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Congresso AHA 2017. Fibrillazione atriale, edoxaban più sicuro del warfarin nella prevenzione degli eventi emorragici gravi e nei pazienti con coronaropatia concomitante

Roma, 15 novembre 2017 - Edoxaban (LIXIANA®), rispetto a warfarin, riduce i sanguinamenti e soprattutto quelli di maggior gravità nei pazienti con FA e riduce significativamente il numero degli eventi ischemici in pazienti con fibrillazione atriale e concomitante coronaropatia. A dimostrarlo sono due approfondite sotto-analisi del trial clinico ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor XA next GEneration in Atrial Fibrillation), presentate all'American Heart Association (AHA) Scientific Session che sta per concludersi ad Anaheim, in California.

La prima sotto-analisi ha analizzato l'incidenza degli eventi emorragici come definiti dalle quattro classificazioni più comuni, e i risultati dimostrano che, in base alla definizione utilizzata, esiste una differenza di circa quattro volte della frequenza di sanguinamenti nei pazienti con FA a rischio di ictus. Inoltre, in coloro che assumevano edoxaban, si è riscontrata una maggior riduzione del rischio di emorragia, rispetto a warfarin, nei sanguinamenti di maggior gravità. "Questi risultati dimostrano che, rispetto alla terapia standard con warfarin, edoxaban riduce sensibilmente il rischio di eventi emorragici, in particolare quelli di maggior gravità", ha spiegato Brian A. Bergmark, autore del TIMI Study Group, Divisione di Medicina Cardiovascolare, Brigham and Women's Hospital e Harvard Medical School di Boston.

Una ulteriore analisi post-hoc del trial ENGAGE AF-TIMI 48, fornisce informazioni su edoxaban in pazienti affetti da FA con coronaropatia conclamata, e ha evidenziato che con edoxaban (60/30 mg) rispetto a warfarin, si verifica una maggior riduzione degli eventi ischemici nei pazienti affetti da coronaropatia rispetto a quelli non affetti. I dati mostrano che nei pazienti affetti da FA e concomitante coronaropatia, coloro che hanno assunto edoxaban hanno presentato una riduzione, rispetto a warfarin, di ictus/eventi embolici sistemici (1,4 versus 2,1%) e di infarto miocardico (1,4 versus 2,0%). I sanguinamenti maggiori, infine, nei pazienti che ricevevano edoxaban sono stati significativamente più bassi rispetto a quelli osservati nei pazienti che ricevevano warfarin, a prescindere dalla presenza di coronaropatia [pazienti con coronaropatia che ricevevano edoxaban vs warfarin (3,5 versus 4,4%); pazienti senza coronaropatia che assumevano edoxaban vs warfarin (2,6 versus 3,2% )].

"Dal momento che i pazienti affetti da FA e coronaropatia concomitante corrono un rischio più alto di infarto miocardico e morte, questi risultati possono avere importanti implicazioni cliniche per gli specialisti che trattino queste frequenti patologie", ha commentato l'altro autore del TIMI Study Group, Thomas A. Zelniker, Divisione di Medicina Cardiovascolare, Brigham and Women's Hospital e Harvard Medical School di Boston.

Il trial ENGAGE AF-TIMI 48 è stato disegnato per valutare i profili di efficacia e sicurezza di edoxaban rispetto a warfarin in 21.105 pazienti affetti da FA e con rischio moderato e alto di ictus (CHADS2≥2) o eventi embolici sistemici.3 "I nuovi dati dell' ENGAGE AF-TIMI 48 trial arricchiscono la mole di conoscenze provenienti dal Programma di ricerca clinico su Edoxaban che fornisce informazioni chiave sui potenziali effetti di questo nuovo anticoagulante orale nelle varie tipologie di pazienti con FA, e in questo caso specifico parliamo di coloro che soffrono anche di coronaropatia o presentano un alto rischio di sanguinamenti", ha concluso il dottor Hans J. Lanz, Direttore Esecutivo del dipartimento Global Medical Affairs di Daiichi Sankyo.