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Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: A subgroup analysis of the ARISTOTLE trial

Title:	Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: A subgroup analysis of the ARISTOTLE trial
Authors:	Easton J. D.; Lopes R. D.; Bahit M. C.; Wojdyla D. M.; Granger C. B.; Wallentin L.; Alings M.; Goto S.; Lewis B. S.; Rosenqvist M.; Hanna M.; Mohan P.; Alexander J. H.; Diener H. -C. ARISTOTLE Committees and Investigators: Christopher B Granger; Lars Wallentin; John H Alexander; Jack Ansell; Rafael Diaz; J Donald Easton; Bernard J Gersh; Michael Hanna; John Horowitz; Elaine M Hylek; John J V McMurray; Puneet Mohan; Freek W A Verheugt; M Cecilia Bahit; Philip Aylward; John Amerena; Kurt Huber; Jozef Bartunek; Alvaro Avezum; Justin A Ezekowitz; Paul Dorian; Fernando Lanas; Liu Lisheng; Jun Zhu; Daniel Isaza; Petr Jansky; Steen Husted; Veli Pekka Harjola; Philippe Gabriel Steg; Stefan H Hohnloser; Matyas Keltai; Prem Pais; Denis Xavier; Basil S Lewis; Raffaele De Caterina; Shinya Goto; Antonio G Hermosillo; Antonio M W Alings; Dan Atar; Luis Segura; Witold Ruzyllo; Dragos Vinereanu; Sergei Varshavsky; Sergey Golitsyn; Byung-Hee Oh; Patrick Commerford; Jose Luis Lopez-Sendon; Marten Rosenquist; Cetin Erol; Alexander Parkhomenko; Greg Flaker; David Garcia; Marc A Pfeffer; Hans-Christoph Diener; Aldo Maggione; Stuart Pocock; Jean-Lucien Rouleau; George Wyse; Sana Al-Khatib; Renato D Lopes; Claes Held; Cheryl Bushnell; Andreas Terent; Sergio Leonardi; Sumeet Subherwal; Zubin Eapen; John Vavalle; Ali Zomorodi; Bradley Kolls; Jeffrey Berger; Jennifer Vergara; Dipen Parikh; Shams Zia; Greg Stashenko; Carlo Lombardi; Robin Matthews; Emil Hagstrom; Axel Akerblom; Christoph Varenhorst; Shala Ghaderi Berntsson; Anna Stenborg; Erik Lundstrom; Helio Guimaraes; Uri Flato; Salete Nacif; Pedro Barros; Leandro Echenique; Patricia Rodrigues; Luciana Armaganijan; Antonio Carlos Lopes; Alvaro Albrecht; M Vico; I Mackinnon; D Vogel; A Gabito; A Cassettari; C Zaidman; O Montaña; A Hrabar; H Jure; H Lastiri; C Poy; A Caccavo; C Cuneo; H Colombo; F Rolandi; A Hershson; M Garrido; A Sanchez; M L Bruno; D Piskorz; J Cuadrado; E Hasbani; J Serra; L Cartasegna; P Schygiel; C Muratore; J Marino; M I Sosa Liprandi; R A Guerrero; H Ramos; D Mercado; L Guzman; C Beneitez; J Estepo; R Torrijos; E Retyk; N Vita; H Luciardi; M Casey; S Orlando; M B Labarta; D Santos; J Amerena; P Purnell; J Horowitz; H Salem; A Liu; L Zimmet; S Roger; F de Looze; R Lehman; B Jackson; D Ashby; W Heddle; J Rogers; D Brieger; P Martin; D Cross; D Walters; J Waites; J Counsell; A Lowy; K Huber; F Stockenhuber; B Pieske; H Striekwold; B Wollaert; H Nachtergaele; J Vijgen; D El Allaf; G Mairesse; G Boxho; P P De Deyn; M Vanderheyden; O Semeraro; P Desfontaines; J Leroy; F Provenier; B Bruneel; M Vrolix; A Peeters; O Deceuninck; J F Saraiva; G Reis; P Rossi; S Zimmermann; J Jaber; R Botelho; E Manenti; J Jorge; L Maia; P Leães; F Villaça Guimaraes Filho; M Fichino; A De Paola; C Kaoru Indio do Brasil; D Albuquerque; L Bodanese; L Matsubara; R Mourilhe Rocha; P Genta; Z Meneghelo; L Oliveira; A Lorga Filho; B Garbelini Jr; G Oliveira; M Teixeira; D Precoma; E Pelloso; A Muniz; M C Valéria Braile; R Ueda; A Rabelo Alves Jr; P Pimentel Filho; L Zimerman; M Coutinho; J Silveira; H Reis; D Moreira; M Paiva; J L Aziz; J Gois; O Dutra; L Yao; G Syan; B Coutu; R Chehayeb; G Sabe-Affaki; C Fortin; D Borts; R Bhargava; D Fell; J Cha; A Pandey; P Boucher; E Sabbah; P Ma; P Talbot; D Spence; A Wade; M Green; J Berlingieri; S Vizel; Y K Chan; M Blostein; M Talajic; L Sterns; F Grondin; T Hruczkowski; R Labonte; M O'Mahony; D Rupka; I Mangat; A Dowell; A Kelly; F St Maurice; S Henein; K Saunders; B Lasko; M Sami; R MacKinnon; Q Rizvi; D O'Keefe; J Ricci; B Gervais; R Hart; S Bose; S Nawaz; S Connors; L Winkler; M Boileau; J Healey; R Collette; T Rebane; B Ramjattan; R Senior; R Therrien; P Wells; C Raffo; J Cobos; S Potthoff; B Stockins; C Pincetti; R Corbalan; M Vejar; W Li; S Zhao; X Chen; S Wu; H Tan; P Qu; X Jiang; M Wei; X Yang; J Li; S Ma; S Gu; Q Y Dai; L Li; B Yu; Y Yin; N Wang; L Gao; S X Zhou; J A Wang; Z Q Li; F Bai; F Zhang; G Lu; Y Chen; Y Zhang; D Jiang; W Zonggui; H Li; K Cao; Q Lu; T Hu; X Wang; R Botero; A Reyes; N Jaramillo; M Urina; S Velez; E Gomez; L Pava; D Isaza; M Dunaj; M Hudcovic; O Jerabek; R Brat; J Spinar; V Dedek; E Zidkova; I Podpera; M Cech; K Gorican; M Micko; M Stribrna; L Frost; C Torp-Pedersen; C Toftager Larsen; C Tuxen; O May; K E Pedersen; G Jensen; T Nielsen; O Nyvad; S Husted; M Gilså Hansen; K Egstrup; J Lomholdt; K Skagen; T Joen Jakobsen; M Olsen; P Grande; J Melin; M Tynni; V P Harjola; J Strand; H Parikka; T Jääskeläinen; J L Corbelli; P Gosse; A Mirode; J Mansourati; G Lavabre; P Defaye; P G Steg; G Kahrmann; T Horacek; A Bauer; S Spitzer; M Schlegl; B Winkelmann; H F Vöhringer; G Stenzel; W Haverkamp; J Harenberg; M Schumacher; J Wunderlich; M Natour; W Rieker; S Gass; J Brachmann; J Jung; H Poppert; R Häge; L Lickfett; R Schoeller; L Goedel-Meinen; A Utech; M Buerke; M Maschke; R Haberl; E von Hodenberg; B Griewing; F Schlachetzki; H Hamer; T Hoch; M Zabel; R Jordan; F Stögbauer; A Hetzel; C Weimar; P Schauerte; D Fischer; A Mügge; A Bittersohl; K Lee; C Yu; F Lakatos; A Vértes; A Kovács; J Takács; A Pálinkás; J Bakai; A Papp; Á Illés; J Tomcsányi; I Szakál; Z László; A Katona; L Jobbágy; K Keltai; C Dézsi; G Lupkovics; A Cziraki; A Mohácsi; K Simon; S Gupta; D Agarwal; M Fulwani; A Naik; A Nambiar; N Chidambaram; B Srinivasasastry; J Joseph; M Padinhare; P Khanna; P Grant; J Arneja; M Gadkari; N Garg; R B Pothineni; S Sathe; S Ramesh; B Malipeddi; A Bharani; H B Gowdappa; V S Prakash; A Dharmadhikari; S Bhandari; N Desai; S Banerjee; N Ghaisas; B Ramagiri; S Sinha; G Gojanur; J Duggal; V Jain; S Dani; P Singh; V Srikanthan; V K Puri; R Gopal; S Viskin; M Shochat; T Hayek; L Reisin; S Rosenheck; B Lewis; R Zimlichman; A Weiss; A Marmor; Y Turgeman; E Klainman; A Francis; M Lahav; M Omary; M Morris; C Olivieri; M Santonastaso; R Fenici; L Mos; A Ghirarduzzi; R De Caterina; S Novo; E Richiardi; S Testa; M Pini; A D'Angelo; A Barsotti; M Donati; M Chiariello; M Galli; G Casolo; L Moretti; Y Atsushi; K Yamamoto; S Goto; H Kihara; T Akihiko; T Saito; H Yoshii; T Sasaki; M Suwa; S Adachi; K Usada; Y Nakamura; K Hayashida; T Yamada; T Iwasawa; Y Kawase; K Sugi; T Murakami; K Satake; T Iwao; K Maemura; Y Koretsune; Y Tsubokou; M Yamashita; Y Sato; F Kouichi; S Yura; A Matsushima; K Iwade; S Kamakura; S Tanaka; H Murata; S Yamamoto; Y Kobayashi; Y Higashi; T Shinozaki; H Ikeda; T Hisaoka; K Node; H Takagi; T K Ong; I Z Abidin; Z Yusof; K Yusoff; O Maskon; M De los Rios Ibarra; M Alcocer Gamba; E Lopez Rosas; C Calvo Vargas; P Fajardo Campos; J Alejandro Cordero-Cabra; C JerJes-Sanchez; I Hernandez Santamaria; L Molina; R Olvera Ruiz; C Arean Martinez; J Gonzalez Guerra; I Morales Gonzalez; J Cervantes-Escarcega; E Julian Chuquiure-Valenzuela; C Riojas; J Gonzalez Hermosillo; A Galicia; P Nierop; F Verheugt; M Daniels; D Lok; A Alings; M Scholten; J Plomp; R Derksen; A Bredero; P Zwart; A Schaap; H Michels; C Van der Zwaan; J Hysing; S Elle; T Omland; P Rønnevik; B Øie; J E Otterstad; N Bogale; T Kjærnli; S Halvorsen; B Bryhni; K Vikenes; W Cabrera; A Rodriguez; C Chavez; R Gamboa; L Segura; O Araoz; R Azanero; L Toce; F Medina; G Bustamante; C Rios Vasquez; M Zubiate; F Collado; E Morales-Palomares; R Sy; D Morales; G Rogelio; M T Abola; E Ramos; M Yamamoto; F De Leon; N Abelardo; G Kania; M Szpajer; M Rajzer; M Janion; M Bronisz; W Ruzyllo; M Piepiorka; M Wendland; T Czerski; R Korzeniak; A Budaj; L Wawrzynska; M Ogorek; P Miekus; W Tracz; A Ocicka-Kozakiewicz; J Stepinska; Z Kiedrowicz; T Pasierski; J Kasprzak; M Galewicz; B Podogrodzka; M Krauze-Wielicka; A Chmielinski; A Boruczkowska-Kaszkowiak; W Piotrowski; D Vinereanu; S Stamate; M Cinteza; C Mihaela Tanaseanu; G Andrei Dan; I Benedek; R M Ionescu; D Lighezan; A Salajan; E Carasca; R Capalneanu; C Pop; C G Fierbinteanu-Braticevici; D Tudor Zdrenghea; D Gaita; I Manitiu; T Nanea; C Arsenescu Georgescu; P Chizhov; A Kastanayan; V Oleynikov; T Treshkur; A Govorin; T Zhelninova; O Barbarash; T Novikova; O Reshetko; E Sivkova; A Obrezan; E Panchenko; S Popov; A Ivleva; D Zotov; A Gordienko; G Kamalov; I Chernichka; A Levin; K Zrazhevsky; S Golitsyn; N Shilkina; A Golovach; G Filonenko; S Bondarev; V Orlov; A Bragina; N Koziolova; A Svistov; S Shustov; I Libov; O Kisliak; E Privalova; O Aleksandrov; E Mazur; Y Karpov; D Belenky; V Kostenko; Y Shubik; M Ruda; G Arutyunov; V Eltishcheva; B Sidorenko; R Oseshnyuk; M Boyarkin; Y Pozdnyakov; N Staxhinskiy; A Sinopalnikov; S Yakushin; A Koniakhin; N Yarohno; Z Sizova; V Zadionchenko; I Klimov; D Duplyakov; S Kanorsky; V Mareev; V Terekhov; V Arkhipov; T Sotnikova; V Yakusevich; V Lesnov; I Gordeev; N Gratsiansky; S Shalaev; V Sulimov; O Talibov; E Zemtsovsky; O Azarin; R S Tan; J Thorne; D De Jong; M Basson; L van Zyl; P Commerford; H Weich; E van Nieuwenhuizen; J Roos; D Kelbe; J Viljoen; T J Hong; B H Oh; K S Park; M H Jeong; C Y Rhim; D J Choi; J H Sung; Y N Kim; J H Bae; S J Tahk; K H Ryu; S U Kwon; T H Rho; T J Cha; D G Shin; P Álvarez García; M Vida; E Galve; J Bruguera; J Roquer; F Olías de la Cruz; M A Paz Bermejo; T Segura; J H Gómez Gómez; A Ugarriza; I Plaza Pérez; J Villacastin; V Bertomeu; R Vargas; J Serena Leal; J Egido Herrero; A Bethencourt González; X Albert; C Gonzalez Juanatey; V Medrano; J Vivancos; T Andersson; C J Lindholm; F Al-Khalili; C Höglund; M Rosenqvist; O Bergström; J Herlitz; G Rasmanis; L Johansson; C Christersson; O Fredholm; M Callander; H Po; J P Pan; C D Tseng; K G Shyu; S H Chu; H Kultursay; B Gorenek; C Erol; G Lip; M Albazzaz; H Kadr; A Cohen; J Cooke; A Agarwal; M Brack; M Pye; M Anderson; F Dunn; Y K Wong; S Glen; G Ford; A Alwail; Z Yousef; M Blagden; D Murdoch; G McInnes; J Camm; W Ridsdill Smith; J J V McMurray; J Webster; D Dutka; B McClements; T Levy; S Yogasundram; A Moriarty; M McCullagh; J Flather; M Gumbley; I Findlay; J Davies; A Cooke; A Ahsan; J Cannon; A Bakhai; A Jacob; T Trouton; A Ajala; A Bartkowiak; D Humiston; W Kufs; K Klancke; P Jetty; D Gupta; V Nadar; K Yousuf; G Sosa-Suarez; S Gill; M Wukelic; N Mayer; D Colan; E Haskel; P Grena; W Haught; R Walsh; K Carr; N Tahirkheli; M Jardula; J Cebe; S Bloom; S Bilazarian; R Gilmore; N Jaffrani; D Goldscher; A Lebowitz; I Friedlander; M Stein; S Promisloff; A Magnano; J Dean; J Gerber; D Perloff; Y Cohen; A Meholick; T Tobin; R Acheatel; P Levanovich; J Ip; J Porterfield; N Seshadri; M McKenzie; A Alfieri; R Gazmuri; B Beanblossom; D Van Hamersveld; J McCriskin; M Gelernt; W Bowden; C Sotolongo; J Lang; S Kaatz; F Agnone; D Hassman; E Flores; F Albrecht; C Hassel; J Quartner; J LaFata; N Bedwell; W Herzog; J Amin; J Usedom; A Brockmyre; R Abadier; C Corder; R Marple; C Lovell; W Henry 3rd; A Chhabra; S Baker; R Bedoya; R Sandoval; M Nathan; D Garcia; K Vora; S Sloan; E Kosinski; R Foster; A Salacata; R Weachter; C Bredlau; P Mehta; C Russo; R Swint Sr; S Rosenthal; K Bybee; B Peart; P Chaudhuri; B Iteld; M Staab; D Rhodes; J Kappler; M Mandviwala; O Niedermaier; C Sofley; M Heiman; S Gips; R Harris; C East; V Nguyen; R Huling; U Thadani; D Travis; F Maislos; M West; R Castello; K Cohen; R Karlsberg; J Schmedtje Jr; D Gottlieb; A MacKinnon; G Noble; P O'Neill; J Roth; J Kobayashi; M Honan; G Hanovich; S Ehrlich; W Wilson; A Warner; A Rubin; E Rivera; S Leu; L Smith; J Agaiby; M Jan; R Gould; S Weiner; J Fleming; J Hemphill; K Parr; M Stoddard; P Curran; K Kurrelmeyer; V Desai; D Kereiakes; E Schwarz; M Lillestol; J Vazquez-Tanus; R Vicari; J White; R Shroff; R Fierer; N Vijay; A Hamad; M Kozinn; D Young; S Fenton; P Ouyang; A Wellford; P Zwerner; P Meyer; J Foley; A Boyle; M Dotani; A Skolnick; C Rodriguez-Fierro; B Hattler; M Rubin; P Hartley; L Tami; E Ball; C McPherson; S Eisenberg; I Niazi; M Orlov; B Bachhuber; C Massey; W Phillips; E Mouhayar; J Griffin; E Blumberg; S Slabic; K Danisa; A Samal; S Rohrbeck; P McCullough; D Dohan; G Aycock; A Jones; J Anderson; R Silverman; W Smith; D Mishkel; N Patterson; H Moore; A Kabour; M Muttreja; W Jaffrani; T Vidic; S Kent; B Platt; R Goldberg; S Kulback; R Patel; A Bazzi; S Goldman; A Roman; C Levin; B Lachterman; Y Chandrashekhar; I Aisiku; C Powers; E Engeron; R Bernstein; S Shah; J Strobel; H Punatar; R Garcia; D Linden; A Al-Mudamgha; A Quick; J Kramer; G Feldman; D Stapleton; M Davis; J Graff; J Galizia; P Wassmer; D Chiu; R Ison; K Curry; M Finneran; A Solomon; B Schifferdecker; J Seger; A Alexander; S Yates; R Ashley Jr; J Cordero-Sepulveda; P Cowen; T Ayres; B Kowalski; S Anton; J Phillips; D Donovan; A Patel; R Smith; J Updegrove; A Buxton; D Clark; J Margolis; G Brooks; R Pernenkil; J Walters; M Richards; P Maccaro; M Pieniek; J Garcia Pulido; C W Lee; J Ilvento; D Riff; B Blue; J Welker; H Karunaratne; P Santucci; M Vatutin; I Kraiz; Y Mostovoy; O Karpenko; V Tseluyko; L Kononenko; V Volkov; A Parkhomenko; G Popik; I Chopey; Y Burmak; S Pavlyk; V Vizir; O Barna; O Sychov; I Vykhovanyuk; V Tashchuk; I Khomazjuk; S Andrievskaya; Z Telyatnikova; O Bondarchuk; V Netiazhenko; N Seredyuk; O Koval; I Kovalsky; A Bazylevych; G Lysenko; M Borschivsky; A Yagensky; G Dzyak; I Bereznyakov; L Rudenko; G Ignatenko; K Amosova; O Voloshyna; L Ivanova; S Tykhonova; E Suprun.
Contributors:	J. D., Easton; R. D., Lope; M. C., Bahit; D. M., Wojdyla; C. B., Granger; L., Wallentin; M., Aling; S., Goto; B. S., Lewi; M., Rosenqvist; M., Hanna; P., Mohan; J. H., Alexander; ARISTOTLE Committees and Investigators: Christopher B Granger, Diener H. -C.; Wallentin, Lar; H Alexander, John; Ansell, Jack; Diaz, Rafael; Donald Easton, J; J Gersh, Bernard; Hanna, Michael; Horowitz, John; M Hylek, Elaine; V McMurray, John J; Mohan, Puneet; A Verheugt, Freek W; Cecilia Bahit, M; Aylward, Philip; Amerena, John; Huber, Kurt; Bartunek, Jozef; Avezum, Alvaro; A Ezekowitz, Justin; Dorian, Paul; Lanas, Fernando; Lisheng, Liu; Zhu, Jun; Isaza, Daniel; Jansky, Petr; Husted, Steen; Pekka Harjola, Veli; Gabriel Steg, Philippe; H Hohnloser, Stefan; Keltai, Matya; Pais, Prem; Xavier, Deni; S Lewis, Basil; De Caterina, Raffaele; Goto, Shinya; G Hermosillo, Antonio; W Alings, Antonio M; Atar, Dan; Segura, Lui; Ruzyllo, Witold; Vinereanu, Drago; Varshavsky, Sergei; Golitsyn, Sergey; Oh, Byung-Hee; Commerford, Patrick; Luis Lopez-Sendon, Jose; Rosenquist, Marten; Erol, Cetin; Parkhomenko, Alexander; Flaker, Greg; Garcia, David; A Pfeffer, Marc; Diener, Hans-Christoph; Maggione, Aldo; Pocock, Stuart; Rouleau, Jean-Lucien; Wyse, George; Al-Khatib, Sana; D Lopes, Renato; Held, Clae; Bushnell, Cheryl; Terent, Andrea; Leonardi, Sergio; Subherwal, Sumeet; Eapen, Zubin; Vavalle, John; Zomorodi, Ali; Kolls, Bradley; Berger, Jeffrey; Vergara, Jennifer; Parikh, Dipen; Zia, Sham; Stashenko, Greg; Lombardi, Carlo; Matthews, Robin; Hagstrom, Emil; Akerblom, Axel; Varenhorst, Christoph; Ghaderi Berntsson, Shala; Stenborg, Anna; Lundstrom, Erik; Guimaraes, Helio
Publication Year:	2012
Collection:	IRIS UNIPV (Università degli studi di Pavia)
Description:	Background: In the ARISTOTLE trial, the rate of stroke or systemic embolism was reduced by apixaban compared with warfarin in patients with atrial fibrillation (AF). Patients with AF and previous stroke or transient ischaemic attack (TIA) have a high risk of stroke. We therefore aimed to assess the efficacy and safety of apixaban compared with warfarin in prespecified subgroups of patients with and without previous stroke or TIA. Methods: Between Dec 19, 2006, and April 2, 2010, patients were enrolled in the ARISTOTLE trial at 1034 clinical sites in 39 countries. 18 201 patients with AF or atrial flutter were randomly assigned to receive apixaban 5 mg twice daily or warfarin (target international normalised ratio 2·0-3·0). The median duration of follow-up was 1·8 years (IQR 1·4-2·3). The primary efficacy outcome was stroke or systemic embolism, analysed by intention to treat. The primary safety outcome was major bleeding in the on-treatment population. All participants, investigators, and sponsors were masked to treatment assignments. In this subgroup analysis, we estimated event rates and used Cox models to compare outcomes in patients with and without previous stroke or TIA. The ARISTOTLE trial is registered with ClinicalTrials.gov, number NTC00412984. Findings: Of the trial population, 3436 (19%) had a previous stroke or TIA. In the subgroup of patients with previous stroke or TIA, the rate of stroke or systemic embolism was 2·46 per 100 patient-years of follow-up in the apixaban group and 3·24 in the warfarin group (hazard ratio [HR] 0·76, 95% CI 0·56 to 1·03); in the subgroup of patients without previous stroke or TIA, the rate of stroke or systemic embolism was 1·01 per 100 patient-years of follow-up with apixaban and 1·23 with warfarin (HR 0·82, 95% CI 0·65 to 1·03; p for interaction=0·71). The absolute reduction in the rate of stroke and systemic embolism with apixaban versus warfarin was 0·77 per 100 patient-years of follow-up (95% CI -0·08 to 1·63) in patients with and 0·22 (-0·03 to 0·47) in those ...
Document Type:	article in journal/newspaper
Language:	English
Relation:	info:eu-repo/semantics/altIdentifier/pmid/22572202; info:eu-repo/semantics/altIdentifier/wos/WOS:000304789800011; volume:11; issue:6; firstpage:503; lastpage:511; numberofpages:9; journal:LANCET NEUROLOGY; http://hdl.handle.net/11571/1341370
DOI:	10.1016/S1474-4422(12)70092-3
Availability:	http://hdl.handle.net/11571/1341370; https://doi.org/10.1016/S1474-4422(12)70092-3
Accession Number:	edsbas.3F7CD1BC
Database:	BASE