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European Journal of Heart Failure 2001 3(1):83-90; doi:10.1016/S1388-9842(00)00117-3
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© 2001 European Society of Cardiology

The impact of heart failure on prognosis of diabetic and non-diabetic patients with myocardial infarction: a 15-year follow-up study

Thomas Melchiora,b,*, Christian Rask-Madsenc, Christian Torp-Pedersenc, Per Hildebrandtd, Lars Køberc and Gunnar Jensena

a Department of Cardiology Medicine B, Hillerød University Hospital DK-3400 Hillerød, Denmark
b Department of Cardiology, Glostrup University Hospital DK-2600 Glostrup, Denmark
c Department of Cardiology, Gentofte University Hospital DK-2900 Hellerup, Denmark
d Department of Cardiology and Endocrinology, Frederiksberg Hospital DK-2000; Frederiksberg, Denmark

* Corresponding author. Tel.: +45-4829-6035; fax: +45-4829-6018. E-mail address: tm{at}heart.dk (T. Melchior).


   Abstract
Top
 Abstract
1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
Background: Information about the occurrence of heart failure in the acute phase of myocardial infarction (MI) in diabetic patients and its impact on prognosis are sparse.

Aim: The purpose of the present study was to describe how MI patients with diabetes mellitus (DM) differed from MI patients without DM with respect to the occurrence of heart failure and with respect to the influence of heart failure on mortality during follow-up 30 days extending to 15 years.

Methods: The study is a retrospective long-term follow-up of prospectively recorded data concerning 1954 consecutive cases of MI admitted to one coronary care unit (CCU) between 1979 and 1983. DM was diagnosed in 10% (n=194), with 17% (n=33) on insulin therapy. Patients with DM comprised of a higher proportion of women (DM 36% vs. no DM 26%, P<0.001) compared with non-diabetic patients. Baseline risk factors were more prevalent in the patients with DM. The cumulative incidence of heart failure was higher among patients with than without DM (DM 54% vs. no DM 34%, P<0.001). The incidence of life-threatening arrhythmias were similar in both groups. Only 2% of patients with DM and heart failure survived 10 years of follow-up compared with 15% of the non-diabetic patients with heart failure (P<0.001). In multivariate analysis DM was not independently associated with 30 days mortality. During long-term follow-up DM was an important risk factor for mortality independent on the presence of heart failure.

Conclusion: DM disposes to the development of heart failure. In acute myocardial infarction diabetic patients with heart failure have a worse prognosis than non-diabetic patients with heart failure.

Key Words: Diabetes mellitus • Heart failure • Myocardial infarction • Mortality • Prognosis

Received January 5, 2000; Revised March 6, 2000; Accepted June 20, 2000


   1. Introduction
Top
 Abstract
 1. Introduction
2. Patients and methods
 3. Results
 4. Discussion
 References
 
In 1888 the German physician Leyden reported the striking finding of paroxysmal nocturnal dyspnoea in patients with diabetes mellitus (DM) [1]. It has since been well known although not very well documented that DM is associated with a significantly increased incidence of overt heart failure. In the Framingham study, men with DM aged 45–74 years had more than twice the frequency of heart failure as their non-diabetic cohorts, and females with DM had a fivefold increased risk [2]. Similar observations have been made in patients with Type 2 DM visiting a diabetic out-patient clinic [3,4]. Several recently published studies have reported increased prevalence rates of heart failure following myocardial infarction (MI) in patients with DM, but most of these studies have included selected MI populations [5–10].

Prognosis after a MI depends on various factors; some of the most important factors are age, left ventricular function and heart failure [5–8,11]. The excess mortality in the population of patients with MI and DM has partly been attributed to their tendency to develop overt heart failure. Patients with DM are at especially high risk of early adverse outcome after MI, but recently the effect of DM itself as a major risk factor for poor early outcome after MI has been questioned [6]. In the GUSTO-1 trial, DM remained an independent determinant of 30 day mortality after correction for clinical and angiographic variables, but heart failure was not included in the multivariate analysis [8]. Information concerning long-term outcome following an MI in patients with DM are more limited [7,9,12]. Likewise only little information is published concerning long-term prognosis in high risk patients, e.g. patients with DM and heart failure discharged from the coronary care unit (CCU) after an MI.

The aim of the present study was in a non-selected consecutive population admitted to hospital because of an acute MI to describe the incidence of heart failure in diabetic and non-diabetic patients. Second, to evaluate the impact of DM, heart failure and other baseline clinical characteristics on mortality during 15 years of follow-up.


   2. Patients and methods
Top
 Abstract
 1. Introduction
 2. Patients and methods
3. Results
 4. Discussion
 References
 
2.1. Patients
Glostrup Hospital serves a population of approximately 250 000 inhabitants. The CCU serves as a primary CCU for this defined suburban area of Copenhagen, Denmark. In the study period all patients with cardiac emergencies were admitted directly to the CCU regardless of age, and the length of stay was determined by a prognostic index based on age and complications [13]. The study included 1954 consecutive patients admitted for a MI from 1979 to 1983. All patients were monitored with ECG recorders during the entire period of hospitalisation. None of the patients received thrombolysis or were subjected to secondary interventions with beta-blockers, ACE inhibitors or other drugs since this was not part of the routine in the department at the time of inclusion. During the entire period the chief physician A. Pedersen reviewed all hospital files, and patient data concerning the presence of MI and infarct-related complications were prospectively recorded in a separate file according to the following strict criteria described below.

2.1.1. Myocardial infarction
The diagnosis of MI was based on the WHO criteria and required 2 out of 3 criteria: the presence of chest pain or typical electrocardiographic changes, and a serial rise in serum creatinine kinase isoenzyme MB activity (CK-MB). Furthermore, patients who died in the emergency room or in the CCU, who were strongly suspected of having a MI were also included. Almost all (>96%) of these patients underwent routine autopsy. A transmural infarction was defined by the evolution of new Q waves with a Q:R amplitude >0.3 with or without Q-wave duration ≥0.04 s. In patients experiencing more than one hospital admission because of MI in the study period, only data concerning the first admission were used.

2.1.2. Diabetes mellitus
The diagnosis of DM was primarily based on medical history (in most cases) or by measurement of persistent hyperglycaemia (≥11 mol/l) during hospitalisation [7]. All patients were treated with diet, 53% were treated with oral hypoglycaemic agents and 17% with insulin. During hospitalisation 56 (29%) of the diabetic patients received one or more doses of insulin. Among the patients with DM discharged from the CCU only 13% were on insulin treatment.

2.1.3. Heart failure
Heart failure was considered present if patients had dyspnoea combined with clinical signs and were treated with diuretics. Clinical signs of heart failure were either persistent rales at lung auscultation and/or a third heart sound, enlarged neck veins, or peripheral oedema. If present, pulmonary vascular enlargement or frank oedema on an upright chest X-ray was used to establish the clinical diagnosis of heart failure. For the diagnosis of heart failure, it was required that medical therapy was instituted. Acute pulmonary oedema was present if patients showed severe shortness of breath with pink frothy sputum and numerous rales. Cardiogenic shock was present if patients presented with a systolic blood pressure <80 mmHg and tachycardia >100 b.p.m. with simultaneous signs of poor peripheral circulation for more than 15 min, and if the cause of shock was judged as being of cardiac origin. Patients were considered having a history of heart failure if they presented heart failure symptoms prior to admittance to the CCU.

2.1.4. Arrhythmia
Ventricular tachycardia was defined as more than 10 successive ventricular pre-mature beats with a frequency of more than 100 b.p.m. Ventricular asystole was defined as cardiac arrest due to third-degree atrioventricular block or sinoatrial block in the ECG >10 s.

2.1.5. History of ischemic heart disease
Patients were classified as having previous MI if they had typical changes in ECG and/or a documentation of hospitalisation for MI prior to the index infarction. Patients with no history of MI presenting a poor R wave progression and/or Q wave on ECG prior to admittance were considered having an old infarction. Patients were considered having ischemic heart disease if they received treatment because of classical effort angina or its equivalent or if a prior diagnosis of angina was provided from hospital files.

2.1.6. History of arterial hypertension
Patients were included if antihypertensive therapy previously was prescribed because of arterial hypertension.

2.2. Follow-up
Follow-up was performed via the Danish Central Personal Register on 26 June 1998. Survival data were available for all patients.

2.3. Statistical analysis
Univariate comparisons of discrete variables were performed by the {chi}2-test and comparisons of continuous variables by the Mann–Whitney test. The probability of survival in various patient subgroups was estimated by the Kaplan–Meier method. Survival curves were compared by the log-rank test. Multivariate comparisons of the influence of several factors on survival was performed using the Cox proportional Hazard method. A single model including all potentially relevant parameters as covariates was used. It was checked graphically (Log(–Log(survival)), that the proportional hazard assumption was valid. Relative risk (hazard ratio) was calculated as exp(parameter estimate). In this paper relative risk is the term used for hazard ratio. For continuous variables this represents the increased risk associated with an increment of 1 of the variable in question. The SAS statistical package (SAS Institute, Cary, USA) was used for calculations


   3. Results
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
4. Discussion
 References
 
Baseline clinical characteristics and in-hospital complications are shown in Table 1. The proportion of females was larger among patients with DM than among non-diabetic subjects (DM: 36% vs. no DM 26%, P<0.01). Patients with DM were older (DM: 64±10.8 years vs. no DM: 61±12 years, P<0.001) and had heart failure more often than non-diabetic patients (DM 54% vs. no DM 34%, P=0.001). The prevalence of medical history of heart failure as well as the cumulative incidence of heart failure during the hospital stay were higher in patients with than without DM (Table 1). Patients with and without DM showed a similar infarct location and cumulative incidence rates of severe arrhythmias.


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  		Table 1 Baseline risk factors and in-hospital complications according to the presence or absence of diabetes mellitus and heart failure during hospitalisation for an acute myocardial infarctiona

 
Short-term mortality rate (30 day: DM 18% vs. no DM 11%) and long-term mortality rate (15 years: DM 96% vs. no DM 74%) were significantly higher in patients with DM than in non-diabetic patients (P<0.001). The Kaplan Meier cumulative mortality curves for diabetic and non-diabetic patients stratified according to the presence of heart failure are shown in Fig. 1. Diabetic and non-diabetic MI patients with heart failure had similar short term mortality rates (30 day: DM: 30% vs. no DM: 25%) but all diabetic patients presenting with heart failure during the acute phase of MI had died within 12 years of follow-up (Fig. 1). The 10 year mortality rate for diabetic patients with heart failure was significantly higher (98%) than in the non-diabetic patients (85%) (P<0.001). In patients without heart failure the difference in 10 year mortality rates between DM (64%) and non-diabetic patients (47%) was also significant (P<0.001) (Fig. 1).


Figure 1
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  		Fig. 1 Kaplan Meier cumulative mortality curves for MI patients admitted to one CCU because of an acute MI stratified according to diabetes and heart failure during hospitalisation. ***P<0.001 between patients with and without DM.

 
To further examine the influence of diabetes on survival, a proportional hazard analysis was performed including the clinical variables listed in Table 2a,b. No significant interaction between the variables used in the model could be demonstrated. The results are shown in Table 2a,b. DM, heart failure, a history of hypertension or a previous MI all had independent adverse impact on mortality. DM had an independent adverse effect on long-term survival only (Table 2).


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  		Table 2 (a) The effect of clinical characteristics on 30 days survival among patients admitted to the CCU because of an acute MI using the Cox proportional hazard methoda

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
References
 
It is well established that increasing age, coronary artery disease and arterial hypertension disposes to the development of heart failure [14]. In a recent population-based study of elderly patients Chae et al. [15] showed that DM was an independent risk factor for heart failure. More important was a positive association between baseline level of HbA1c and the risk of developing heart failure in elderly patients. In the present study a history of heart failure as well as newly developed heart failure were more frequently present in the patients with than without DM admitted to the CCU with a MI. Moreover all patients with heart failure were older than their counterparts without heart failure, indicating the importance of age for the development of heart failure. It is well known that ageing also increases the prevalence of DM. Abbud et al. [12] found in an state-wide myocardial infarction database that the effect of DM on the 3 year mortality rate declined with increasing age, suggesting the increased role of other risk factors with ageing. The more frequent development of heart failure in diabetic MI patients as compared with non-diabetic subjects in the present study is not explained by larger infarct size in the former patients. In accordance with several other studies the maximum CK-MB level was lower in diabetic patients than in non diabetic patients, suggesting that diabetics may have smaller infarcts than patients without DM [5–7,16–18]. Attempts to quantitate infarct size using enzymatic estimates in DM may be misleading, because of the frequent prevalence of structural changes in the diabetic myocardium, which may interfere with the release kinetics of CK-MB from the necrotic area. Diabetic and non-diabetic patients has similar global left ventricular ejection fraction, but the normal compensatory hyperkinetic response in the non-infarcted area was, however, blunted in the diabetic patients in MI studies using repeated ventriculography [5,8]. This finding may reflect a more extensive coronary artery disease in diabetic patients with MI.

In the present study heart failure has an overwhelming impact on short- and long-term mortality in patients with MI. If heart failure is present in the MI patients, DM adds even more to the unfavourable long-term out-come, than could be attributed to heart failure alone, especially in low risk patients. Contrary the findings in several other studies [5,8,19,20] DM did not have any independent adverse impact on short-term mortality in the present study. Despite the fact that heart failure was almost twice as frequent in the patients with than without DM in the MILIS Study [5] and in the GUSTO-1 trial [8] heart failure was not included in the multivariate analysis in order to determine the independent determinants of short-term mortality! Acceleration of the coronary atherosclerosis and perhaps impaired collateral formation [21,22] may be important pathogenic mechanisms influencing long-term outcome. The consequences are an increased reinfarction rate [17] and the development of heart failure in patients surviving the initial MI, which may explain the increased long-term mortality associated to DM even in patients without heart failure during the initial phase of an acute MI. Both increased adrenergic drive and insulin resistance during the acute phase of MI increases free fatty oxidation at the expense of glucose oxidation may lead to myocardial dysfunction [21,23]. In the DIGAMI study heart failure was the most common reason for morbidity and mortality during the first year of follow-up [19,23]. Intensified metabolic control improved the long-term prognosis in these patients, especially in low risk patients [19,23]. We may speculate whether strict glycaemic control in low risk patients with MI has a preventive effect on the development of heart failure during early hospitalisation and/or after discharge from the hospital. Studies on newly diagnosed Type 2 diabetics have shown that impaired left ventricular function may improve, when hyperglycaemia is corrected by diet or oral hyperglycaemic drugs [24].

Although clinical features of autonomic neuropathy generally occur in patients with long-term diabetes, the information concerning the impact of diabetes on the risk of ventricular arrhythmia's during MI in patients are limited. Few studies have reported increased rates of sudden cardiac death in diabetic patients who survived a myocardial infarction [5,25,26]. In the GISSI-2 Study [26] the frequency of sudden death was only slightly increased among diabetic women. In accordance with several other studies [5,9,10,26] diabetes does not increase the risk of ventricular arrhythmia's during initial phase of MI.

Concerns could be addressed to the fact that this study is conducted in the prethrombolytic era. In Denmark thrombolytic therapy was first established as a cornerstone in the treatment of MI in 1988. Long-term mortality data concerning MI patients in the thrombolytic era will first be available in a few years. In Denmark only one-third of the patients with a MI are treated with thrombolytic agents, which probably represents the fraction of patients with ST-segment elevations or bundle branch block in the ECG. Data from the Fibrinolytic Therapy Trialists Collaboration Group did show that thrombolytic treatment may be more effective in patients with DM [27], which may induce some bias concerning one-third of the patients in the present study. Patients with DM and MI are still less likely to receive thrombolytic treatment, possibly because of fear for bleeding complications [28,29], although the risk of retinal haemorrhages in diabetic patients receiving thrombolytic treatment in thrombolytic trials is not increased [6,26]. The clinical benefit of thrombolysis include reduction in left ventricular failure and cardiogenic shock in MI populations. Unexpectedly, trials performed in the thrombolytic era did find similar prevalence rates of cardiogenic shock and pulmonary oedema in diabetic patients as in studies from the préthrombolytic period [5–10,26]. Most patients in recent published and older studies were not consecutively included, which makes interpretation of data difficult. In the TAMI study [6] and in the GUSTO-I trial [8] thrombolytic therapy for acute MI was equally effective in achieving early coronary patency in diabetic and in non-diabetic patients, but diabetic patients nevertheless had still a more adverse short-term outcome. A time-related change of risk of death during long-term follow-up in MI patients seems to be similar in cohorts of patients not treated with thrombolytic therapy (the present study population) and in a cohort receiving such treatment [11]. Another limitation may be the fact that the diagnosis of heart failure was based on clinical characteristics, auscultation and X-rays. Today echocardiography is important in the investigation of heart failure, permitting an etiological diagnosis in the large majority of cases, but this modality was not available in the present study.

The findings from the present study may further draw the attention to the early treatment of heart failure in DM. In the AIRE study [30] patients with early clinical evidence of heart failure, independent of the echo, who did receive ramipril had a lower mortality rate compared with patients on placebo. Data from the GISSI III trial [31], SOLVD trials [32] and TRACE Study [33] likewise seem to indicate that ACE inhibitors do have a beneficial effect on mortality, especially in diabetic patients with MI and in diabetic patients with impaired left ventricular function. In the HOPE study ramipril significantly reduced cardiovascular death, stroke, MI and the incidence of heart failure in diabetic patients with preserved ventricular function and no heart failure symptoms [34]. A second and unexpected finding was a lower incidence of DM in the ramipril group compared with the placebo group during the 4 years of follow-up [34]. In the present study no data on the use of ACE-inhibitors and beta-blockers were available, so further studies including diabetic patients, e.g. high risk patients are highly needed.


   References
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 

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