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Fibrillazione atriale, arruolato il primo paziente di ENTRUST-AF PCI, lo studio Daiichi Sankyo in pazienti sottoposti a intervento coronarico percutaneo

Roma, 6 marzo 2017 - Daiichi Sankyo ha arruolato il primo paziente di ENTRUST-AF PCI, lo studio internazionale, randomizzato di fase 3 che confronterà il trattamento con l'inibitore diretto del fattore Xa in monosomministrazione giornaliera LIXIANA® (edoxaban) e la terapia standard a base di antagonisti della vitamina K in pazienti affetti da fibrillazione atriale e sottoposti con successo a un intervento coronarico percutaneo (PCI) con inserimento di stent. Il trial è parte del programma di Ricerca Clinica Edoxaban, che valuta l'uso di questo farmaco in un ampio range di pazienti, con diverse condizioni cardiovascolari e in differenti setting clinici.

"ENTRUST AF-PCI è un trial importante per i pazienti con fibrillazione atriale sottoposti a intervento coronarico percutaneo, che richiedono terapia antipiastrinica e somministrazione cronica di edoxaban, farmaco approvato per la prevenzione dell'ictus" ha dichiarato Andreas Goette, primario del Dipartimento di cardiologia e terapia intensiva del St. Vincenz-Hospital di Paderborn, Germania, e principale sperimentatore dello studio

ENTRUST-AF PCI (EdoxabaN TReatment VersUS Vitamin K Antagonist in PaTients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) è uno studio prospettico di fase 3, randomizzato a gruppi paralleli, in aperto con endpoint cieco, che ha lo scopo di valutare efficacia e sicurezza di edoxaban in monosomministrazione giornaliera rispetto al trattamento con antagonisti della vitamina K in pazienti affetti da fibrillazione atriale e sottoposti a intervento coronarico percutaneo con impianto di stent. Il trial ha l'obiettivo di verificare l'incidenza di sanguinamenti maggiori o clinicamente rilevanti, così come definiti dalle linee guida ISTH. In questo studio saranno arruolati 1.500 pazienti da 200 cliniche distribuite in Europa, Corea, Taiwan e Ucraina, che saranno randomizzati a ricevere per 12 mesi un trattamento a base di edoxaban in associazione con clopidogrel, o un altro antagonista del P2Y12, oppure un trattamento con antagonisti della vitamina K in associazione con clopidogrel e aspirina per 1-12 mesi. Per maggiori informazioni: https://clinicaltrials.gov/ct2/show/NCT02866175?term=ENTRUST-AF+PCI&rank=1

"Questo studio si aggiungerà al corpus di evidenze fornite dal Programma di Ricerca Clinica di edoxaban, e i risultati faciliteranno gli specialisti nella comprensione del potenziale di riduzione del rischio di sanguinamenti in pazienti con fibrillazione atriale sottoposti a procedure PCI" ha spiegato il dottor Hans Lanz, Direttore esecutivo del dipartimento Global Medical Affairs di Daiichi Sankyo.

Il programma di ricerca clinica su edoxaban

Daiichi Sankyo si impegna ad ampliare le conoscenze scientifiche su edoxaban con un vasto programma di ricerca dedicato a valutarne l'uso in una vasta gamma di patologie cardiovascolari, tipologie di pazienti e situazioni cliniche, nella fibrillazione atriale (FA) e nel tromboembolismo venoso (TEV). Il programma include molteplici trial randomizzati controllati (RCT), registri e studi non interventistici al fine di generare nuovi dati da studi clinici e da situazioni di vita reale, relativi all'utilizzo di edoxaban nelle popolazioni affette da FA e TEV. Tra ricerche completate, in corso e future, Daiichi Sankyo prevede il coinvolgimento di 100.000 pazienti, inclusi i soggetti vulnerabili e a più alto rischio.

I trial randomizzati controllati includono:

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation - Edoxaban vs. warfarin nei soggetti sottoposti a cardioversione della fibrillazione atriale) sui pazienti affetti da FA sottoposti a cardioversione elettrica;

- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI - Trattamento con edoxaban vs. VKA nei pazienti sottoposti a PCI), nei pazienti affetti da FA sottoposti a intervento coronarico percutaneo;

- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer - Edoxaban nella tromboembolia venosa associata al cancro) nei pazienti colpIliti da cancro e da un evento di TEV.

Inoltre, esistono studi di registri globali e regionali che forniranno importanti dati reali sull'uso di edoxaban e di altri anticoagulanti orali nella pratica quotidiana:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with non valvular Atrial Fibrillation - Trattamento con edoxaban nella pratica clinica di routine nei pazienti con fibrillazione atriale non valvolare);

- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism - Trattamento con edoxaban nella pratica clinica di routine nei pazienti con tromboembolia venosa);

- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE - Gestione dell'edoxaban nelle procedure diagnostiche e terapeutiche relative a FA e TEV);

- Prolungamento di PREFER in FA (PREvention oF thromboembolic events - European Registry - Prevenzione degli eventi tromboembolici - Registro europeo) nei pazienti affetti da FA.