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:
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:
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)
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
COROFLEX
Please
InTek
Jupiter
Polysulfon
Paclitaxel
0
B Braun
Coroflex
Polysulfon
Paclitaxel
0
EUCA-TAX
Eucatech
ST Flex
Paclitaxel
0
LUC-CHOPIN
Balton
Chopin
Paclitaxel
0
OMEGA
Globamed
Omega
biodegradable
Polymer
biodegradable
Polymer
no Polymer
Paclitaxel
0
TAXCOR
EuroCOR
Genius Megaflex
Biopolymer
Paclitaxel
0
Transferability of data between different DES:
1. Does a CE mark mean, a stent is safe and effective ?
NO !
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:
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)
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, ISARDESIRE, 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, NORDICBif-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-OUTII, 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-VISR, TAXUS-VI, TYPHOON, ZEST, ZOOMAX-I, ZOOMAX-II
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)
NO !
3. Can data be transferred for modifications of a specific
stent ?
(DES-1a vs. DES-1b)
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)
Stent:
Material:
better deliverability, better
expansion
Possible
Improvements
for
DES:
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
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
Stent X prodotto da A e C
Stent X1 prodotto da A
Stent X2 prodotto da C
Changes in
Stent Material
Randomized Trial
are required
Changes in
Stent Design
Registry
are enough
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)
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