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Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013. Graphical abstract: [Figure not available: see fulltext.]
Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry
Lip G. Y. H.;Kotalczyk A.;Teutsch C.;Diener H. -C.;Dubner S. J.;Halperin J. L.;Ma C. -S.;Rothman K. J.;Marler S.;Gurusamy V. K.;Huisman M. V.;Abban D. W.;Aziz E.;Kalan M. B.;Abdul N.;Backes L. M.;Bradman D.;Abud A. M.;Badings E.;Brautigam D.;Adams F.;Bagni E.;Breton N.;Addala S.;Baker S. H.;Brouwers P. J. A. M.;Adragao P.;Bala R.;Browne K.;Ageno W.;BaldiCortada A. J. B.;Aggarwal R.;Bruni S. B. A.;Agosti S.;BanerjeeBrunschwig S. C.;Agostoni P.;Bank A.;Buathier H.;Aguilar F.;Esquivias G. B.;Buhl A.;Linares J. A.;BarrBullinga C. J.;Aguinaga L.;BartlettCabrera M. J. W.;Ahmed J.;Basic KesCaccavo V. A.;Aiello A.;BaulaCai G. S.;Ainsworth P.;BehrensCaine S. S.;Aiub J. R.;BellCalo A. L.;Al-Dallow R.;Benedetti R.;Calvi V.;Alderson L.;MazuecosSanchez J. B. M. C.;Velasco J. A. A.;BenhalimaCandeias B. R.;Alexopoulos D.;Bergler-Klein J.;Capuano V.;Manterola F. A.;BerneauCapucci J. -B. A.;Aliyar P.;BernsteinCaputo R. A. R.;Alonso D.;BerrospiRizo P. T. C.;da Costa F. A. A.;Berti S.;Cardona F.;Amado J.;da BerzCosta Darrieux A. F. C.;Amara W.;Best E.;Vera Y. C. D.;Amelot M.;BettencourtCarolei P. A.;Amjadi N.;BetzuCarreno R. S.;Ammirati F.;BhagwatCarvalho R. P.;Andrade M.;Bhatta L.;Cary S.;Andrawis N.;BiscioneCasu F. G.;Annoni G.;Bisignani G.;Bisignani C.;Ansalone G.;BlackCayla T. G.;Ariani M. K.;BlochCelentano M. J. A.;Arias J. C.;Bloom S.;Cha T. -J.;Armero S.;Blumberg E.;Cha K. S.;Arora C.;BoChae M. J. K.;Aslam M. S.;Bohmer E.;Chalamidas K.;Asselman M.;Bollmann A.;Challappa K.;Audouin P.;Bongiorni M. G.;Chand S. P.;Augenbraun C.;Boriani G.;Chandrashekar H.;Aydin S.;Chartier D. J.;Chartier L.;Aydin S.;Bott J.;Chatterjee K.;Ayryanova I.;Bottacchi E.;Antero C.;Ayala C.;Cheema A.;Davis G.;Evonich R.;Cheema A.;Davy J. -M.;Evseeva O.;Chen L.;Dayer M.;Ezhov A.;Chen S. -A.;De Biasio M.;Fahmy R.;Chen J. H.;De Bonis S.;Fang Q.;Chiang F. -T.;De Caterina R.;Farsad R.;Chiarella F.;De Franceschi T.;Fauchier L.;Chih-Chan L.;de Groot J. R.;Favale S.;Cho Y. K.;De Horta J.;Fayard M.;Choi J. -I.;De La Briolle A.;Fedele J. L.;Choi D. J.;de la Pena Topete G.;Fedele F.;Chouinard G.;de Paola A. A. V.;Fedorishina O.;Chow D. H. -F.;de Souza W.;Fera S. R.;Chrysos D.;de Veer A.;Ferreira L. G. G.;Chumakova G.;De Wolf L.;Ferreira J.;Valenzuela E. J. J. R. C.;Decoulx E.;Ferri C.;Nica N. C.;Deepak S.;Ferrier A.;Cislowski D. J.;Defaye P.;Ferro H.;Clay A.;Munoz F. D. -C.;Finsen A.;Clifford P.;Brkljacic D. D.;First B.;Cohen A.;Deumite N. J.;Fischer S.;Cohen M.;Di Legge S.;Fonseca C.;Cohen S.;Diemberger I.;Almeida L. F.;Colivicchi F.;Dietz D.;Forman S.;Collins R.;Dionisio P.;Frandsen B.;Colonna P.;Dong Q.;French W.;Compton S.;dos Santos F. R.;Friedman K.;Connolly D.;Dotcheva E.;Friese A.;Conti A.;Doukky R.;Fruntelata A. G.;Buenostro G. C.;D'Souza A.;Fujii S.;Coodley G.;Dubrey S.;Fumagalli S.;Cooper M.;Ducrocq X.;Fundamenski M.;Coronel J.;Dupljakov D.;Furukawa Y.;Corso G.;Duque M.;Gabelmann M.;Sales J. C.;Dutta D.;Gabra N.;Cottin Y.;Duvilla N.;Gadsboll N.;Covalesky J.;Duygun A.;Galinier M.;Cracan A.;Dziewas R.;Gammelgaard A.;Crea F.;Eaton C. B.;Ganeshkumar P.;Crean P.;Eaves W.;Gans C.;Crenshaw J.;Ebels-Tuinbeek L. A.;Quintana A. G.;Cullen T.;Ehrlich C.;Gartenlaub O.;Darius H.;Eichinger-Hasenauer S.;Gaspardone A.;Dary P.;Eisenberg S. J.;Genz C.;Dascotte O.;Jabali A. E.;Georger F.;Dauber I.;Shahawy M. E.;Georges J. -L.;Davalos V.;Hernandes M. E.;Georgeson S.;Davies R.;Izal A. E.;Giedrimas E.;Gierba M.;Haruna T.;Jarmukli N.;Ortega I. G.;Hayek E.;Jeanfreau R. J.;Gillespie E.;Healey J.;Jenkins R. D.;Giniger A.;Hearne S.;Sanchez C. J.;Giudici M. C.;Heffernan M.;Jimenez J.;Gkotsis A.;Heggelund G.;Jobe R.;Glotzer T. V.;Heijmeriks J. A.;Joen-Jakobsen T.;Gmehling J.;Hemels M.;Jones N.;Gniot J.;Hendriks I.;Jorge J. C. M.;Goethals P.;Henein S.;Jouve B.;Goldbarg S.;Her S. -H.;Jung B. C.;Goldberg R.;Hermany P.;Jung K. T.;Goldmann B.;Del Rio J. E. H.;Jung W.;Golitsyn S.;Higashino Y.;Kachkovskiy M.;Gomez S.;Hill M.;Kafkala K.;Mesa J. G.;Hisadome T.;Kalinina L.;Gonzalez V. B.;Hishida E.;Kallmunzer B.;Hermosillo J. A. G.;Hoffer E.;Kamali F.;Lopez V. M. G.;Hoghton M.;Kamo T.;Gorka H.;Hong K.;Kampus P.;Gornick C.;Hong S.;Kashou H.;Gorog D.;Horbach S.;Kastrup A.;Gottipaty V.;Horiuchi M.;Katsivas A.;Goube P.;Hou Y.;Kaufman E.;Goudevenos I.;Hsing J.;Kawai K.;Graham B.;Huang C. -H.;Kawajiri K.;Greer G. S.;Huckins D.;Kazmierski J. F.;Gremmler U.;Hughes K.;Keeling P.;Grena P. G.;Huizinga A.;Saraiva J. F. K.;Grond M.;Hulsman E. L.;Ketova G.;Gronda E.;Hung K. -C.;Khaira A. S.;Gronefeld G.;Hwang G. -S.;Khripun A.;Gu X.;Ikpoh M.;Kim D. -I.;Torres I. G. T.;Imberti D.;Kim Y. H.;Guardigli G.;Ince H.;Kim N. H.;Guevara C.;Indolfi C.;Kim D. K.;Guignier A.;Inoue S.;Kim J. S.;Gulizia M.;Irles D.;Kim J. S.;Gumbley M.;Iseki H.;Kim K. S.;Gunther A.;Israel C. N.;Kim J.;Ha A.;Iteld B.;Kinova E.;Hahalis G.;Iyer V.;Klein A.;Hakas J.;Jackson-Voyzey E.;Kmetzo J. J.;Hall C.;Jaffrani N.;Kneller G. L.;Han B.;Jager F.;Knezevic A.;Han S.;James M.;Koh S. M. A.;Hargrove J.;Jang S. -W.;Koide S.;Hargroves D.;Jaramillo N.;Kollias A.;Kooistra J. A.;Li W.;McClure J.;KoonsLi J. X.;McCormack T.;Koschutnik M.;Lichy C.;McGarity W.;Kostis W. J.;McGarityKostisLieber I.;McIntyre H.;Kovacic D.;Horacio R.;Rodriguez L.;McLaurin B.;Kowalczyk J.;Lin H.;Alvaro F.;Palomino M.;Koziolova N.;Lip G. Y. H.;Melandri F.;Kraft P.;Liu F.;Meno H.;Kragten J. A.;Liu H.;Menzies D.;Krantz M.;Esperon G. L.;Mercader M.;Krause L.;Navarro N. L.;Meyer C.;Krenning B. J.;Lo E.;Meyer B.;Krikke J. F.;Lokshyn S.;Miarka J.;Kromhout Z.;Lopez A.;Mibach F.;Krysiak W.;Lopez-Sendon J. L.;Michalski D.;Kumar P.;Menezes A.;Filho L.;Michel P.;Kumler T.;Lorraine R. S.;Chreih R. M.;Luengas M. K.;Luengas A.;Mikdadi G.;KuoLuke J. -Y. R.;Mikus M.;KuppersLuo A. M.;Milicic D.;Kurrelmeyer K.;Lupovitch S.;Militaru C.;Kwak C. H.;Lyrer P.;Minaie S.;Laboulle B.;Ma C.;Minescu B.;Ma A.;Ma G.;Mintale I.;Ter Lai W.;Madariaga I.;Mirault T.;Lam A.;Maeno K.;Mirro M. J.;Lam Y. Y.;Magnin D.;Mistry D.;Lanas Zanetti F.;Maid G.;Miu N.;Landau V.;Mainigi C. K.;Miyamoto N.;Landini G.;Makaritsis K.;Moccetti T.;Lanna Figueiredo E.;Malhotra R.;Mohammed A.;Larsen T.;Manning R.;Nor A.;Lavandier M.;Manolis K. A.;Mollerus M.;LeBlanc J.;Andres H.;Hurtado M.;Molon G.;Lee M.;Mantas H. I.;Mondillo S.;Lee C. -H.;Jattin F. M.;Moniz P.;Lehman J.;Maqueda V.;Mont L.;Leitao A.;Marchionni N.;Montagud V.;Lellouche N.;Ortuno F. M.;Montana O.;Lelonek M.;Santana A. M.;Monti C.;Lenarczyk R.;Martinez J.;Moretti L.;Lenderink T.;Maskova P.;Mori K.;Gonzalez S. L.;Hernandez N. M.;Moriarty A.;Leong-Sit P.;Matsuda K.;Morka J.;Leschke M.;Maurer T.;Moschini L.;Ley N.;Mauro C.;Moschos N.;Li Z.;May E.;Mugge A.;Li X.;Mayer N.;Mulhearn T. J.;Muresan C.;Jose E. P.;Precoma D. B.;Muriago M.;Padilla F. G. P.;Prelle A.;Musial W.;Rios V. P.;Prodafikas J.;Musser C. W.;Pajes G.;Protasov K.;Musumeci F.;Pandey A. S.;Pye M.;Nageh T.;Paparella G.;Qiu Z.;Nakagawa H.;Paris F.;Quedillac J. -M.;Nakamura Y.;Park H. W.;Raev D.;Nakayama T.;Park J. S.;Grado C. A. R.;Nam G. -B.;Parthenakis F.;Rahimi S.;Nanna M.;Passamonti E.;Raisaro A.;Natarajan I.;Patel R. J.;Rama B.;Nayak H. M.;Patel J.;Ramos R.;Naydenov S.;Patel M.;Ranieri M.;Nazlic J.;Patrick J.;Raposo N.;Nechita A. C.;Jimenez R. P.;Rashba E.;Nechvatal L.;Paz A.;Rauch-Kroehnert U.;Negron S. A.;Pengo V.;Reddy R.;Neiman J.;Pentz W.;Renda G.;Neuenschwander F. C.;Perez B.;Reza S.;Neves D.;Rios A. M. P.;Ria L.;Neykova A.;Perez-Cabezas A.;Richter D.;Miguel R. N.;Perlman R.;Rickli H.;Nijmeh G.;Persic V.;Rieker W.;Nizov A.;Perticone F.;Vera T. R.;Campos R. N.;Peters T. K.;Ritt L. E.;Nossan J.;Petkar S.;Roberts D.;Novikova T.;Pezo L. F.;Briones I. R.;Nowalany-Kozielska E.;Pflucke C.;Escudero A. E. R.;Nsah E.;Pham D. N.;Pascual C. R.;Fragoso J. C. N.;Phillips R. T.;Roman M.;Nurgalieva S.;Phlaum S.;Romeo F.;Nuyens D.;Pieters D.;Ronner E.;Nyvad O.;Pineau J.;Roux J. -F.;de Los Rios Ibarra M. O.;Pinter A.;Rozkova N.;O'Donnell P.;Pinto F.;Rubacek M.;O'Donnell M.;Pisters R.;Rubalcava F.;Oh S.;Pivac N.;Russo A. M.;Oh Y. S.;Pocanic D.;Rutgers M. P.;Oh D.;Podoleanu C.;Rybak K.;O'Hara G.;Politano A.;Said S.;Oikonomou K.;Poljakovic Z.;Sakamoto T.;Olivares C.;Pollock S.;Salacata A.;Oliver R.;Garcea J. P.;Salem A.;Ruiz R. O.;Poppert H.;Bodes R. S.;Olympios C.;Porcu M.;Saltzman M. A.;Omaszuk-Kazberuk A.;Reino A. P.;Salvioni A.;Asensi J. O.;Prasad N.;Vallejo G. S.;Fernandez M. S.;Sokal A.;Tu T. M.;Saporito W. F.;Yan Y. S. O.;Tuininga Y.;Sarikonda K.;Sotolongo R.;Turakhia M.;Sasaoka T.;de Souza O. F.;Turk S.;Sati H.;Sparby J. A.;Turner W.;Savelieva I.;Spinar J.;Tveit A.;Scala P. -J.;Sprigings D.;Tytus R.;Schellinger P.;Spyropoulos A. C.;Valadao C.;Scherr C.;Stakos D.;van Bergen P. F. M. M.;Schmitz L.;Steinwender C.;van de Borne P.;Schmitz K. -H.;Stergiou G.;van den Berg B. J.;Schmitz B.;Stiell I.;van der Zwaan C.;Schnabel T.;Stoddard M.;Van Eck M.;Schnupp S.;Stoikov A.;Vanacker P.;Schoeniger P.;Streb W.;Vasilev D.;Schon N.;Styliadis I.;Vasilikos V.;Schwimmbeck P.;Su G.;Vasilyev M.;Seamark C.;Su X.;Veerareddy S.;Searles G.;Sudnik W.;Mino M. V.;Seidl K. -H.;Sukles K.;Venkataraman A.;Seidman B.;Sun X.;Verdecchia P.;Sek J.;Swart H.;Versaci F.;Sekaran L.;Szavits-Nossan J.;Vester E. G.;Serrati C.;Taggeselle J.;Vial H.;Shah N.;Takagi Y.;Victory J.;Shah V.;Takhar A. P. S.;Villamil A.;Shah A.;Tamm A.;Vincent M.;Shah S.;Tanaka K.;Vlastaris A.;Sharma V. K.;Tanawuttiwat T.;Dahl J.;Shaw L.;Tang S.;Vora K.;Sheikh K. H.;Tang A.;Vranian R. B.;Shimizu N.;Tarsi G.;Wakefield P.;Shimomura H.;Tassinari T.;Wang N.;Shin D. -G.;Tayal A.;Wang M.;Shin E. -S.;Tayebjee M.;Wang X.;Shite J.;Berg J. M.;Wang F.;Sibilio G.;Tesloianu D.;Wang T.;Silver F.;The S. H. K.;Warner A. L.;Sime I.;Thomas D.;Watanabe K.;Simmers T. A.;Timsit S.;Wei J.;Singh N.;Tobaru T.;Weimar C.;Siostrzonek P.;Tomasik A. R.;Weiner S.;Smadja D.;Torosoff M.;Weinrich R.;Smith D. W.;Touze E.;Wen M. -S.;Snitman M.;Trendafilova E.;Wiemer M.;Filho D. S.;Tsai W. K.;Wiggers P.;Soda H.;Tse H. F.;Wilke A.;Sofley C.;Tsutsui H.;Williams D.;Williams M. L.;Yan P. Y. B.;Zhang P.;Witzenbichler B.;Yang T.;Zhang J.;Wong B.;Yao J.;Zhao S. P.;Wong K. S. L.;Yeh K. -H.;Zhao Y.;Wozakowska-Kaplon B.;Yin W. H.;Zhao Z.;Wu S.;Yotov Y.;Zheng Y.;Wu R. C.;Zahn R.;Zhou J.;Wunderlich S.;Zarich S.;Zimmermann S.;Wyatt N.;Zenin S.;Zini A.;Wylie J.;Zeuthen E. L.;Zizzo S.;Xu Y.;Zhang H.;Zong W.;Xu X.;Zhang D.;Zukerman L. S.;Yamanoue H.;Zhang X.;Yamashita T.
2022-01-01
Abstract
Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013. Graphical abstract: [Figure not available: see fulltext.]
Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice_ GLORIA-AF Registry CLINICAL RESEARCH IN CARDIOLOGY 2022.pdf
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Descrizione: registro osservazionale internazionale per confrontare efficacia e sicurezza dei nuovi anticoagulanti orali in pazienti con fibrillazionne atriale
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Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
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