The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients
With Atrial Fibrillation (RELY-ABLE) Study.
Author(s): Connolly SJ(1), Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA,
Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ,
Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD,
Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky
P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J,
Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS,
Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles
E, Yusuf S.
Affiliation(s): Author information:
(1)Population Health Research Institute, McMaster University and Hamilton Health
Sciences, Hamilton, Canada.connostu@phri.ca
Publication date & source: 2013, Circulation. , 128(3):237-43
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.
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