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

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

Lo stent

DES – Drug eluting stent

Lots of DES ever received CE-Certificate !

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)

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)

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

CE-approved DES in Europe without randomized studies STENT Company Platform Carrier Drug Number of Randomized Studies APOLLO InTek Jupiter Polysulfon Paclitaxel COROFLEX Please B Braun Coroflex EUCA-TAX Eucatech ST Flex biodegradable Polymer LUC-CHOPIN Balton Chopin OMEGA Globamed Omega no Polymer TAXCOR EuroCOR Genius Megaflex Biopolymer ...are all Paclitaxel-eluting stents like TAXUS ?

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) NO !

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)

some DES were ineffective, some DES very effective 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

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) NO !

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)

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

DES Components: Stent Material Stent Design

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

DES X: First in man  CE mark

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

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) sometimes YES sometimes NO

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.

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