La trasferibilita dei risultati clinici tra device. Il caso dello stent medicato Roberto Violini...
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Transcript of La trasferibilita dei risultati clinici tra device. Il caso dello stent medicato Roberto Violini...
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
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 !