Generalizability of the EAST-AFNET 4 trial: assessing outcomes of early rhythm-control therapy in patients with atrial fibrillation

Abstract Background The Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST-AFNET 4) demonstrated clinical benefit of early rhythm-control therapy in patients with recently diagnosed atrial fibrillation (AF) and concomitant cardiovascular conditions (CHA2DS2-VASc-Score ≥2) compared to the current practice of limited rhythm-control therapy to improve AF-related symptoms. Purpose To evaluate the generalizability of the EAST-AFNET 4 trial in routine practice, we assessed the proportion of patients who would have met trial eligibility and examined the association between early rhythm-control and clinical outcomes. Methods Using a large US administrative database, we identified 109,739 patients with newly diagnosed AF from July 28th, 2011 to December 30th, 2016, the enrollment period of the EAST-AFNET 4 trial. Eligibility for trial inclusion was assessed based on inclusion criteria. Eligible patients were classified as either receiving early rhythm-control, i.e AF ablation and/or any antiarrhythmic drug therapy, within the first year after AF diagnosis (N=27,106) or patients not receiving early rhythm-control (N=82,633). The date 12 months after the first AF diagnosis was defined as the index date and the start of the follow up period. Propensity score overlap weighting was used to balance patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare early rhythm-control with no early rhythm-control for the primary outcome of a composite end point of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction. Results Eligible for the trial were 72.9% (82,633/109,739) of all patients with newly diagnosed AF. Early rhythm-control therapy was associated with a reduction in the composite end point in the overall cohort of patients (hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.75–0.97; P=0.015) with largely consistent treatment effects between patients eligible or ineligible for the trial. The reduction of stroke risk associated with early rhythm-control therapy was found in the overall cohort (HR 0.66; 95% CI 0.47–0.93; P=0.017) and in the trial-eligible cohort (HR 0.67; 95% CI 0.45–0.98; P=0.041). Conclusion In a large health care data set, the majority of patients with newly diagnosed AF were eligible for the trial. Early rhythm-control therapy was associated with a 15% reduction in the composite end point of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction, with the greatest benefit in the reduction of stroke risk. The treatment effect was consistent between patients eligible or ineligible for the trial. Patients in routine practice had higher rates of adverse outcomes than the trial, but the relative risk reduction with early rhythm-control therapy was similar. These data demonstrate the potential of early rhythm-control therapy to reduce outcomes in patients with AF. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): German Heart Foundation (Mit Fördermitteln der Deutschen Herzstiftung e.V.)

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3153Rate versus rhythm control and mortality in atrial fibrillation patients: a Danish nationwide cohort study

European Heart Journal ◽

10.1093/eurheartj/ehz745.0041 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

F Dalgaard ◽

S Al-Khatib ◽

J Pallisgaard ◽

C Torp-Pedersen ◽

T B Lindhardt ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Heart Disease ◽

Control Strategy ◽

Rate Control ◽

Channel Blocker ◽

Rhythm Control ◽

All Cause Mortality ◽

Control Therapy

Abstract Background Treatment of AF patients with rate or rhythm drug therapy have shown no difference in mortality in clinical trials. However, the generalizability of these trials to real-world populations can be questioned. Purpose We aimed to investigate the all-cause and cardiovascular (CV) mortality risk in a nationwide AF cohort by treatment strategy (rate vs. rhythm) and by individual drug classes. Methods We queried the Danish nationwide registries from 2000 to 2015 to identify patients with AF. A rate control strategy included the use of one or more of the following medications: beta-blocker, digoxin, and a class-4 calcium channel blocker (CCB). A rhythm control strategy included the use of an anti-arrhythmic drug (amiodarone and class-1C). Primary outcome was all-cause mortality. Secondary outcome was CV mortality. Adjusted incidence rate ratios (IRR) were computed using Poisson regression with time-dependent covariates allowing patients to switch treatment during follow-up. Results Of 140,697 AF patients, 131,793 were on rate control therapy and n=8,904 were on rhythm control therapy. At baseline, patients on rhythm control therapy were younger (71 yrs [IQR: 62–78] vs 74 [65–82], p<0.001) more likely male (63.5% vs 51.7% p<0.001), had more prevalent heart failure (31.1% vs 19.4%, p<0.001) and ischemic heart disease (40.1% vs. 23.3%, p<0.001), and had more prior CV-related procedures; PCI (7.4% vs. 4.0% p<0.001) and CABG (15.0% vs. 2.3%, p<0.001). During a median follow up of 4.0 (IQR: 1.7–7.3) years, there were 64,653 (46.0%) deaths from any-cause, of which 27,025 (19.2%) were CVD deaths. After appropriate adjustments and compared to rate control therapy, we found a lower IRR of mortality and CV mortality in those treated with rhythm control therapy (IRR: 0.93 [95% CI: 0.90–0.97] and IRR 0.84 [95% CI: 0.79–0.90]). Compared with beta-blockers, digoxin was associated with increased risk of all-cause and CV mortality (IRR: 1.26 [95% CI: 1.24–1.29] and IRR: 1.32 [95% CI: 1.28–1.36]), so was amiodarone: IRR for all-cause mortality: 1.16 [95% CI: 1.11–1.21] and IRR for CV mortality: 1.12 [95% CI: 1.05–1.19]. Class-1C was associated with lower all-cause (0.43 [95% CI: 0.37–0.49]) and CV mortality (0.35 [95% CI: 0.28–0.44]). Figure 1. Models were adjusted for age, sex, ischemic heart disease, stroke, chronic obstructive pulmonary disease, chronic kidney disease, valvular atrial fibrillation, bleeding, diabetes, ablation, pacemaker, implantable cardioverter defibrillator, hypertension, heart failure, use of loop diuretics, calendar year, and time on treatment. Abbreviations; CCB; calcium channel blocker, PY; person years. Conclusions In a real-world AF cohort, we found that compared with rate control therapy, rhythm control therapy was associated with a lower risk of all-cause and CV mortality. The reduced mortality risk with rhythm therapy could reflect an appropriate patient selection. Acknowledgement/Funding The Danish Heart Foundation

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Early Rhythm Control Therapy in Patients with Atrial Fibrillation and Heart Failure

Circulation ◽

10.1161/circulationaha.121.056323 ◽

2021 ◽

Author(s):

Andreas Rillig ◽

Christina Magnussen ◽

Ann-Kathrin Ozga ◽

Anna Suling ◽

Axel Brandes ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Ejection Fraction ◽

Left Ventricular ◽

Rhythm Control ◽

Left Ventricular Ejection ◽

Ventricular Ejection Fraction ◽

Heart Failure Patients ◽

Patients With Heart Failure ◽

Control Therapy

Background: Even on optimal therapy, many patients with heart failure and atrial fibrillation experience cardiovascular complications. Additional treatments are needed to reduce these events, especially in patients with heart failure and preserved left ventricular ejection fraction (HFpEF). Methods: This prespecified subanalysis of the randomized EAST - AFNET 4 trial assessed the effect of systematic, early rhythm control therapy (ERC; using antiarrhythmic drugs or catheter ablation) compared to usual care (UC, allowing rhythm control therapy to improve symptoms) on the two primary outcomes of the trial and on selected secondary outcomes in patients with heart failure, defined as heart failure symptoms NYHA II-III or left ventricular ejection fraction [LVEF] <50%. Results: This analysis included 798 patients (300 (37.6%) female, median age 71.0 [64.0, 76.0] years, 785 with known LVEF). The majority of patients (n=442) had HFpEF (LVEF≥50%; mean LVEF 61% ± 6.3%), the others had heart failure with mid-range ejection fraction (n=211; LVEF40-49%; mean LVEF 44% ± 2.9%) or heart failure with reduced ejection fraction (n=132; LVEF<40%; mean LVEF 31% ± 5.5%). Over the 5.1-year median follow-up, the composite primary outcome of cardiovascular death, stroke or hospitalization for worsening of heart failure or for acute coronary syndrome occurred less often in patients randomized to ERC (94/396; 5.7 per 100 patient-years) compared with patients randomized to UC (130/402; 7.9 per 100 patient-years; hazard ratio 0.74 [0.56-0.97], p=0.03), not altered by heart failure status (interaction p-value=0.63). The primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) occurred in 71/396 (17.9%) heart failure patients randomized to ERC and in 87/402 (21.6%) heart failure patients randomized to UC (hazard ratio 0.85 [0.62-1.17], p=0.33). LV ejection fraction improved in both groups (LVEF change at two years: ERC 5.3%±11.6%, UC 4.9%±11.6%, p=0.43). ERC also improved the composite outcome of death or hospitalization for worsening of heart failure. Conclusions: Rhythm control therapy conveys clinical benefit when initiated within one year of diagnosing atrial fibrillation in patients with signs or symptoms of heart failure. Clinical Trial Registration: Unique Identifiers: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, Study web site www.easttrial.org; URLs: www.controlled-trials.com; https://clinicaltrials.gov; https://www.clinicaltrialsregister.eu

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Atrial fibrillation in congestive heart failure: is rhythm control therapy superior to rate control therapy?

Journal of Cardiac Failure ◽

10.1016/s1071-9164(03)00436-6 ◽

2003 ◽

Vol 9 (5) ◽

pp. S55

Author(s):

Sana M. Al-Khatib ◽

Linda Shaw ◽

Monica Shah ◽

Chris O'Connor ◽

Robert M. Califf

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Congestive Heart Failure ◽

Rate Control ◽

Rhythm Control ◽

Control Therapy

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Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening—mHealth Screening to Prevent Strokes (mSToPS)

PLoS ONE ◽

10.1371/journal.pone.0258276 ◽

2021 ◽

Vol 16 (10) ◽

pp. e0258276

Author(s):

Steven R. Steinhubl ◽

Jill Waalen ◽

Anirudh Sanyal ◽

Alison M. Edwards ◽

Lauren M. Ariniello ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Atrial Fibrillation ◽

Clinical Outcomes ◽

Clinical Event ◽

Newly Diagnosed ◽

Clinical Events ◽

High Event ◽

Asymptomatic Individuals ◽

New Diagnosis

Background Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes. Methods mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized. Results Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls. Conclusions At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events. Trail registration The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.

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Rhythm control in patients with atrial fibrillation and heart failure: a meta-analysis of randomized controlled trials

European Heart Journal ◽

10.1093/eurheartj/ehab724.0890 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

S.Z Ramos ◽

A.L.D Te-Rosano

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Risk Ratio ◽

Control Strategy ◽

Rate Control ◽

Meta Analysis ◽

Rhythm Control ◽

Forest Plot ◽

Randomized Controlled ◽

All Cause Mortality

Abstract Background Atrial fibrillation (AF) is a common arrhythmia that can promote or worsen heart failure (HF). Limited data exist to guide treatment for patients with AF with HF regarding rate versus rhythm control. Purpose To perform a meta-analysis of randomized controlled trials (RCT) in the determination of the efficacy of rhythm control as compared to rate control among patients with AF and HF. Methods Extensive search of PubMed, Cochrane Library, Ovid, EMBASE, Google scholar, and Medline was done up to October 2020. Studies were limited to RCTs comparing rhythm control in patients with atrial fibrillation and heart failure with rate control. Outcome measures include all-cause mortality and cardiovascular mortality. Statistical analysis was done using Review manager V5.3. Results A total of 9800 patients were included in the pooled analysis of the comparison of rhythm control versus rate control strategy in patients with AF and HF. All pooled analyses were done using random effects model. The pooled risk ratio for all-cause mortality of rate control vs rhythm control did not achieve significance at 1.15, with 95% CI 0.91 to 1.45, and p=0.24. There was statistically significant heterogeneity across the two studies with I2 of 54% and p=0.02 (Figure 1A). The pooled risk ratio for cardiovascular mortality in rate control strategy vs rhythm control is 1.19, with 95% CI 0.94 to 1.50, and p=0.15 (Figure 1B). Eight trials with 9987 participants reported stroke. The pooled risk ratio of stroke in rate control vs rhythm control is 1.11, with 95% CI 0.84 to 1.46, and p=0.47 (Figure 1C). The 95% CI for the pooled risk ratio cross 1.00, indicating an equivocal result. Our results do not indicate statistical heterogeneity across the studies with I2 of 28% and p=0.27. Seven trials with 8311 participants reported bleeding. The pooled risk ratio of hospitalization for bleeding in rate control vs rhythm control is 1.18, with 95% CI 0.81 to 1.73, and p=0.39 (Figure 1D). Thus, we have insufficient evidence to demonstrate whether rate or rhythm control have significantly higher or lower risk for bleeding. Four trials with 8468 participants reported hospitalization rate. The pooled risk ratio of hospitalization in rate control compared to rhythm control is 0.96, with 95% CI 0.86 to 1.07, and p=0.42 (Figure 1E). None of the studies individually showed statistically significant differences but AF–CHF showed benefit of rate control in the first year after enrolment (p=0.001) and a tendency favouring rate control (p=0.06) when the study was analysed in full length except for AF-CHF. Conclusion Among patients with AF and concomitant HF, there is no sufficient evidence between rate and rhythm control strategies in their effects to rates of mortality and major clinical outcomes; therefore, choosing an appropriate therapeutic strategy should consider individual variations such as patient preferences, comorbidities, and treatment cost. FUNDunding Acknowledgement Type of funding sources: None. Forest Plot A–C Forest Plot D–E

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Cabins, castles, and constant hearts: rhythm control therapy in patients with atrial fibrillation

European Heart Journal ◽

10.1093/eurheartj/ehz782 ◽

2019 ◽

Vol 40 (46) ◽

pp. 3793-3799c ◽

Cited By ~ 7

Author(s):

Stephan Willems ◽

Christian Meyer ◽

Joseph de Bono ◽

Axel Brandes ◽

Lars Eckardt ◽

...

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Atrial Fibrillation ◽

Left Ventricular Function ◽

Antiarrhythmic Drugs ◽

Left Ventricular ◽

Rhythm Control ◽

Af Ablation ◽

Control Therapy

Abstract Recent innovations have the potential to improve rhythm control therapy in patients with atrial fibrillation (AF). Controlled trials provide new evidence on the effectiveness and safety of rhythm control therapy, particularly in patients with AF and heart failure. This review summarizes evidence supporting the use of rhythm control therapy in patients with AF for different outcomes, discusses implications for indications, and highlights remaining clinical gaps in evidence. Rhythm control therapy improves symptoms and quality of life in patients with symptomatic AF and can be safely delivered in elderly patients with comorbidities (mean age 70 years, 3–7% complications at 1 year). Atrial fibrillation ablation maintains sinus rhythm more effectively than antiarrhythmic drug therapy, but recurrent AF remains common, highlighting the need for better patient selection (precision medicine). Antiarrhythmic drugs remain effective after AF ablation, underpinning the synergistic mechanisms of action of AF ablation and antiarrhythmic drugs. Atrial fibrillation ablation appears to improve left ventricular function in a subset of patients with AF and heart failure. Data on the prognostic effect of rhythm control therapy are heterogeneous without a clear signal for either benefit or harm. Rhythm control therapy has acceptable safety and improves quality of life in patients with symptomatic AF, including in elderly populations with stroke risk factors. There is a clinical need to better stratify patients for rhythm control therapy. Further studies are needed to determine whether rhythm control therapy, and particularly AF ablation, improves left ventricular function and reduces AF-related complications.

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Association between Atrial Fibrillation, Myocardial Infarction, Heart Failure and Mortality in Patients with Nontuberculous Mycobacterial Infection: a nationwide population-based study

Scientific Reports ◽

10.1038/s41598-019-51801-w ◽

2019 ◽

Vol 9 (1) ◽

Author(s):

Chan Soon Park ◽

Eue-Keun Choi ◽

Bongseong Kim ◽

Kyung-Do Han ◽

So-Ryoung Lee ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Atrial Fibrillation ◽

Mycobacterial Infection ◽

Population Based ◽

Newly Diagnosed ◽

Increased Risk ◽

Significant Difference ◽

Risk Patients ◽

The Impact

Abstract NTM infection demonstrates an increasing incidence and prevalence. We studied the impact of NTM in cardiovascular events. Using the Korean nationwide database, we included newly diagnosed 1,730 NTM patients between 2005 and 2008 and followed up for new-onset atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), ischemic stroke (IS), and death. Covariates-matched non-NTM subjects (1:5, n = 8,650) were selected and analyzed. Also, NTM infection was classified into indolent or progressive NTM for risk stratification. During 4.16 ± 1.15 years of the follow-up period, AF, MI, HF, IS, and death were newly diagnosed in 87, 125, 121, 162, and 468 patients. In multivariate analysis, NTM group showed an increased risk of AF (hazard ratio [HR] 2.307, 95% confidence interval [CI] 1.560–3.412) and all-cause death (HR 1.751, 95% CI 1.412–2.172) compared to non-NTM subjects, whereas no significant difference in MI (HR 0.868, 95% CI 0.461–1.634), HF (HR 1.259, 95% CI 0.896–2.016), and IS (HR 1.429, 95% CI 0.981–2.080). After stratification, 1,730 NTM patients were stratified into 1,375 (79.5%) indolent NTM group and 355 (20.5%) progressive NTM group. Progressive NTM showed an increased risk of AF and mortality than indolent NTM group. Screening for AF and IS prevention would be appropriate in these high-risk patients.

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Atrial fibrillation and the risk for myocardial infarction, all-cause mortality and heart failure: A systematic review and meta-analysis

European Journal of Preventive Cardiology ◽

10.1177/2047487317715769 ◽

2017 ◽

Vol 24 (14) ◽

pp. 1555-1566 ◽

Cited By ~ 64

Author(s):

Vidar Ruddox ◽

Irene Sandven ◽

John Munkhaugen ◽

Julie Skattebu ◽

Thor Edvardsen ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Atrial Fibrillation ◽

Systematic Review ◽

Meta Analysis ◽

All Cause Mortality

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Comparative Effectiveness of Early Rhythm Control Versus Rate Control for Cardiovascular Outcomes in Patients With Atrial Fibrillation

Journal of the American Heart Association ◽

10.1161/jaha.121.023055 ◽

2021 ◽

Author(s):

Daehoon Kim ◽

Pil‐Sung Yang ◽

Seng Chan You ◽

Eunsun Jang ◽

Hee Tae Yu ◽

...

Keyword(s):

Myocardial Infarction ◽

Heart Failure ◽

Atrial Fibrillation ◽

Rate Control ◽

Cardiovascular Death ◽

Population Based ◽

Cardiovascular Outcomes ◽

Rhythm Control ◽

Control Treatment ◽

Control Rhythm

Background Rhythm control is associated with better cardiovascular outcomes than usual care among patients with recently diagnosed atrial fibrillation (AF). This study investigated the effects of rhythm control compared with rate control on the incidence of stroke, heart failure, myocardial infarction, and cardiovascular death stratified by timing of treatment initiation. Methods and Results We conducted a retrospective population‐based cohort study including 22 635 patients with AF newly treated with rhythm control (antiarrhythmic drugs or ablation) or rate control in 2011 to 2015 from the Korean National Health Insurance Service database. Propensity overlap weighting was used. Compared with rate control, rhythm control initiated within 1 year of AF diagnosis decreased the risk of stroke. The point estimates for rhythm control initiated at selected time points after AF diagnosis are as follows: 6 months (hazard ratio [HR], 0.76; 95% CI, 0.66–0.87), 1 year (HR, 0.78; 95% CI, 0.66–0.93), and 5 years (HR, 1.00; 95% CI, 0.45–2.24). The initiation of rhythm control within 6 months of AF diagnosis reduced the risk of hospitalization for heart failure: 6 months (HR, 0.84; 95% CI, 0.74–0.95), 1 year (HR, 0.96; 95% CI, 0.82–1.13), and 5 years (HR, 2.88; 95% CI, 1.34–6.17). The risks of myocardial infarction and cardiovascular death did not differ between rhythm and rate control regardless of treatment timing. Conclusions Early initiation of rhythm control was associated with a lower risk of stroke and heart failure–related admission than rate control in patients with recently diagnosed AF. The effects were attenuated as initiating the rhythm control treatment later.

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Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial

European Heart Journal ◽

10.1093/eurheartj/ehab593 ◽

2021 ◽

Cited By ~ 1

Author(s):

Stephan Willems ◽

Katrin Borof ◽

Axel Brandes ◽

Günter Breithardt ◽

A John Camm ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Primary Outcome ◽

Rhythm Control ◽

Event Analysis ◽

Time To Event ◽

Coronary Syndrome ◽

Asymptomatic Patients ◽

Control Therapy

Abstract Aims Clinical practice guidelines restrict rhythm control therapy to patients with symptomatic atrial fibrillation (AF). The EAST-AFNET 4 trial demonstrated that early, systematic rhythm control improves clinical outcomes compared to symptom-directed rhythm control. Methods and results This prespecified EAST-AFNET 4 analysis compared the effect of early rhythm control therapy in asymptomatic patients (EHRA score I) to symptomatic patients. Primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome, analyzed in a time-to-event analysis. At baseline, 801/2633 (30.4%) patients were asymptomatic [mean age 71.3 years, 37.5% women, mean CHA2DS2-VASc score 3.4, 169/801 (21.1%) heart failure]. Asymptomatic patients randomized to early rhythm control (395/801) received similar rhythm control therapies compared to symptomatic patients [e.g. AF ablation at 24 months: 75/395 (19.0%) in asymptomatic; 176/910 (19.3%) symptomatic patients, P = 0.672]. Anticoagulation and treatment of concomitant cardiovascular conditions was not different between symptomatic and asymptomatic patients. The primary outcome occurred in 79/395 asymptomatic patients randomized to early rhythm control and in 97/406 patients randomized to usual care (hazard ratio 0.76, 95% confidence interval [0.6; 1.03]), almost identical to symptomatic patients. At 24 months follow-up, change in symptom status was not different between randomized groups (P = 0.19). Conclusion The clinical benefit of early, systematic rhythm control was not different between asymptomatic and symptomatic patients in EAST-AFNET 4. These results call for a shared decision discussing the benefits of rhythm control therapy in all patients with recently diagnosed AF and concomitant cardiovascular conditions (EAST-AFNET 4; ISRCTN04708680; NCT01288352; EudraCT2010-021258-20).

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