Download Should rhythm control be preferred in younger atrial fibrillation

J Interv Card Electrophysiol (2012) 35:71–80
DOI 10.1007/s10840-012-9687-0
Should rhythm control be preferred in younger atrial
fibrillation patients?
Shaojie Chen & Yuehui Yin & Mitchell W. Krucoff
Received: 20 February 2012 / Accepted: 10 April 2012 / Published online: 22 May 2012
# Springer Science+Business Media, LLC 2012
Abstract
Purpose Rate- and rhythm control are two fundamental
strategies to treat atrial fibrillation (AF). However, there
are inconsistent results between clinical trials about which
treatment should be preferred. The aims of this study were
to systematically summarize the clinical trials and compare
rate- and rhythm control strategies regarding composite
outcome of all cause mortality, worsening heart failure,
and thromboembolic and bleeding events.
Methods English and non-English studies that were published from 1966 onwards were included in this metaanalysis if they were prospective randomized controlled
trials which compared rate- and rhythm control strategies
in patients with AF. The individual and combined outcomes
were analyzed quantitatively with odds ratio and 95 % confidence interval.
Results Ten prospective randomized controlled trials with
7,876 patients were identified. There was no significant
difference regarding primary composite outcome (11.47 vs.
11.03 % per year; odds ratio (OR), 1.03; 95 % confidence
interval (CI), 0.90–1.20; P00.64) between rate- and rhythm
S. Chen (*) : Y. Yin (*)
Department of Cardiology, The Second Affiliated
Hospital of Chongqing Medical University,
76# Linjiang Road, Yuzhong District,
Chongqing 400010, China
e-mail: [email protected]
e-mail: [email protected]
M. W. Krucoff
Duke University Medical Center,
Durham, NC 27705, USA
e-mail: [email protected]
M. W. Krucoff
Duke Clinical Research Institute,
Durham, NC 27705, USA
control groups in overall age group. Meta-analysis for studies
with mean age <65 years showed that rate control had significantly higher risk in primary composite outcome compared
with rhythm control (8.74 vs. 4.80 % per year; OR, 1.89;
95 %CI, 1.26–2.86; P00.002).
Conclusions A significant trend towards that rhythm control
may be a preferable strategy for younger AF patients was
observed in this study.
Keywords Atrial fibrillation . Treatment strategy
Abbreviations
ACC American College of Cardiology
AF
Atrial fibrillation
AHA American Heart Association
CAD Coronary artery disease
CI
Confidence interval
ESC
European Society of Cardiology
EH
Essential hypertension
NA
Not available
OR
Odds ratio
RCTs Randomized controlled trials
1 Introduction
Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about six million individuals in the developed
countries [1, 2]. The prevalence of AF in age older than
40 years is approximately 2.3 %, after 65 years, it increases
up to almost 6 % [1–3]. AF has been recognized, with
increasing concern, as a potentially disabling illness, which
is closely associated with hospital admission, heart failure,
stroke, and death, bringing heavy economic burden to the
society [4, 5].
72
However, treatment of AF remains one of the most difficult tasks of cardiology. For a decade, several studies have
compared the strategy of maintenance of sinus rhythm,
called rhythm control, with the strategy of heart rate control
during AF and found that the rhythm control strategy was
not superior to rate control in terms of mortality [6–15],
although some subsequent analysis identified the presence
of sinus rhythm as a factor of improved survival [16]. One
of the reasons explaining the non-superiority of the rhythm
control strategy was that the benefit of sinus rhythm was
offset by the side effects of antiarrhythmic agents. Consequently, attention was directed to non-pharmacological therapies, particularly to catheter ablation strategy. However,
despite the reported good results of various types of interventions in the hands of highly qualified teams, catheter
ablation cannot be applied to all patients with AF or to all
types of AF. Therefore, with the new generation of antiarrhythmic agents emerging, there is still a demand for pharmacological therapy aimed at the prevention of AF recurrences
for the AF patients.
Previous systematic reviews were reported in 2005 including clinical studies published before the year 2004; in the
study, the Atrial Fibrillation Follow-up Investigation of
Rhythm Management (AFFIRM) study [6], with the mean
age of 69.7 years was predominantly included, suggested
strong but not significant trend in favor of rate control strategy
regarding all cause mortality and stroke [17, 18]. Recently, a
large-scale clinical trial, AF-CHF study [13], also including
relatively older patients, suggested that rhythm control was
not superior to rate control strategy.
In recent years, several new RCTs comparing the two
strategies have been reported [11–15]. With enlarged sample
size, we perform an updated systematic review and metaanalysis to further compare rate- and rhythm control strategies in composite outcome of major AF endpoints, all cause
mortality, worsening heart failure, and thromboembolic and
bleeding events.
2 Methods
To perform a systematic review and meta-analysis of open
clinical trials is still challenging because of different study
designs and intrinsic biases. We conducted this study according
to the guideline of PRISMA Statement “The PRISMA statement for reporting systematic reviews and meta-analysis of
studies that evaluate healthcare interventions: explanation and
elaboration” [19].
2.1 Eligibility criteria
Studies were included if they met: (1) study population with
non-rheumatic AF; (2) comparison of rate control and rhythm
J Interv Card Electrophysiol (2012) 35:71–80
control strategies; (3) prospective randomized trial; (4)
intention-to-treat principle; (5) clear interpretation of results;
and (6) follow-up period >1 year.
2.2 Exclusion criteria
The exclusion criteria included: (1) equivocal treatment
allocation process; (2) severe imbalances at baseline characteristics between two groups; and (3) loss of follow-up
more than 20 %.
2.3 Information sources and study selection
Electronic and literature search were performed in Medline,
The Cochrane Library, The Clinical Trials, and Embase
Database up to December 31, 2011 using the search theme
“atrial fibrillation, rate control, and rhythm control” without
language restriction. The abstract from the ACC, AHA, and
ESC were also searched for the past 5 years.
2.4 Quality assessment and data extraction
Two blinded investigators independently reassessed each study
included in our analysis according to the guideline of PRISMA
statement [19]; the key points of quality assessment criteria
were summarized as follows: (1) clear research objective; (2)
clear definition of study population; (3) overall cohesiveness
and strictness of trial design; (4) appropriate statistical method;
(5) clear definition of outcome variables; (6) independent
assessment of outcome variables; (7) sufficient follow-up duration; and (8) no selective loss of follow-up. We also used
Jadad Score Questionnaire System to assess methodological
quality of included studies; the questions were: (1) Was the
study described as randomized?; (2) Was the study described
as double blind?; (3) Was there a description of withdrawals
and dropouts? Each “yes” scored a single point, whereas each
“no” scored zero point. The final score of one, two, and three
points represented low, medium, and high methodological
quality. Divergence was resolved by consensus if necessary.
Detailed characteristics of included studies were recorded on
our original information table. Primary outcome for this study
was a composite outcome of all cause mortality, worsening
heart failure, thromboembolic events, and bleeding events.
2.5 Statistical analysis
First of all, incidence per year of each individual outcome
variable was calculated as statistical unit to accommodate
the different follow-up periods of each study. The significance between two groups of this meta-analysis was estimated by odds ratio (OR) with a two-tailed 95 % confidence
intervals (CI) in a fixed-effects model for consistent outcome variables and a random-effects model for inconsistent
J Interv Card Electrophysiol (2012) 35:71–80
73
1367 citations related to search theme
1351 excluded based on titles and abstracts
because apparently not relevant to our
analysis
16 relevant clinical trials for further
evaluation
6 studies excluded
Three articles were postoperative trials [20-22].
Two articles enrolled patients with rheumatic
atrial fibrillation [23, 24].
One study s withdrawal 20% [25].
10 studies finally identified
Fig.1 Flow diagram of studies selection
assessment. Six studies were excluded because three trials
were postoperative studies [20–22], two studies enrolled
rheumatic atrial fibrillation [23, 24], and one study had
incomplete follow-up [25]. Consequently, ten prospective
randomized trials [6–15] were finally enrolled in this metaanalysis. Table 1 showed the methodological quality assessment of included studies according to the PRISMA statement [19]. And based on the Jadad Questionnaire Score
System, nine included studies [6–14] scored 3 points and
one included studies [15] scored 2 points.
3.2 Baseline characteristics of included study
outcome variables. Heterogeneity was assessed by means of
Cochran Q test. Statistic value I2 represents the degree of
inconsistency with a score of 25, 50, and 75 % representing
low, moderate, and high level of inconsistency, respectively. I2
value more than 75 % or P value for the test of heterogeneity
less than 0.01 was considered significantly heterogeneous
between studies. All statistical analyses procedures were performed by Revman 5.0 software package (Review Manager,
Version5.0, The Cochrane Collaboration, Oxford, UK).
3 Results
3.1 Study selection
The study selection process was illustrated in Fig. 1. A total
of 1,367 citations were retrieved in our primary search.
After screening titles and abstracts, 1,351 were filtrated
because they were retrospective observational studies, commentaries, and reviews or apparently not relevant to our
subject. The remaining 16 studies were selected for further
The basic characteristics of included studies were presented
in Table 2. The overall study population included in this
study was 7,876 with 34 % female, 3,932 allocated in rate
control group and 3,944 in rhythm control group. The mean
AF duration differed from 110 days to 14.5 months. The
AFFIRM study [6] and AF-CHF study [13] enrolled both
paroxysmal and persistent AF patient, while J-RHYTHM
study included only paroxysmal AF patient [14]. The remaining seven studies enrolled persistent AF patient. There were
four studies that specifically enrolled patients with heart failure history [11–13, 15]. Five studies had mean age less than
65 years [7, 10, 11, 14, 15], while the remaining five studies
had mean age more than 65 years [6, 8, 9, 12, 13]. The
therapeutic approaches included beta-blockers, digitalis, and
calcium blockers in the rate control group and antiarrhythmic
agents and electrical cardioversion in the rhythm control
group, plus anticoagulants according to the guideline. Amiodarone combined electrical cardioversion was the most frequently used regimen to reestablish sinus rhythm, whereas the
selection of atrioventricular node blocking agents (β-blockers,
digitalis, and diltiazem) was dependent on the original study
design. The mean age, follow-up period, and sinus rhythm
restoration and maintenance rate of each study ranged from 55
Table 1 Assessment of the methodological quality of ten randomized controlled trials
Wyse
Hohnloser Carlsson Van Gelder Opolski
Okçün
Shelton
Roy
Ogawa
Kanorskiĭ
et al. [6] et al. [7]
et al. [8] et al. [9]
et al. [10] et al. [11] et al. [12] et al. [13] et al. [14] et al. [15]
Clear definition of study
population?
Clear definition of
outcomes and
outcome assessment?
Independent assessment
of outcomes?
Sufficient duration
of follow-up?
No selective of loss
during follow-up?
Prognostic factors and
confounders identified?
NA not available
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
NA
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
NA
74
J Interv Card Electrophysiol (2012) 35:71–80
Table 2 Baseline characteristics of ten included randomized controlled trials studies
Study
Sample size
Study population
Mean follow-up
duration
Loss of
follow-up (no.)
Mean age
(year)
Female (%)
CAD (%)
EH (%)
Wyse et al. [6]
Rate, 2,027
Rhythm, 2,033
Paroxysmal or
persistent AF
3.5 years
71
69.7
39.3
26.1
50.8
Hohnloser et al. [7]
Rate, 125
Rhythm, 127
Persistent,
symptomatic AF
1 year
6
60.5
27
23.4
48.8
Carlsson et al. [8]
Rate, 100
Rhythm, 100
Persistent AF
1.6 years
0
65.8
36.5
43.5
62.5
Van Gelder et al. [9]
Rate, 256
Rhythm, 266
Persistent AF or
atrial flutter
2.3 years
9
68
36.6
27.4
49.0
Opolski et al. [10]
Rate, 101
Rhythm, 104
Persistent AF
1.7 years
0
60.8
34.6
43.9
64.3
Okçün et al. [11]
Rate, 84
Rhythm, 70
36 months
37
59.4
33.1
0
50.6
Shelton et al. [12]
Rate, 31
Rhythm, 30
Persistent AF
and nonischemic
heart failure
Persistent AF and
heart failure
14 months
0
72.4
16
49.1
68.9
Roy et al. [13]
Rate, 694
Rhythm, 682
37 months
79
67
18
48.0
47.5
Ogawa et al. [14]
Rate, 404
Rhythm, 419
Paroxysmal or
persistent AF and
heart failure
Paroxysmal AF
578 days
62
64.7
30.7
7.1
42.8
Kanorskiĭ et al. [15]
Rate, 110
Rhythm, 113
Persistent AF and
heart failure
2 years
0
55.8
41.7
NA
NA
AF atrial fibrillation, CAD coronary artery disease, EH essential hypertension, NA not available
Table 3 Individual and combined outcome events of ten randomized controlled trials (rate control/rhythm control)
Study
Overall death
(no./no.)
Worsening heart
failure events
(no./no.)
Bleeding events
(no./no.)
Thromboembolic
events (no./no.)
Wyse et al. [6]
89/102
11/12
39/36
25/27
Combined outcome
events (no./no.)
164/177
Study population (no.)
Rate control, 2,027
Rhythm control, 2,033
Hohnloser et al. [7]
2/2
1/0
0/1
1/0
4/3
Rate control, 125
Carlsson et al. [8]
5/3
18/24
5/7
1/3
29/37
Rate control, 100
Van Gelder et al. [9]
8/8
NR
5/4
6/9
19/21
Opolski et al. [10]
1/2
NR
3/5
1/2
5/9
Rhythm control, 127
Rhythm control, 100
Rate control, 256
Rhythm control, 266
Rate control, 101
Rhythm control, 104
Okçün et al. [11]
12/2
9/1
2/0
3/2
26/5
Rate control, 84
Shelton et al. [12]
1/1
NR
NR
NR
1/1
Rate control, 31
88/86
NR
4/3
166/159
Rate control, 694
2/3
4/1
1/1
3/3
10/8
Rate control, 404
Kanorskiĭ et al. [15]
13/7
NR
NR
14/8
27/15
Rate control, 110
ORs for individual
and combined
outcome
5.3/5.0 %; OR,
1.03; P00.78
3.81/3.61 %; OR,
1.04; P00.75
1.78/1.73 %; OR,
1.02; P00.91
1.49/1.46 %; OR,
1.02; P00.9
Rhythm control, 70
Rhythm control, 30
Roy et al. [13]
74/70
Rhythm control, 682
Ogawa et al. [14]
Rhythm control, 419
Rhythm control, 113
NR not reported, OR odds ratio, 95 % CI 95 % confidence interval
11.47/11.03 %; OR,
1.03; P00.64
J Interv Card Electrophysiol (2012) 35:71–80
Fig. 2 The meta-analysis of each single outcome for overall patients
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J Interv Card Electrophysiol (2012) 35:71–80
Table 4 Individual and composite outcome events of five randomized controlled trials with mean age <65 years (rate control/rhythm control)
Study
Overall death
(no./no.)
Worsening heart
failure events
(no./no.)
Bleeding events
(no./no.)
Thromboembolic Composite outcome Study population (no.)
events (no./no.) events (no./no.)
1/0
0/1
1/0
4/3
3/5
1/2
5/9
Hohnloser et al. [7]
2/2
Opolski et al. [10]
1/2
Okçün et al. [11]
12/2
9/1
2/0
3/2
26/5
Ogawa et al. [14]
2/3
4/1
1/1
3/3
10/8
13/7
NR
NR
14/8
27/15
Kanorskiĭ et al. [15]
ORs for individual
and composite
outcome
NR
3.64/1.92 %; OR, 2.28/0.32 %; OR, 0.84/0.97 %; OR, 2.67/1.8 %; OR,
1.89; P00.05
5.6; P00.01
0.86; P00.77
1.49; P00.24
Rate control, 125
Rhythm control, 127
Rate control, 101
Rhythm control, 104
Rate control, 84
Rhythm control, 70
Rate control, 404
Rhythm control, 419
Rate control, 110
Rhythm control, 113
8.74/4.8 %; OR,
1.89; P00.002
NR not reported, OR odds ratio, 95 % CI 95 % confidence interval
to 72 years, 1 to 3.5 years, and 38 to 72.7 %. The proportion of
patient with coronary artery disease at baseline ranged from
7.1 to 49.1 %. Approximately 50 % of the participants had
essential hypertension history at enrollment.
3.3 Primary outcome
The individual and composite outcome events of all included studies were listed in Table 3. All included studies
reported the data of all cause mortality, whereas four studies
did not report the data of worsening heart failure [9, 10, 12,
15], three studies did not report the data of bleeding events
[12, 13, 15], and one study did not report the data of
thromboembolic events [12]. The odds ratio and 95 % confidence interval for all cause mortality, worsening heart
failure, bleeding event, and thromboembolic event in all
included studies were (5.3 vs. 5.0 %; OR, 1.03; 95 % CI,
0.84–1.26; P00.78), (3.81 vs. 3.61 %; OR, 1.04; 95 % CI,
0.80–1.36; P00.75), (1.78 vs. 1.73 %; OR, 1.02; 95 % CI,
0.70–1.49; P00.91), and (1.49 vs. 1.46 %; OR, 1.02; 95 %
CI, 0.71–1.48; P00.9), with no statistical significance, respectively (Fig. 2). There was no significant heterogeneity
between all included studies.
The individual and composite outcome events of included studies with mean age less than 65 years were listed in
Table 4. The odds ratio and 95 % confidence interval for all
cause mortality, worsening heart failure, bleeding event and
thromboembolic event were (3.64 vs. 1.92 %; OR, 1.89;
95 % CI, 1.01–3.35; P00.05), (2.28 vs. 0.32 %; OR, 5.6;
95 % CI, 1.44–21.69; P00.01), (0.84 vs. 0.97 %; OR, 0.86;
95 % CI, 0.31–2.41; P00.77), and (2.67 vs. 1.8 %; OR,
1.49; 95 % CI, 0.76–2.90; P 00.24), respectively. The
patients in the rate control group experienced significantly
higher risks of overall mortality and worsening heart failure
compared that in the rhythm control group, but patients in
both groups experienced similar risks of bleeding events and
thromboembolic events (Fig. 3).
For overall patients, no significant difference regarding
composite outcome between rate- and rhythm control
groups was observed (11.47 vs. 11.03 %; OR, 1.03, 95 %
CI, 0.90–1.20; P00.64) (Fig. 4(a)). When we excluded five
studies [6, 8, 9, 12, 13] with mean age of more than 65 years,
the rate control group was associated with a significant
higher risk of composite outcome compared with the rhythm
control group (8.74 vs. 4.80 %; OR, 1.89, 95 % CI, 1.26–
2.86; P00.002) (Fig. 4(b)).
4 Discussion
Atrial fibrillation is the most common cardiac arrhythmia that
increases in prevalence with age. As the general population
grows older, clinicians will more frequently see this disease in
their clinic population. In order to most effectively treat this
disorder, physicians need to understand the key issues, including the use of rhythm control versus ventricular rate control
and how to reduce the risk of ischemic stroke, bleedings, heart
failure events, and treatment for the basic disease. In addition,
AF management is particularly challenged by comorbidities
including hypertension, coronary artery disease, congestive
heart failure, and cardiac hypertrophy especially frequently
presenting in the relatively old age group, which confer poor
cardioversion rate, increased risks for AF complications, and
drug-related side effects.
The major studies on rhythm versus rate control were the
AFFIRM study [6], the RACE study [9], and the AF-CHF
J Interv Card Electrophysiol (2012) 35:71–80
Fig. 3 The meta-analysis of each single outcome for studies with mean age <65 years
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J Interv Card Electrophysiol (2012) 35:71–80
Fig. 4 The meta-analysis of composite outcome for overall and mean age <65 years subset studies
study [13]. These studies have shown that primary rate
control is not inferior to rhythm control and rhythm control
by pharmacological interventions is associated with higher
mortality in the relatively older AF patients. Therefore, firstline therapy in the elderly patient with symptomatic AF is
usually a primary rate control strategy. However, a post hoc
survival analysis for AFFIRM study [6] showed that the
maintenance of sinus was associated with a 47 % reduction
of all cause mortality, while the use of antiarrhythmic drugs
resulted in a 49 % increased risk of death. The survival
benefit of rhythm control was greatly offset by the adverse
effect of antiarrhythmic drugs but not rate control strategy,
especially the aforementioned studies predominantly enrolled patients in relatively older age group who had poor
tolerance of antiarrhythmic drugs and tend to the occurrence
of proarrhythmia [16].
Moreover, the recent ATHENA study signalized that
safely maintained sinus rhythm by novel antiarrhythmic
drugs may prevent cardiovascular hospitalization or overall
death in patients with AF [26]. On the other hand, the recent
RACEII study showed no clinical benefit of a strict rate
control versus a lenient rate control with target resting heart
rates of about 115 beats per minute in terms of clinical
cardiovascular events [27]. Therefore, antiarrhythmic drugs
with the aim to maintain sinus rhythm seems needed if
patient remains symptomatic despite optimal rate control,
but the increased risk for proarrhythmia, drug interactions,
and age-related comorbidities in the elderly population
should be carefully considered.
Heart failure and AF share common risk factors and often
coexist, and they both increase the cardiovascular mortality.
Deleterious hemodynamic effects of AF result in further decrease in left ventricular function and progress of heart failure.
Incidence of worsening heart failure was 3.7 % per year in this
study, with the highest rate (12.7 %) occurred in the AF-CHF
study [13], where death from heart failure occupied 30 % of
the total mortality. The present study showed that rate control
strategy in younger AF patients was associated with a strikingly higher risk of worsening heart failure compared with
rhythm control strategy (2.28 vs. 0.32 %, OR, 5.60, 95 % CI,
1.44–21.69), and this result mainly contributed to our composite outcome, suggesting that the rhythm control strategy
conducted in relatively younger AF patients may prevent the
progress of heart failure.
Strokes and bleeds often result in higher mortality rates.
The use of oral anticoagulants plus routine coagulation function monitoring is an important intervention in preventing AFrelated ischemic and bleeding events. But older patients have
higher risk of stroke if not taking oral anticoagulants and
higher risk of bleeding with the use of oral anticoagulants.
J Interv Card Electrophysiol (2012) 35:71–80
Therefore, the recommendation for anticoagulation is still a
challenging task for the clinician treating AF patients in the
old age, although several new anticoagulation agents are
emerging. This study showed that there was no significant
difference in reducing the risks of thromboembolic and bleeding events in the overall age group or subgroup under age
65 years, suggesting that the thromboembolic and bleeding
risks might be primarily affected by the patients’ own situation
and administration of anticoagulation therapy but not rate or
rhythm control strategy.
79
4.
5 Limitations
5.
This systematic review and meta-analysis combines data
across randomized controlled studies in order to estimate
different treatment strategy effects with relatively more precision. Different follow-up periods, baseline characteristic, and
different patterns of clinical practice in different countries may
contribute to heterogeneity among trials. Also, the results for
studies with mean age of less than 65 years was based on some
small–moderate sample size studies, and the overlap of age
ranges among these included studies is unavoidable. Some
larger scale and better designed clinical trials for the relatively
younger AF patients may be needed.
6.
7.
8.
9.
6 Conclusion
Although up to date there is no statistical difference between
rate- and rhythm control strategies for AF patients in the overall
age group, a strong and significant trend towards preference of
rhythm control strategy for relatively younger AF patients is
observed in this meta-analysis, and the rate control strategy
may be an acceptable option for the AF patients in older age.
10.
11.
Acknowledgments We would like to acknowledge all the investigators in those clinical trials that we included in this study.
12.
Conflict and interest
None.
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