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N Engl J Med. 2009 May 14;360(20):2066-78. doi: 10.1056/NEJMoa0901301. Epub 2009 Mar 31.

Effect of clopidogrel added to aspirin in patients with atrial fibrillation.

Collaborators (615)

Connolly SJ, Yusuf S, Camm J, Chrolavicius S, Commerford P, Flather M, Hart RG, Hohnloser SH, Joyner C, Pfeffer M, Gaudin C, Blumenthal M, Marchese C, Connolly SJ, Pogue J, Chrolavicius S, Hart R, Pfeffer M, Hohnloser S, Yusuf S, Anand I, Arthur H, Avezum A, Budaj A, Ceremuzynski L, De Caterina R, Diaz R, Dorian P, Flaker G, Fox KA, Franzosi MG, Goldhaber S, Golitsyn S, Granger C, Halon D, Hermosillo A, Hunt D, Jansky P, Karatzas N, Keltai M, Kozan O, Lanas F, Lau CP, Le Heuzey JY, Lewis BS, Morais J, Morillo C, Paolasso E, Peters RJ, Pfisterer M, Piegas L, Pipilis A, Sitkei E, Swedberg K, Talajic M, Valentin V, Van Mieghem W, Varigos J, Ameriso S, Atra M, Avezum A, Berwanger O, Bonilla C, Bornstein N, Budaj A, Chamiec T, Chan YK, Cottin Y, Csiba L, Cybulski J, Czepiel A, De Raedt H, Diaz R, Dvorakova H, Eikelboom J, Ergene O, Fodor G, Galli M, Gardinale E, Golitsyn S, Granger C, Gross B, Goodfield P, Halon D, Happola O, Healey J, Himbert D, Hunt D, Jacobsson F, Jansky P, Kalvach P, Karatzas N, Keltai M, Kies B, Laine M, Lam A, Le Heuzey JY, Lewis BS, Lewis S, Leys D, Maggioni AP, Massaro A, Mayosi BM, Norrving B, Okay T, Olah L, Osende JO, Oto A, Peeters A, Penicka M, Perakis A, Piegas L, Pipilis A, Pizzolato G, Rafti F, Renkin J, Siva A, Steg PG, Stockins B, Strozynska E, Swedberg K, Turazza F, Vanderhoven L, Vizel S, Widimsky P, Zaborski J, Albers G, Hankey G, Hart RG, Norrving B, Shuaib A, Silva J, Wyse DG, Cairns JA, Gent M, Hirsh J, Marler J, Pritchett E, Wittes J, Beresh H, Floyd L, Gasic Z, Holadyk-Gris I, Lawrence M, Moro I, Perry S, Roberts J, Rodrigues T, Robinson L, Stevens C, Worthy L, Yuan F, Ahuad Guerrero RA, Allall O, Amuchastegui LM, Boskis M, Bustamante Labarta MH, Castellanos CR, Chiale P, Cuneo CA, Czcczuo A, Gabito AJ, Garrido M, Guzmán LA, Hasban EG, Hershson AR, Hominal MA, Krauss JG, Luciardi HL, Marzetti EM, Montaña OR, Rabinovich RF, Ramos HR, Sanchez AS, Schygiel PO, Sumay GM, Vogel DR, Zaidman CJ, Aroney GM, Ashby DT, Barlow MA, Cooke P, Cross DB, Fitzpatrick MA, Garrahy P, Karrasch J, Nelson GI, Rees D, Roger SD, Rogers J, Singh BB, Stickland JF, Waites JH, Walsh WF, Eichinger J, Huber K, Leisch F, Boland J, Conraads VM, Cools FJ, De Roy L, El Allaf D, Mairesse GH, Vankelecom B, Abrantes J, Armaganijan D, Atié J, Blacher C, Bodanese LC, Braga JC, Braile MV, Chaves H, Coelho OR, Cunha CL, De Lima GG, de Paola AA, Esteves JP, Francischetti A, Francischetti AE, Lorga-Filho AM, Maia LN, Marcussi DM, Marin-Neto JA, Meneghelo ZM, Rocha RM, Nogueira PR, Oigman W, Paiva M, Précoma DB, Rabelo W, Rabelo A Jr, Rassi S, Rassi A Jr, Reis G, Rossi PR, Rossi Neto JM, Saraiva JK, Sobral-Filho DC, Zimmermann SL, Ashton TA, Bhargava R, Carroll S, Chehayeb R, Connors SP, Constance C, Costi P, Coutu B, Crystal E, Douketis JD, Fortin C, Fox BA, Gupta MK, Krahn AD, Kuritzky R, Kwok K, Leader R, Ma P, Mangat I, Maranda CR, Matangi MF, Moddel G, Mukherjee A, Nawaz S, Palaic M, Pandey AS, Rebane TM, Ruel M, Sapp JL, Senaratne MP, St-Hilaire R, Talbot P, To TB, Vakani M, Weigel MA, Wulffhart Z, Yao L, Zaniol D, Conejeros CR, Corbalán R, Dussaillant GR, Escobar E, Hassi ME, Parra CA, Stockins BA, Varleta PE, Berka L, Dedek V, Florian J, Hejhal O, Herold M, Klimsa Z, Kotik I, Simon J, Smetana K, Spinar J, Spinarová L, Tousek F, Husted S, Nielsen T, Pehrson S, Tuxen C, Harjola VP, Huikuri HV, Kettunen RV, Melin JH, Peuhkurinen K, Carlioz R, Coisne D, Decoulx E, Defaye P, Demarcq JM, Gacem K, Galley DL, Lardoux HM, Mabo P, Mansour M, Olive TG, Poulard JE, Pruvot CF, Rey JL, Bauer WR, Baumann G, Berghöfer G, Boehm G, Borggrefe MM, Brücker G, Darius H, Duray GZ, Felix SB, Fink P, Fritz H, Haberl R, Hoffmann S, Horacek T, Kalusche DW, Kasper W, Katus HA, Klepzig HH, Loos U, Merher R, Munzel T, Neuzner J, Ochs HR, Pieske B, Pollock BW, Schmidt A, Schumacher M, Seidl K, Speier U, Spitzer SG, Stenzel G, Volkmann H, Wunderlich J, Zacharzowsky U, Antonakoudis H, Georgakopoulos N, Goudevenos JA, Iliopoulos TA, Kallikazaros I, Pyrgakis VN, Skoufas P, Chan WK, Chan HW, Fung JW, Li SK, Wong KS, Forster T, Kárpáti P, Keltai K, Kovacs A, Kurta G, Laszlo Z, Rapi J, Regos L, Rostas L, Szakál I, Tomcsanyi J, Toth C, Bloch L, Khader N, Klainman E, Koukoui D, Lotan C, Marmor A, Omary MZ, Reisin LH, Vered Z, Zeltser D, Zimlichman R, Bianconi L, Bicego D, Cosmi D, Filigheddu F, Garini A, Lunati M, Moretti L, Mos L, Pontiroli AE, Renda G, Ricci S, Rossi P, Santonastaso M, Scioli GA, Stramba-Badiale M, Terrosu P, Omar R, Ong TK, Ahmad WA, Alvarado R, Calvo C, Cordero-Cabra JA, Hernández I, Jerjes-Sanchez C, Lara S, Lopez Rosas E, Molina L, Morales E, Petersen-Aranguren F, Picos Bovio EM, Pozas G, Robles Torres FJ, Holwerda K, Lok DJ, Nierop R, Pieterse MG, van der Heijden R, van Kempen L, Oie BK, Omland TM, Otterstad J, von Brandis C, Bronisz M, Chizynski K, Czerski T, Dluzniewski M, Gessek J, Gieroba A, Gniot JR, Gorny J, Halaczuiewicz H, Janik K, Janion M, Jerzykowska O, Kawka-Urbanek T, Kincel K, Kocon S, Kopaczewski J, Krasowski W, Makuch M, Malinowski S, Miastkowski Z, Mickiewicz-Pawlowska M, Miekus P, Obrebska-Tabaczka E, Ogorek M, Piasecka-Krysiak E, Piepiorka AW, Piotrowski W, Pluta W, Puzio E, Rekosz J, Sinkiewicz W, Stopinski M, Szelemej R, Tendera M, Trusz-Gluza M, Wilkoszynski M, Zalska B, Antunes E, Carrageta MO, de Sousa J, Martins L, Mendonca MI, Silvestre I, Akatova EV, Aleksandrov V, Antuch EA, Arutyunov G, Bart B, Belousov YB, Chernichka II, Dovgalevsky P, Gratsiansky N, Ivleva AY, Kislyak OA, Mareyev VY, Maykov EB, Milyagin V, Novikova TN, Panchenko EP, Reshetko O, Semernin E, Sidorenko BA, Sinopalnikov A, Skvortsova V, Solomatin A, Sukhinina TS, Suslina ZA, Titkov Y, Tsyrline V, Chan B, Foo D, Omar AR, Teo WS, Brown BG, Ebrahim IO, Gibson GJ, Klug E, Marx JD, Mntla PS, Okreglicki A, Pretorius M, Roos JS, Snyders F, van Zyl LJ, Cano L, Garcia-Puig J, Hernandez-Madrid A, Mostaza JM, Orriach MD, Sabate X, Viñolas X, Blomström P, Jacobsson F, Johansson L, Klintberg L, Lycksell M, Nilsson O, Rasmanis G, Nilehn KE, Ulvenstam G, Baumgartner RW, François M, Gallino A, Moccetti T, Tettenborn BE, Chou HT, Kuo JY, Lai WT, Lin JL, Lin LJ, Ueng KC, Yeih DF, Bakar M, Ilerigelen B, Kumral E, Nisanci Y, Savas ZI, Adgey Y, Brack MJ, Cleland J, Davey PP, Davies J, Glen SK, Jennings K, Levy T, Lip GY, Moriarty AJ, Pearson C, Purvis JA, Pye MP, Savelieva I, Senior R, Trouton TG, Ahmed IS, Amin M, Anderson JL, Bauernfeind RA, Belew K, Bilazarian SD, Black RA, Burton ME, Cebe JE, Chandrashekhar YS, Chen C, Das D, Denny DM, Desai V, Fahmy RN, Fishbein GJ, Gelernt MD, Gerber J, Goldberg MC, Grena PG, Honan MB, Hunter JJ, Jacobson J, Jarmukli NF, Klancke K, Kobayashi JF, Lewis SJ, Little T, Mallis I, Marani AM, Marshall JJ, Meltzer P, Menapace FJ, O'Neill PG, Pearce DJ, Quick A, Ravipudi S, Rivera E, Sackett M, Salerno DM, Schussheim A, Sheikh K, Shettigar UR, Treasure CB, Vidaillet H, Vijay N, Wagner D, Walker JL, Winters SL, Young DR, Zoble RG.

Abstract

BACKGROUND:

Vitamin K antagonists reduce the risk of stroke in patients with atrial fibrillation but are considered unsuitable in many patients, who usually receive aspirin instead. We investigated the hypothesis that the addition of clopidogrel to aspirin would reduce the risk of vascular events in patients with atrial fibrillation.

METHODS:

A total of 7554 patients with atrial fibrillation who had an increased risk of stroke and for whom vitamin K-antagonist therapy was unsuitable were randomly assigned to receive clopidogrel (75 mg) or placebo, once daily, in addition to aspirin. The primary outcome was the composite of stroke, myocardial infarction, non-central nervous system systemic embolism, or death from vascular causes.

RESULTS:

At a median of 3.6 years of follow-up, major vascular events had occurred in 832 patients receiving clopidogrel (6.8% per year) and in 924 patients receiving placebo (7.6% per year) (relative risk with clopidogrel, 0.89; 95% confidence interval [CI], 0.81 to 0.98; P=0.01). The difference was primarily due to a reduction in the rate of stroke with clopidogrel. Stroke occurred in 296 patients receiving clopidogrel (2.4% per year) and 408 patients receiving placebo (3.3% per year) (relative risk, 0.72; 95% CI, 0.62 to 0.83; P<0.001). Myocardial infarction occurred in 90 patients receiving clopidogrel (0.7% per year) and in 115 receiving placebo (0.9% per year) (relative risk, 0.78; 95% CI, 0.59 to 1.03; P=0.08). Major bleeding occurred in 251 patients receiving clopidogrel (2.0% per year) and in 162 patients receiving placebo (1.3% per year) (relative risk, 1.57; 95% CI, 1.29 to 1.92; P<0.001).

CONCLUSIONS:

In patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable, the addition of clopidogrel to aspirin reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage. (ClinicalTrials.gov number, NCT00249873.)

2009 Massachusetts Medical Society

PMID:
19336502
[PubMed - indexed for MEDLINE]
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