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N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.

Collaborators (492)

Hrabar AD, Caccavo A, Licheri A, Alvarisqueta AF, Abud AM, Estrada C, Sueldo CP, Montenegro E, Duronto EA, Blanco FL, Berra FC, Ferré Pácora FA, Lopez GM, Calvo G, Azize GM, Luquez HA, Ramos H, Colombo HR, Guetta JN, Resk JH, Medrano JC, Costabel JP, Carbajales J, Schiavi LB, Saggia LI, Oliva MA, Casas M, Snitman M, Litvak Bruno MR, Cluigt N, Vita NA, Guzman PN, Zangroniz PD, Villarreal RA, Bonato RR, Nani S, Sassone SA, Macin SM, Arias VE, Alexopoulos C, Brieger D, Colquhoun D, Heddle WF, Podczeck-Schweighofer A, Ebner C, Scherr D, Lang IM, Huber K, Guedes A, Convens C, Cools F, Vercammen J, Bartunek J, Sinnaeve P, Rossenbacker T, Pereira AH, Kormann AM, Freitas AF, Fonseca AGT, de Quadros A, Janella BL, Kalil CAA, Rodrigues CS, Precoma DB, Ramacciotti E, Resende ES, Figueiredo EL, Manenti ER, Costa FAD, Feitosa G, Reis HJL, Ribeiro HB, de Moraes JBMX Jr, Dantas JMM, Nicolau JC, Saraiva JFK, Reolão J, Piegas LS, Oliveira LFA, Ritt LEF, Braile MCVB, Dracoulakis MA, de Santos MON, Leães PE, Filho PP, Rech RL, Ueda R, Silvestrini TL, Michalaros YL, Manolova A, Mihov AK, Yatseva B, Velikov C, Raev DH, Markov D, Vassilev D, Georgiev E, Benov HO, Daskalov I, Petrov IP, Milanova M, Shehova-Yankova NS, Lazov PV, Beleva S, Marchev ST, Gelev VL, Tyrrell B, Wong B, Dion D, LaFlamme D, Rupka DW, Shukla D, Sabbah E, Nadra IJ, Bata I, Cherry JM, Toleva O, Dehghani P, Vijayaraghavan R, Welsh R, Bagur R, Labonte RE, Vizel S, Fort S, Huynh T, Quan VH, Pesant Y, Isaza D, Accini Mendoza JL, Gomez JE, Jaramillo Gomez NI, Knezevic A, Ruzic A, Horvat D, Milicic D, Selthofer-Relatic K, Pesek K, Pravecek MK, Kovacic M, Manola S, Persic V, Alan D, Belohlavek J, Larsen CT, Brønnum-Schou J, Veien KT, Christensen LS, Maeng M, Steffensen R, Angoulvant D, Beygui F, Range G, Cayla G, Aupetit JF, Elbaz M, Delarche N, Meneveau N, Ghanem A, Hagendorff A, Wilke A, Hummel A, Axthelm C, Kadel C, Langer C, Stellbrink C, Jacobshagen C, Gross CM, Blessing EEB, Minden HH, Darius H, Bogossian H, Wienbergen H, Ebelt H, Dreger H, Thiele H, Ince H, Akin I, Eitel I, Kreis I, Appel KF, Maier L, Bergmann M, Moser M, Toursarkissian N, Menck N, Ritter O, Bernhardt P, Nordbeck P, Stöhring R, Schwinger R, Braun-Dullaeus RC, Maier SKG, Schellong S, Steiner S, Rudolph T, Dengler TJ, Geisler T, Rauch-Kröhnert U, Jung W, Jungmair W, Komócsi A, Papp A, Vértes A, Mohácsi A, Herczeg B, Merkely B, Dézsi CA, Kis E, Lakatos F, Kerecsen G, Piros GA, Takács J, Tomcsányi J, Keltai K, Kovács Z, Mathur A, Baxi HA, Narendra J, Gupta J, Kumbla M, Jamwal NK, Arora P, Katz A, Shotan A, Schiff E, Freedberg NA, Amir O, Hussein O, Kracoff OH, Alcalai R, Adawi SY, Viskin S, Hayek T, Hasin Y, Rozenman Y, Nam CW, Lee CW, Choi DJ, Jeon DS, Park HW, Son JW, Jeong JO, Cha KS, Oh S, Rha SW, Park YH, On YK, Bazzoni Ruiz AE, Valdespino AR, Castro Montes BE, Ramos Lopez GA, Llamas Esperón GA, Solache G, Macías García JS, Leiva-Pons JL, De Los Rios Ibarra MO, Willems FF, Beyerbacht HP, van de Wal R, Hysing J, Lappegard KT, Vinge LE, Halvorsen S, Pönitz V, Chavez Ayala CA, Medina Palomino FA, Garcia Matheus JC, Włodarczak A, Budaj A, Lubinski A, Czarnecka D, Wojciechowski D, Skonieczny G, Kasprzak JD, Wranicz JK, Szachniewicz J, Kincel KK, Zmudka K, Lesiak M, Piekarski M, Wujkowski M, Lica-Gorzynska M, Miekus P, Feusette P, Bartkowiak R, Korzeniak R, Sinkiewicz W, Musial W, Krolikowski Z, Gaspar A, Pinto F, Almeida F, Martinez J, Brandão L, Santos LM, Mateus P, Monteiro P, Pernencar S, Mornoş C, Olinic DM, Vinereanu D, Zdrenghea DT, Ortan FO, Cinteza M, Popescu M, Voicu O, Todea SBF, Babes V, Vishnevskiy AY, Kuimov AD, Duplyakov DV, Kosmacheva E, Pokushalov E, Gordeev IG, Zrazhevskiy KN, Sorokin LA, Ermoshkina LG, Zykov MV, Ruda MY, Bulashova O, Smolenskaya OG, Orlikova OV, Grishaev SL, Shalaev SV, Boldueva SA, Kuznetsov V, Makukhin V, Kostenko V, Shvarts Y, Kobalava ZD, Selakovic A, Tosic BP, Sakac DB, Pavlovic M, Dekleva M, Tasic NM, Hinic S, Jozic T, Potpara T, Dzupina A, Pella D, Majercak I, Striezova I, Fedacko J, Gonsorcik J, Fecik J, Selecky J, Antalik L, Hranai M, Gocar M, Kokles M, Oriesek R, Regueiro A, Ibánez B, Djurovic DP, Gutierrez Ibañes E, Ridocci-Soriano F, Diaz Fernandez J, Artaecheverria Zuazo JJ, Escudier Villa JM, Nuñez Villota J, Sanmartin Fernandez M, Chinchurreta Capote PA, Muñoz Aguilera R, Vera Ripoll T, Mainar Tello V, Björklund F, Jensen J, Andersson J, Lauermann J, Hamid M, Angerås O, Hijazi Z, Windecker S, Fischer TA, Yagensky AV, Goloborodko BI, Kyrychenko II, Vakaliuk IP, Kovalskyy I, Rishko MV, Sydor N, Karpenko OI, Parkhomenko OM, Koval OA, Godlevska O, Zhurba S, Maslovskyi VY, Netiazhenko VZ, Tashchuk VK, Shcherbak VP, Tseluyko VI, Cooke A, Wrigley B, Francis CM, Barr C, Gorog DA, Lip GYH, Irving J, Mills J, Storey RF, Levy T, Cheema AA, Salacata AS, Tenaglia AN, Meholick AW, Vedere AR, Patrello AJ, Spaedy A, Martin AC, Holland BH, Duffy BK, Schuler B, Treasure CB, Paraboschi C, Pickett CA, Rowan CJ, Longnecker CR, Hess CN, Hinchman DA, Schneider DJ, Murdock DK, Baldwin DE, Flores EA, Sirulnick EJ, Ahmad F, Aggarwala G, Dhar G, Kichura GM, Turitto G, Sampognaro GC, Sharma GK, Chandna H, Truong HTD, Poock J, Walia JS, Zelenka JT, Amin JK, Foucauld J, Chambers J, Abbott JD, Strobel JS, Dy JR, Nour KA, Sullenberger LE, Younis LT, Gonzales L, Chane M, Foster MT, King MY, Grabarczyk MA, Izzo MR, Leesar MA, Bernabei MA, Cavender MD, Janik MJ, Buchbinder M, Arcarese M, Yeh M, Sheth MJ, Sinno MC, Shoukfeh MF, Alhaddad M, Ranadive NV, Jaffrani NA, Little NK, Shammas N, Assi NA, Almousalli O, Chan P, Horwitz PA, Rozeman PA, Singh P, Aggarwal R, Gopinathannair R, Manshadi R, Korabathina R, Gilmore RM, Feldman RB, Schnitzler RN, Harrison RW, Gandhi SN, Graham S, Krueger SK, Jones SE, Rowe SK, Bazaz SB, Haddad TM, Povsic TJ, Badami UA, Abernethy WB, Mirza ZA.

Abstract

BACKGROUND:

Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear.

METHODS:

In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events.

RESULTS:

Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group.

CONCLUSIONS:

In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).

PMID:
30883055
DOI:
10.1056/NEJMoa1817083
[Indexed for MEDLINE]

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