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N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.

Ticagrelor in Patients with Stable Coronary Disease and Diabetes.

Collaborators (1436)

Carnero G, Duronto E, Besada D, Chacon C, Zangroniz P, Solis S, Liberman A, Sernia V, Alvarisqueta A, Maffei L, Gomez Vilamajo O, García C, Sicer M, Muntaner J, Bordonava A, Albisu J, Zanini A, Rista L, Hominal M, Navarro Estrada J, Prado A, Mohr Gosparini D, Schiavi B, Colquhoun D, Amerena J, Morbey C, Hammett C, Dart A, Lehman R, Hamilton A Jr, Worthley M, Purnell P, Whelan A, MacIsaac R, Arya KM, Linjawi S, Proietto J, Prasad L, Drexel H, Brath H, Schnack C, Hanusch U, Fließer-Görzer E, Paulweber B, Ebenbichler C, Prager R, Huber K, Wolzt M, Auer J, Berger R, Schernthaner GH, Verwerft J, Vrolix M, Faes D, Striekwold H, Sinnaeve P, Timmermans P, Guedes A, Dangoisse V, Delforge M, Nimmegeers J, Stammen F, Buysschaert I, Hoffer E, Hollanders G, Vervoort G, Coussement P, De Maeseneire S, Janssens L, Baracioli L, Franken M, Guimarães F, Vasconcellos E, Saraiva J, Pereira A, Santos Q, Rossi P, Maia L, Madeira M, Lacativa P, Pereira M, Botelho R, Reis G, Eliaschewitz F, Borges J, Nascimento C, Garcia MF, Fortes JA, De Souza WKSB, Pimentel P, Hissa M, Franchetti M, Precoma D, Ortiz C, Frack C, Hernandes M, Saporito W, Rossi Dos Santos F, Kormann A, Neuenschwander F, Dutra O, Rassi N, Tanajura L, Souza J, Junior DS, Leaes P, Forte A, Piscitelli Bonansea TC, Marin J, Cerqueira MJ, Lima E Silva FA, Michalaros Y, Manenti E, Machado B, Cercato C, Arruda J, Figueiredo E, Milanova M, Tenev D, Gogov A, Karageorgiev D, Aliman O, Kolchev T, Al Samra I, Rusev N, Georgieva N, Kondov R, Rusinov V, Petrov I, Stanchev G, Konteva M, Dincheva A, Yaneva Z, Buyuklieva R, Vatova R, Ilieva K, Runev N, Kolomanov B, Petrov I, Iliev N, Tisheva S, Chompalova B, Tokmakova M, Raev D, Byanov K, Markov D, Mihov L, Mihov A, Milcheva N, Minchev M, Miteva L, Mollov M, Borisov B, Tihchev T, Karakolev V, Dimov B, Georgiev S, Smilov L, Gallo R, Bertrand O, Mehta S, Constance C, Sussex B, Zadra R, Kouz S, Chehayeb R, Pandey A, Dion D, Bailey G, Hill L, Ramanathan K, Dorsch M, Nanji A, Babapulle M, Montigny M, Gosselin G, Dehghani P, Rupka D, Pichette F, Cieza TA, Teefy P, Kostuk W, Kassam S, Mansour S, Cheung S, Della Siega A, O'Keefe D, Sabbah É, Bell A, Chouinard G, Wong B, Miller M, St-Maurice F, Gaudet D, Lachance P, Rosenbloom A, Bata I, Le May M, Petrella R, Fortin C, Gossard D, Dumas R, Ing D, Boyrazian H, Huynh TT, Hart R, Belle-Isle J, Shukla D, Mazza G, Cha J, Bessoudo R, Henein S, Kelly A, Fréchette A, Vizel S, Liutkus J, O'Mahony M, Halperin F, Kooy J, Graham J, Senior P, Bailey A, Wojcik R, Knight D, Wilderma I, Prieto J, Villablanca A, Raffo C, Pincetti C, Conejeros C, Roman O, Rodriguez M, Varleta P, Goldberg C, Bustos C, Sandoval J, Arriagada G, Corbalan R, Leon L, Potthoff S, Cobos J, Figueroa C, Li H, Zhao Q, Zhang J, Wang Y, Ma J, He Y, Luo M, Zhang A, Zhang N, Chai Y, Ma G, Wang H, Ma J, Liu Z, Liu P, He L, Song Z, Dong X, Tao L, Li Z, Su X, Kong X, Niu H, Ge J, Luo Z, Huang W, Peng D, Yuan Z, Lievano Triana M, Arana C, Jaramillo N, Accini J, Botero R, Trujillo Dada F, Sanchez Vallejo G, Hernandez H, Manzur F, Isaza D, Molina D, Gomez Mesa J, Quintero A, Luengas C, Kuchar R, Hajek P, Busak L, Michalik D, Matyasek I, Marusincova I, Kucera D, Jerabek O, Honkova M, Dedek V, Rihacek I, Kos P, Slaby J, Machkova M, Zidkova E, Elbl L, Grunfeldova H, Carda J, Mrozek V, Maly J, Milkovic R, Malecha J, Skalicka H, Oral I, Krcova E, Lisa L, Belohlavek J, Miklik R, Cermak O, Bednarova J, Peroutka Z, Majtan B, Padour M, Spinar J, Dalby Kristensen S, Refsgaard J, Holmvang L, Dixen U, Gustafsson I, Nielsen H, Egstrup K, Jensen LO, Sykulski R, Rasmussen O, Andries A, Gram J, Luckow A, Nielsen G, Sørensen T, Nyman K, Mäkelä J, Strand J, Nieminen S, Taurio J, Kuusela M, Valle T, Pietilä M, Kekki S, Strandberg T, Pansieri M, Decoulx E, Goube P, Labriolle A, Labeque JN, Range G, Cottin Y, Cayla G, Montalescot G, Danchin N, Angoulvant D, Ferrari E, Elbaz M, Dubreuil O, Steg PG, Fontaine C, Vaquette B, Sorbets E, Wilke A, Appel KF, Taggeselle J, Förster A, Toursarkissian N, Schmidt E, Bott J, Al-Zoebi A, Hennig D, Fischer S, Schön N, Sauter J, Simonis G, Nischik R, Rieker W, Schenkenberger I, Behnke T, Klausmann G, Trenk D, Weigmann I, Ganz X, Jeserich M, Peldschus M, Hahn M, Rummel R, Reuter H, Von Münchhausen C, Djacenko S, Von Engelhardt C, Theis E, Hei P, Chan M, Ying M, Wong M, Wai Sing Chu D, Ma R, Siu SC, Tsang CC, Turi T, Motyovszki Á, Merkely B, Király C, Andrássy P, Sárszegi Z, Kiss RG, Fülöp T, Zilahi Z, Édes I, Papp A, Müller G, Czigány A, Zólyomi S, Korányi L, Takács J, Juhász F, Herczeg B, Benczur B, Földi A, Nagy AC, Bakai J, Simon É, Greschik I, Bódi M, Kancz S, Püski L, Nagy L, Kirschner R, Tóth L, Kerényi Z, Simonyi G, Prabhavathi P, Gowdaiah P, Mehta V, Chag M, Gadkari M, Ramamurthee K, Das A, Sawhney JS, Banerjee S, Sathe P, Adhyapak S, Klutstein M, Greenberg G, Lev E, Rozenman Y, Arbel Y, Chorin E, Havakuk O, Nikolsky E, Roguin A, Lewis B, Bashkin A, Ferrario M, Assanelli E, Salvioni A, Senni M, Musumeci G, Piatti P, 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Ramos Lopez G, Garcia Cantu E, De Los Ríos Ibarra M, Padilla F, Pagola Carrasco J, Virgen Carrillo L, Dorantes Garcia J, Askar AN, Aguilar Salinas C, Alcocer Gamba M, Guizar Sanchez C, González Cantú A, Velasco Sánchez R, Carranza Madrigal JM, Martijn J, Eck V, Ronner-Oostenrijk E, The S, Van De Wal R, Zwart P, Nierop P, De Nooijer CR, Werner H, Westendorp I, Van Der Zwaan C, Crijns H, Kietselaer B, Cornel JH, Strikwerda S, Dewilde W, Bos R, De Melker E, Kuijper A, Van Houwelingen K, Louwerenburg H, Plomp J, Dantzig JM, Prins F, Van Kesteren H, Hooft Van Huysduynen-Monraats P, Willems F, Amoroso G, Gravdal SA, Risberg K, Gullestad L, Dahl Hofseth O, Norheim A, Asprusten EA, Nilsen D, Van Den Heuvel C, Gibbs C, Khusrawi A, Arora S, Sandvik J, Tomala T, Lappegård KT, Kjaernli T, Berg-Johansen J, Hagemeier R, Skjelvan G, Rodriguez A, Godoy A, Rodriguez V, Berrospi P, Chavez C, Negron S, Heredia J, Medina F, Manrique H, Cabrera W, Cordova F, Quinteros T, Minchola Haro J, Regalado S, 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Skura M, Pilecki P, Koprowski A, Majchrzak P, Krzyzagórska E, Powierza S, Kaczmarek B, Sliwinska T, Zelazowska K, Wozniak I, Sztembis R, Landa K, Matyszczak-Toniak L, Strojek K, Piepiorka M, Malinowski R, Górska M, Mendyk A, Romanowski L, Zinka E, Reszka Z, Skierkowska J, Uzunow A, Laskowska-Derlaga E, Stanciulescu G, Creteanu M, Spiridon M, Dobreanu V, Iosipescu LC, Vinereanu D, Istratoaie O, Pirvu O, Coman I, Militaru C, Cinteza M, Puntus E, Schekotov V, Kosmacheva ED, Koziolova N, Pavlov P, Supryadkina T, Kopylov P, Kazakov A, Aksentiev S, Didenko Y, Vishneva E, Repin A, Smolenskaya O, Mantserova O, Sementsov D, Khrustalev O, Konstantinov V, Boldueva S, Ezhov A, Privalova E, Chernyavsky A, Kamalov G, Galyavich A, Zubeeva G, Nechaeva G, Treshkur T, Shustov S, Dzhaiani N, Osokina N, Panov A, Shutemova E, Makukhin V, Kropotina T, Tsyba L, Karpov Y, Sizova Z, Ballyuzek M, Tarasov N, Demchenko E, Barbarash O, Kobalava Z, Moiseev V, Markov V, Kuznetsov V, Viktorova I, Sergienko I, Ermoshkina L, Khasanov N, Khlevchuk T, Baglikov A, Shalaev S, Zonova E, Reznik E, Storozhakov G, Haisheva L, Morugova T, Lomakin N, Vishnevsky A, Shvarts Y, Magnitskaya O, Mikhailusova M, Pavlysh E, Libov I, Zateyschikova A, Kostenko V, Edin A, Khovaeva Y, Stryuk R, Khirmanov V, Kanorskiy S, Yakushin S, Zrazhevsky K, Kondrashkina O, Barabashkina A, Zakharov K, Omer H, Bdeir B, Al-Saif S, Al-Faleh H, Al-Shehri A, El-Amin O, Alshehri H, Almutairi F, Bazari R, Antalik L, Krajci P, Urban M, Fazekas F, Pella D, Koleny D, Paulov S, Macek V, Vinanska D, Jamriskova L, Such S, Fulop P, Farsky S, Bugan V, Strbova J, Micko K, Palka J Jr, Sivak V, Makotoko E, Fourie N, Burgess L, Nortje H, Rust Theron FC, Pillai P, Ranjith N, Trokis J, Pillay S, Reddy J, Nunkoo T, Kapp C, Distiller L, Urbach D, Horak A, Van Zyl L, Coetzee K, Bayat J, Dawood S, Mitha I, Padayachee T, Punt Z, Dalby A, Farzana F, Koo BK, Ahn T, Hong SJ, Yoon J, Oh SK, Jeong MH, Kim DI, Chang K, Kim W, Hahn JY, Cha KS, Lee JH, Kim YJ, 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Abstract

BACKGROUND:

Patients with stable coronary artery disease and diabetes mellitus who have not had a myocardial infarction or stroke are at high risk for cardiovascular events. Whether adding ticagrelor to aspirin improves outcomes in this population is unclear.

METHODS:

In this randomized, double-blind trial, we assigned patients who were 50 years of age or older and who had stable coronary artery disease and type 2 diabetes mellitus to receive either ticagrelor plus aspirin or placebo plus aspirin. Patients with previous myocardial infarction or stroke were excluded. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria.

RESULTS:

A total of 19,220 patients underwent randomization. The median follow-up was 39.9 months. Permanent treatment discontinuation was more frequent with ticagrelor than placebo (34.5% vs. 25.4%). The incidence of ischemic cardiovascular events (the primary efficacy outcome) was lower in the ticagrelor group than in the placebo group (7.7% vs. 8.5%; hazard ratio, 0.90; 95% confidence interval [CI], 0.81 to 0.99; P = 0.04), whereas the incidence of TIMI major bleeding was higher (2.2% vs. 1.0%; hazard ratio, 2.32; 95% CI, 1.82 to 2.94; P<0.001), as was the incidence of intracranial hemorrhage (0.7% vs. 0.5%; hazard ratio, 1.71; 95% CI, 1.18 to 2.48; P = 0.005). There was no significant difference in the incidence of fatal bleeding (0.2% vs. 0.1%; hazard ratio, 1.90; 95% CI, 0.87 to 4.15; P = 0.11). The incidence of an exploratory composite outcome of irreversible harm (death from any cause, myocardial infarction, stroke, fatal bleeding, or intracranial hemorrhage) was similar in the ticagrelor group and the placebo group (10.1% vs. 10.8%; hazard ratio, 0.93; 95% CI, 0.86 to 1.02).

CONCLUSIONS:

In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, those who received ticagrelor plus aspirin had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin. (Funded by AstraZeneca; THEMIS ClinicalTrials.gov number, NCT01991795.).

PMID:
31475798
DOI:
10.1056/NEJMoa1908077

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