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Anticoagulation wit...
Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes
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- Kirchhof, P. (författare)
- Atrial Fibrillat Network, Munster, Germany.;Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany.;German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany.
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- Toennis, T. (författare)
- Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany.;German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany.
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- Goette, A. (författare)
- Atrial Fibrillat Network, Munster, Germany.;St Vincenz Hosp Paderborn, Dept Cardiol & Intens Care Med, Paderborn, Germany.
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- Camm, A. J. (författare)
- St Georges Univ London, Cardiovascular & Cell Sci Res Inst, London, England.;Imperial Coll London, London, England.
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- Diener, H. C. (författare)
- Univ Duisburg Essen, Inst Med Informat Biometry & Epidemiol, Dept Neuroepidemiol, Essen, Germany.
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- Becher, N. (författare)
- Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany.;German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany.
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- Bertaglia, E. (författare)
- Azienda Osped Univ Padova, Unita Operat Complessa Cardiol, Padua, Italy.
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- Blomqvist Lundqvist, C. (författare)
- Uppsala universitet,Institutionen för medicinska vetenskaper,Örebro Univ, Sch Med Sci, Fac Med & Hlth, Dept Cardiol, Örebro, Sweden.
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- Borlich, M. (författare)
- Segeberger Kliniken, Ctr Heart, Bad Segeberg, Germany.
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- Brandes, A. (författare)
- Odense Univ Hosp, Dept Cardiol, Odense, Denmark.;Esbjerg Hosp Univ Hosp Southern Denmark, Dept Cardiol, Esbjerg, Denmark.
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- Cabanelas, N. (författare)
- Fernando Fonseca Hosp, Dept Cardiol, Amadora, Portugal.
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- Calvert, M. (författare)
- Natl Inst Hlth & Care Res NIHR, Birmingham Biomed Res Ctr, Ctr Patient Reported Outcome Res, Inst Cardiovasc Sci,Inst Appl Hlth Res, Birmingham, W Midlands, England.;Univ Birmingham, NIHR Appl Res Collaborat West Midlands, Birmingham, W Midlands, England.
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- Chlouverakis, G. (författare)
- Univ Crete, Sch Med, Biostatist Lab, Iraklion, Greece.
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Dan, G. -A (författare)
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- de Groot, J. R. (författare)
- Univ Amsterdam, Amsterdam Univ, Dept Clinical & Expt Cardiol, Ctr Heart,Med Ctr,Amsterdam Cardiovasc Sci, Amsterdam, Netherlands.
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- Dichtl, W. (författare)
- Med Univ Innsbruck, Dept Internal Med Cardiol & Angiol 3, Innsbruck, Austria.
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- Kravchuk, B. (författare)
- Ukraine Acad Med Sci, Natl Inst Cardiovasc Surg, Kiev, Ukraine.
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- Lubinski, A. (författare)
- Med Univ Gdansk, Dept Cardiol & Internal Dis, Gdansk, Poland.
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- Marijon, E. (författare)
- Hop Europeen Georges Pompidou, Div Cardiol, Paris, France.
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- Merkely, B. (författare)
- Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary.
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- Mont, L. (författare)
- Univ Barcelona, Hosp Clin, Barcelona, Spain.;Inst Invest Biomed August Pi Sunyer, Barcelona, Spain.;Ctr Invest Biomed Red Cardiovasc, Madrid, Spain.
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Ozga, A. -K (författare)
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- Rajappan, K. (författare)
- John Radcliffe Hosp, Oxford Univ Hosp NHS Fdn Trust, Dept Cardiac, Oxford, England.
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- Sarkozy, A. (författare)
- Univ Hosp Antwerp, Dept Cardiol, Edegem, Belgium.
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- Scherr, D. (författare)
- Med Univ Graz, Dept Cardiol, Graz, Austria.
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- Sznajder, R. (författare)
- Leszek Giec Upper Silesian Med Ctr, Dept Elect & Heart Failure, Katowice, Poland.
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- Velchev, V. (författare)
- Med Univ Sofia, St Anna Univ Hosp Sofia, Cardiol Clin, Sofia, Bulgaria.
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- Wichterle, D. (författare)
- Inst Clin & Expt Med, Dept Cardiol, Prague, Czech Republic.
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- Sehner, S. (författare)
- Univ Med Ctr Hamburg Eppendorf, Inst Med Biometry & Epidemiol, Hamburg, Germany.
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- Simantirakis, E. (författare)
- Herakl Univ Hosp Herakl, Dept Cardiol, Iraklion, Greece.
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- Lip, G. Y. H. (författare)
- Univ Liverpool, Liverpool Ctr Cardiovasc Sci, Liverpool, Merseyside, England.;Univ Liverpool, Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England.;Aalborg Univ, Dept Clin Med, Danish Ctr Hlth Serv Res, Aalborg, Denmark.
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- Vardas, P. (författare)
- Biomed Res Fdn Acad, Athens, Greece.;Hygeia Hosp Grp, Athens, Greece.
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- Schotten, U. (författare)
- Atrial Fibrillat Network, Munster, Germany.;Maastricht Univ, Dept Cardiol, Maastricht, Netherlands.;Maastricht Univ, Dept Physiol, Maastricht, Netherlands.
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- Zapf, A. (författare)
- Univ Med Ctr Hamburg Eppendorf, Inst Med Biometry & Epidemiol, Hamburg, Germany.
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Atrial Fibrillat Network, Munster, Germany;Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany.;German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany. Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany.;German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany. (creator_code:org_t)
- Massachusetts Medical Society, 2023
- 2023
- Engelska.
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Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 389:13, s. 1167-1179
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- BACKGROUND Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year). CONCLUSIONS Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.)
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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- Av författaren/redakt...
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Kirchhof, P.
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Toennis, T.
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Goette, A.
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Camm, A. J.
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Diener, H. C.
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Becher, N.
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visa fler...
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Bertaglia, E.
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Blomqvist Lundqv ...
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Borlich, M.
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Brandes, A.
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Cabanelas, N.
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Calvert, M.
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Chlouverakis, G.
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Dan, G. -A
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de Groot, J. R.
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Dichtl, W.
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Kravchuk, B.
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Lubinski, A.
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Marijon, E.
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Merkely, B.
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Mont, L.
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Ozga, A. -K
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Rajappan, K.
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Sarkozy, A.
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Scherr, D.
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Sznajder, R.
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Velchev, V.
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Wichterle, D.
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Sehner, S.
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Simantirakis, E.
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Lip, G. Y. H.
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Vardas, P.
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Schotten, U.
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Zapf, A.
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