione dei risultati clinici e spirito critico sono gli strumenti per arrivare ad una scelta responsabile dei device.

  22. Stents are lifelong implanted devices There is no recall action for stents !