La “trasferibilita’” dei risultati clinici tra device.

Il caso dello stent medicato

Roberto VioliniCardiologia Interventistica

AO S.Camillo Forlanini - Roma

L’angioplastica coronarica

RESTENOSI30-40% solo pallone15-20% stent< 6 % stent medicato

Lo stent

DES – Drug eluting stent

Lots of DES ever received CE-Certificate !

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:Transferability of data between different DES:

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:Transferability of data between different DES:

Does a CE mark mean, a stent is safe and effective ?Does a CE mark mean, a stent is safe and effective ?

Restenosis after 6 MonthsRestenosis after 6 Months

STENT Company Platform Carrier DrugNumber of

Randomized Studies

APOLLO InTek Jupiter Polysulfon Paclitaxel 0COROFLEX

Please B Braun Coroflex Polysulfon Paclitaxel 0

EUCA-TAX Eucatech ST Flex biodegradable Polymer Paclitaxel 0

LUC-CHOPIN Balton Chopin biodegradable Polymer Paclitaxel 0

OMEGA Globamed Omega no Polymer Paclitaxel 0

TAXCOR EuroCOR Genius Megaflex Biopolymer Paclitaxel 0

CE-approved DES in Europe without randomized studiesCE-approved DES in Europe without randomized studies

...are all P

aclitaxel-e

luting stents lik

e

TAXUS ?

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:Transferability of data between different DES:

NO !

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:Transferability of data between different DES:

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 ineffectiv

e,

some DES very effective

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:Transferability of data between different DES:

NO !

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:Transferability of data between different DES:

Possible Improvements for DES: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

DES Components:DES Components:

Stent MaterialStent Material

Stent DesignStent 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 markDES X: First in man CE mark

Changes in Stent DesignChanges in

Stent DesignChanges in

Stent MaterialChanges in

Stent Material

Stent X prodotto da A e C

Stent X1 prodotto da A Stent X2 prodotto da C

Randomized Trial

are required

Registry

are enough

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:Transferability of data between different DES:

sometimes YESsometimes NO

ConclusioneAl 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 devicesStents are lifelong implanted devices

There is no recall a

ction fo

r

stents !