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http://hdl.handle.net/2445/175933
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DC Field | Value | Language |
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dc.contributor.author | Dangas, George D. | - |
dc.contributor.author | Tijssen Jan G.P. | - |
dc.contributor.author | Wöhrle, Jochen | - |
dc.contributor.author | Søndergaard, Lars | - |
dc.contributor.author | Gilard, Martine | - |
dc.contributor.author | Möllmann, Helge | - |
dc.contributor.author | Makkar, Raj R. | - |
dc.contributor.author | Herrmann Howard C. | - |
dc.contributor.author | Giustino, Gennaro | - |
dc.contributor.author | Baldus, Stephan | - |
dc.contributor.author | Backer, Ole de | - |
dc.contributor.author | Guimarães, Ana H.C. | - |
dc.contributor.author | Gullestad, Lars | - |
dc.contributor.author | Kini, Annapoorna | - |
dc.contributor.author | von Lewinski, Dirk | - |
dc.contributor.author | Mack, Michael | - |
dc.contributor.author | Moreno, Raúl | - |
dc.contributor.author | Schäfer, Ulrich | - |
dc.contributor.author | Seeger, Julia | - |
dc.contributor.author | Tchétché, Didier | - |
dc.contributor.author | Thomitzek, Karen | - |
dc.contributor.author | Valgimigli, Marco | - |
dc.contributor.author | Vranckx, Pascal | - |
dc.contributor.author | Welsh, Robert C. | - |
dc.contributor.author | Wildgoose, Peter | - |
dc.contributor.author | Volkl, Albert A. | - |
dc.contributor.author | Zazula, Ana | - |
dc.contributor.author | van Amsterdam, Roland G.M. | - |
dc.contributor.author | Mehran, Roxana | - |
dc.contributor.author | Windecker, Stephan | - |
dc.contributor.author | Cequier Fillat, Àngel R. | - |
dc.contributor.author | GALILEO Investigators | - |
dc.date.accessioned | 2021-03-31T11:06:49Z | - |
dc.date.available | 2021-03-31T11:06:49Z | - |
dc.date.issued | 2020-01-09 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/175933 | - |
dc.description.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.). | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1911425 | - |
dc.relation.ispartof | New England Journal of Medicine, 2020, vol. 382, num. 2, p. 120-129 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1911425 | - |
dc.rights | (c) Massachusetts Medical Society, 2020 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Aspirina | - |
dc.subject.classification | Ús terapèutic | - |
dc.subject.classification | Catèters | - |
dc.subject.other | Aspirin | - |
dc.subject.other | Therapeutic use | - |
dc.subject.other | Catheters | - |
dc.title | A controlled trial of rivaroxaban after transcatheter aortic-valve replacement | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 706481 | - |
dc.date.updated | 2021-03-31T11:06:49Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31733180 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
Files in This Item:
File | Description | Size | Format | |
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706481.pdf | 339.17 kB | Adobe PDF | View/Open |
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