European Heart Journal

European Heart Journal Advance Access originally published online on November 7, 2006
European Heart Journal 2006 27(24):2969-2974; doi:10.1093/eurheartj/ehl363

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Diabetes known or newly detected, but not impaired glucose regulation, has a negative influence on 1-year outcome in patients with coronary artery disease: a report from the Euro Heart Survey on diabetes and the heart

Mattie Lenzen¹, Lars Ryden², John Öhrvik², Malgorzata Bartnik², Klas Malmberg², Wilma Scholte op Reimer¹, Maarten L. Simoons^1,* on behalf of the Euro Heart Survey Investigators

¹ Thoraxcenter, Department of Cardiology, Erasmus University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands
² Department of Cardiology, Karolinska University Hospital, Solna, Stockholm, Sweden

Received 24 May 2006; revised 25 September 2006; accepted 19 October 2006; online publish-ahead-of-print 7 November 2006.

^* Corresponding author. Tel: +31 10 463 3938. E-mail address: m.simoons{at}erasmusmc.nl

	Abstract

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Aims Although diabetes is known to be a major contributor to cardiovascular diseases, as well as an independent predictor for adverse outcomes in patients with coronary artery disease (CAD), information on the prognosis of patients with CAD and newly diagnosed diabetes or impaired glucose regulation (IGR) is scarce. The objective of this study was to explore 1-year outcome in relation to different glucometabolic states of patients participating in the Euro Heart Survey on diabetes and the heart.

Methods and results In 4676 out of 4961 patients, information on the relation between 1-year outcome and glucometabolic state, which was based on oral glucose tolerance test (OGTT) or fasting glucose plasma, was available. A normal glucose metabolism was identified in 947 patients, IGR (impaired fasting glucose or impaired glucose tolerance) in 1116 patients, and diabetes in 1877 patients of whom 1425 were previously diagnosed and 452 newly diagnosed. In total, 736 patients could not be classified, as no OGTT or fasting plasma glucose was performed. Previously recognized and newly detected diabetes was associated with an increased risk of 1-year mortality when compared with patients with normal glucose regulation [hazard ratio (HR) 2.4, 95% confidence interval (CI) 1.5–3.8 and HR 2.0, 95% CI 1.1–3.6, respectively)]. IGR, however, could not be identified as an independent predictor for 1-year mortality (HR 1.1, 95% CI 0.6–1.9).

Conclusion This study confirmed that patients with CAD and known diabetes are at high risk for mortality and cardiovascular events and demonstrated that patients with newly diagnosed diabetes are at intermediate risk for adverse outcomes. IGR, however, could not be identified as an independent predictor for adverse outcomes during the 1-year follow-up period.

Key Words: Diabetes • Impaired glucose regulation • Coronary artery disease • Euro Heart Survey

	Introduction

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Diabetes is a major contributor to cardiovascular diseases, including coronary heart, cerebrovascular, and peripheral artery disease, as well as an independent predictor for adverse outcomes in patients with coronary artery disease (CAD).^1–5 In addition, modestly elevated levels of blood glucose below the level defined as diabetes have been identified as an independent cardiovascular risk factor,⁶ and the GAMI study (Glucose tolerance in patients with Acute Myocardial Infarction) revealed that abnormal glucose tolerance is an important risk factor for future cardiovascular events after myocardial infarction.⁷ This is of major concern, as Norhammer et al.⁸ demonstrated that abnormal glucose regulation is present in most patients with CAD, a finding confirmed by the Euro Heart Survey on diabetes and the heart.⁹ Yet, information on the prognosis of patients with CAD and newly diagnosed diabetes or impaired glucose regulation (IGR), when compared with patients with known diabetes and those who have normal glucose regulation, is lacking.

The Euro Heart Survey on diabetes and the heart was designed to assess the prevalence of diabetes and IGR in patients with CAD in clinical practice.⁹ This survey also included a 1-year follow-up providing a unique opportunity to explore 1-year outcome in relation to the different glucometabolic states of these patients.

	Methods

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Euro Heart Survey on diabetes and the heart
Between February 2003 and January 2004, 4961 patients from 110 hospitals in 25 member countries of the European Society of Cardiology were recruited to the Euro Heart Survey on diabetes and the heart after informed consent. The details of this survey have been described elsewhere.⁹ Briefly, all consecutive patients, admitted or visiting the cardiology outpatient clinic, were screened for a diagnosis of CAD. Clinical characteristics, treatment and results of tests (e.g. fasting glucose or OGTT) were collected in an electronic database. Patients were followed-up with respect to survival, cardiovascular procedures and events, and treatment for at least 1-year.

Glucometabolic state
Investigators were asked to provide measurements of fasting plasma glucose and oral glucose tolerance test (OGTT) in all patients without previously diagnosed diabetes. When an OGTT was available, fasting plasma glucose obtained at that particular occasion was used for patient characterization. Overall, fasting plasma glucose was measured in 2515 patients, an OGTT in 1819 patients, while in 736 patients without known diagnoses of diabetes no fasting plasma glucose or OGTT was measured. The results of the OGTT, or fasting plasma glucose only when no OGTT was performed, were used to categorize patients as having ‘normal glucose regulation’, ‘IGR’, or ‘newly diagnosed diabetes’ in accordance with the World Health Organization (WHO) 1999 definitions.¹⁰ Patients with a recorded history of diabetes were classified as ‘known diabetes’ and those without FPG or OGTT as ‘not classified’ (Table 1). IGR included impaired fasting glucose and impaired glucose tolerance.

View this table: [in this window] [in a new window]   Table 1 Classification of glucometabolic state

 
Statistical analysis
Descriptive statistics included counts and percentages for categorical variables, and mean with corresponding standard deviations for continuous variables. Differences between patients with and without follow-up information were analysed by ² and Student's t-test. Kaplan–Meier curves were computed for all-cause mortality and the composite endpoint of major cardiovascular events, including all-cause mortality, myocardial infarction, and stroke. The Log-rank test was used for comparing the differences in survival and cardiovascular events. Multivariable Cox proportional hazard modelling was used to analyse the association between glucometabolic state at survey entry and 1-year outcome. We adjusted for variables which reached a P-value of <0.15 in the unadjusted analyses. These variables were age, gender, history of myocardial infarction, heart failure, peripheral vascular disease, stroke, hyperlipidaemia, diagnosis at admission, and treatment with anti-thrombotic agents, lipid lowering drugs, and beta-blockers at discharge. Results are reported as hazard ratios (HRs) with associated 95% confidence intervals (CIs). The assumption of proportional hazards was assessed and satisfied by visual inspection of the log–log survival curves for the categorical variables and by using the Schoenfeld residuals. For the continuous variable (age), we constructed age-groups and used a graphical approach to verify the linearity assumption. All analyses were carried out with SPSS statistical software version 12.01. A P-value (two-sided) of <0.05 was considered statistically significant.

As we used a combination of OGTT measurements and, when not available, fasting plasma glucose only, we acknowledge that our glucometabolic classification of patients may be challenged. Therefore, we repeated the analyses using only patients who were classified according to OGTT and patients who were classified by fasting glucose only. In addition, the reference group, as used in the multivariable Cox proportional hazard modelling, was based on patients with normal glucose regulation measured by either fasting plasma glucose only or OGTT. As we acknowledge that patients with normal fasting glucose in whom no OGTT measurement was performed may have impaired glucose tolerance, we repeated the analysis using only patients with OGTT measurement and normal glucose regulation as reference group (n=668). Since the results of the additional analyses were highly consistent, we only report on our original choice.

	Results

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A total of 4961 patients enrolled the Euro Heart Survey on diabetes and the heart, of which follow-up information was missing in 285 patients (6%). Therefore, the total study population of the present study included 4676 patients. When comparing the clinical characteristics between patients who were lost to follow-up and those who were included in our analyses, no major differences were observed (mean age 65 vs. 67 years, diabetes 30 vs. 33%). Only the proportion of males differed between these two groups (70 vs. 78%, respectively).

The median follow-up duration was 374 days (interquartile range: 366–397 days). Three-quarter of all patients with a known glucometabolic state (n=3940) appeared to have diabetes or an abnormal glucose regulation (Table 2), as diabetes was previously diagnosed in 1425 patients, newly diagnosed in 452 patients, and an IGR was observed in 1116 patients. Only 947 of all patients who could be classified according to their glucometabolic state had a normal glucose metabolism. We were unable to classify 736 patients since no information on OGTT or fasting plasma glucose was available.

View this table: [in this window] [in a new window]   Table 2 Baseline characteristics in relation to glucometabolic state

 
Differences in baseline characteristics between patients with different glucometabolic states are presented in Table 2. Patients with abnormal glucose regulation were older when compared with those with normal glucose regulation. A history of cardiovascular events and female gender was seen more often in patients with previously diagnosed diabetes when compared with the other patient groups (36 vs. 26–28%). The lowest prevalence of a cardiovascular history was observed in patients with newly diagnosed diabetes (53 vs. 62–78%). Conversely, these newly diagnosed diabetics were more likely to be admitted with an acute coronary syndrome (58 vs. 24–40%). At the time of discharge or after consultation on the outpatients, most patients were prescribed anti-thrombotic drugs, lipid-lowering drugs (of which in 97% a statin), beta-blockers and ACE-inhibitor or angiotensin receptor blockers (Table 2).

Outcome
The worst outcome was observed in patients with previously known diabetes, as the mortality and incidence of myocardial infarction and stroke was twice as high as in the other patients (Table 3). Patients with newly diagnosed diabetes clearly presented as an intermediate group, as the 1-year mortality in these patients (5.5%) was in-between patients with known diabetes (7.7%) and patients with normal glucose regulation (2.2%), IGR (2.7%), and those who could not be classified (3.7%).The highest incidence of the composite of mortality, myocardial infarction, or stroke was also observed in patients with known diabetes (14.5%), followed by newly diagnosed diabetes (8.4%) and subsequently by the other subgroups (5.6–6.8%).

View this table: [in this window] [in a new window]   Table 3 Cumulative cardiovascular events during 1-year follow-up in relation to glucometabolic state

 
The Kaplan–Meier curves presenting time to mortality and the composite of mortality, myocardial infarction, or stroke over a 1-year period continuously diverged for patients with diabetes and those in the other glucometabolic states (Figure 1). Additionally, the curves also diverged for patients with known and newly diagnosed diabetes. Survival curves of patients with normal glucose regulation, IGR, or those who could not be classified were identical. Overall, log-rank statistics showed significant differences in survival and survival free of myocardial infarction or stroke among the patient groups (P<0.001).

View larger version (17K): [in this window] [in a new window] [Download PowerPoint slide]   Figure 1 1-year follow-up outcome in relation to glucometabolic state. Patients who could not be classified (n=736) were excluded from the analysis.

 
After adjustment for a broad range of clinical and demographic characteristics, both known diabetes and newly diagnosed diabetes remained associated with an increased risk of 1-year mortality (HR 2.4, 95% CI 1.5–3.8 and HR 2.0, 95% CI 1.1–3.6, respectively). Patients with known diabetes also had an increased risk of myocardial infarction and stroke (Table 4). Patients with IGR, however, were not at higher risk of adverse outcomes when compared with patients with normal glucose regulation.

View this table: [in this window] [in a new window]   Table 4 Relative risk of of adverse outcomes at 1-year according to glucometabolic state

 
In the methods section, we acknowledged that our glucometabolic classification of patients may be challenged, and therefore performed analyses on the classification of patients according to OGTT measurements or fasting glucose only. This additional analysis enabled us to look into more detail in patients with IGR. In 713 out of these 1116 patients, an OGTT was performed, of whom 587 patients were known to have impaired glucose tolerance. Although we observed a higher prevalence of mortality, myocardial infarction, and stroke in patients with impaired glucose tolerance (6%) when compared with those with impaired fasting glucose only (4%), neither of these glucometabolic states could be identified as an independent predictor for adverse outcomes (adjusted HR 1.7, 95% CI 0.7–4.5).

	Discussion

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The main finding of the present study is that the presence of diabetes, known or previously unrecognized, is an independent predictor of adverse outcomes in patients with CAD. IGR (i.e. impaired fasting glucose or impaired glucose tolerance), however, could not be identified as an independent predictor for adverse outcomes.

As shown previously,⁹ abnormal glucose metabolism (i.e. diabetes or IGR) was frequently observed in patients with CAD who enrolled the Euro Heart Survey on diabetes and the heart. In only one-quarter of patients, we observed a normal glucose regulation, whereas almost half of the patients had diabetes. Moreover, we confirmed that previously known diabetes was associated with an increased risk for adverse outcomes,^1–5 and found that newly diagnosed diabetes also had a negative influence on prognosis.

Patients with newly diagnosed diabetes clearly were more likely to be admitted with an acute coronary syndrome, whereas a cardiovascular history was seen less often when compared with the other glucometabolic states. This finding may be indicative for the fact that these patients are more vulnerable for a cardiovascular disease and acute coronary syndrome was the first manifestation of this disease.

In accordance with the WHO¹⁰ guidelines, the study protocol requested fasting plasma glucose and OGTT in all patients without previously diagnosed diabetes. A measurement of fasting glucose was performed in three-quarter of all these patients, whereas OGTT was performed in just over one-half. Moreover, in 36% of the patients with IGR, no OGTT was measured in order to exclude the diagnosis of diabetes, which is acknowledged as an important risk factor in patients with a cardiovascular disease. In the remaining 64%, the OGTT revealed that the majority of these patients had an impaired glucose tolerance. In contrast to the DECODE study,^11,12 we could not identify impaired glucose tolerance as a better predictor of mortality than impaired fasting glucose alone. It should be noted, however, that due to the relatively small numbers of patients with IGR, diagnosed by means of an OGTT, the failure to confirm a worse outcome for patients with impaired glucose tolerance may be due to a Type II error. Additionally, the follow-up period in our study was restricted to 1-year, when compared with the median follow-up of almost 9 years in DECODE.¹²

Besides confirming that patients with previously known diabetes had an increased risk of death, myocardial infarction, or stroke, we clearly identified patients with previously unrecognized diabetes as being at increased risk of major adverse events during the 1-year follow-up period. In contrast to the results of the GAMI-follow-up trial,⁷ no differences were observed in event rates between patients with normal glucose regulation and IGR. It should be noted, however, that all participants of the GAMI trial were admitted with an acute myocardial infarction and followed for almost 3 years, whereas the present study included a heterogeneous group of patients with CAD, admitted on cardiology wards or visiting the cardiology outpatient clinics, and followed them for only about 1 year. This period may be a too short to observe an increased risk for adverse events in patients with CAD and IGR.

Although IGR could not be identified as an independent predictor for adverse outcomes, it has been shown that IGR markedly increases the risk of developing diabetes.^13,14 It is even estimated that the annual incidence of evolving diabetes is between 6–12% in patients with impaired glucose tolerance.^15,16 As diabetes is strongly associated with adverse outcomes, interventions aiming at delaying or preventing the onset of diabetes may prove beneficial for patients with IGR. Several studies have shown that lifestyle and pharmacological interventions are effective in delaying or preventing diabetes in patients with impaired glucose tolerance.^16–18

Lifestyle changes aiming at preventing diabetes may also prove effective in modifying other risk factors like obesity, hypertension, and dyslipidaemia.¹⁹ Future research, however, is needed to study the effect of these interventions on adverse outcomes in patients with CAD and IGR. In addition to promoting lifestyle changes, a more aggressive pharmacological treatment of patients with diabetes is advocated, as a number of modifiable factors are known to contribute to the unfavourable prognosis of these patients.^20,21 These factors include hyperglycaemia-induced endothelial cell dysfunction, increased pro-coagulation, impaired fibrinolysis, and dysfunctional arterial remodelling. Therefore, and in addition to good glycaemic control, beta-blockers, anti-thrombotic drugs, statins, and ACE-inhibitors should be considered in the pharmacological management of patients with established CAD and diabetes mellitus.^20,22–24 Although many patients were treated with these advised drugs, there is still room for improvement.

Diabetes and IGR are also known to be associated with an increased risk of stroke.²⁵ Although we observed a higher incidence of stroke in patients with known diabetes, no association between newly detected diabetes and stroke was found in our database. It should be noted, however, that the lack of significant association with stroke may be due to a lack of power. Similarly, we found no significant association between IGR and stroke.

In conclusion, in this large population of patients with CAD, we confirmed that patients with known diabetes are at high risk for mortality and cardiovascular events and demonstrated that patients with newly diagnosed diabetes are at intermediate risk for adverse outcomes. Impaired glucose metabolism, however, did not significantly increase 1-year mortality or cardiovascular events. It should be noted, however, that the follow-up period was only 1 year.

	Acknowledgements

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The authors are grateful to the Euro Heart Survey Team, National coordinators, participating centres, local investigators, and data-collecting officers. The Euro Heart Survey was supported by industry sponsors and supporting institutions as published earlier.⁹ M.J.L. was supported by the Netherlands Heart Foundation (2000T101).

Conflict of interest: none declared.

	References

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This Article Abstract FREE Full Text (PDF) All Versions of this Article: 27/24/2969    most recent ehl363v1 E-letters: Submit a response Alert me when this article is cited Alert me when E-letters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Archive Download to citation manager Search for citing articles in: ISI Web of Science (15) Request Permissions Disclaimer Google Scholar Articles by Lenzen, M. Search for Related Content PubMed PubMed Citation Articles by Lenzen, M. Social Bookmarking          What's this?

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