Format

Send to

Choose Destination
N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

Collaborators (727)

Dangas GD, Windecker S, Mehran R, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, van Amsterdam RGM, Thomitzek K, Wildgoose P, Colombo A, Prendergast B, Makkar R, Mack M, Webb J, Marx SO, Corvaja N, Ghodsi N, DiStefano D, Kaufman D, Meller J, Milstein M, Weinberger J, Young Cha J, Fox K, Block P, Pocock S, de Vries T, Kirsch B, Verspohl G, van Amsterdam R, Guimaraes A, Alkema M, Altema J, Franklin-Bond T, Welsh R, Temple T, Parrotta J, von Lewinski D, Legrand V, Kala P, Søndergaard L, Tchétché D, Möllmann H, Baldus S, Schäfer U, Tamburino C, de Winter R, Gullestad L, Buszman P, Moreno R, James S, Hildick-Smith D, Herrmann H, Dauerman H, Kolesnik E, Verheyen N, Schmidt A, Kastner J, Schrutka L, Stojkovic S, Scherzer S, Koller L, Lang I, Kreiner G, Pichler P, Weidenauer D, Adlbrecht C, Strouhal A, Delle Karth G, Fiegl N, Huber M, Secky L, Schober A, Eber B, Lassnig E, Porodko M, Maurer E, Hoppe U, Hammerer M, Prinz E, Wintersteller W, Lichtenhauer M, Wernly B, Steinwender C, Grund M, Lambert T, Nahler A, Huber K, Wessely E, Egger F, Smetana P, Jager B, Geppert A, Andric T, Lancellotti P, Gach O, Benit E, Ferdinande B, Dens J, Cantor W, Peniston C, Prabhakar M, Hussain F, Teng C, Tyrrell B, Meyer S, Shanks M, Butler C, Horlick E, Osten M, Wood D, Ramanathan K, Htun NM, Attinger A, Della Siega A, Pelzer E, Robinson S, Nadra I, Lounsbury N, Sorenson S, Martin E, Munoz A, Iqbal MB, Jesshope S, Nadeem SN, Sullivan J, Wood J, Beydoun H, Radhakrishnan S, Fremes S, Wijeysundera H, Feld Y, Toma J, Elbaz-Greener G, McCaig K, Asgar A, Bonan R, Dorval JF, Ibrahim R, Cartier R, Demers P, Lamarche Y, Basmadjian A, Cademartiri F, Pham M, Robillard J, Henri C, Terrone D, Toleva O, Kass M, Šebo M, Třetina M, Kočka V, Linková H, Sulženko J, Bednář F, Toušek P, Zelίzko M, Bronislav J, Zelizko M, Vymetalova J, Barciakova L, Kotrč M, de Backer O, Jørgensen T, Dagnegard H, Østergaard L, Veien KT, Christensen NL, Nissen H, Fallesen C, Terkelsen CJ, Christiansen E, Mathiassen ON, Noergaard B, Gilard M, Didier R, Nicol P, Picart M, Castellant P, Dumonteil N, Sauguet A, St Etienne C, Ivanes F, Angoulvant D, Genet T, Delepine S, Pinaud F, Caussin C, Veugeois A, Van Belle E, Juthier F, Mugnier A, Rousse N, Himbert D, Urena M, Abtan T, Kim WK, Fischer-Rasokat U, Renker M, Osman N, Liebetrau C, Walther T, Doss M, Baumgarten H, Schmidt S, Wagner A, Lauer B, Richter S, Reents W, Zacher M, Barth S, Lenos A, Toelg R, Abdel-Wahab M, Richardt G, Schwarz B, El Marwardy M, Sulimov D, Kebernik J, Kaur J, Landt M, Arnold M, Achenbach S, Lang S, Bal Z, Marwan M, Gruber M, Roether J, Lengerer S, Stangl V, Baldenhofer G, Dreger H, Schoebel C, Taubert T, Meissler S, Herold J, Braun-Dullaeus R, Wiegand C, Wagner M, Nowak S, Gori T, Schulz E, Münzel T, Siedel P, Hollmann S, Ruff B, Debl K, Fischer M, Endemann D, Resch M, Ergresits JJ, Strack C, Werner N, Nickenig G, Twelker K, Adam M, Stundl A, Fuchs A, Halbach M, Von Hodenberg E, Grunebaum JP, König W, Hengstenberg C, Husser O, Braun S, Pellegrini C, Lanig C, Santer D, Ates S, Schacher N, Joner M, Abt B, Wegehenkel E, Mootz R, Kohler H, Geisler T, Borst O, Müller K, Droppa M, Landmesser U, Fröhlich G, Lauten A, Heuberger A, Steinbeck L, Wewetzer W, Friebel J, Hoting M, Girker G, Kempfert J, Meyer A, Unbehaun A, Polzin A, Dannenberg L, Kleinebrecht L, Zeus T, Sotemann D, Afzal SS, Piayda KD, Zako S, Mohring AM, Schäfer S, Schmitt S, Deuschl F, Karakas M, Sydow K, Conradi L, Schofer N, Moser A, Widder J, Tillmanns J, Zwadlo C, Kempf T, Zimmermann A, Abou Moulig V, Haenselmann A, Tongers J, Knoll V, Haude M, Degen H, Rottländer D, Niethammer M, Schächinger V, Boes C, Bufe A, Guelker J, Bansemir L, Ilousis D, Jansen R, von Zur Muhlen C, Reinoehl J, Ahrens I, Rilinger J, Stachon P, Wennekes Neagu V, Bugger H, Diehl P, Thiele H, Haußig S, Linke A, Hoellriegel R, Holzhey D, Winzer E, Woitek F, Kiefer P, Desch S, Binner C, Mangner N, Frey N, Frank D, Lambers M, Kuhn C, Deichstetter M, Brück B, Nagel B, Schlichting A, Eggebrecht H, Lindhoff-Last E, Schulze-Waltrup N, Blumenstein J, Froemke J, Marks M, Sahin D, Bourhaial H, Lohmann M, Schroeder J, Brandenburg V, Wöhrle J, Rottbauer W, Seeger J, Gonska B, Markovic S, Bothner C, Scharnbeck D, Awad B, Baumhardt M, Hartveg P, Rodewald C, Hoffmeister U, Dragomir S, Scheller B, Schirmer S, Millenaar D, Lavall D, Kratz M, Tiroch K, Gunzenhausen P, Bleiziffer S, Ruge H, Kreuzpointner R, Goppel G, Erlebach M, Firschke C, Hambrecht R, Fiehn E, Kuehl M, Osteresch R, Pader P, Grunwald S, Ben Ammar A, Wienbergen F, Fach A, Kudaibergenov H, Martel-Coll A, Capranzano P, Di Simone E, Picci A, Bruschi G, Canova P, Nava S, Soriano F, Colombo P, Valsecchi O, Fiocca L, Serino F, Vassileva A, Collaku E, Musumeci G, Reimers B, Malanchini G, Pagnotta P, Pisaniello M, Rossi M, Ferrante G, Gasparini G, Parenti D, Stefanini G, Panico C, Tarantini G, Figliozzi S, Napodana M, Fraccaro C, Barioli A, Matteo M, Giannini F, Latib M, Gitto M, Mangieri A, Pagliaro B, Petronio AS, De Carlo M, Angelillis M, Giannini C, Spontoni P, Tijssen R, Kalkman D, Nassif M, Van Mieghem N, Daemen J, Kroon H, van Gils L, El Faquir N, Rahhab Z, Meuwissen M, Dewilde W, den Heijer P, Schaap J, Vos J, Hosseth A, Jenssen K, Bendz B, Busund R, Steigen T, Erling Dahl P, Cappelen Endresen P, Bleie Ø, Loland KH, Packer E, Sandberg S, Fil W, Domaradzki W, Swiatkiewicz M, Witkowski A, Chmiielak Z, Dabrowski M, Jastrzębski J, Kosek M, Wilimski R, Arendarczyk A, Galeote García G, Jiménez Valero S, Gemma D, Sánchez Recalde A, Del Valle R, Moris C, Avanzas P, Hernandez-Garcia JM, Muñoz García A, Alonso Briales J, Chueca González EM, Dominguez Franco A, de Lemos R, Sabate M, Riba RA, Enriquez MH, Barrabes A, Costa F, Cequier A, Salas M, Carol GM, Nato M, Christersson C, Jönelid B, Varenhorst C, Räber L, Moschovitis A, Pilgrim T, Stortecki S, Praz F, Vollenbroich R, Holler R, Haener J, Lanz J, Capek L, Jeger R, Kaiser C, Twerenbold R, Fahrni G, Wein B, Buser P, Toggweiler S, Cuculi F, Brinkert M, Jamshidi P, Holy E, Binder R, Nietlispach F, Templin C, Taramasso M, Maisano F, Maier W, Moccetti T, Grazia Rossi M, Monti C, Carmela C, Elena P, Binda E, Drljenica C, Khawaja Z, Hilling Smith R, Cunnington M, Malkin C, Kovac J, Roberts E, Hancock J, Redwood S, Joseph J, Allen C, Khawaja MZ, Manoharan G, Owens C, Spence M, McQuillan C, Uren N, Pessotto R, Cruden N, Roberts D, Chua Y, Ghosh A, Tay J, Curzen N, Rawlins J, Calver A, Miskolczi S, Tsang G, Ohri S, Edwards R, Zaman A, Das R, Banning A, Kharbanda R, MacCarthy P, Adalati O, Tzalamouras V, Roy J, Kini A, Sharma S, Kovacic J, Khan A, Ragosta M, Ailawadi G, Ghanta R, Kern J, Lim DS, Yarboro L, Anwaruddin S, Chang G, Desai N, Giri J, Li R, Vallabhajosyula P, Pitts J, Szeto W, Szerlip M, Brinkman W, Brown D, Gopal A, Gunukula S, Harrington K, Ryan W, Potluri S, Holper E, Kindsvater S, Davidson C, Flaherty J, Malaisrie SC, Thinh Pham D, Ricciardi M, Sweis R, Churyla A, Gupta A, Griffith BP, Gottlieb S, Terrien E, Moossavi S, Chava S, El-Haddad M, Worgan B, Abernethy A, Rambod M, Lahoud R, Alkhalil I, Azarbal A, Chhatriwalla A, Cohen D, Baron S, Hart A, Allen K, Applegate R, Zhao D, Gandhi S, Feldman T, Salinger M, Levisay J, Guerrero M, Russell H, Petrossian G, Balan P, Arain S, Dhoble A, Loyalka P, Smalling R, Kleiman N, Barker C, Little S, Ramchandani M, Reardon M, Reyes M, Sarker K, Gray T, Reul S, Ben-Dor I, Satler L, Kereiakes D, Bailey K, Bruce J, Sarembock I, Choo J, O'Neill W, Greenbaum A, Eng M, Wang D, Cohen M, De Marchena E, Alfonso C, Dyal M, Martinez C, Spriggs S, Navas J, Barry M, Babaliaros V, Thourani V, Devireddy C, Harjai K, Young B, Hopkins E, Manganiello M, Agarwal S, Meraj P, Rutkin B, Jauhar R, Boutis L, Cheng W, Nakamura M, Chakravarty T, Khouw S, Sorajja P, Poulose A, Pedersen W, Goessl M, Kapadia S, Kirshnaswamy A, Mick S, Bakaeen F, Navia J, Kipperman R, Cohen B, Brown J, Slater J, Xydas S, Magovern C, Polomsky M, Genereux P, Popma J, Pinto D, Laham R, Cutlip D, Guibone K, Papazian S, Soffer D, Angiolillo D, Bass T, Antoun P, Pirris J, Zenni M, Suryadevera S, Mooney J, Luber J, Reiter R, Mixon T, Lawrence M, Chawla A, McAllister D, Yazdani S, Sherwood M, Geloo N.

Abstract

BACKGROUND:

Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.

METHODS:

We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns.

RESULTS:

After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).

CONCLUSIONS:

In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

PMID:
31733180
DOI:
10.1056/NEJMoa1911425

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center