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European Journal of Heart Failure 2007 9(10):1038-1043; doi:10.1016/j.ejheart.2007.07.002
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© 2007 European Society of Cardiology

Dobutamine stress echocardiography and the effect of revascularization on outcome in diabetic and non-diabetic patients with chronic ischaemic left ventricular dysfunction

Lauro Cortigiania,*, Rosa Sicarib, Alessandro Desideric, Riccardo Bigid, Francesco Bovenzia, Eugenio Picanob on behalf of the VIDA (Viability Identification with Dobutamine Administration) Study Group

a Division of Cardiology, Hospital "Campo di Marte" Lucca, 55032 Lucca, Italy
b CNR, Institute of Clinical Physiology Pisa, Italy
c Cardiovascular Research Foundation, S. Giacomo Hospital Castelfranco Veneto, Italy
d Cardiology, Department of Medicine and Surgery, University School of Medicine Milan, Italy

* Corresponding author. Tel.: +39 583 970450; fax: +39 583 970445. E-mail address: lacortig{at}tin.it (L. Cortigiani).


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Aim: To evaluate the interaction between prognostic effect of revascularization and viability in diabetic and non-diabetic patients with ischaemic left ventricular dysfunction.

Methods: 612 patients with angiographically proven coronary artery disease and left ventricular ejection fraction <35% underwent dobutamine stress echocardiography to assess viability (peak-rest wall motion score index >0.4). 262 patients (75 diabetics, 187 non-diabetics) underwent revascularization and 350 (88 diabetics, 262 non-diabetics) were on medical therapy.

Results: During follow-up 215 patients died. Independent predictors of mortality in revascularized patients were resting left ventricular ejection fraction (HR=0.93, 95% CI 0.89–0.97, p<0.0001), {Delta} WMSI>40 (HR=0.44, 95% CI 0.23–0.85, p=0.01), and age (HR=1.03, 95% CI 1.00–1.06, p=0.04). In medically treated patients, independent predictors of mortality were diabetes mellitus (HR=1.64, 95% CI 1.13–2.38, p=0.009), number of diseased vessels (HR=1.27, 95% CI 1.03–1.56, p=0.02), and age (HR–1.02, 95% CI 1.00=1.04, p–0.03). In revascularized patients, 4-year mortality was 15% in those with viability and 26% in those without viability (p=0.04), there was no difference between diabetics and non-diabetics (24% vs 22%; p=0.24).

Conclusions: Viability at dobutamine stress echocardiography independently predicts improved outcome following revascularization in non-diabetics as well as diabetic patients with ischaemic left ventricular dysfunction.

Key Words: Diabetes mellitus • Stress echocardiography • Coronary artery disease • Prognosis

Received February 14, 2007; Revised May 8, 2007; Accepted July 2, 2007


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Left ventricular dysfunction is a major predictor of adverse outcome in coronary artery disease [1]. Myocardial revascularization may restore left ventricular function [2,3] and improve survival [4]; however, it involves greater-than-usual periprocedural risk in patients with severe functional impairment [5]. Evidence of contractile reserve is associated with better outcome [6-13] and therefore may help in decision making. However, the interaction between prognostic effect of revascularization and presence of tissue viability in diabetes mellitus has not been definitely established [14]. The issue is important due to the increasing prevalence of diabetes [15] in the general population and the reported high risk in diabetic patients [16-18] following myocardial revascularization [19,20].

This prospective, multicenter study aimed to evaluate the prognostic effect of revascularization in diabetic and non-diabetic patients with chronic ischaemic left ventricular dysfunction, according to the presence or absence of viable myocardium assessed by dobutamine stress echocardiography.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Patients
Between January 1992 and December 2003, 612 patients (519 men, 93 women; aged 63±10 years) were prospectively enrolled. Of these, 163 (27%) were diabetics according to World Health Organization criteria [21]. Patients were enrolled if they had: 1) angiographically proven coronary artery disease (visually assessed >70% diameter reduction of >1 major coronary vessel on a coronary angiogram); 2) severe left ventricular dysfunction (ejection fraction <35% by single plane area-length method with 2-dimensional echocardiography); and 3) adequate acoustic window (>13 out of 16 myocardial segments visualized). Patients with a history of acute myocardial infarction in the last 3 months, renal insufficiency requiring treatment, severe obstructive pulmonary disease, severe symptomatic vascular disease or stroke with neurologic sequelae, were excluded.

Informed consent was obtained from all patients, and the study protocol was approved by the local ethics committees. Hypertension and hypercholesterolaemia were defined according to standard definitions [22,23].

Two hundred and sixty-two (43%) patients (75 diabetics, 187 non-diabetics) underwent myocardial revascularization (coronary surgery or percutaneous intervention) within 6 months of enrolment. The remaining 350 patients (57%) (88 diabetics, 262 non-diabetics) were maintained on medical therapy. The decision to revascularize was made independently by the referring physician, who was unaware of the study aim. Stress echo data were collected and analyzed by stress echocardiographers who were not involved in making surgical or medical treatment decisions. Since the project was investigative and used only the low dose dobutamine protocol for the detection of myocardial viability, the data were not considered for clinical decision making.

2.2. Resting and stress echocardiography
Dobutamine was given according to the low-dose protocol (5 µg/kg/min followed by 10 µg/kg/min, each step lasting 5 min). Echocardiographic images were assessed semiquantitatively using a 16 segment, 4-point scale model of the left ventricle, where 1 = normal, 2 = hypokinetic, 3 = akinetic, and 4 = dyskinetic [24]. Wall motion score index (WMSI) was assessed as the ratio between the sum of scores and the number of visualized segments. The difference between peak and rest WMSI ({Delta}WMSI) indicated the overall contractile reserve. The presence of viable myocardium was defined as {Delta}WMSI>0.4 [12]. Quality control of stress echo reading was done as previously described [25].

2.3. Follow-up
Outcome was determined from patient interviews at the outpatient clinic, hospital chart reviews and telephone interviews with the patient, a close relative or referring physician. Death was the only end-point in the study. In order to avoid possible misclassification of the cause of death [26], overall mortality was considered. Therefore, follow-up data were analyzed for the prediction of all-cause mortality.

2.4. Statistical analysis
Continuous variables are expressed as mean±SD. Differences between groups were compared using Student's t and chi-square statistics, as appropriate. Survival analysis was done with product-limit Kaplan-Meier methods using the log-rank test. Follow-up started from the date of the intervention in patients undergoing revascularization and from the stress echo in medically treated patients. The association between selected variables and outcome was assessed with the Cox's proportional hazard model using univariate and stepwise multivariate procedures. A significance of 0.05 was required for a variable to be included into the multivariate model, whilst a p value of 0.1 was the cut-off for exclusion. Hazard ratios (HR) with the corresponding 95% confidence interval (CI) were estimated. Statistical significance was set at p<0.05. Statistical Package for the Social Sciences (SPSS release 11.0, Chicago, Illinois) was used for analysis.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
Main clinical, echocardiographic, and angiographic findings in revascularized and medically treated patients are listed in Table 1.Mean left ventricular ejection fraction in the whole study population was 28±6%: and was higher in revascularized than in medically treated patients (p<0.0001).


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  		Table 1 Characteristics of revascularized and medically treated patients

 
Of the 262 revascularized patients, 164 (63%) underwent surgery (45 diabetics, 119 non-diabetics), and 98 (37%) underwent angioplasty (30 diabetics, 68 non-diabetics). Compared to non-diabetic patients, those with diabetes were older (64±9 vs 61±10 years; p=0.01), had a lower left ventricular ejection fraction (28±6 vs 29±5; p=0.03), and more diseased vessels (2.51±0.90 vs 2.26±0.83; p=0.03). No intergroup difference in {Delta} WMSI (0.25±0.23 vs 0.23±0.22; p=0.59) was observed.

Among the 350 patients (88 diabetics, 262 non-diabetics) undergoing medical treatment, diabetics were older (66±9 vs 62±11; p=0.001), and had more diseased vessels (2.38±0.75 vs 2.18±0.84; p=0.06). However, no difference in left ventricular ejection fraction (26±7 vs 27±6; p=0.17), or {Delta} WMSI (0.15±0.19 vs 0.16±0.21; p=0.63) was found between diabetics and non-diabetics.

3.1. Outcome
Follow-up information was available in all subjects. During a mean follow-up of 42±31 months, 215 (35%) patients died, of these 68 (26%) had undergone revascularization and 147 (41%) received medical treatment (p=0.0001).

In the revascularized group, 11/70 patients (16%) with viable myocardium died compared to 57/192 patients (30%) without viable myocardium. Seventeen (6%) patients, 6 (8%) diabetics and 11 (6%) non-diabetics (p=0.53), died early (within 1 month) after revascularization. Of these, 3 had viable and 14 non-viable myocardium (4% vs 7%; p=0.38). In addition, 15 had undergone surgery and 2 angioplasty (9% vs 2%; p=0.02); overall, no difference in mortality was found between the two intervention strategies (28% vs 22%; p=0.32).

In the medically treated group, 22/55 patients (40%) with myocardial viability died compared to 125/305 patients (41%) without viability.

3.2. Outcome prediction
Univariate and multivariate predictors of mortality in the two treatment groups are reported in Table 2.


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  		Table 2 Univariate and multivariate indicators of mortality in revascularized and medically treated patients

 
Among revascularized patients, resting left ventricular ejection fraction (HR=0.93, 95% CI 0.89-0.97, p<0.0001), {Delta} WMSI>40 (HR=0.44, 95% CI 0.23-0.85, p=0.01), and age (HR=1.03, 95% CI 1.00-1.06, p=0.04) were independent prognostic indicators. The 4-year mortality rate was 15% in patients with and 26% in those without viability (p=0.04) (Fig. 1) with no difference between diabetics and non-diabetics (24% vs 22%; p=0.24) (Fig. 2). The 4-year mortality rate was 26% in non-viable revascularized patients and 42% in non-viable medically treated (p<0.001).


Figure 01
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  		Fig. 1 Kaplan-Meier survival curves for revascularized and medically treated patients, according to the presence or absence of myocardial viability. The number of patients examined each year is shown.

 


Figure 02
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  		Fig. 2 Kaplan-Meier survival curves for revascularized and medically treated patients, according to the presence or absence of diabetes. The number of patients examined each year is shown.

 
Among medically treated patients, diabetes mellitus (HR=1.64, 95% CI 1.13-2.38, p=0.009), the number of diseased vessels (HR=1.27, 95% CI 1.03-1.56, p=0.02), and age (HR=1.02, 95% CI 1.00-1.04, p=0.03) were independently associated with mortality (Table 2). The 4-year mortality rate was 36% in patients with and 42% in those without viability (p=0.57) (Fig. 1); it was significantly higher in diabetics than in non-diabetics (55 vs 38%; p=0.0006) (Fig. 2).


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
To predict the prognostic effect of myocardial revascularization in patients with chronic ischaemic left ventricular dysfunction is a major clinical problem, due to the unfavourable outcome associated with medical therapy [1]. This is of particular interest in diabetic patients who are at increased basal risk [16-18]. In accordance with previous clinical trials [27,28], diabetes was the strongest predictor of mortality among clinical, angiographic and echocardiographic variables of medically treated patients in our study. Previous studies have identified the favourable prognostic impact of a large amount of dysfunctional but viable myocardium, assessed with dobutamine stress echocardiography, in patients undergoing myocardial revascularization [7-12]. To the best of our knowledge, the present study includes the largest number of patients with chronic ischaemic left ventricular dysfunction undergoing dobutamine stress echocardiography for the assessment of tissue viability. In addition, overall mortality was the only objective and unbiased end-point [26]. In keeping with previous findings, we found the presence of a substantial amount of tissue viability to be independently associated with better survival following revascularization. Compared to medical treatment, revascularization was associated with lower mortality in non-diabetic as well as diabetic patients with viable myocardium. This represents an important and novel finding of our investigation. In a recent smaller report, coronary revascularization was able to prevent left ventricular remodelling in both non-diabetic and diabetic patients with viable myocardium [14]. However, the risk of cardiac death was increased in the presence of diabetes. In particular, 5-year mortality in diabetics with viable myocardium was markedly higher compared to that of non-diabetics with viable myocardium and similar to that of non-diabetics without viable myocardium [14]. Previous studies have reported an increased short- and long-term mortality following revascularization in diabetic patients [19,20]. This finding was not confirmed by our study, which showed a similar 4-year survival in diabetics and non-diabetics undergoing revascularization, despite the higher risk profile of the diabetic patients. Similarly, we found no significant inter-group difference in early post-intervention mortality. We also showed evidence of prognostic benefit by revascularization in both diabetic and non-diabetic patients, regardless of the presence of viable myocardium. The prognostic significance of revascularization in patients without viability has previously been investigated, but with controversial results. In a meta-analysis of 24 viability studies, 7 of which used dobutamine stress echocardiography, absence of viability was associated with no significant difference in outcome [29]. Conversely, some authors reported improved survival after revascularization irrespective of the presence of viable myocardium [30,31]. We showed a beneficial prognostic impact of revascularization both in patients with and without viability, although survival was significantly better in the former group. Of note, the finding was ascertained in both the diabetic and non-diabetic population. The reduction of the ischaemic burden and stabilization of the arrhythmic substrate [32] may in part explain the benefit of revascularization in patients with chronic ischaemic left ventricular dysfunction. In those with viability, additional mechanisms may include recovery of left ventricular function [10], prevention of ongoing left ventricular remodelling [33], and improvement of diastolic function [34]. There is now an emerging body of literature that suggests that patients who are revascularized [29] have a better prognosis, but the evidence was not as certain and universally accepted at the time of data collection as it is today. The decision to revascularize a patient is complex and multifactorial and must take into account many different variables, including clinical presentation, coronary anatomy, left ventricular function, evidence of ischaemia, and documentation of viability by several different independent techniques. In addition, local access to invasive procedures can vary widely between different centres. Even when all these variables are kept constant in a single centre, there are still issues related to differences in opinion, intuition and bias.

The results of the present study suggest that both non-diabetic and diabetic patients with ischaemic left ventricular dysfunction and substantial contractile reserve at inotropic stress can undergo coronary interventions with acceptable risk that is outweighed by the potential improvement in survival.

4.1. Study limitations
Diabetic patients were grouped together and were not classified as type 1 or type 2 diabetes. This is in accordance with the most recent recommendations [35] on diagnosis and risk stratification of coronary artery disease, as patients have not been separately evaluated in previous clinical trials. Due to the long recruitment period, the outcome based on stress test results may have potentially been influenced by evolution of methodology, technology, experience, and advances in therapy. The study was observational, and did not influence patient management. Data on myocardial viability from low dose stress echocardiography were not considered in the decision making process for patient management, since at the time of data acquisition, physicians were unaware of the importance of this parameter in terms of potential benefit at long-term follow-up.

The effect of inducible ischaemia was not assessed in our study. Stress test evidence of ischaemia is, per se, a marker of myocardial viability and an indication for ischaemia-guided revascularization [36]. The quest for myocardial ischaemia can be challenging and somewhat risky in these patients, since the left ventricle is often dilated and distorted and patients who are unable to exercise maximally, may be more vulnerable to major side effects during high dose pharmacological testing [25].


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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