Background. The prospective, single-arm, observational, phase 4 ETNA-AF Europe study collected real-world data about safety, effectiveness and therapeutic adherence in European patients with non-valvular atrial fibrillation newly prescribed with edoxaban and followed up for 4 years. Methods. Overall, 13 164 patients were included in the full-analysis set, which means that they had at least one documentation after baseline at 4 years. The current paper reports about the 3329 Italian patients out of the whole European population. Results. In the Italian cohort, median age was 76.0 (69.0-82.0) years, with 57.4% of the patients being ≥75 years old. The CHA2DS2-VASc score was >4 in 586 (18.1%) patients. At baseline, 670 (20.8%) patients were classified as frail by the investigators. Edoxaban 30 mg/day was prescribed to 1013 (31.8%) patients: these were older, with more comorbidities and a lower estimated creatinine clearance compared with those receiving 60 mg/day. All-cause mortality was 4.1%/year and there were very low yearly rates of bleeding and thromboembolic events: major bleeding, 0.9%; intracranial hemorrhage, 0.2%; ischemic stroke, 0.3%; systemic embolism, <0.1%. These events were more frequent in patients ≥75 years or in patients with renal impairment or treated with edoxaban 30 mg/day. Advancing age was not associated with an increased incidence of intracranial bleeding. Conclusions. These findings confirm the favorable long-term safety and effectiveness profile of edoxaban in non-valvular atrial fibrillation patients treated in routine clinical care in Italy.
The ETNA-AF Europe Registry: 4-year data of edoxaban use in atrial fibrillation in the Italian real world compared to the European cohort / Riva, L.; Ando, G.; Anselmi, M.; Cemin, R.; Nassiacos, D.; Fionda, G.; De Caterina, R.; Adragna, N.; Agnelli, G.; Agosti, S.; Agostoni, P.; Alfonsi, F.; Ameri, P.; Amico, A. F.; Amico, F.; Ammirati, F.; Antonicelli, R.; Arena, G.; Aschieri, D.; Baccarini, S.; Baldini, U.; Balsa-Mo, M.; Barba, F.; Barbato, O.; Bartolini, C.; Beltrame, A.; Bencardino, G.; Bertorelli, M.; Bolognese, L.; Bolzani, V.; Patti, G.; Bongiorni, M. G.; Boriani, G.; Brunetti, N. D.; Bruzzese, G.; Bucciarelli, P.; Cafro, A.; Caldarola, P.; Caliendo, L.; Callerame, M.; Calo, L.; Cannone, M.; Capoferri, A.; Caprioglio, F.; Caramanno, G.; Carbonieri, E.; Castagna, F.; Carletti, R.; Carrabba, N.; Cattafi, G.; Baroni, M.; Cavallini, C.; Cireddu, M.; Cirrincione, V.; Cittadini, A.; Clemente, M. A.; Colonna, P.; Contarini, M.; Corda, M.; Corzani, A.; Cosentino, E.; Costantino, M. F.; Costoli, A.; Cuccia, C.; Cupini, L. M.; D'Ambrosio, C.; De An-Gelis, G.; De Be-Nedittis, G.; De Cesare, N.; De Luca, N.; De Micheli, V.; Di Belardino, N.; Di Lorenzo, E.; Fiore, C.; Di Lorenzo, L.; Di Muro, M. R.; Di Pede, F.; Diemberger, I.; Diomedi, M.; Di Tano, G.; D'Onofrio, A.; D'Orazio, S.; Favale, S.; Fedele, F.; Feola, M.; Ferri, C.; Fossi, C.; Fresco, C.; Fucili, A.; Gallone, G.; Gaddeo, C.; Gestra, R.; Giustetto, C.; Grimaldi, M.; Guarini, P.; Guarnera, S.; Guerra, F.; Gulizia, M.; Iacovoni, A.; Iliceto, S.; Indolfi, C.; Laffi, M.; Landolina, M. E.; Licciardello, G.; Liso, A.; Lodigiani, C.; Lupi, A.; Marchionni, N.; Marcucci, R.; Margonato, A.; Mariani, A.; Mattei, L.; Mauro, C.; Mazzone, A.; Mazzone, C.; Melillo, G.; Meloni, L.; Menichelli, M.; Milli, M.; Modugno, G.; Mureddu, G. F.; Napoletano, C.; Nicolis, D.; Nigro, G.; Noussan, P.; De Salvia, A.; Visconti, L. O.; Pagliani, L.; Paloscia, L.; Paonessa, K.; Parati, G.; Pardi, S.; Passamonti, E.; Pas-Santino, A.; Perale, L.; Perna, G. P.; Petacchi, R.; Petruccelli, E.; Piacenti, M.; Piazzi, E.; Piemontese, C.; Piepoli, M.; Pignatelli, P.; Piovaccari, G.; Pola, R.; Pontremoli, R.; Qua-Glione, R.; Rapacciuolo, A.; Rebulla, E.; Reggiani, A.; Tomasi, L.; Renda, G.; Riccardi, R.; Riccioni, G.; Ricottini, E.; Themistoclakis, S.; Rillo, M.; Risaliti, F.; Romano, I.; Rubino, G.; Ruzzolini, M.; Sacca, S.; Sangiuolo, R.; Santi, R.; Sarli, G.; Sarullo, F. M.; Scherillo, M.; Sciacqua, A.; Scipione, P.; Senatore, G.; Sibilio, G.; Solimene, F.; Sollazzo, V.; Storti, C.; Tamburino, C.; Tammaro, P.; Terrosu, P.; Tondo, C.; Trianni, M.; Tuccillo, B.; Urbinati, S.; Valente, S.; Valle, R.; Vannucchi, V.; Varbella, F.; Verlato, R.; Vetrano, A.; Volpe, M.; Zennaro, M.; Ziliotti, M.; Berisso, M. Z.. - In: GIORNALE ITALIANO DI CARDIOLOGIA. - ISSN 1827-6806. - 25:11(2024), pp. 819-832. [10.1714/0000.43289]
The ETNA-AF Europe Registry: 4-year data of edoxaban use in atrial fibrillation in the Italian real world compared to the European cohort
Riva L.;Anselmi M.;Agosti S.;Ameri P.;Barba F.;Bartolini C.;Caliendo L.;Cittadini A.;D'Orazio S.;Ferri C.;Lupi A.;Mauro C.;Pardi S.;Piepoli M.;Rapacciuolo A.;Renda G.;Scherillo M.;Sciacqua A.;Sibilio G.;Solimene F.;Sollazzo V.;Storti C.;Valle R.;Vetrano A.;
2024
Abstract
Background. The prospective, single-arm, observational, phase 4 ETNA-AF Europe study collected real-world data about safety, effectiveness and therapeutic adherence in European patients with non-valvular atrial fibrillation newly prescribed with edoxaban and followed up for 4 years. Methods. Overall, 13 164 patients were included in the full-analysis set, which means that they had at least one documentation after baseline at 4 years. The current paper reports about the 3329 Italian patients out of the whole European population. Results. In the Italian cohort, median age was 76.0 (69.0-82.0) years, with 57.4% of the patients being ≥75 years old. The CHA2DS2-VASc score was >4 in 586 (18.1%) patients. At baseline, 670 (20.8%) patients were classified as frail by the investigators. Edoxaban 30 mg/day was prescribed to 1013 (31.8%) patients: these were older, with more comorbidities and a lower estimated creatinine clearance compared with those receiving 60 mg/day. All-cause mortality was 4.1%/year and there were very low yearly rates of bleeding and thromboembolic events: major bleeding, 0.9%; intracranial hemorrhage, 0.2%; ischemic stroke, 0.3%; systemic embolism, <0.1%. These events were more frequent in patients ≥75 years or in patients with renal impairment or treated with edoxaban 30 mg/day. Advancing age was not associated with an increased incidence of intracranial bleeding. Conclusions. These findings confirm the favorable long-term safety and effectiveness profile of edoxaban in non-valvular atrial fibrillation patients treated in routine clinical care in Italy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
