Digoxin in patients with permanent atrial fibrillation: data from the RACE II study

doi:10.1016/j.hrthm.2014.06.007

Digoxin in patients with permanent atrial fibrillation: data from the RACE II study

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation.

OBJECTIVES: To assess the association of digoxin with cardiovascular (CV) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF: A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets.

METHODS: The primary outcome was a composite of CV morbidity and mortality. Secondary outcomes included CV hospitalization and all-cause mortality or heart failure (HF) hospitalization. Of the 614 patients, 608 (99%) completed the dose-adjustment phase. Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up. The median follow-up period was 2.9 years (interquartile range 2.7-3.0 years).

RESULTS: In total, 284 patients (46.7%) used digoxin after the dose-adjustment phase (median dosage 0.250 mg; interquartile range 0.0625-0.750 mg). These patients were more often women, previously admitted for HF, had an increased left ventricular end-systolic diameter, and more often randomized to strict rate control. By using Cox proportional hazards regression analysis, the use of digoxin was not associated with an increased risk for the primary and secondary outcomes. For the primary outcome, the 3-year estimated cumulative incidence was 12.9% vs 13.4% in the digoxin group vs the no-digoxin group (unadjusted hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.62-1.52). Incidence was 19.4% vs. 19.5% for CV hospitalization (unadjusted HR 1.00; 95% CI 0.69-1.45) and 6.6% vs. 9.9% for all-cause mortality or HF hospitalization (unadjusted HR 0.62; 95% CI 0.34-1.13) in the digoxin group vs the no-digoxin group.

CONCLUSION: The use of digoxin was not associated with increased morbidity and mortality.

Original language	English
Pages (from-to)	1543-50
Number of pages	8
Journal	Heart Rhythm
Volume	11
Issue number	9
DOIs	https://doi.org/10.1016/j.hrthm.2014.06.007
Publication status	Published - Sept 2014
Externally published	Yes

Keywords

Aged
Anti-Arrhythmia Agents/administration & dosage
Atrial Fibrillation/drug therapy
Cause of Death/trends
Digoxin/administration & dosage
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Heart Rate/drug effects
Humans
Male
Netherlands/epidemiology
Retrospective Studies
Survival Rate/trends
Time Factors
Treatment Outcome

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10.1016/j.hrthm.2014.06.007

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@article{dd670f0080c64319aceaad85b491a81f,

title = "Digoxin in patients with permanent atrial fibrillation: data from the RACE II study",

abstract = "BACKGROUND: The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation.OBJECTIVES: To assess the association of digoxin with cardiovascular (CV) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF: A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets.METHODS: The primary outcome was a composite of CV morbidity and mortality. Secondary outcomes included CV hospitalization and all-cause mortality or heart failure (HF) hospitalization. Of the 614 patients, 608 (99%) completed the dose-adjustment phase. Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up. The median follow-up period was 2.9 years (interquartile range 2.7-3.0 years).RESULTS: In total, 284 patients (46.7%) used digoxin after the dose-adjustment phase (median dosage 0.250 mg; interquartile range 0.0625-0.750 mg). These patients were more often women, previously admitted for HF, had an increased left ventricular end-systolic diameter, and more often randomized to strict rate control. By using Cox proportional hazards regression analysis, the use of digoxin was not associated with an increased risk for the primary and secondary outcomes. For the primary outcome, the 3-year estimated cumulative incidence was 12.9% vs 13.4% in the digoxin group vs the no-digoxin group (unadjusted hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.62-1.52). Incidence was 19.4% vs. 19.5% for CV hospitalization (unadjusted HR 1.00; 95% CI 0.69-1.45) and 6.6% vs. 9.9% for all-cause mortality or HF hospitalization (unadjusted HR 0.62; 95% CI 0.34-1.13) in the digoxin group vs the no-digoxin group.CONCLUSION: The use of digoxin was not associated with increased morbidity and mortality.",

keywords = "Aged, Anti-Arrhythmia Agents/administration & dosage, Atrial Fibrillation/drug therapy, Cause of Death/trends, Digoxin/administration & dosage, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Heart Rate/drug effects, Humans, Male, Netherlands/epidemiology, Retrospective Studies, Survival Rate/trends, Time Factors, Treatment Outcome",

author = "Mulder, {Bart A} and {Van Veldhuisen}, {Dirk J} and Crijns, {Harry J G M} and Tijssen, {Jan G P} and Hillege, {Hans L} and Marco Alings and Michiel Rienstra and {Van den Berg}, {Maarten P} and {Van Gelder}, {Isabelle C}",

year = "2014",

month = sep,

doi = "10.1016/j.hrthm.2014.06.007",

language = "English",

volume = "11",

pages = "1543--50",

journal = "Heart Rhythm",

issn = "1547-5271",

publisher = "Elsevier",

number = "9",

}

TY - JOUR

T1 - Digoxin in patients with permanent atrial fibrillation

T2 - data from the RACE II study

AU - Mulder, Bart A

AU - Van Veldhuisen, Dirk J

AU - Crijns, Harry J G M

AU - Tijssen, Jan G P

AU - Hillege, Hans L

AU - Alings, Marco

AU - Rienstra, Michiel

AU - Van den Berg, Maarten P

AU - Van Gelder, Isabelle C

PY - 2014/9

Y1 - 2014/9

N2 - BACKGROUND: The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation.OBJECTIVES: To assess the association of digoxin with cardiovascular (CV) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF: A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets.METHODS: The primary outcome was a composite of CV morbidity and mortality. Secondary outcomes included CV hospitalization and all-cause mortality or heart failure (HF) hospitalization. Of the 614 patients, 608 (99%) completed the dose-adjustment phase. Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up. The median follow-up period was 2.9 years (interquartile range 2.7-3.0 years).RESULTS: In total, 284 patients (46.7%) used digoxin after the dose-adjustment phase (median dosage 0.250 mg; interquartile range 0.0625-0.750 mg). These patients were more often women, previously admitted for HF, had an increased left ventricular end-systolic diameter, and more often randomized to strict rate control. By using Cox proportional hazards regression analysis, the use of digoxin was not associated with an increased risk for the primary and secondary outcomes. For the primary outcome, the 3-year estimated cumulative incidence was 12.9% vs 13.4% in the digoxin group vs the no-digoxin group (unadjusted hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.62-1.52). Incidence was 19.4% vs. 19.5% for CV hospitalization (unadjusted HR 1.00; 95% CI 0.69-1.45) and 6.6% vs. 9.9% for all-cause mortality or HF hospitalization (unadjusted HR 0.62; 95% CI 0.34-1.13) in the digoxin group vs the no-digoxin group.CONCLUSION: The use of digoxin was not associated with increased morbidity and mortality.

AB - BACKGROUND: The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation.OBJECTIVES: To assess the association of digoxin with cardiovascular (CV) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF: A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets.METHODS: The primary outcome was a composite of CV morbidity and mortality. Secondary outcomes included CV hospitalization and all-cause mortality or heart failure (HF) hospitalization. Of the 614 patients, 608 (99%) completed the dose-adjustment phase. Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up. The median follow-up period was 2.9 years (interquartile range 2.7-3.0 years).RESULTS: In total, 284 patients (46.7%) used digoxin after the dose-adjustment phase (median dosage 0.250 mg; interquartile range 0.0625-0.750 mg). These patients were more often women, previously admitted for HF, had an increased left ventricular end-systolic diameter, and more often randomized to strict rate control. By using Cox proportional hazards regression analysis, the use of digoxin was not associated with an increased risk for the primary and secondary outcomes. For the primary outcome, the 3-year estimated cumulative incidence was 12.9% vs 13.4% in the digoxin group vs the no-digoxin group (unadjusted hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.62-1.52). Incidence was 19.4% vs. 19.5% for CV hospitalization (unadjusted HR 1.00; 95% CI 0.69-1.45) and 6.6% vs. 9.9% for all-cause mortality or HF hospitalization (unadjusted HR 0.62; 95% CI 0.34-1.13) in the digoxin group vs the no-digoxin group.CONCLUSION: The use of digoxin was not associated with increased morbidity and mortality.

KW - Aged

KW - Anti-Arrhythmia Agents/administration & dosage

KW - Atrial Fibrillation/drug therapy

KW - Cause of Death/trends

KW - Digoxin/administration & dosage

KW - Dose-Response Relationship, Drug

KW - Female

KW - Follow-Up Studies

KW - Heart Rate/drug effects

KW - Humans

KW - Male

KW - Netherlands/epidemiology

KW - Retrospective Studies

KW - Survival Rate/trends

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/j.hrthm.2014.06.007

DO - 10.1016/j.hrthm.2014.06.007

M3 - Article

C2 - 24924587

SN - 1547-5271

VL - 11

SP - 1543

EP - 1550

JO - Heart Rhythm

JF - Heart Rhythm

IS - 9

ER -

Digoxin in patients with permanent atrial fibrillation: data from the RACE II study

Abstract

Keywords

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