scholarly journals Are the results of the RATE-AF trial reproducible in daily practice? Clinical outcomes with digoxin vs beta-blocker for heart rate control in permanent atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
P.H Spiesser ◽  
N Clementy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Beta Blocker ◽  
Rate Control ◽  
Daily Practice ◽  
Heart Rate Control ◽  
Clinical Events ◽  
Permanent Atrial Fibrillation ◽  
Significant Difference ◽  
Yearly Rate

Abstract Background There is little evidence to support selection of heart rate control therapy in patients with permanent atrial fibrillation (AF), in particular those with coexisting heart failure. In the recent RATE-AF trial that included patients with permanent AF and symptoms of heart failure, treatment with low-dose digoxin or bisoprolol did not result in statistically significant difference in quality of life at 6 months. The purpose of the study was to analyse whether the clinical outcomes may differ among unselected patients with permanent AF treated with digoxin or beta-blocker seen in daily practice. Methods All patients with atrial fibrillation (AF) seen in an academic institution were identified in a database. We examined the clinical course of 8962 consecutive patients with AF seen over a 10-year period. The adverse outcomes were investigated during follow-up and we identified the causes of death. Among them 1,787 patients had the RATE-AF criteria of inclusion (permanent AF, age ≥60 and NYHA ≥2), of whom 512 patients (29%) were treated with beta-blocker alone, 425 (24%) were treated with digoxin alone and 237 (13%) were treated with both a beta-blocker and digoxin. Outcomes in patients treated with beta-blocker alone or digoxin alone were compared after 1:1 propensity-score matching. Results After propensity score matching, 270 patients treated with beta-blocker were matched 1:1 with 270 patients treated with digoxin. In these patients (age 79±8 years, CHA2DS2VASc score 4.0±1.3), 125 deaths were recorded during a follow-up of 2.2±2.7 years (median 1.1, interquartile 0.1–3.5 years, yearly rate of death 10.4%) including 72 cardiovascular deaths (yearly rate 6.0%). Major clinical events (all-cause death, myocardial infarction, ischemic stroke or major bleeding) were recorded in 192 patients (yearly rate 19.1%). In this matched analysis, risk was not statistically significant in the 2 groups for all-cause death (HR 0.95, 95% CI 0.67–1.35 for beta-blocker use vs digoxin use), cardiovascular death (HR 1.23, 95% CI 0.77–1.96 for beta-blocker use vs digoxin use) or major clinical events (HR 0.98, 95% CI 0.74–1.31 for beta-blocker use vs digoxin use). Conclusion Our analysis included more patients and had a longer follow-up than in the RATE-AF trial, resulting in a 10-fold higher number of clinical events. We found that among patients with permanent AF and symptoms of HF, there was no statistically significant difference in the risk of all-cause death, cardiovascular mortality and major clinical events between those treated with digoxin or beta-blocker. Concerns regarding the use of digoxin, such as the narrow therapeutic window and drug interactions, were not issues resulting in worse clinically relevant cardiovascular outcomes with the approach used in the current study. FUNDunding Acknowledgement Type of funding sources: None.

P3793Spironolactone in patients with permanent atrial fibrillation, possible heart failure protective potential

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Dabrowski ◽  
T Chwyczko ◽  
I Kowalik ◽  
E Smolis-Bak ◽  
A Borowiec ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Beta Blocker ◽  
Interstitial Fibrosis ◽  
Randomized Study ◽  
Treated Group ◽  
Control Treatment ◽  
Permanent Atrial Fibrillation ◽  
Minute Walk

Abstract Background Atrial fibrillation (AF) promotes electrical, neurohormonal and structural remodeling of atria and ventricles. Long lasting AF leads to atrial interstitial fibrosis, apoptosis, loss of myofibrils and finally to heart failure (HF). Purpose The aim of the study was impact of aldosterone antagonist, spironolactone, on exercise tolerance and neurohormonal activity in patients with permanent AF without symptoms of HF. Methods In prospective, randomized study patients with permanent AF at least for 1 year, no signs and symptoms of HF and stable clinical condition were included. Patients were randomized to: beta-blocker plus spironolactone (dose: 25 mg) treatment and rate-control treatment with only beta-blocker. Propranolol, metoprolol and bisoprolol were used, doses were adjusted to achieve resting heart rate 60–80/min. Ergospirometry (CPX) and 6-minute walk (6-MWT) tests were performed during separate days. Results Study group consisted of 49 patients, 69% men, mean age 62.1±9.6 without structural and chronic active diseases, mean time of arrhythmia was 5.5 years, Q1: 2, Q3: 8 years. Follow-up was 11.2 months. All patients were treated with beta-blockers, 27 patients were treated with 25 mg spironolactone. Surprisingly physical capacity in 6-minute walk test (6-MWT) in studied patients was not significantly reduced in comparison with values ranges for healthy volunteers. After 11.2 months follow-up significantly longer exercise time (433±113 vs. 367±162 sec, p<0.05) and lower maximal HR (159±25 vs. 165±22 beats/min, p<0.0550) were observed in spironolactone treated group. Other CPX variables did not differ significantly between groups after 11,2 months: VO2: 20.7±5.1 vs. 20.1±4.8 [ml/kg/min]; VO2 as % of normal value: 78.4±15.2 vs. 76.8±15.2; O2 pulse: 12±2.8 vs. 12.7±3.6 [ml/beat]; AT: 1.4±0.3, 1.6±0.5 [L/min]; VE: 74.9±20.0, 72.6±17.9 [L/min]. All spirometric variables worsened after 11.2 months: VC: 4.3±1.1 vs. 3.8±0.8 [L], p<0.0005, FVC: 4.2±1.1 vs. 3.8±1.0 p<0.005 [L], FEV1: 3.1±0.8 vs. 2.8±0.7 [L], p<0.01. In spironolactone treated group after 11.2 months BNP concentrations were significantly lower: Q1: 54, Q2: 83, Q3: 100 vs. Q1: 42, Q2: 93; Q3: 184 ng/L (p=0.025) and aldosterone levels were markedly increased: Q1: 216, Q2: 266; Q3:443 vs. Q1: 169; Q2: 228; Q3:294 ng/dL (p=0.0007). Conclusions In patients with permanent atrial fibrillation cardiopulmonary exercise responses were markedly abnormal, but exercise capacity was increased after spironolactone treatment. Deterioration of spirometry results might be due to beta-blocker treatment. In spironolactone treated group BNP levels were significantly lower what may correspond to its heart failure protective activity.

Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation

Heart ◽  
2020 ◽  
pp. heartjnl-2020-317229 ◽  
Author(s):  
Anthony P Carnicelli ◽  
Sana M Al-Khatib ◽  
Denis Xavier ◽  
Frederik Dalgaard ◽  
Peter D Merrill ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Study Drug ◽  
Treatment Groups ◽  
Patient Request ◽  
Clinical Events ◽  
Significant Difference ◽  
Ischaemic Attack

AimsThe ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin. We sought to describe patients from ARISTOTLE who prematurely permanently discontinued study drug.Methods/ResultsWe performed a posthoc analysis of patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period. Discontinuation rates and reasons for discontinuation were described. Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation. A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation. Patients with discontinuation were more likely to be female and had a higher prevalence of cardiovascular disease, diabetes, renal impairment and anaemia. Premature permanent discontinuation was more common in those randomised to warfarin than apixaban (23.4% vs 21.4%; p=0.002). The most common reasons for discontinuation were patient request (46.1%) and adverse event (34.9%), with no significant difference between treatment groups. The cumulative incidence of clinical events ≤30 days after premature permanent discontinuation for all-cause death, thromboembolism, myocardial infarction, and major bleeding was 5.8%, 2.6%, 0.9%, and 3.0%, respectively. No significant difference was seen between treatment groups with respect to clinical outcomes after discontinuation.ConclusionPremature permanent discontinuation of study drug in ARISTOTLE was common, less frequent in patients receiving apixaban than warfarin and was followed by high 30-day rates of death, thromboembolism and major bleeding. Initiatives are needed to reduce discontinuation of oral anticoagulation.

scholarly journals Do we have a new drug for heart rate control in patients with permanent atrial fibrillation? Response

2020 ◽  
Vol 73 (12) ◽  
pp. 1083-1084
Author(s):  
Adolfo Fontenla ◽  
Juan Tamargo Menéndez ◽  
María López Gil ◽  
Fernando Arribas
Keyword(s):  
Atrial Fibrillation ◽  
Heart Rate ◽  
Rate Control ◽  
Heart Rate Control ◽  
New Drug ◽  
Permanent Atrial Fibrillation

A Comparison of Rate Control Agents for the Treatment of Atrial Fibrillation: Follow-Up Investigation of the AFFIRM Study

2021 ◽  
pp. 107424842098745
Author(s):  
Ninad Zaman ◽  
Gerald Naccarelli ◽  
Andrew Foy
Keyword(s):  
Atrial Fibrillation ◽  
Calcium Channel ◽  
Calcium Channel Blocker ◽  
Beta Blocker ◽  
Rate Control ◽  
Channel Blocker ◽  
Control Agent ◽  
Limited Data ◽  
Baseline Characteristics

There are limited data from randomized controlled trials comparing rate control agents in atrial fibrillation. Patient-level data from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial was used to compare outcomes in patients randomized to the rate control arm who were treated with a single rate control agent at baseline. The rate control agents used were beta-blockers, non-dihydropyridine calcium channel blockers, and digoxin. The independent variable for this analysis was the initial study drug used and the dependent variables were time to first hospitalization and time to death from any cause. We analyzed 1,144 out of 2,027 participants assigned to the rate control group who were on a single rate control agent at the start of the trial. There were 485 (42.5%) participants in the beta-blocker group, 344 (30%) in the calcium channel blocker group, and 315 (27.5%) in the digoxin group. All hospitalization and all-cause mortality occurred in 55.9% and 12.5% of those in the beta-blocker group, 58.4% and 16.7% in the calcium channel blocker group, and 55.2% and 21.1% in the digoxin group, respectively. After adjustment for differences in baseline characteristics, there were no significant differences in time to hospitalization or death for any group. In the AFFIRM trial, the initial rate control drug used was not associated with statistically significant differences in time to hospitalization or death after controlling for differences in baseline characteristics. There is limited data at present to guide the selection of rate control agents in patients with atrial fibrillation.

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