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10.3 Quadro dell’analisi degli studi clinici sulla trombosi dello stent in seguito a interruzione/sospensione della doppia terapia

antipiastrinica (DAPT)

La famiglia di stent XIENCE ha dimostrato di possedere caratteristiche di sicurezza ed efficacia nel corso di diversi studi condotti su

pazienti inseriti nella vita reale, con un rischio standard/modesto e un rischio esteso; questi stent hanno dimostrato di essere associati

a modesti tassi di trombosi (Stent Thrombosis, ST).

Sono inclusi pazienti che hanno sospeso o interrotto la doppia terapia antipiastrinica (DAPT) trascorso 1 mese dall’impianto di stent

coronarico. Gli studi clinici descritti a seguire e/o trattati nella letteratura già pubblicata sono stati analizzati per studiare la correlazione

fra trombosi dello stent e DAPT.

I dati (Tabella 10.3-1) derivano da un’analisi congiunta a livello di paziente degli studi pre- e post-commercializzazione seguenti:

Pre-commercializzazione: SPIRIT II, SPIRIT III, SPIRIT IV

Post-commercializzazione: SPIRIT V, SPIRIT Women, XIENCE V USA, XIENCE V India

Tabella 10.3-1: Trombosi dello stent (accertata/probabile secondo ARC) successiva a interruzione/sospensione della DAPT nei

730 giorni vs nessuna interruzione; dati raccolti da 7 studi pre- e post-commercializzazione

7 studi raggruppati (risultati a 2 anni)

N = 11.219

DAPT interrotta ≤30 giorni

DAPT interrotta da > 30 giorni a

730 giorni

Nessuna interruzione della

DAPT

Successiva ST

(acc./prob.)

2,51%

(12/478)

0,38%

(13/3.445)

0,66%

(44/6.648)

11.0 MODALITÀ DI FORNITURA

Sterile –

Il dispositivo è sterilizzato con gas ossido di etilene. Apirogeno. Non utilizzare se la confezione è aperta o danneggiata.

Questo dispositivo è monouso e non deve essere riutilizzato su un nuovo paziente poiché dopo il primo utilizzo le prestazioni risultano

compromesse. Le modifiche di tipo meccanico, fisico e/o chimico, introdotte dall’uso ripetuto del dispositivo, dalla sua pulizia e/o

dalla risterilizzazione, possono compromettere l’integrità del design e/o dei materiali, portando alla contaminazione del dispositivo

dovuta alla presenza di fessure e/o spazi ristretti, riducendone la sicurezza e/o compromettendone le prestazioni. L’assenza delle

etichette originali può determinare l’uso scorretto del dispositivo ed eliminarne le caratteristiche di tracciabilità. L’assenza della

confezione originale potrebbe causare danni al dispositivo, perdita di sterilità e rischio di lesioni per il paziente e/o l’operatore.

Contenuto –

Un (1) sistema di stent coronarico a rilascio di everolimus XIENCE Sierra.

Conservazione –

Conservare in luogo fresco, asciutto e al riparo dalla luce. Proteggere dalla luce. Non estrarre dalla scatola di cartone

fino al momento dell’uso. Conservare a una temperatura di 25 °C (77 °F); escursioni ammesse fino a 15–30 °C (59–86 °F).

EL2115538 (2017-1

1-03

)

Page 40 of 206

Printed on : 2017-11-03

Содержание XIENCE Sierra

Страница 1: ...m rkning av medicinsk utrustning Grafische symbolen voor de etikettering van medische hulpmiddelen Grafiske symboler beregnet til m rkning af medicinske produkter Symbole graficzne do oznaczania sprz...

Страница 2: ...mstillingsdato Graphical Symbols for Medical Device Labeling Grafische Symbole zur Beschriftung von Medizinprodukten Symboles graphiques pour l tiquetage des dispositifs m dicaux S mbolos gr ficos uti...

Страница 3: ...nificada Anv nd inte produkten om f rpackningen r skadad Gebruik het product niet als de verpakking beschadigd is M ikke anvendes hvis pakningen er beskadiget Stent post dilatation limit Nachdilatatio...

Страница 4: ...erolimus Eluting Coronary Stent System is contraindicated for use in Patients who cannot tolerate including allergy or hypersensitivity to procedural anticoagulation or the post procedural antiplatele...

Страница 5: ...sible for everolimus systemic concentrations to approach immunosuppressive levels temporarily especially in patients who also have hepatic insufficiency or who are taking drugs that inhibit CYP3A4 or...

Страница 6: ...the target lesion Note If removal of a stent system is required prior to deployment ensure that the guiding catheter is coaxially positioned relative to the stent delivery system and cautiously withd...

Страница 7: ...days None None None None Clinical Follow up 30 180 240 270 days 1 to 5 years 30 180 270 days 1 to 3 years 30 days 240 days 1 to 3 years 30 180 days 1 to 3 years 30 180 days 1 to 3 years Angiographic...

Страница 8: ...e treatment of patients with de novo coronary artery lesions XIENCE V India is a prospective open label multi center observational single arm registry to evaluate XIENCE V EECSS s continued safety and...

Страница 9: ...lysis of the following pre and post market trials Pre market SPIRIT II SPIRIT III SPIRIT IV Post market SPIRIT V SPIRIT Women XIENCE V USA XIENCE V India Table 10 3 1 Stent Thrombosis ARC Definite Pro...

Страница 10: ...ei L sionen der Koronararterie chronisch vollst ndig verschlossener Koronararterienl sionen definiert als L sion der Koronararterie mit TIMI Blutfluss 0 f r mehr als 3 Monate und L sionen der Bifurkat...

Страница 11: ...nicht klinischen Tests reicht das vom Produkt verursachte Bildartefakt bei Bildgebung mit einer Gradientenecho oder Spin Echo Pulssequenz und einem 3T MRT System etwa 6 mm ber die XIENCE Sierra Stent...

Страница 12: ...Austrittskerbe des F hrungsdrahts flie t Hinweis Die Manipulation des Stents beim Sp len des F hrungsdrahtlumens vermeiden da dadurch die Setzung des Stents am Ballon beeintr chtigt werden kann 9 3 3...

Страница 13: ...vollst ndiger Kontakt zur Gef wand vorliegt kann ein gr erer Ballon verwendet werden um den Stent weiter aufzudehnen Der Stent kann mithilfe eines d nnen nicht berdehnbaren Hochdruck Ballonkatheters...

Страница 14: ...0 30 0 53 158 0 20 0 40 52 Sp ter Verlust im Segment mm 0 14 0 39 343 0 26 0 46 158 0 16 0 41 52 Bin re Restenose im Stent 2 3 8 343 5 7 9 158 3 8 2 52 Bin re Restenose im Segment 4 7 16 344 8 9 14 15...

Страница 15: ...terien XIENCE V Indien ist ein prospektives multizentrisches einarmiges Open Label Beobachtungsregister zur Beurteilung der fortgesetzten Sicherheit und Wirksamkeit des XIENCE V EECSS w hrend der komm...

Страница 16: ...PT Unterbrechung Abbruch Die Sicherheit und Wirksamkeit sowie niedrige Stentthromboseraten ST Raten der XIENCE Produktreihe von Stents konnten in verschiedenen Studien mit Hoch und Standardrisikopatie...

Страница 17: ...situant l int rieur de petits vaisseaux coronaires des l sions pour lesquelles un traitement entra ne l emprisonnement des branches lat rales l sions avec une branche lat rale de diam tre 2 mm ou une...

Страница 18: ...t compatible avec l IRM sous conditions dans des configurations uniques et avec chevauchements d une longueur maximale de 71 mm Un patient portant ce dispositif peut passer un examen IRM dans les cond...

Страница 19: ...nflage Ballonnet d angioplastie pour pr dilatation de taille appropri e Ballonnet d angioplastie non compliant pour post dilatation de taille appropri e Robinet trois voies Dispositif de rotation Anti...

Страница 20: ...les bandes des marqueurs du ballonnet de la deuxi me endoproth se XIENCE Sierra doivent tre plac es l int rieur de l endoproth se d ploy e avant de proc der au d ploiement 4 V rifier nouveau la posit...

Страница 21: ...4 158 9 6 5 52 Remarques Les donn es correspondent la moyenne mm ET ou n N N repr sente le nombre total de patients M repr sente le nombre total de l sions Les essais SPIRIT III et SPIRIT Small Vessel...

Страница 22: ...ble RLC induites par isch mie Les essais SPIRIT Small Vessel et SPIRIT PRIME ont utilis la d finition de la RLC cliniquement justifi e plut t que celle de la RLC induite par isch mie L chec du vaissea...

Страница 23: ...march XIENCE V USA Phase I 1 an SPIRIT V tude bras unique XIENCE V India 1 an 2 ans 1 an 2 ans XIENCE V N 8040 XIENCE V N 2663 XIENCE V N 2663 XIENCE V N 990 XIENCE V N 990 chec de la l sion cible TL...

Страница 24: ...s sur 2 ans N 11 219 Interruption du double traitement antiplaquettaire 30 jours Interruption du double traitement antiplaquettaire 30 jours 730 jours Aucune interruption du double traitement antiplaq...

Страница 25: ...tratamiento de pacientes que presenten reestenosis del stent en lesiones de una arteria coronaria lesiones cr nicas en una arteria coronaria con oclusi n total definidas como lesiones en una arteria...

Страница 26: ...cuenta las posibles interacciones con f rmacos tanto sist micas como locales en la pared del vaso a la hora de decidir si se coloca el stent XIENCE Sierra a un paciente que est tomando alg n f rmaco...

Страница 27: ...e el stent se desplazara del bal n Nota Si se observa aire en el cuerpo repita los pasos 3 a 5 del apartado 9 3 3 Preparaci n del sistema dispensador para evitar la expansi n irregular del stent 9 4 P...

Страница 28: ...PRIME Por consiguiente en este apartado se resumen los datos de los ensayos cl nicos para XIENCE V y XIENCE PRIME 10 1 Ensayos cl nicos previos a la comercializaci n Los principales resultados de segu...

Страница 29: ...0 1 104 Muerte de origen card aco 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 IM 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Muerte de orig...

Страница 30: ...e de origen card aco el IM atribuido al vaso tratado y la RLT inducida por isquemia En SPIRIT SV y PRIME se utiliz la definici n de RLT cl nicamente indicada en lugar de la RLT inducida por isquemia E...

Страница 31: ...guno Ninguno Ninguno Ninguno Tabla 10 2 2 Resultados cl nicos principales de los ensayos de la familia SPIRIT y XIENCE V posteriores a la comercializaci n XIENCE V USA Fase I 1 a o SPIRIT V SAS XIENCE...

Страница 32: ...e 2 a os N 11 219 DAPT interrumpido 30 d as DAPT interrumpido 30 730 d as Sin interrupci n de DAPT Posterior TS seg prob 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 PRESENTACI N Est ril este dispositiv...

Страница 33: ...5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Per il trattamento di pazienti che si presentano con ristenosi in stent in lesioni dell arteria coronaria lesioni croniche del...

Страница 34: ...E Sierra se rilevato con una sequenza d impulsi gradient echo o spin echo 5 8 Interazioni tra farmaci Vedere la sezione 6 1 Interazioni con farmaci o altre sostanze Alcuni farmaci influiscono sul meta...

Страница 35: ...a al rubinetto a tre vie collegarlo a alla porta di gonfiaggio del prodotto Non piegare l ipotubo del prodotto durante il collegamento al dispositivo di gonfiaggio siringa 3 Con la punta rivolta verso...

Страница 36: ...li degli altri sistemi di stent Abbott Vascular a scambio rapido RX e degli altri cateteri per dilatazione coronarica Se paragonato a XIENCE V EECSS ed a XIENCE PRIME EECSS XIENCE Sierra EECSS ha gli...

Страница 37: ...1 0 1 104 Morte cardiaca 0 4 10 2 416 0 4 5 1 195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 IM 1 9 45 2 416 3 1 37 1 195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Morte cardiaca o IM...

Страница 38: ...ardiaca IM attribuito al vaso target e TLR rivascolarizzazione della lesione target causata da ischemia SPIRIT SV e PRIME hanno impiegato la definizione di TLR indicata clinicamente anzich quella di T...

Страница 39: ...gli studi delle famiglie SPIRIT e XIENCE V post commercializzazione XIENCE V USA Fase I 1 anno SPIRIT V SAS XIENCE V India 1 anno 2 anni 1 anno 2 anni XIENCE V N 8 040 XIENCE V N 2 663 XIENCE V N 2 66...

Страница 40: ...N 11 219 DAPT interrotta 30 giorni DAPT interrotta da 30 giorni a 730 giorni Nessuna interruzione della DAPT Successiva ST acc prob 2 51 12 478 0 38 13 3 445 0 66 44 6 648 11 0 MODALIT DI FORNITURA S...

Страница 41: ...ento de doentes com uma reestenose dentro do stent nas les es da art ria coron ria les es cr nicas da art ria coron ria com oclus o total definidas como les es da art ria coron ria com um fluxo TIMI d...

Страница 42: ...ca quando administrado por via oral juntamente com ciclosporina CsA N o foram efetuados estudos formais sobre a intera o com medicamentos com o XIENCE Sierra por causa da exposi o limitada ao everolim...

Страница 43: ...to se as bolhas persistirem 7 Se tiver utilizado uma seringa ligar um dispositivo de insufla o preparado torneira 8 Abrir a torneira para o sistema de entrega 9 Manter na posi o neutra Nota N o induzi...

Страница 44: ...um desempenho do SSCEE XIENCE Sierra semelhante ao desempenho dos stents XIENCE V e XIENCE PRIME Os dados dos ensaios cl nicos dos stents XIENCE V e XIENCE PRIME s o assim resumidos nesta sec o 10 1...

Страница 45: ...3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 Morte Card aca 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 EM 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5...

Страница 46: ...aca EM atribu do ao vaso alvo e TLR causada por isquemia Os ensaios cl nicos SPIRIT SV e PRIME utilizaram a defini o de TLR clinicamente indicada em vez da defini o de TLR causada por isquemia TVF in...

Страница 47: ...nt sem braquiterapia pr via m ximo de 4 stents com elui o de everolimus SEE planeados De acordo com a norma de cuidados do centro Tamanho da les o Sem restri es angiogr ficas RVD 2 25 4 0 mm Comprimen...

Страница 48: ...et ria Dupla DAPT A gama de stents XIENCE demonstrou seguran a e efic cia em m ltiplos ensaios realizados com doentes reais padr o de baixo risco e de risco alargado e demonstraram baixas taxas de tro...

Страница 49: ...23 mm 28 mm 33 mm eller 38 mm med en referensk rldiameter p 2 00 mm och 4 25 mm 3 0 KONTRAINDIKATIONER XIENCE Sierra everolimusavgivande kransk rlsstentsystem r kontraindicerat f r anv ndning till Pat...

Страница 50: ...pr vningar F r patienter som f r flera XIENCE Sierra enheter samtidigt kan det dock vara m jligt att systemiska koncentrationer av everolimus tillf lligt n rmar sig immunsuppressiva niv er s rskilt ho...

Страница 51: ...ska inte utf ras om stenten inte r korrekt placerad i m llesionen Obs Om avl gsnande av ett stentsystem kr vs f re placering m ste man s kerst lla att guidekatetern r koaxialt placerad i f rh llande...

Страница 52: ...00 XIENCE PRIME Totalt 100 XIENCE PRIME Behandling Upp till tv de novo lesioner i olika epikardiella k rl Upp till tre de novo lesioner h gst tv lesioner per epikardiellt k rl Upp till tv de novo lesi...

Страница 53: ...h TVR p grund av ischemi vilket anv ndes f r SPIRIT II SPIRIT III och SPIRIT IV MACE inkluderar hj rtd d MI och TLR p grund av ischemi Tabell 10 1 4 SPIRIT sortimentet av kliniska pr vningar huvudsakl...

Страница 54: ...XIENCE V USA l ngsiktig uppf ljningskohort XIENCE V USA AV DAPT kohort SPIRIT V SAS XIENCE V India Studietyp design Multicenter Prospektiv Enkelarmad Multicenter Prospektiv Enkelarmad Multicenter Rand...

Страница 55: ...DAPT avbrott Sortimentet med XIENCE stentar har uppvisat s kerhet och effekt i flera pr vningar med verkliga patienter med standardrisk l g risk och ut kad risk och uppvisat l ga stenttrombosfrekvens...

Страница 56: ...15 mm 18 mm 23 mm 28 mm 33 mm of 38 mm met een referentievatdiameter van 2 00 mm en 4 25 mm 3 0 CONTRA INDICATIES Het XIENCE Sierra everolimus eluerend coronair stentsysteem is gecontra indiceerd voo...

Страница 57: ...everolimus kan worden be nvloed door geneesmiddelen die ook van deze routes gebruikmaken Everolimus blijkt ook de klaring van sommige receptplichtige geneesmiddelen te verminderen als het middel oraal...

Страница 58: ...ysteem 1 Maak een vulinstrument spuit gereed met verdund contrastmiddel 2 Bevestig een vulinstrument spuit aan de stopkraan bevestig het aan de vulpoort van het product Buig de binnenste slang van het...

Страница 59: ...EECSS XIENCE Xpedition EECSS en XIENCE Alpine EECSS De XIENCE Sierra EECSS verschilt alleen wat betreft het stentplaatsingssysteem van de XIENCE Alpine EECSS Het stentplaatsingssysteem van de XIENCE S...

Страница 60: ...1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 Hartdood 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 MI 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 39...

Страница 61: ...CE V India is een prospectief open label multicenter observationeel register met n groep waarin de veiligheid en werkzaamheid van de XIENCE V EECSS op lange termijn wordt ge valueerd tijdens commercie...

Страница 62: ...daard of laag risico en met hoger risico in alledaagse omstandigheden de aantallen stenttrombose waren laag Dit is inclusief pati nten bij wie de behandeling met twee trombocytenaggregatieremmers DAPT...

Страница 63: ...mm 33 mm eller 38 mm med en referencekardiameter p 2 00 mm og 4 25 mm 3 0 KONTRAINDIKATIONER XIENCE Sierra Everolimus eluerende koronarstentsystem er kontraindiceret til brug hos Patienter der ikke ka...

Страница 64: ...ke observeret i de kliniske unders gelser SPIRIT og XIENCE stent familien Det er dog muligt at systemiske koncentrationer af everolimus hos patienter som modtager flere XIENCE Sierra anordninger samti...

Страница 65: ...se eller l srivelse af stenten Fasthold guidewirens placering p tv rs af l sionen og fjern fremf ringssystemet og guidingkatetret som en enkelt enhed 7 F r fremf ringssystemet frem over guidewiren til...

Страница 66: ...10 1 4 viser unders gelsernes design angiografiske resultater for unders gelser der kr vede angiografisk opf lgning og v sentlige kliniske resultater henholdsvis efter 1 r og fra seneste opf lgning T...

Страница 67: ...revet TLR 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 Isk misk drevet TVR ikke TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Stenttro...

Страница 68: ...d de novo koronararteriel sioner XIENCE V India er en prospektiv ben observerende multicenterregisterunders gelse med n arm til evaluering af den fortsatte sikkerhed og effektivitet for XIENCE V EECSS...

Страница 69: ...siko lav risiko og udvidet risiko og udviste lave rater for stenttrombose ST Dette omfatter patienter der enten holdt op med eller afbr d dobbelt antitrombocytbehandling DAPT efter 1 m ned efter impla...

Страница 70: ...42 mm 0 056 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5 F 1 42 mm 0 056 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5 F 1 42 mm 0 056 12 1216 16 1621 86 F 9 5 2 0 Everolimus XIENCE Sierra de nov...

Страница 71: ...s XIENCE Sierra everolimus XIENCE Sierra 5 9 everolimus XIENCE Sierra SPIRIT XIENCE XIENCE Sierra everolimus CYP3A4 P 5 10 everolimus everolimus XIENCE Sierra SPIRIT XIENCE everolimus 1 Certican 2015...

Страница 72: ...IENCE XIENCE PCI PCI PC 9 0 9 1 1 2 3 4 EECSS XIENCE Sierra EECSS XIENCE Sierra 9 2 2 3 10 20 cc 1 000 u 500 cc HepNS 2 44 mm 0 096 0 36 mm 0 014 x 175 cm 1 1 9 3 9 3 1 1 RX 2 9 3 2 1 HepNS 9 3 3 1 2...

Страница 73: ...SS XIENCE Sierra EECSS XIENCE V XIENCE PRIME XIENCE Xpedition XIENCE Alpine EECSS XIENCE Sierra EECSS XIENCE PRIME XIENCE Xpedition XIENCE Alpine EECSS XIENCE Sierra EECSS XIENCE Alpine XIENCE Sierra...

Страница 74: ...novo RVD 2 5 3 75 mm 28 mm RVD 2 5 4 25 mm2 28 mm RVD 2 25 2 50 mm 28 mm RVD 2 25 4 25 mm 22 mm XIENCE PRIME CS RVD 2 25 4 25 mm 22 mm XIENCE PRIME LL RVD 2 5 4 25 mm 22 mm 32 mm 240 1 TLR TLF 1 TLF 1...

Страница 75: ...9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 2 2 54 2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104 TLR 2 3 56...

Страница 76: ...0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9 54...

Страница 77: ...VR 7 04 185 2627 10 34 265 2562 ARC 7 2 545 7522 4 23 111 2627 5 74 147 2562 1 9 19 986 2 8 26 942 3 3 249 7505 TLR 4 6 349 7522 1 90 50 2627 3 04 78 2562 1 2 12 986 1 5 14 942 TVR TLR 2 3 176 7522 1...

Страница 78: ...SPIRIT IV SPIRIT V SPIRIT XIENCE V XIENCE V 10 3 1 ARC DAPT 730 7 7 2 N 11 219 DAPT 30 DAPT 30 730 DAPT ST 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 1 Everolimus XIENCE Sierra 25 C 77 F 15 30 C 59 86...

Страница 79: ...z stupca v Eur pskom spolo enstve Outer diameter rednica zewn trzna K ls tm r Vn j pr m r D ap Vonkaj priemer Inner diameter rednica wewn trzna Bels tm r Vnit n pr m r ap Vn torn priemer Stent length...

Страница 80: ...18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 u pacjent w u kt rych wyst pi a restenoza w stencie za o onym w zw onym odcinku t tnicy wie cowej przewlek e zmiany charakteryzuj ce...

Страница 81: ...a z zastosowaniem sekwencji echa gradientowego lub sekwencji impuls w echa spinowego i systemu obrazowania rezonansem magnetycznym o indukcyjno ci pola magnetycznego 3 T 5 8 Interakcje z lekami Patrz...

Страница 82: ...i zast pi go innym Post powa zgodnie z procedur zwracania produkt w w przypadku nieu ytego urz dzenia 9 3 2 P ukanie kana u prowadnika 1 Kana prowadnika przep ukiwa roztworem HepNS dop ki p yn nie za...

Страница 83: ...ak w przypadku innych system w stentu RX firmy Abbott Vascular i wie cowych cewnik w rozszerzaj cych W por wnaniu do wyrob w XIENCE V EECSS i XIENCE PRIME EECSS system XIENCE Sierra EECSS posiada iden...

Страница 84: ...2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104 TLR spowodowana niedokrwieniem 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR spowodowana niedokr...

Страница 85: ...iany docelowej TLR z powodu niedokrwienia W badaniach SPIRIT SV i PRIME stosowano definicj ponownej rewaskularyzacji stentowanego odcinka TLR ze wskaza klinicznych a nie TLR spowodowanej niedokrwienie...

Страница 86: ...us EES Zgodnie ze standardami obowi zuj cymi w plac wce opieki Wielko zmiany Brak ogranicze dotycz cych angiografii RVD 2 25 4 0 mm D ugo 28 mm na podstawie oceny wizualnej Brak ogranicze dotycz cych...

Страница 87: ...IENCE wykaza a bezpiecze stwo i skuteczno stosowania w rzeczywistej praktyce medycznej co stwierdzono na podstawie wielu r nych bada klinicznych u pacjent w o standardowym niskim ryzyku oraz pacjent w...

Страница 88: ...zi hossznak minden esetben r videbbnek kell lennie a n vleges sztenthosszn l 8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm vagy 38 mm 2 00 mm s 4 25 mm k z tti referenciav red ny tm r mellett 3 0 ELLENJAV...

Страница 89: ...zott m rt k Ez rt amikor a XIENCE Sierra sztent be ltet s re vonatkoz d nt st m rlegelik egy olyan beteg eset n aki az everolimusszal ismerten k lcs nhat sba l p gy gyszert szed vagy ha egy XIENCE Sie...

Страница 90: ...zi jellemz i alapj n kell d nteni Ha el t g t st v geznek korl tozni kell a PTCA ballonnal t rt n el t g t s hossz t hogy elker lhet legyen a XIENCE Sierra sztent ter let n k v li rs r l s 3 Hossz l z...

Страница 91: ...sg lattal llap tott k meg A SPIRIT III RCT volt a legfontosabb randomiz lt klinikai vizsg lat RCT amely meg llap totta a XIENCE V sztent TAXUS Express sztenthez TAXUS sztent viszony tott egyen rt k s...

Страница 92: ...9 1 0 1 104 Sz vhal l 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 MI 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Sz vhal l vagy MI 2 2 54 2...

Страница 93: ...jes tm ny nek tov bbi felm r se volt de novo sz vkoszor r l zi kkal rendelkez betegek kezel s ben A XIENCE V India egy prospekt v ny lt multicentrikus megfigyel ses egykaros regiszter a XIENCE V EECSS...

Страница 94: ...zsg lat sor n bizony totta biztons goss g t s hat soss g g t tov bb ezen eszk z k mellett a sztenttromb zis stent thrombosis ST el fordul si ar nya is alacsonynak bizonyult Ebbe beletartoznak azok a b...

Страница 95: ...rn ch art ri definovan jako l ze koron rn ch art ri s pr tokem TIMI 0 trvaj c d le ne 3 m s ce a l ze bifurkace koron rn art rie Ve v ech p padech mus b t d lka o et ovan l ze men ne nomin ln d lka st...

Страница 96: ...insuficienci funkce jater nebo kte u vaj l ky inhibuj c CYP3A4 nebo p glykoprotein Proto je zapot eb v novat pozornost pacient m u vaj c m jin imunosupresivn p pravky nebo pacient m ohro en m potla e...

Страница 97: ...pr vn um st n v c lov l zi nesm se prov st jeho expanze Pozn mka Pokud je nutn stent vyjmout je t p ed rozvinut m ujist te se e je vodic katetr um st n v jedn linii se zav d c m syst mem stentu a syst...

Страница 98: ...press kontrola 1 2301 Celkem 150 XIENCE V 2 25 mm Celkem 400 XIENCE PRIME Celkem 100 XIENCE PRIME L ba A dv l ze de novo v r zn ch epikardi ln ch c v ch A t i l ze de novo maxim ln dv l ze na epikardi...

Страница 99: ...55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 Ischemi vyvolan TVR mimo c lovou l zi 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromb za stentu Definice...

Страница 100: ...sla v t to tabulce odpov daj po tu pacient Pacient je zapo t n pro ka dou ud lost a ka d asov obdob pouze jedenkr t Do daj v ech hodnocen se po taj i hodnoty za okno tolerance 28 dn K TLF pat srde n...

Страница 101: ...edchoz brachyterapie max 4 pl novan EES Podle standardn p e pracovi t Velikost l ze Bez angiografick ch omezen RVD 2 25 4 0 mm D lka 28 mm podle vizu ln ho odhadu Bez angiografick ch omezen Prim rn c...

Страница 102: ...K TLF pat srde n smrt infarkt myokardu p isouzen c lov c v podle definice protokolu a klinicky indikovan TLR 10 3 Anal za hrnu klinick ch hodnocen pro tromb zu stentu po p eru en ukon en l by DAPT ad...

Страница 103: ...ir Operasyonel antikoag lasyon veya operasyon sonras antiplatelet rejimine kar alerji veya a r duyarl l k da dahil olmak zere tolere edemeyen hastalar Everolimus veya yap sal olarak ili kili bile ikle...

Страница 104: ...risi klinik ara t rmalarda ba kl k sistemi bask lanmas g zlemlenmemi tir Ancak ayn anda birden fazla XIENCE Sierra cihaz uygulanan hastalar i in zellikle ayn zamanda karaci er yetmezli i olan ya da CY...

Страница 105: ...erhangi bir anda ola and bir diren hissedilecek olursa k lavuz kateter ve stent yerle tirme sisteminin tamam tek bir nite olarak kart lmal d r Bu i lem floroskopiyle do rudan g r nt leme alt nda yap l...

Страница 106: ...k Yok Yok Klinik Takip 30 180 240 270 g n 1 5 y l 30 180 270 g n 1 3 y l 30 g n 240 g n 1 3 y l 30 180 g n 1 3 y l 30 180 g n 1 3 y l Anjiyografik Takip 240 g n N 564 Yok 240 g n N 69 Yok Yok 1 TAXUS...

Страница 107: ...fi de novo koroner arter lezyonlar olan hastalar n tedavisinde XIENCE V EECSS performans n de erlendirmeye devam etmektir XIENCE V Hindistan Hindistan da ger e e uygun senaryolarda ticari kullan m s r...

Страница 108: ...ger ek hasta al malar nda g venli ini ve etkinli ini g stermi ve d k stent trombozu ST oranlar g stermi tir Buna koroner stent implantasyonunun 1 ay ndan sonra ikili antitromboz tedavisini DAPT b raka...

Страница 109: ...3 5 4 0 12 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Vo v etk ch pr padoch by d ka o etrovanej l zie mala by men ia ako menovit d ka stentu 8 mm 12 m...

Страница 110: ...inn l tka stentu XIENCE Sierra je imunosupres vum V klinick ch sk aniach typov ho radu stentov SPIRIT a XIENCE nebola pozorovan imunosupresia U pacientov ktor m bolo naraz implantovan ch nieko ko ste...

Страница 111: ...dzaciemu syst mu udr ujte neutr lny tlak Oto n hemostatick ventil otvorte naj ir ie ako sa d 5 Zav dzac syst m nasa te sp na proxim lnu as vodiaceho dr tu udr iavajte pri tom polohu vodiaceho dr tu po...

Страница 112: ...jadra stentov ho syst mu XIENCE PRIME a XIENCE PRIME LL pri ktorom sa preuk zala bezpe nos a innos stentov XIENCE PRIME a XIENCE PRIME LL Tabu ky 10 1 1 a 10 1 4 predstavuj koncepcie sk ania angiogra...

Страница 113: ...2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR sp soben isch miou nie TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromb za stentu...

Страница 114: ...India je prospekt vny otvoren multicentrick pozorovac jednovetvov register na hodnotenie trvalej bezpe nosti a innosti XIENCE V EECSS pri komer nom pou it v re lnych podmienkach v Indii V tabulk ch 1...

Страница 115: ...on en du lnej antiagrega nej terapie DAPT Typov rad stentov XIENCE preuk zal bezpe nos a innos vo viacer ch sk aniach s be n mi resp n zkorizikov mi a vysokorizikov mi skuto n mi pacientmi a pouk zal...

Страница 116: ...ean Valtuutettu edustaja Euroopan yhteis ss Outer diameter Diametru exterior Ulkol pimitta Inner diameter Diametru interior Sis l pimitta Stent length Lungimea stentului Stentin pituus Guiding cathete...

Страница 117: ...42 mm 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5F 0 056 1 42 mm 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5F 0 056 1 42 mm 12 1216 16 1621 86 F 9 5 2 0 XIENCE Sierra everolimus de novo 12 jai...

Страница 118: ...mus XIENCE Sierra 5 9 Everolimus a XIENCE Sierra SPIRIT XIENCE a XIENCE Sierra everolimus CYP3A4 5 10 everolimus everolimus a XIENCE Sierra SPIRIT XIENCE everolimus 6 0 6 1 Everolimus P4503A4 CYP3A4 P...

Страница 119: ...r 2014 Votubia 2014 Afinitor 2015 Zortress 2015 www MHRA gov uk www ema europa eu www fda gov PCI PCI 9 0 9 1 1 2 3 4 XIENCE Sierra EECSS XIENCE Sierra EECSS 9 2 2 3 10 20 cc 1000 u 500 cc HepNS 0 096...

Страница 120: ...NCE V TAXUS Express TAXUS SPIRIT IV XIENCE V TAXUS Express TAXUS de novo 28 mm 2 5 mm 4 25 mm SPIRIT IV XIENCE V TAXUS Express SPIRIT SV XIENCE V 2 25 mm SPIRIT PRIME XIENCE PRIME XIENCE PRIME LL XIEN...

Страница 121: ...33 319 8 1 11 136 4 5 18 399 7 7 8 104 1 0 25 2416 1 3 15 1195 1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3...

Страница 122: ...73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9 54 605 12 9 37 28...

Страница 123: ...T SPIRIT V SAS XIENCE V 8040 4663 868 2663 977 18 de novo 4 everolimus 2 25 4 0 mm 28 mm ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3...

Страница 124: ...1 45 2627 2 97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81 60 7380...

Страница 125: ...2 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 n toate cazurile lungimea leziunii tratate ar trebui s fie mai mic dec t lungimea nominal a stentului 8 mm...

Страница 126: ...medical atunci c nd a fost administrat pe cale oral mpreun cu ciclosporina CsA Nu au fost realizate studii formale privind interac iunile medicamentoase cu stentul XIENCE Sierra din cauza expunerii l...

Страница 127: ...de la 3 la 5 p n c nd este eliminat tot aerul Nu utiliza i produsul dac bulele de aer persist 7 Dac a fost utilizat o sering ata a i la robinet un dispozitiv de umflare preg tit 8 Deschide i robinetul...

Страница 128: ...XIENCE PRIME De aceea datele provenite din studiile clinice pentru XIENCE V i XIENCE PRIME sunt prezentate pe scurt n aceast sec iune 10 1 Studii clinice pre comercializare Siguran a i eficacitatea pr...

Страница 129: ...2 5 10 399 2 9 3 104 TVR determinat de ischemie non TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromboz de stent ARC stabilit probabil 0 29 7 2391 1 10 13 1181 0 9...

Страница 130: ...acela de a continua evaluarea performan elor XIENCE V EECSS n tratarea pacien ilor cu leziuni de novo ale arterelor coronare XIENCE V India este un registru prospectiv deschis multicentric observa io...

Страница 131: ...stenturi XIENCE a demonstrat siguran i eficacitate n multiple studii clinice cu pacien i reali cu riscuri standard sc zute i extinse i a demonstrat rate de tromboz de stent ST sc zute Aceasta include...

Страница 132: ...16 16 1621 87 3 25 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 86 Fr...

Страница 133: ...Sierra 3 5 8 6 1 P4503A4 CYP3A4 P PgP XIENCE Sierra XIENCE Sierra XIENCE Sierra 1 Certican 2015 Afinitor 2014 Votubia 2014 Afinitor 2015 Zortress 2015 www MHRA gov uk www ema europa eu www fda gov 5...

Страница 134: ...American College of Cardiology ACC American Heart Association AHA Society for Cardiovascular Angiography and Interventions SCAI ESC XIENCE DAPT DAPT XIENCE DAPT XIENCE 9 0 9 1 1 2 3 4 XIENCE Sierra X...

Страница 135: ...XIENCE Xpedition XIENCE Alpine XIENCE Sierra XIENCE Alpine XIENCE Sierra RX Abbott Vascular XIENCE V XIENCE PRIME XIENCE Sierra XIENCE Sierra 28 XIENCE Sierra XIENCE PRIME XIENCE V XIENCE Sierra XIENC...

Страница 136: ...NCE PRIME LL RVD 2 5 4 25 22 32 240 1 TLR TLF 1 TLF 1 TLF 1 TVF 270 30 180 240 270 1 5 30 180 270 1 3 30 240 1 3 30 180 1 3 30 180 1 3 240 N 564 240 N 69 1 TAXUS 1 1 TAXUS Libert 2 RVD 2 5 3 75 3 5 TA...

Страница 137: ...8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 2 2 54 2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104...

Страница 138: ...399 0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8...

Страница 139: ...V USA AV DAPT SPIRIT V SAS XIENCE V India 8040 4663 868 2663 977 18 de novo 4 2 25 4 0 28 ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3...

Страница 140: ...97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81 60 7380 0 65 17 260...

Страница 141: ...entin l pimitta mm Stentin pituus mm L keannos g 3 5 4 0 8 53 3 5 4 0 12 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Kaikissa tapauksissa hoidetun leesi...

Страница 142: ...suudet voivat heill l hesty v liaikaisesti immunosuppressiivisia arvoja erityisesti potilailla joilla on my s maksan vajaatoimintaa tai jotka k ytt v t CYP3A4 sytokromia tai P glykoproteiinia est vi l...

Страница 143: ...ntti tulee ulos ohjainkatetrista l vie j rjestelm v kisin eteenp in Vastus saattaa olla merkkin ongelmasta ja liiallisen voiman k ytt saattaa vaurioittaa stentti ja saada sen siirtym n paikaltaan Pid...

Страница 144: ...eri Kliininen SPIRIT PRIME tutkimus P kokojen rekisteri Pitk n leesion rekisteri Tutkimustyyppi suunnitelma Monikeskuksinen Satunnaistettu Yks issokkoutettu Aktiivikontrolloitu Monikeskuksinen Satunna...

Страница 145: ...miaper inen kohdeleesion uudelleenahtauma 2 3 prosenttia 56 2 416 4 6 prosenttia 55 1 195 3 4 prosenttia 22 655 5 6 prosenttia 18 319 5 1 prosenttia 7 136 2 5 prosenttia 10 399 2 9 prosenttia 3 104 Is...

Страница 146: ...hokkuutta todellisessa k yt ss sen j lkeen kun se tuli markkinoille Yhdysvalloissa ja jossa my s tuetaan FDA n DAPT koskevaa aloitetta Yksiryhm isen SPIRIT V tutkimuksen tavoitteena oli jatkaa XIENCE...

Страница 147: ...F sis lt syd nkuoleman kohdesuoneen liittyv n syd ninfarktin tutkimussuunnitelman m rityksen mukainen ja kliinisesti indisoidun TLR n 10 3 Kliinisten tutkimusten yhdistelm analyysi stentin tromboosist...

Страница 148: ...vnik v Evropski skupnosti Outer diameter Ytre diameter V lisdiameeter r jais diametrs I orinis skersmuo Zunanji premer Inner diameter Indre diameter Sisediameeter Iek jais diametrs Vidinis skersmuo No...

Страница 149: ...verolimuseluerende koronarstentsystem er kontraindisert for bruk hos Pasienter som ikke kan tolerere inkludert allergi eller overf lsomhet for prosedyrerelatert antikoagulasjon eller blodplatehemmende...

Страница 150: ...rsiktighet med pasienter som tar andre immunsuppressive midler eller som er utsatt for immunsuppresjon 5 10 Potensiale for lipid kning Oral bruk av everolimus hos nyretransplanterte pasienter og pasie...

Страница 151: ...u p se at ledekateteret er plassert koaksialt i forhold til stentutleggingssystemet og trekke stentutleggingssystemet forsiktig tilbake i ledekateteret Hvis unormal motstand merkes n r stenten trekkes...

Страница 152: ...180 240 270 dager 1 til 5 r 30 180 270 dager 1 til 3 r 30 dager 240 dager 1 til 3 r 30 180 dager 1 til 3 r 30 180 dager 1 til 3 r Angiografisk oppf lging 240 dager N 564 Ingen 240 dager N 69 Ingen Ing...

Страница 153: ...joner XIENCE V India er en prospektiv pen flersenter observasjonsstudie med n enkelt gruppe for evaluere kontinuerlig sikkerhet og effekt av XIENCE V EECSS ved kommersiell reell bruk i India Tabell 10...

Страница 154: ...se av kliniske studier for stenttrombose etter DAPT avbrudd seponering XIENCE familien av stenter har vist sikkerhet og effekt i flere studier hos reelle pasienter med standard lav risiko og utvidet r...

Страница 155: ...2 00 mm kuni 4 25 mm 3 0 VASTUN IDUSTUSED Everoliimust elueeriv p rgarteri stendis steem XIENCE Sierra on vastun idustatud j rgmistel juhtudel Patsiendid kes allergia v i litundlikkuse t ttu ei talu...

Страница 156: ...uluvate patsientide v i muid immunosupressante v tvate patsientide korral olla ettevaatlik 5 10 Lipiidide hulga t usu potentsiaal Suukaudset everoliimust kasutatakse neerusiirdamise korral ja kaugelea...

Страница 157: ...uleb enne stendi paigaldamist eemaldada paigutage juhtkateeter stendi sisestuss steemiga koaksiaalselt ning t mmake stendi sisestuss steem ettevaatlikult juhtkateetrisse Kui tunnete stendi juhtkateetr...

Страница 158: ...e novo kahjustust erinevates epikardiaalsetes veresoontes Kuni kolm de novo kahjustust kuni kaks kahjustust igas epikardiaalses veresoones Kuni kaks de novo kahjustust erinevates epikardiaalsetes vere...

Страница 159: ...4 Stenditromboos ARC kindel t en oline 0 29 7 2391 1 10 13 1181 0 9 6 650 0 6 2 316 1 5 2 136 0 5 2 399 0 0 0 104 ARC kindel 0 3 6 2385 0 8 10 1183 0 8 5 650 0 3 1 317 0 7 1 138 0 5 2 399 0 0 0 104 M...

Страница 160: ...p rgarteri kahjustustega patsientide ravis XIENCE V India on prospektiivne avatud mitmekeskuseline vaatluslik he haruga registriuuring et hinnata stendi XIENCE V EECSS j tkuvat ohutust ja t husust re...

Страница 161: ...as Stendiperekonna XIENCE ohutus ja t husus on ilmnenud mitmes standardse madala riskiga ja suurema riskiga reaalsete patsientide uuringus Ilmnenud on ka stenditromboosi ST madal esinemissagedus See h...

Страница 162: ...sinsvada diametram j b t 2 00 mm un 4 25 mm 3 0 KONTRINDIK CIJAS XIENCE Sierra everol mu izdalo a koron r stenta sist ma ir kontrindic ta pacientiem kam ir nepanes ba aler ija vai pastiprin ta jut ba...

Страница 163: ...amu everol mu pacientiem kam ir p rst d ta niere vai progres jo a nieru nu karcinoma konstat ja saist bu ar paaugstin tu holester na un triglicer du l meni serum da os gad jumos vi i bija j rst Ietekm...

Страница 164: ...et stenta pieg des sist mu vad t jkatetr Ja velkot stentu virzien uz vad t jkatetru rodas neparasta pretest ba stenta pieg des sist ma un vad t jkatetrs ir j izvelk abi kop Tas j veic ar tie as vizual...

Страница 165: ...IENCE V 2460 TAXUS Express kontrolgrupa 12301 Kop 150 2 25 mm XIENCE V Kop 400 XIENCE PRIME Kop 100 XIENCE PRIME rst ana L dz diviem de novo boj jumiem da dos epikarda asinsvados L dz trim de novo boj...

Страница 166: ...2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 I mijas ierosin ta TVT rpus TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Stenta tromboze...

Страница 167: ...cientus ar de novo koron r s art rijas boj jumiem XIENCE V India ir perspekt vs atkl ts daudzcentru nov ro anas vienas grupas re istrs lai nov rt tu XIENCE V EECSS ilglaic gu dro umu un efektivit ti k...

Страница 168: ...zos p t jumos gan standarta gan zema riska un papla in ta riska pacientiem re los apst k os k ar uzr d ja zemus stentu trombozes ST l me us Tas ietver pacientus kas piln b vai uz laiku p rtrauca du lo...

Страница 169: ...mm kai standartin s kraujagysl s skersmuo yra 2 00 mm ir 4 25 mm 3 0 KONTRAINDIKACIJOS XIENCE Sierra everolim i skirian io vainikin s arterijos stento sistema kontraindikuotina naudoti Pacientams kuri...

Страница 170: ...10 Galimas lipid padid jimas Per burn vartojamo everolimo skyrimas pacientams kuriems persodintas inkstas ir pa engusi inksto l steli karcinoma susij s su padid jusia cholesterolio ir triglicerid kon...

Страница 171: ...eikia i imti kaip vien prietais Tai darykite tiesiogiai steb dami fluoroskopu 8 U darykite besisukant hemostatin vo tuv Dabar stentas paruo tas i skleisti 9 5 I skleidimo proced ra D MESIO Stento vidi...

Страница 172: ...NCE V 2 460 TAXUS Express kontrol 1 2301 I viso 150 2 25 mm XIENCE V I viso 400 XIENCE PRIME I viso 100 XIENCE PRIME Gydymas Iki dviej de novo pa eidim skirtingose epikardin se kraujagysl se Iki trij...

Страница 173: ...4 136 2 0 8 399 4 8 5 104 I eminis TLR 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 I eminis TVR ne TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 39...

Страница 174: ...spektyvinis atviras daugiacentris steb jimo vienos grup s registras skirtas XIENCE V EECSS nuolatiniam saugumui ir veiksmingumui vertinti komerci kai naudojant realiomis s lygomis Indijoje 10 2 1 10 2...

Страница 175: ...dartin s ma os rizikos bei i pl stin s rizikos reali pacient tyrim buvo nustatytas XIENCE grup s stent saugumas ir veiksmingumas taip pat buvo nustatytas ma as stento tromboz s ST da nis Tai apima pac...

Страница 176: ...rih mora biti dol ina zdravljene lezije manj a od nazivne dol ine stenta 8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm ali 38 mm pri referen nem premeru ile med 2 00 mm in 4 25 mm 3 0 KONTRAINDIKACIJE Sist...

Страница 177: ...ki jemljejo zdravila ki zavirajo CYP3A4 ali P glikoprotein Zato je potrebna previdnost pri bolnikih ki jemljejo druge imunosupresive ali pri katerih obstaja tveganje za imunsko supresijo 5 10 Mo nost...

Страница 178: ...ti glejte razdelek 9 6 Postopek odstranjevanja Ozna evalca na balonu nakazujeta robove stenta in meje balona S irjenjem stenta ne smete za eti e stent ni ustrezno name en v ciljni leziji Opomba e je p...

Страница 179: ...le encev skupno 1 002 XIENCE V 668 kontrola TAXUS Express 334 skupno 3 690 XIENCE V 2 460 kontrola TAXUS Express 1 2301 skupno 150 2 25 mm XIENCE V skupno 400 XIENCE PRIME skupno 100 XIENCE PRIME Zdra...

Страница 180: ...4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromboza stenta po ARC definitivna verjetna 0 29 7 2391 1 10 13 1181 0 9 6 650 0 6 2 316 1 5 2 136 0 5 2 399 0 0 0 104 po ARC definitivn...

Страница 181: ...a Odpoved ciljne lezije TLF vklju uje sr no smrt miokardni infarkt pripisan ciljni ili in z ishemijo povzro eno revaskularizacijo ciljne lezije TLR tudiji SPIRIT SV in PRIME sta namesto z ishemijo pov...

Страница 182: ...1 leto SPIRIT V SAS XIENCE V India 1 leto 2 leti 1 leto 2 leti XIENCE V N 8040 XIENCE V N 2663 XIENCE V N 2663 XIENCE V N 990 XIENCE V N 990 Odpoved ciljne lezije TLF po ARC 9 4 707 7522 5 25 138 2627...

Страница 183: ...rezultati N 11 219 DAPT prekinjena v 30 dneh DAPT prekinjena v 30 730 dneh Brez prekinitve DAPT Poznej a tromboza stenta def verj 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 VSEBINA OB DOBAVI Sterilno...

Страница 184: ...the European Community Perwakilan resmi di komunitas Eropa Outer diameter Outer diameter Inner diameter Inner diameter Stent length Stent length Guiding catheter Guiding catheter Non pyrogenic Non pyr...

Страница 185: ...16 1621 87 3 25 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 86 F 9 5 2...

Страница 186: ...ENCE Sierra SPIRIT XIENCE XIENCE Sierra CYP3A4 P 5 10 XIENCE Sierra SPIRIT XIENCE 6 0 6 1 P4503A4 CYP3A4 CsA CYP3A4 XIENCE Sierra XIENCE V 1 Certican UK label Mar 2015 Afinitor EU authorization SPC De...

Страница 187: ...ss US label Sept 2015 www MHRA gov uk www ema europa eu www fda gov SPC 9 0 9 1 1 2 3 4 XIENCE Sierra EECSS XIENCE Sierra EECSS 9 2 2 3 10 20 HepNS 1000 500 0 096 2 44 0 014 0 36 x 175 1 1 9 3 9 3 1 1...

Страница 188: ...US Express TAXUS SPIRIT IV XIENCE V TAXUS Express TAXUS de novo 28 2 5 4 25 SPIRIT IV XIENCE V TAXUS Express SPIRIT Small Vessel SV Registry XIENCE V 2 25 SPIRIT PRIME XIENCE PRIME XIENCE PRIME LL XIE...

Страница 189: ...10 3 33 319 8 1 11 136 4 5 18 399 7 7 8 104 1 0 25 2416 1 3 15 1195 1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 24...

Страница 190: ...99 0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9...

Страница 191: ...NCE V USA AV SPIRIT V XIENCE V India 8040 4663 868 2663 977 18 de novo 4 2 25 4 0 28 ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3 EL21...

Страница 192: ...7522 1 71 45 2627 2 97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81...

Страница 193: ...2 mm 15 mm 18 mm 23 mm 28 mm 33 mm atau 38 mm dengan reference vessel diameter 2 00 mm dan 4 25 mm 3 0 KONTRAINDIKASI XIENCE Sierra Everolimus Eluting Coronary Stent System sebaiknya tidak digunakan p...

Страница 194: ...saat ini ini mendapatkan Stent XIENCE Sierra 5 9 Kemungkinan Supresi Kekebalan Everolimus bahan aktif stent XIENCE Sierra adalah zat imunosupresif Supresi kekebalan tidak terjadi pada kelompok stent S...

Страница 195: ...menggunakan kekuatan berlebihan dapat menyebabkan kerusakan atau terlepasnya stent Pertahankan penempatan guide wire di sepanjang lesi dan lepaskan delivery system serta guiding catheter sebagai satu...

Страница 196: ...SPIRIT dari Rancangan Percobaan Klinis XIENCE V Sebelum Dipasarkan SPIRIT III RCT SPIRIT IV Registri SPIRIT Small Vessel Percobaan Klinis SPIRIT PRIME Registri Ukuran Inti Registri Lesi Panjang Tipe R...

Страница 197: ...3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR Karena Iskemi Non TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Trombosis Stent ARC Pasti Mungkin 0 29 7 2391...

Страница 198: ...uk observasi dan dilakukan pada satu kelompok saja untuk mengevaluasi kelangsungan keamanan dan keefektifan XIENCE V EECSS selama penggunaan komersial di dunia nyata di India Tabel 10 2 1 sampai 10 2...

Страница 199: ...sis Percobaan Klinis untuk Trombosis Stent Setelah Interupsi Penghentian DAPT Kelompok stent XIENCE terbukti aman dan efektif dalam beberapa percobaan pada pasien standar berisiko rendah maupun pasien...

Страница 200: ...15 12 8 1 42 0 056 5F 12 1216 16 1621 84 4 0 38 33 28 23 18 15 12 8 1 42 0 056 5F 12 1216 16 1621 86 F 9 5 2 0 XIENCE Sierra Everolimus 12 65 50 2 3 0 1 0 XIENCE Sierra Everolimus CoCr L 605 XIENCE S...

Страница 201: ...fda gov www MHRA gov uk www ema europa eu 2015 5 9 XIENCE Sierra XIENCE SPIRIT XIENCE Sierra CYP3A4 5 10 XIENCE Sierra XIENCE SPIRIT 6 0 6 1 P4503A4 CYP3A4 CsA CYP3A4 XIENCE XIENCE V XIENCE V Sierra...

Страница 202: ...0 XIENCE SPIRIT 10 0 XIENCE PRIME XIENCE V EECSS XIENCE Sierra EECSS XIENCE Alpine EECSS XIENCE Xpedition EECSS EECSS XIENCE Sierra EECSS XIENCE Alpine EECSS XIENCE Xpedition EECSS XIENCE PRIME EECSS...

Страница 203: ...E V 2458 N TAXUS 1229 N XIENCE V 669 N TAXUS 333 N 2 25 XIENCE V 144 N 401 N 104 N 4 0 2416 97 6 8 1195 81 5 3 655 35 9 7 319 31 8 1 136 11 4 5 399 18 7 7 104 8 5 5 2416 134 7 7 1195 92 8 5 655 56 11...

Страница 204: ...5 2348 105 6 0 1158 70 7 1 605 43 11 2 286 32 3 0 133 4 2 0 399 8 4 8 104 5 TLR 6 3 2348 148 7 9 1158 92 8 9 605 54 12 9 286 37 5 3 133 7 2 5 399 10 2 9 104 3 TVR 5 6 2348 132 5 4 1158 63 8 8 605 53 1...

Страница 205: ...1 2 6 7522 194 1 71 2627 45 2 97 2562 76 0 9 986 9 1 7 942 16 1 4 7522 108 1 10 2627 29 1 87 2562 48 0 9 986 9 1 7 942 16 6 3 7522 475 3 54 2627 93 4 45 2562 114 1 3 986 13 1 6 942 15 2 2 7505 162 0 8...

Страница 206: ...L 800 227 9902 FAX 800 601 8874 Outside USA TEL 951 914 4669 Outside USA FAX 951 914 2531 2017 Abbott Abbott Vascular International BVBA Park Lane Culliganlaan 2B 1831 Diegem BELGIUM TEL 32 2 714 14 1...

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