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N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.

Apixaban with antiplatelet therapy after acute coronary syndrome.

Collaborators (960)

Harrington RA, Wallentin L, Alexander JH, James S, Lopes RD, Mohan P, Liaw D, Diaz R, Amerena J, Huber K, Cools F, Nicolau J, Raev D, Goodman S, Corbalan R, Huo Y, Urina-Triana M, Jansky P, Husted S, Niemela K, Montalescot G, Darius H, Keltai M, Pais P, Lewis B, De Caterina R, Ogawa H, Park SJ, Leiva-Pons JL, Cornel J, Verheugt F, White H, Atar D, Gallegos-Cazorla A, Ramos W, Ruzyllo W, Vinereanu D, Ruda M, Tan RS, Fridrich V, Theron Hdu T, Lopez-Sendon J, Jernberg T, Luscher T, Erol C, Flather M, Parkhomenko A, Bhatt D, Miller J, Simoons M, Armstrong P, De Lemos J, Kimura T, Maggioni A, Pocock S, Hatch L, Banks M, Handler A, Perkins L, Heath A, Lokhnygina Y, Dickerson S, Stone A, Lee K, Garg J, Hanna M, Fiedorek F, Bocquet JM, Kolivodiakos N, Townes L, Rossi L, Braceras R, Pouleur H, Jackson N, Hessinger D, Ponder-Lee V, Griffith K, Dremsizov T, Bevan A, Murphy C, Okabe M, Knoll J, Burr A, Mahaffey K, Al-Khatib S, Hernandez A, Kolls B, Leonardi S, Mehta R, Melloni C, Newby LK, Roe M, Shah B, Szczech L, Tricoci P, Truffa A, Vavalle J, Cavalcanti AB, Echenique L, Gonzaga C, Guimaraes HP, Armaganijan L, Fernandez A, Luquez H, Cuadrado J, Schiavi L, Caccavo A, Prado A, Colombo H, Ahuad Guerrero R, Baccaro J, Bustamante Labarta G, Sanchéz A, Ramos H, Hershson A, Sosa Liprandi A, Zaidman C, Hrabar A, Mercado D, Beloscar J, Cassettari A, Lobo Marquez L, Riccitelli M, Ubaldini J, Licheri A, León de la Fuente R, Albisu J, Berli M, Fuselli J, Cohen Arazi H, Peñaloza N, Marcos Schmidberg J, Poy C, Marino J, D'Amico A, Aiub J, Zapata G, Diez F, Bendersky M, Romero S, Ibañez J, Caruso O, Hains A, Hammett C, Horowitz J, Amerena J, Colquhoun D, Dick R, Blenkhorn A, Challa P, Schrale R, Flecknoe-Brown S, Hii CS, Huber K, Leisch F, Stockenhuber F, Weidinger F, Delle Karth G, Drexel H, Cools F, Striekwold H, Wollaert B, El Allaf D, Vervoort G, Vercammen J, Bartunek J, Muyldermans L, Hermans K, Janssens L, Dangoisse V, Ortiz CC, Knopfholz J, Borelli FA, Saporito WF, Sternieri MC, Botelho RV, Coutinho MS, Carvalho AC, Genta PR, Jatene JA, Dutra OP, Pimentel Filho P, Ueda R, Saraiva JF, Brazil MS, Alves Júnior AR, Fonseca AG, Franken M, Medeiros AM, Maia LN, Garzon PG, Bassan R, Timerman A, Afiune Neto A, Braga JC, Leães PE, Medeiros CR, Sartori IP, Reis G, Raposo Filho JJ, Garcia MF, Ribeiro JP, Manenti ER, Gomes MM, Gotchev D, Guenova D, Petranov S, Donova T, Parvanova Z, Gotcheva N, Raev D, Sardovski S, Stoimenov S, Tisheva S, Zlatareva N, Mihov A, Karastanev K, Mollov M, Petrov I, Sirakova V, Lazov P, Vizel S, Cha J, Yan A, Syan G, Silagy S, Bakbak A, Labonte R, Lam A, Senaratne M, Picard JP, Rajinder S, Kouz S, Chan A, Phaneuf DC, Lefkowitz A, Syed J, Murray P, Burton J, Dhillon R, Bata I, Sussex B, Hui W, Jakubowski M, Grondin F, Pesant Y, Klinke W, Dery JP, Overgaard C, Cleveland D, Cherry J, Pandey A, Lara TC, MacDonald P, Haichin R, Vijayaraghavan R, Pincetti C, Potthoff S, Chávez E, Lindh M, Sepulveda P, Roessler I, Pedemonte O, Albornoz F, Olivares C, Huo Y, Fu G, Xu W, Li ZQ, Li L, Yang Z, Hu T, Wang J, Ma H, Ma G, Huang D, Wong B, Yin Y, Jiang X, Sheng G, Wu M, Chen Y, Guo Y, Luo Y, Xiang D, Zheng Y, Li W, Yang C, Yuan Z, Botero R, Gomez E, Urina M, Jaramillo N, Mejia A, Orozco L, Sanchez D, Lopez Pareja M, Moncada M, Manzur Jattin F, Molina de Salazar DI, Dedek V, Spinar J, Mandakova E, Hrabos V, Budesinsky T, Vojacek J, Sovova E, Mrozek J, Frost L, Brønnum-Schou J, Lindhardt T, Jensen G, Larsen CT, Nielsen T, Husted S, Sykulski R, Grande P, Nielsen H, Ilveskoski E, Tierala I, Montalescot G, Gacem K, Mirode A, Galley D, Martelet M, Ohlmann P, Delarche N, Farah B, Bayet G, Niethammer M, Darius H, Hengstenberg C, Kreuzer J, Buerke M, Nienaber C, Diefenbach C, Kirchhof P, Bergmann M, Butter C, Werner N, Haude M, Omran H, Schwimmbeck P, Ferrari M, Park JW, Kleinertz K, Altmann O, Möllmann H, Machraoui A, Lauer B, Tiefenbacher C, Schaertl A, Moehlenkamp S, Kruells-Muench J, Giesler T, Axthelm C, Dissmann M, Behrens S, Vöhringer HF, Schunkert H, Jobbagy L, Papp A, Kovacs A, Lupkovics G, Nagy L, Palinkas A, Sereg M, Vertes A, Zamolyi K, Laszlo Z, Nagy A, Veress G, Regos L, Soltesz P, Kis E, Merkely B, Sitkei E, Kovacs Z, Csapo K, Tomcsanyi J, Nagy G, Edes I, Valco J, Garg N, Gupta J, Fulwani M, Sathe S, Sathayanarayana P, Parikh K, Sawhney JP, Singh P, Gupta S, Panwar R, Patel T, Chandwani P, Oomman A, Sarna M, Sathe S, Hardas S, Mathur A, Thanvi S, Srinivas A, Jathappa N, Pinto B, Raghuraman B, Pothineni R, Tongia R, Mahorkar U, Reddy N, Sambasivam K, Thacker H, Sengupta S, Arneja J, Lewis B, Katz A, Zeltser D, Weiss A, Omary M, Hayek T, Mosseri M, Francis A, Atar S, Gottlieb S, Meisel S, Rosenschein U, Marmor A, Butneru A, Kracoff O, Pollak A, Mazen E, Marenzi G, De Caterina R, Calabro P, DeLuca G, Moretti L, De Ferrari G, Berti S, Noguchi Y, Betsuyaku T, Muroya T, Obata H, Ooie T, Shigematsu S, Tanaka H, Kobayashi S, Momiyama Y, Sakuragi S, Nishijima T, Saito M, Sadamatsu K, Takeyasu N, Tanabe K, Inagaki M, Kakuta T, Nishino M, Hiasa Y, Sakai Y, Tsukahara K, Ojio S, Hokimoto S, Nakamura S, Uesugi M, Koga T, Kawai K, Kamiya H, Endo T, Uchiyama T, Iwasawa T, Shimomura H, Hirayama H, Tanaka N, Ajioka M, Michishita I, Nishi Y, Mizoguchi T, Nakao K, Yamada T, Ikeda M, Park KS, Ahn Y, Hong TJ, Kim SK, Rha SW, Rhim CY, Shin EK, Yoon J, Tahk SJ, Park SJ, Kim JH, Seung KB, Jeong YH, Kim KS, Kim YK, Lee SR, Leiva-Pons J, Lopez Rosas E, De los Rios Ibarra M, Fajardo Campos P, Garcia Castillo A, Ramirez Isunza J, Ramos Lopez G, Martin del Campo AL, Matadamas N, Alcocer Gamba M, Delgado L, Hinojosa P, Petersen F, Hernandez J, Carmona Barron C, Riojas C, Remes Ruiz R, Gonzalez Guerra J, Cardosa Torres F, Hernandez Herrera C, Aguila Marin J, Ramos Corrales M, Nacoud Askar A, Cornel J, Gosselink AT, Huizenga A, Verheul J, Frederiks J, Hoogslag PA, van Haelst P, Van Hessen MW, Theunissen L, Plomp J, Den Hartog F, Gho B, Liem A, Westendorp I, Moens A, Davidson L, Hamer A, Scott D, Richards M, Luke R, Atar D, Halvorsen S, Hurtig U, Andersen K, Gjertsen E, Rolstad OJ, Sparby JA, Nordrehaug J, Ponitz V, Oie E, Dimmen A, Azañero Reyna R, Bustamante Novella G, Medina Palomino F, Salazar Candiotti OC, Toce Yañez L, Rios Vasquez C, Gallegos Cazorla A, Britto Palacios F, Araoz Tarco O, Gómez Sánchez J, Pinto Concha J, Hernández Zúñiga J, Vargas Pacheco N, Castillo León R, Chavez Huapalla E, Bustos Lahura LE, Copaja Flores AH, Mayorga Espichan MJ, Reszka Z, Bronisz M, Drozdz J, Gil R, Derlaga B, Gessek J, Janik K, Kiedrowicz Z, Miekus P, Wendland M, Kalarus Z, Bryniarski L, Dabrowski M, Pluta W, Janion M, Hoffmann A, Musial W, Buksinska-Lisik M, Ruzyllo W, Jaworska K, Kurek P, Nessler B, Krzciuk M, Kuc K, Kasprzak J, Wysokinski A, Korzeniak R, Zarebinski M, Lewandowska-Stanek H, Kuzniar J, Wrzosek B, Kusnierz B, Kopaczewski J, Manitiu I, Salajan A, Olariu C, Stamate S, Pop C, Dimulescu D, Ionescu D, Matei A, Teodorescu I, Avram R, Vinereanu D, Cinteza M, Minescu B, Levin A, Zrazhevsky K, Duda A, Khrustalev O, Petrov A, Sayganov S, Shilkina N, Shustov S, Zotov D, Svistov A, Markov V, Parfenova T, Panchenko E, Yakusevich V, Boyarkin M, Filonenko G, Yakushin S, Zadionchenko V, Belenky D, Shalaev S, Mazur E, Fomin V, Goloschekin B, Kalinina S, Novikova N, Perepech N, Rodoman G, Shogenov Z, Shvarts Y, Fokina E, Suvorov A, Kamalov G, Barbarash O, Karpov Y, Drapkina O, Ruda M, Koziolova N, Pasechnik E, Bokarev I, Chernichka I, Chizhov P, Arutyunov G, Barbarich V, Gordeev I, Konstantinov V, Kostenko V, Oleynikov V, Libov I, Shlyakhto E, Sherenkov A, Reshetko O, Zateyshchikov D, Stazhinskiy N, Pozdnyakov Y, Akatova E, Starodubtcev A, Zalevsky G, Struk R, Chia S, Chong E, Bolvanska N, Fridrich V, Studencan M, Micko K, Curilla E, Poliacik P, Striezova I, Kovar F, Behuncik M, Basson M, Bayat J, Mabin T, Naidu R, van Zyl L, Sarvan M, Swanepoel N, Essop M, Theron H, Badenhorst J, Horak A, Shein K, Quintana Rendón ML, Bruguera J, Vida M, Gonzalez Juanatey J, Paz Bermejo MA, Rubio Sanz R, Benedicto Buendía A, Lopez Aranda M, Piqué M, Jimenez Navarro M, del Río A, Figueras J, Gonzalez Juanatey C, Hernández-Molina R, Cruz Fernández JM, Avanzas P, Camprubi Portau M, Muñoz Aguilera R, López de Sá E, Plaza Pérez I, Rodríguez García J, Fernnadez-Portales J, Molina E, Blanco Varela J, Hamid M, Bergström O, Risenfors M, Jernberg T, Fredholm O, Lindvall H, Kallryd A, Lugnegård J, Oldgren J, Amin J, Ahremark U, Tornvall P, Enander PO, Rickli H, Moccetti T, Mach F, Eberli F, Corti R, Ozaydin M, Kucukoglu S, Kultursay H, Erol C, Ebinc H, Brack M, Kadr H, Alwail A, Tait G, Moriarty A, Cooke J, Alamgir F, Purcell I, Aggarwal R, Dutka P, Cooke A, McGowan J, Rudenko L, Prokhorov O, Parkhomenko A, Bereznyakov I, Popik G, Tseluyko V, Volkov V, Vatutin M, Tashchuk V, Shershnyova O, Syvolap V, Kraiz I, Dzyak G, Batushkin V, Kovalsky I, Ivanova L, Abrahamovych O, Koval O, Bagriy A, Goloborodko B, Yagensky A, Kamlesh D, McLaurin B, Walder J, Ravipudi S, Oberoi M, Bowden WD, Casale P, Haught H, Rosenthal S, Badami U, McLellan B, Gould R, Walsh RL, Rhodes D, Waldman A, Sofley CW, Nadaud M, Flores EA, Bartkowiak A, Dor I, Dotani M, Salacata A, Brilakis E, Halpern S, Rivera E, Schwartzman J, Mahoney P, Moore R, Corder C, Cragg D, Blumberg E, Bishop A, Perez J, Raskin S, Gogia H, Fintel D, Haque I, Jones A, Acheatel R, Baman R, Jaffrani N, Raffetto J, French W, Hermany P, Rosenberg M, Jackson B, Lundbye J, Reison D, Seals AA, Alexander J, Peberdy M, Wilcox M, Brott B, Kabour A, Zakhary B, Allen R, Alfieri A, Taheri H, Preciado M, Baldwin D, Miller S, Birkhahn R, Tahirkheli N, Assi N, Breisblatt W, Chandra R, Rossi J, Tunio J, Mostel E, Galloway J, Patel D, El Hafi S, White A, Bach R, Donovan J, Kleiman N, Lipsitt M, MacDonald L, Matthai W, George F, Patel A, Miller A, Thel M, Guild C, Eisen H, Seshadri N, Tang S, Eisenstein I, Hassel C, Kazimir M, Meckel C, Pow T, Saucedo J, Sharma G, Chandrashekhar Y, Michael S, Thomas A, Lamas G, Amidi M, Iteld B, James E, Bolad I, Henry K, Pearce A, Raveendran G, McCriskin J, Bart B, Brockie R, Lui H, Nair N, Reddy R, Wu W, Tee H, Gonzales L, Kavinsky C, Nathan S, David W, Humiston D, Amine M, Tandar A, Kang G, Samal A, Bass P 3rd, Arif I, Marais H, Barquet G, Weaver D, Baig M, Prashad R, Bapat A, Gordon P, Held J, Mehta A, Mulamalla N, Aycock G, Lambert C, McGrew F, Rogers W, Clemson B, Ansinelli R, White D, Kersh R, Mohan S, Vora K, Younis L, Abadier R, Patel J, Davis M, Lau T, Berk M, Kieval J, Ferrari D, Shoukfeh M, Sharma M, Umbach R, Abernethy W, Foucauld J, Ranadive N, Haitas B, Izzo M, Tinker W, Dobies D, Gupta S, Chane M, Carstens J, Shah A, Koren M, Kastelic R, Quinn T, Mann J 3rd, Bloom S, Katz D, Bachhuber B, Steinberg K, Altamirano-Salazar J, Niedermaier O, Nygaard T, Albirini A, Tolleson T, Erickson B, Hearne S, Ali M, Ghali M, Chan M, Roman A, Torres R, Rodriguez M.

Author information

  • 1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA. john.h.alexander@duke.edu

Abstract

BACKGROUND:

Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome.

METHODS:

We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events.

RESULTS:

The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events. With a median follow-up of 241 days, the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 279 of the 3705 patients (7.5%) assigned to apixaban (13.2 events per 100 patient-years) and in 293 of the 3687 patients (7.9%) assigned to placebo (14.0 events per 100 patient-years) (hazard ratio with apixaban, 0.95; 95% confidence interval [CI], 0.80 to 1.11; P=0.51). The primary safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition occurred in 46 of the 3673 patients (1.3%) who received at least one dose of apixaban (2.4 events per 100 patient-years) and in 18 of the 3642 patients (0.5%) who received at least one dose of placebo (0.9 events per 100 patient-years) (hazard ratio with apixaban, 2.59; 95% CI, 1.50 to 4.46; P=0.001). A greater number of intracranial and fatal bleeding events occurred with apixaban than with placebo.

CONCLUSIONS:

The addition of apixaban, at a dose of 5 mg twice daily, to antiplatelet therapy in high-risk patients after an acute coronary syndrome increased the number of major bleeding events without a significant reduction in recurrent ischemic events. (Funded by Bristol-Myers Squibb and Pfizer; APPRAISE-2 ClinicalTrials.gov number, NCT00831441.).

Comment in

PMID:
21780946
[PubMed - indexed for MEDLINE]
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