Τίτλος:
A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Dangas, G.D.
Tijssen, J.G.P.
Wöhrle, J.
Søndergaard, L.
Gilard, M.
Möllmann, H.
Makkar, R.R.
Herrmann, H.C.
Giustino, G.
Baldus, S.
de Backer, O.
Guimarães, A.H.C.
Gullestad, L.
Kini, A.
von Lewinski, D.
Mack, M.
Moreno, R.
Schäfer, U.
Seeger, J.
Tchétché, D.
Thomitzek, K.
Valgimigli, M.
Vranckx, P.
Welsh, R.C.
Wildgoose, P.
Volkl, A.A.
Zazula, A.
van Amsterdam, R.G.M.
Mehran, R.
Windecker, S.
GALILEO Investigators
Περιοδικό:
The New England journal of medicine
Εκδότης:
Massachussetts Medical Society
Λέξεις-κλειδιά:
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
DOI:
10.1056/NEJMoa1911425
