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N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation.

Collaborators (473)

Navarro Estrada JLC, Nicholls S, Huber K, Schoors D, Nicolau J, Raev D, Mehta S, Lanas Zanetti FT, Gomez E, Pocanic D, Jansky P, Airaksinen J, Montalescot G, Nickenig G, Vardas P, Lee SWL, Kiss RG, Kaul U, Crean P, Kornowski R, De Caterina R, Seung KB, Gaxiola López E, Oude Ophuis T, White H, Halvorsen S, Opolski G, Morais J, Zateyshchikov D, Tan RS, Hatala R, Kovacic D, López Sendón JL, Erlinge D, Hwang JJ, Krittayaphong R, Ongen Z, Ozkor M, Mauri L, Van de Werf F, Andreotti F, Hamm C, Ohman EM, Tijssen JGP, Garasic J, Pehrson S, Kolansky D, MacDonald M, Sturm J, Peeters A, Van Tosh A, Hirsch K, Duronto EA, Macin SM, Trivi MS, Paoletti F, Albisu Di Gennaro JP, Sassone SA, Egido JAA, Hasbani E, Rogers J, Amerena J, Walters D, Oldfield G, Eccleston D, Nelson G, Shetty P, Hoppe U, Sturmberger T, Borin C, Buysschaert I, De Man F, Voet J, Debruyne P, De Vroey F, De Wolf A, Verheye S, Castro Rodriguez J, Flores-Vivian G, de Paola AAV, Moreira Baracioli L, Leite Tanajura LF, Maia LN, Zimmermann S, Dutra O, Botelho R, Précoma DB, Nikolov F, Docheva E, Marchev S, Dzhurova-Stoyneva S, Kamenova Z, Petrov I, Velikov C, Ayala-Paredes F, Cheema A, Hartleib M, Labonte R, Madan M, Martucci G, Bilodeau L, Ducas J, Charbonneau F, Bertrand O, MacDougall A, Billingsley I, Gomez Saenz Laguna RJ, Albornoz Alarcón FJ, Medina Fariña ME, Puentes Rico AA, Castillo Barrios GA, Velez Pelaez S, Gomez Lopez EA, Gomez Mesa JE, Saaibi Solano JF, Montenegro Arenas AC, Starcevic B, Brusich S, Miskulin R, Pintaric H, Bulum J, Alan D, Taborsky M, Linhart A, Spacek R, Klimsa Z, Kryza R, Kellnerova I, Dedek V, Cermak O, Padour M, Zelizko M, Miklik R, Lehto M, Nyman K, Pinola T, Sia J, Silvain J, Carrie D, Mansourati J, Leclercq F, Ferrari E, El Mahmoud R, Dillinger JG, De La Briolle A, Motreff P, Koning R, Khanoyan P, Vanzetto G, Darius H, Dengler T, Haas J, Stellbrink C, Haverkamp W, Schächinger V, Wachter R, Kreis I, Heuer H, Schellong S, Liebetrau C, Möllmann H, Braun-Dullaeus R, Mügge A, Münzel T, Wöhrle J, Frey N, Geisler T, Höllriegel R, Vlachojannis M, Piper C, Schirmer S, Westermann D, Karakas M, Götte A, Ince H, Divchev DG, Tiefenbacher C, Rauch-Kroehnert U, Waltenberger J, Schäufele T, Zarse M, Vorpahl M, Tiroch K, Pörner TC, Hoffmann U, Vester EG, Sievers B, Brachmann J, Schmidt B, Rieber J, Olbrich HG, Natour M, Bergmann MW, Witzenbichler B, Diemert P, Uher T, Stumpf J, Mudra H, Prondzinsky R, Hansen C, Wakili R, Hahalis G, Alexopoulos D, Patsilinakos S, Karvounis H, Mihalis L, Vavouranakis E, Sionis D, Kartalis A, Tziakas D, Kanakakis I, Chan K, Yan BPY, Lam YY, Chow DHF, Lau CL, Lee MKY, Andreka P, Ungi I, Horvath I, Edes I, Ruzsa Z, Vijan VM, Naik A, Karna SK, Thanvi S, Jyotsna M, Gurugubelli R, Karandikar NG, Chouhan N, Gadkari P, Mahon N, McAdam B, Crowley J, Weisz G, Nikolsky E, Atar S, Rozenman Y, Kleiner-Shochat M, Bolognese L, Cardillo MT, Crea F, Cuccia C, Mauro C, Menichelli M, Colonna G, Montinaro A, Moretti C, Musumeci G, Senni M, Tamburino C, Maddestra N, Romeo F, Tespili M, Berti S, Nassiacos D, Picchi A, Yokoyama H, Higuma T, Fusazaki T, Kozuma K, Shimohama T, Shizuta S, Sato K, Hoshizaki H, Hasegawa K, Fujimoto Y, Shimizu W, Hara H, Tanaka S, Nanasato M, Hirayama H, Nakagami T, Zen K, Fujii K, Naruko T, Tsujimoto M, Shinke T, Takahashi A, Yasaka Y, Hosokawa S, Doi M, Takeda K, Ando K, Kawasaki T, Takenaka T, Hiroi S, Suzuki M, Ohta H, Okishige K, Wada A, Haruta S, Koike A, Shibata Y, Hirayama A, Hata Y, Saito K, Saeki T, Yamaguchi J, Cha KS, Kim W, Lee SH, Lee JW, Hwang GS, Cho J, Shim JM, Jeong MH, Park HS, Rha SW, Lee JH, Kim YJ, Kim DI, Hong MK, Llamas Esperon GA, Martínez Sanchez CR, Carrillo Calvillo J, Oude Ophuis AJM, Aksoy I, Haitsma D, van Dantzig JM, Lipsic E, De Swart BRM, Jessurun GAJ, van de Wal RMA, Nunn C, Devlin G, Gullestad L, Larsen T, Brekk AK, Pönitz V, Grzelakowski P, Gniot J, Musial W, Kleinrok A, Wozakowska-Kaplon B, Raczak G, Elmasri N, Loboz-Grudzien K, Wysokinski A, Gabriel H, Monteiro P, Costa M, Calé R, Pinto F, Ferreira RC, Gordeev I, Freidlin M, Levashov S, Khasanov N, Kamalov G, Kosmacheva E, Ivanenko V, Guseva G, Novikova T, Treshkur T, Barbarash O, Sukmanova I, Bokeriya O, Lim TW, Juhas S, Hudec M, Hranai M, Cercek M, Kanic V, Reschner H, Martín V, González Juanatey JR, Zamorano JL, Bruguera Cortada J, López de Sa Areses E, Cequier A, Ortas R, Diarte JA, Rumoroso JR, Hernández JM, Martínez A, Núnez Gil I, Guisado A, Galve E, Mainar Latorre L, Kastberg R, Hornestam B, Löfgren M, Engdahl J, Swahn E, Dolata CD, Sangeri K, Bhiladvala P, Samad BA, Hsieh IC, Lu TM, Chen CP, Lo PH, Lee CH, Lin TH, Tseng WK, Sritara P, Wongcharoen W, Wongvipaporn C, Oguzhan A, Nadir A, Goktekin O, Karaca M, Duygu H, Dursun H, Kozan O, Aydogdu S, Acikel S, Yeter E, Okuyan E, Melek M, Gurmen T, Eren M, Demir M, Yilmaz O, Kirma C, Boztosun B, Turen S, Butler R, Lee K, Witherow F, Ramsewak A, Clifford P, Talwar S, Chitkara K, Swanson N, Gershlick AH, Joffe I, Crenshaw J, Iwaoka R, Browne KF, Bouchard A, Elmariah S, Yeh R, Aboufakher R, Chakravarthy M, Westerhausen D, Wright WP Jr, Gonzalez RE, Caldera AE, Crowley S, Ginete W, Haddad N, Kabour A, Vasaiwala S, Banerjee S, Chang D, Jain A, Rosenberg M, Shehadeh A, Tang A, Tandar A, Felten W, Parashara D, Sorof S, Bernstein RC, Butman S, Sharma M, Angiolillo D, Abedallhadi S, Devarapalli S, Erickson B, Fail P, Fong P, Khan M, Monroe VS, Perez J, Sudarshan S, Corbelli J, Zelman RB, Mirza Z, Talreja D, Davis S.

Author information

1
From the Baim Institute for Clinical Research (C.P.C., J.L.J.), Brigham and Women's Hospital, Heart and Vascular Center, and Harvard Medical School (C.P.C., D.L.B.), and the Cardiology Division, Massachusetts General Hospital, and Harvard Medical School (J.L.J.) - all in Boston; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (G.Y.H.L.), Boehringer Ingelheim, Bracknell (R.H., J.M.), and Imperial College, London, London (P.G.S.) - all in the United Kingdom; Cleveland Clinic, Cleveland (S.G.E.); Kyoto University, Department of Cardiovascular Medicine, Kyoto, Japan (T.K.); Aarhus University Hospital, Skejby, Denmark (M.M.); University Heart and Vascular Center, Budapest, Hungary (B.M.); Klinikum der Stadt Ludwigshafen am Rhein, Medizinische Klinik B, Ludwigshafen (U.Z.), Boehringer Ingelheim, Ingelheim (S.G., M.N., E.K.), and Johann Wolfgang Goethe University, Department of Medicine, Division of Cardiology, Frankfurt am Main (S.H.H.) - all in Germany; St. Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.B.); and the French Alliance for Cardiovascular Trials, F-CRIN Network, DHU FIRE, Université Paris Diderot, INSERM Unité 1148, and Hôpital Bichat Assistance Publique, Paris (P.G.S.).

Abstract

BACKGROUND:

Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.

METHODS:

In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also tested for the noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization.

RESULTS:

The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; P<0.001 for noninferiority; P<0.001 for superiority) and 20.2% in the 150-mg dual-therapy group as compared with 25.7% in the corresponding triple-therapy group, which did not include elderly patients outside the United States (hazard ratio, 0.72; 95% CI, 0.58 to 0.88; P<0.001 for noninferiority). The incidence of the composite efficacy end point was 13.7% in the two dual-therapy groups combined as compared with 13.4% in the triple-therapy group (hazard ratio, 1.04; 95% CI, 0.84 to 1.29; P=0.005 for noninferiority). The rate of serious adverse events did not differ significantly among the groups.

CONCLUSIONS:

Among patients with atrial fibrillation who had undergone PCI, the risk of bleeding was lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864 .).

PMID:
28844193
DOI:
10.1056/NEJMoa1708454
[Indexed for MEDLINE]
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