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

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Presentazione sul tema: "La trasferibilita dei risultati clinici tra device. Il caso dello stent medicato Roberto Violini Cardiologia Interventistica AO S.Camillo Forlanini - Roma."— Transcript della presentazione:

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

2 Langioplastica 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 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES:

7 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES:

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

9 STENTCompanyPlatformCarrierDrug Number of Randomized Studies APOLLOInTekJupiterPolysulfonPaclitaxel0 COROFLEX Please B BraunCoroflexPolysulfonPaclitaxel0 EUCA-TAXEucatechST Flex biodegradable Polymer Paclitaxel0 LUC-CHOPINBaltonChopin biodegradable Polymer Paclitaxel0 OMEGAGlobamedOmegano PolymerPaclitaxel0 TAXCOREuroCOR Genius Megaflex BiopolymerPaclitaxel0 CE-approved DES in Europe without randomized studies...are all Paclitaxel-eluting stents like TAXUS ?

10 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES: NO !

11 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES:

12 103 randomized DES Studies in 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 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES: NO !

14 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES:

15 Possible Improvements for DES: Balloon: better stent deliverability, better stent expansion Stent: Material: better deliverability, better expansion Design: better deliverability, better expansion Polymer: better drug release Drug: high efficacy without prolonged DAPT Shaft: better stent deliverability 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 in Stent Material Stent X prodotto da A e C Stent X1 prodotto da AStent X2 prodotto da C Randomized Trial are required Registry are enough

20 1.Does a CE mark mean, a stent is safe and effective ? 2.Are all DES the same ? (DES-1 vs. DES-2) 3.Can data be transferred for modifications of a specific stent ? (DES-1a vs. DES-1b) Transferability of data between different DES: sometimes YES sometimes NO

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 sullutilizzatore finale. Attenta valutazione dei risultati clinici e spirito critico sono gli strumenti per arrivare ad una scelta responsabile dei device.

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

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