Emorragia intracranica da DOAC: conferme di efficacia per andexanet alfa


Andexanet alfa è il primo antidoto specificamente studiato per invertire rapidamente gli effetti anticoagulanti degli inibitori orali diretti del fattore Xa

andexanet alfa

Lo Studio di Fase IV post-marketing ANNEXA-I volto a valutare l’efficacia e la sicurezza di andexanet alfa nei pazienti che sviluppano emorragia intracranica durante il trattamento con inibitori orali del fattore Xa, come apixaban e rivaroxaban, è stato interrotto anticipatamente.1 La decisione si basa sul raggiungimento dei prestabiliti criteri di interruzione per superiorità, rispetto alle attuali strategie terapeutiche, in termini di efficacia emostatica, ovvero la capacità di limitare l’espansione di un’emorragia cerebrale potenzialmente pericolosa per la vita.1,2

L’interruzione anticipata dello studio è stata raccomandata dal Comitato Indipendente di Monitoraggio dei Dati e della Sicurezza (Data and Safety Monitoring Board – DSMB) a seguito di una valutazione di efficacia ad interim prevista dal protocollo, che ha mostrato i benefici dell’inversione di andexanet alfa dopo che 450 pazienti erano stati randomizzati e seguiti per un mese, in maniera anticipata rispetto a quanto originariamente previsto nell’arruolamento dello studio.

“Siamo soddisfatti che lo studio ANNEXA-I abbia raggiunto l’endpoint di efficacia all’analisi ad interim predefinita, mostrando come andexanet alfa garantisca un miglior controllo delle emorragie con l’inversione mirata dell’anticoagulazione, rispetto al trattamento standard”, commenta il Prof. Danilo Toni, Professore Ordinario di Neurologia, Past President di Italian Stroke Association, Direttore Unità di Trattamento Neurovascolare Policlinico Umberto I Dipartimento Neuroscienze Umane, Università La Sapienza, Principal Investigator dello Studio ANNEXA-I in Italia. “I benefici mostrati in termini di efficacia emostatica nei pazienti in trattamento con anticoagulanti Orali ad Azione Diretta (DOAC), che sviluppano emorragie potenzialmente fatali o fortemente impattanti sulla loro qualità di vita, sottolineano il potenziale di andexanet alfa di modificare la pratica clinica. Siamo impazienti di condividere i risultati completi di efficacia e sicurezza, con l’augurio che questi dati aprano la strada a nuove indicazioni sul trattamento di emorragie potenzialmente letali”.

Andexanet alfa è il primo antidoto specificamente studiato per invertire rapidamente gli effetti anticoagulanti degli inibitori orali diretti del fattore Xa in caso di emorragia potenzialmente fatale o incontrollata.3 Il trattamento ha ottenuto l’approvazione accelerata negli Stati Uniti ed è approvato nell’Unione Europea, Svizzera e Regno Unito per gli adulti trattati con gli inibitori del fattore Xa apixaban e rivaroxaban. Andaxenet alfa è attualmente autorizzato in Italia per l’utilizzo ospedaliero ed è attualmente in fase di valutazione AIFA per la rimborsabilità.

L’utilizzo di andexanet alfa è raccomandato da più di 15 linee guida nazionali e internazionali in molteplici discipline.4-19

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