(Circulation. 1999;100:376-380.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Trandolapril Reduces the Incidence of Atrial Fibrillation After Acute Myocardial Infarction in Patients With Left Ventricular Dysfunction
From the Department of Cardiology P, Gentofte University Hospital (O.D.P., L.K., C.T.-P.), and the Department of Medicine, Viborg Sygehus (H.B.), Denmark.
Correspondence to Ole Dyg Pedersen, MD, Department of Cardiology P, Gentofte University Hospital, Niels Andersensvej 65, 2900 Hellerup, Denmark. E-mail odplc{at}dadlnet.dk
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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Background—Studies have suggested that ACE inhibitors have an antiarrhythmic effect on ventricular arrhythmias. Whether they have an effect on atrial fibrillation is unknown.
Methods and Results—We investigated the effect of ACE inhibition with trandolapril on the incidence of atrial fibrillation in patients with reduced left ventricular function secondary to acute myocardial infarction. The patients in this study were those who qualified for inclusion into the TRAndolapril Cardiac Evaluation (TRACE) study, a randomized double-blind placebo-controlled study and who had sinus rhythm on the ECG obtained at randomization. Patients who fulfilled the criteria for inclusion were randomized to treatment with the ACE inhibitor trandolapril or placebo and were followed up for 2 to 4 years. Development and time to occurrence of atrial fibrillation in one 12-lead ECG recorded at the outpatient visits was the primary end point of this investigation. Of the 1749 patients included in the TRACE study, 1577 had sinus rhythm on the ECG recorded at randomization. Of these patients, 790 were randomized to trandolapril treatment and 787 to placebo treatment. The groups differed only slightly with respect to baseline characteristics. A total of 64 patients developed atrial fibrillation during the 2- to 4-year follow-up period. Significantly more patients developed atrial fibrillation in the placebo group than in the trandolapril group, 5.3% (n=42) versus 2.8% (n=22), respectively, P<0.05. Cox multivariable regression analysis, adjusting for important baseline characteristics, revealed that trandolapril treatment significantly reduced the risk of developing atrial fibrillation (RR, 0.45; 95% CI, 0.26 to 0.76; P<0.01).
Conclusions—The results from the present study demonstrate that trandolapril treatment reduces the incidence of atrial fibrillation in patients with left ventricular dysfunction after acute myocardial infarction.
Key Words: angiotensin • enzymes • fibrillation • myocardial infarction
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Angiotensin-converting enzyme inhibitor drugs are not antiarrhythmic in the conventional sense, but it has been suggested that they reduce the occurrence of arrhythmias in patients with ischemic heart disease and left ventricular dysfunction.1 This reduction has been reported primarily as a decrease in the occurrence of ventricular arrhythmias.2 3 4 Although the antiarrhythmic mechanism of ACE inhibitors is not completely understood,1 it is possible that they affect the tendency to develop supraventricular arrhythmias, such as atrial fibrillation. Webster et al5 observed that ACE inhibition was associated with a trend toward reduction of the frequency of atrial premature beats over time in addition to a decrease in atrial pressure. In another study, Van den Berg et al6 observed that pretreatment with an ACE inhibitor before DC cardioversion of atrial fibrillation caused a nonsignificant reduction of the relapse rate. These observations indicate that ACE-inhibitor treatment might reduce the occurrence of atrial fibrillation, an aspect that has not previously been investigated. In the present investigation, we studied whether the ACE inhibitor trandolapril had any effect on the incidence of atrial fibrillation in patients with left ventricular dysfunction after acute myocardial infarction.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The patients in the present study are those who were included in the TRAndolapril Cardiac Evaluation (TRACE) study,7 a randomized double-blind placebo-controlled study, and who had sinus rhythm at the 12-lead ECG obtained at randomization. The design of the TRACE study has previously been described in detail.8 Briefly, consecutive patients >18 years old admitted to 27 centers in Denmark in the period May 1990 to June 1992 with acute myocardial infarction were screened for inclusion into the study. Patients who fulfilled the criteria for inclusion and who had impaired left ventricular function determined by echocardiography (wall motion index [WMI]
1.2,
corresponding to a left ventricular ejection fraction
[LVEF] 36%) were randomized to trandolapril treatment or placebo
between days 3 and 7 after the onset of symptoms of myocardial
infarction. The study drug was initially given as 1 mg/d and, if
possible, was increased to 2 mg/d before discharge from hospital.
Approximately 4 weeks after the myocardial infarction, the dose was
increased to 4 mg/d if possible. Patients who did not tolerate the dose
increase were kept on a lower dose, a minimum of 1 mg/d. The patients
were followed up for 2 to 4 years after inclusion. They were seen 1
month after inclusion, after an additional 2 months, and thereafter
every 3 months until the study was completed. At each of these
outpatient visits, a clinical examination including blood sampling was
performed and a 12-lead ECG was recorded. The blood samples were
collected according to a standardized method in the morning after an
overnight fast and 
24 hours after the last dose of the trial
medication. All measurements were performed in 1 central laboratory.
The evaluation of the ECGs by the investigators was entered into the
patient's case report form. Atrial fibrillation was defined as absence
of P waves, coarse or fine fibrillatory waves, and completely irregular
RR intervals. In addition, at the visits at 3 months, 6 months, and 12
months after randomization, a new echocardiographic
examination was performed to determine left ventricular
function. The echocardiographic method used for the
screening and follow-up procedure has been described in
detail.9 10 In a 9-segment model of the left ventricle,
WMI was calculated by use of a reverse scoring system, as described by
Berning et al.10 With this method, WMI multiplied by 0.3
gives a precise estimation of LVEF. In this article, we primarily
report the estimated LVEF. For comparison, WMI=2.0 corresponds to
LVEF=60%, WMI=1.2 corresponds to LVEF=35%, and WMI=0.6 corresponds to
LVEF=18%. The ethics committee of the participating departments
approved the study. Informed consent was obtained before patients were
included in the study.
Statistical Methods
Differences in baseline characteristics between the groups were
examined by use of 
2 and Mann-Whitney tests
for categorical and continuous variables, respectively. Categorical
data are presented as percentages, and continuous variables
are presented as median values. Development and time to
occurrence of atrial fibrillation in one 12-lead ECG during the
follow-up was the primary end point of the study. The cumulative
incidences of atrial fibrillation in the trandolapril-treated group and
the placebo group were estimated by the Kaplan-Meier method and are
presented in a Kaplan-Meier plot. The log-rank test was used to
assess differences between the groups. Cox proportional-hazards
regression analysis was used to examine the risk reduction
between the groups, with adjustment for important baseline
characteristics. A stepwise backward procedure was used, excluding
variables above a value of P=0.05. A value of
P<0.05 was considered statistically significant. All
statistical analyses were performed by use of the SAS
statistical package (SAS Institute).
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Study Population
Of 1749 patients randomized to the TRACE study, 1577 had sinus rhythm at the time of randomization. These are the patients investigated in the present study. Of the 1577 patients with sinus rhythm, 790 were randomized to trandolapril treatment and 787 to placebo treatment.
Development of Atrial Fibrillation
A total of 64 patients developed atrial fibrillation during the
follow-up period. In the placebo group, 5.3% (n=42) developed atrial
fibrillation, whereas in the trandolapril group, 2.8% (n=22) developed
atrial fibrillation, P<0.05 (Figure 1
). Cox multivariable regression
analysis revealed that trandolapril treatment significantly
reduced the risk of developing atrial fibrillation (RR, 0.45; 95% CI,
0.26 to 0.76; P<0.01), with adjustment for a number of
baseline characteristics.
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Eighteen baseline variables were originally included in the Cox model. After the stepwise backward Cox regression procedure was performed, 6 variables remained in the model. The following factors were significantly related to development of atrial fibrillation: severe congestive heart failure at baseline, left ventricular function, male sex, use of digitalis at baseline, age, and systolic blood pressure.
Baseline Characteristics
The distribution of the baseline characteristics between treatment
groups is shown in Table 1. There
were differences between the trandolapril group and the placebo group.
The patients in the trandolapril group had a slightly higher
diastolic blood pressure at baseline than the placebo
group. Slightly more patients received nitrates, and there was a trend
toward a higher prevalence of history of angina at baseline in the
trandolapril group and this group was less often treated with
diuretics. The differences were small, and none of the other
baseline characteristics differed between the groups. Except for
digoxin, very few patients—6 total—received antiarrhythmic treatment
at baseline.
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Important Variables During the Follow-Up Period
The serum potassium concentration was almost unchanged during
follow-up and was not significantly different between the groups with
and without atrial fibrillation during follow-up. In the placebo group,
the serum potassium concentrations in the groups that developed/did not
develop atrial fibrillation were (median values, 5th and 95th
percentiles) at baseline, 4.1 (3.5 to 5.1) mmol/L versus 4.1 (3.4
to 4.8) mmol/L; at day 5, 4.4 (3.6 to 4.6) mmol/L versus 4.4
(3.7 to 5.0) mmol/L; at day 30, 4.2 (3.9 to 4.7)
mmol/L versus 4.2 (3.7 to 4.9) mmol/L; and at last visit, 4.6 (3.9
to 4.9) mmol/L versus 4.4 (3.6 to 5.1) mmol/L. In the
trandolapril group, the serum potassium concentrations in the groups
that developed/did not develop atrial fibrillation were at baseline,
4.1 (3.2 to 5.2) mmol/L versus 4.1 (3.4 to 4.8) mmol/L; at
day 5, 4.3 (3.6 to 5.3) mmol/L versus 4.3 (3.6 to 4.8)
mmol/L; at day 30, 4.1 (3.6 to 5.2) mmol/L versus 4.2 (3.5 to
4.8) mmol/L; and at last visit, 4.3 (3.6 to 5.1) mmol/L
versus 4.2 (3.5 to 4.9) mmol/L.
As in the main study, LVEF increased during the first year of follow-up. There was a nonsignificant trend toward a lower LVEF in the groups that developed atrial fibrillation, but when the moderate changes of LVEF obtained at 3, 6, and 12 months were included in a multivariate Cox model as a time-dependent variable, the importance of the ACE inhibitor for prevention of atrial fibrillation was not changed. In contrast, development of heart failure as a time-dependent variable in the Cox model was associated with a trend toward development of atrial fibrillation (P=0.08), but the effect of trandolapril remained consistent (P<0.01).
Mortality in Patients Who Developed Atrial Fibrillation
There was a trend toward a higher mortality in patients who
developed atrial fibrillation during the follow-up period (RR, 1.2;
95% CI, 0.73 to 2.06; P=NS).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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It has been reported that ACE inhibitors reduce the incidence of ventricular arrhythmias,2 3 4 but the present study is the first to demonstrate that ACE-inhibitor treatment also reduces the incidence of atrial fibrillation. In patients with sinus rhythm and left ventricular dysfunction secondary to myocardial infarction, ACE-inhibitor treatment with trandolapril reduced the risk of developing atrial fibrillation by 55% during a 2- to 4-year follow-up period.
Incidence of Atrial Fibrillation
The incidence of atrial fibrillation in our study was lower than
reported in some recent post–myocardial infarction
studies.11 12 13 14 However, the incidences observed in those
studies cannot be compared with the incidence in our study. Those
studies reported the incidence during the entire hospitalization,
whereas our study reports the incidence from the time of randomization,
which was from day 2 to day 6 (mean, 4.5 days) after the myocardial
infarction and during a 2- to 4-year follow-up period.7
Importantly, patients without sinus rhythm at the time of randomization
(10%) were excluded from our study. In fact, the incidence in our
study was higher than the incidence in the general population recently
reported from the Framingham study.15
Characteristics
The randomized groups differed slightly with respect to a few
baseline characteristics (Table 1
), but it is unlikely that
these differences account for the difference observed with respect to
development of atrial fibrillation. Importantly, adjustment for these
variables in the multivariable regression analysis did
not affect the result.
Mechanisms
Several possible mechanisms exist by which ACE
inhibitors may have antiarrhythmic activity. These include
decrease of wall stress, modulation of refractoriness, interference
with ion currents, ß-blocking properties, modification of sympathetic
tone, and stabilization of electrolyte
concentrations.16 17 18 19 20 21
Serum Potassium
It is believed that ACE inhibition stabilizes the serum potassium
concentration and that this may prevent the development of
arrhythmias.20 The serum potassium concentration
remained virtually unchanged during the follow-up in the groups that
developed atrial fibrillation and not different from the groups that
did not develop atrial fibrillation. Thus, it is unlikely that the
difference in development of atrial fibrillation was caused by changes
in the extracellular potassium concentration.
Ventricular Function and Heart Failure
The difference in incidence of atrial fibrillation cannot be
explained by differences in left ventricular
systolic function (Table 2).
Deterioration of left ventricular function and development
of clinical heart failure are expected to precipitate development of
atrial fibrillation. Although the observed difference in development of
atrial fibrillation could not be explained by differences in left
ventricular function, it may be related to the increased
development of heart failure observed in the placebo group. In our
analysis, there was a trend toward an association with
development of severe heart failure, but the effect of ACE inhibition
remained consistent.
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Atrial Stretch
We have no data to explain the underlying mechanism of the finding
in our study. However, increasing evidence suggests that atrial stretch
induced by increased atrial pressure may precipitate atrial
fibrillation through an effect on atrial
refractoriness.21 22 Interestingly, it is known that ACE
inhibitors decrease atrial pressure,5 and in
patients with chronic mitral regurgitation, ACE
inhibitors reduce
regurgitation.23 Therefore, it is possible
that ACE-inhibitor treatment minimizes the susceptibility
to develop atrial fibrillation by lowering atrial pressure and reducing
left atrial enlargement. Whether this is the mechanism of the
present finding remains to be demonstrated.
Mortality
It has recently been reported that development of atrial
fibrillation in the general population is associated with increased
mortality.15 Accordingly, we found a trend toward an
increased mortality in those patients who developed atrial fibrillation
after acute myocardial infarction. We had much shorter follow-up than
Benjamin et al15 and fewer patients who developed atrial
fibrillation. A longer follow-up period might have resulted in a
significant result. Whether prevention of development of atrial
fibrillation also reduces mortality remains unanswered.
In the main TRACE study, trandolapril, in addition to reducing all-cause mortality, also reduced sudden cardiac death, and in the present study, the incidence of atrial fibrillation is reduced. ACE inhibitors attenuate left ventricular enlargement after acute myocardial infarction.24 Therefore, it might be possible that these findings are all a result of an optimal treatment of the underlying heart disease.
Limitations
There are limitations of this study. The present
analysis was not a prespecified end point in the TRACE study.
However, the 12-lead ECGs, which are the basis of the analysis,
were prospectively recorded and evaluated. Therefore, only the
statistical analysis was done retrospectively.
The end point of this study was the time to the first occurrence of atrial fibrillation on one 12-lead ECG recorded at the routine follow-up visits in the 2- to 4-year follow-up period. This may not reflect the true burden of atrial fibrillation, and it remains unanswered whether Holter monitoring every 3 months would have captured more cases of atrial fibrillation. It is also important to mention that we did not record episodes that occurred outside the planned routine visits. These limitations may have influenced the registration of atrial fibrillation, but this was similar for the 2 groups. It also means that we did not differentiate between development of paroxysmal and persistent/permanent atrial fibrillation.
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Acknowledgments |
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The TRACE study was supported by a grant from Roussel Uclaf, Romainville, France, and Knoll, Ludwigshafen, Germany.
Received December 31, 1998; revision received April 12, 1999; accepted April 28, 1999.
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left ventricular dysfunction secondary to acute myocardial
infarction. Patients with sinus rhythm (n=1577) were randomized to
trandolapril treatment or placebo treatment. The study demonstrates
that ACE inhibition with trandolapril reduces the incidence of atrial
fibrillation by 55% in a 2- to 4-year follow-up period.
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