TY - JOUR
TI - A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
AU - Dangas, G.D.
AU - Tijssen, J.G.P.
AU - Wöhrle, J.
AU - Søndergaard, L.
AU - Gilard, M.
AU - Möllmann, H.
AU - Makkar, R.R.
AU - Herrmann, H.C.
AU - Giustino, G.
AU - Baldus, S.
AU - de Backer, O.
AU - Guimarães, A.H.C.
AU - Gullestad, L.
AU - Kini, A.
AU - von Lewinski, D.
AU - Mack, M.
AU - Moreno, R.
AU - Schäfer, U.
AU - Seeger, J.
AU - Tchétché, D.
AU - Thomitzek, K.
AU - Valgimigli, M.
AU - Vranckx, P.
AU - Welsh, R.C.
AU - Wildgoose, P.
AU - Volkl, A.A.
AU - Zazula, A.
AU - van Amsterdam, R.G.M.
AU - Mehran, R.
AU - Windecker, S.
AU - GALILEO Investigators
JO - The New England journal of medicine
PY - 2020
VL - 382
TODO - 2
SP - 120-129
PB - Massachussetts Medical Society
SN - null
TODO - 10.1056/NEJMoa1911425
TODO - acetylsalicylic acid;  clopidogrel;  rivaroxaban;  acetylsalicylic acid;  antithrombocytic agent;  blood clotting factor 10a inhibitor;  clopidogrel;  rivaroxaban, aged;  Article;  bleeding;  cardiovascular mortality;  clinical outcome;  controlled study;  drug efficacy;  drug safety;  female;  human;  incidence;  major clinical study;  male;  multicenter study;  priority journal;  randomized controlled trial;  side effect;  thromboembolism;  transcatheter aortic valve implantation;  very elderly;  atrial fibrillation;  bleeding;  cardiovascular disease;  clinical trial;  combination drug therapy;  comparative study;  heart valve prosthesis;  intention to treat analysis;  Kaplan Meier method;  mortality;  thromboembolism, Aged;  Aged, 80 and over;  Aspirin;  Atrial Fibrillation;  Cardiovascular Diseases;  Clopidogrel;  Drug Therapy, Combination;  Factor Xa Inhibitors;  Female;  Heart Valve Prosthesis;  Hemorrhage;  Humans;  Intention to Treat Analysis;  Kaplan-Meier Estimate;  Male;  Platelet Aggregation Inhibitors;  Rivaroxaban;  Thromboembolism;  Transcatheter Aortic Valve Replacement
TODO - 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. Copyright © 2019 Massachusetts Medical Society.
ER -