About: The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study     Goto   Sponge   NotDistinct   Permalink

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  • Background During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. Methods and Results Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. Conclusions During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. Clinical Trial Registration URL: . Unique identifier: NCT00808067.
  • Background During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. Methods and Results Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. Conclusions During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. Clinical Trial Registration URL: . Unique identifier: NCT00808067. (en)
Title
  • The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study
  • The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study (en)
skos:prefLabel
  • The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study
  • The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study (en)
skos:notation
  • RIV/00064203:_____/13:10209573!RIV14-MZ0-00064203
http://linked.open...avai/predkladatel
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • I
http://linked.open...iv/cisloPeriodika
  • 3
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 85402
http://linked.open...ai/riv/idVysledku
  • RIV/00064203:_____/13:10209573
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • stroke; hemorrhage; dabigatran; atrial fibrillation (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • AU - Australské společenství
http://linked.open...ontrolniKodProRIV
  • [07F8859FB41F]
http://linked.open...i/riv/nazevZdroje
  • Circulation
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 128
http://linked.open...iv/tvurceVysledku
  • Heidbuchel, Hein
  • Jánský, Petr
  • Ezekowitz, Michael D.
  • Alings, Marco
  • Amerena, John V.
  • Avezum, Alvaro
  • Baumgartner, Iris
  • Brueckmann, Martina
  • Budaj, Andrzej J.
  • Chen, Jyh-Hong
  • Connolly, Stuart J.
  • Dans, Antonio L.
  • Darius, Harald
  • Di Pasquale, Giuseppe
  • Eikelboom, John
  • Ferreira, Jorge
  • Flaker, Greg C.
  • Flather, Marcus D.
  • Franzosi, Maria Grazia
  • Golitsyn, Sergey P.
  • Halon, David A.
  • Hohnloser, Stefan H.
  • Huber, Kurt
  • Kamensky, Gabriel
  • Keltai, Matyas
  • Kim, Sung Soon
  • Oldgren, Jonas
  • Pogue, Janice
  • Reilly, Paul A.
  • Wallentin, Lars
http://linked.open...ain/vavai/riv/wos
  • 000321897400018
issn
  • 0009-7322
number of pages
http://bibframe.org/vocab/doi
  • 10.1161/CIRCULATIONAHA.112.001139
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