(Circulation. 1997;96:2551-2556.)
© 1997 American Heart Association, Inc.
Articles |
Relationship Between Diabetes Mellitus and Long-term Survival After Coronary Bypass and Angioplasty
From the Duke Heart Center, Duke University Medical Center, Durham, NC.
Correspondence to Gregory W. Barsness, MD, Duke Clinical Research Institute, 2024 W Main St, Durham, NC 27705. E-mail barsn001{at}onyx.mc.duke.edu
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Abstract |
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Background Recent subgroup analyses of randomized trials have suggested that percutaneous intervention in diabetic patients with multivessel disease results in higher mortality than coronary artery bypass graft surgery (CABG). We studied the relationship between diabetes and survival after revascularization in a large prospective cohort of patients with multivessel coronary artery disease.
Methods and Results By analyzing data for 3220 patients
(24% diabetic) with symptomatic two- or three-vessel
coronary disease who were undergoing
percutaneous transluminal coronary angioplasty
(PTCA) or CABG at Duke University Medical Center between 1984 and 1990,
we found that at 5 years, unadjusted survival in the group of patients
undergoing CABG was 74% in diabetics and 86% in nondiabetics.
Similarly, 5-year survival among PTCA patients was 76% in diabetics
and 88% in patients without diabetes. After adjustment for baseline
characteristics, diabetic patients receiving either PTCA or CABG had
significantly poorer survival than nondiabetics
(
2=43.56, P<.0001). Unlike previous
studies, however, there was no significant differential effect of
diabetes on outcome between patients treated with PTCA and those
treated with CABG (2=0.01, P=.91).
Conclusions Although diabetes was associated with a worse long-term outcome after both PTCA and CABG in patients with multivessel coronary artery disease, the effect of diabetes on prognosis was similar in both treatment groups. Thus, our findings support the concept that the choice of initial revascularization strategy should not be based exclusively on a history of diabetes but rather should rely on other factors, such as angiographic suitability and clinical status.
Key Words: diabetes mellitus • angioplasty • bypass • survival
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Introduction |
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Diabetes is a recognized risk factor for poor outcome after either percutaneous1 2 3 4 or surgical5 6 7 8 9 10 11 12 13 revascularization, yet diabetic patients constitute up to 25% of patients presenting for such procedures. Although revascularization strategies for multivessel CAD have been shown to be equivalent in eight previously published randomized trials,14 a recent subgroup analysis from BARI15 suggests that diabetic patients may have significantly better long-term survival with CABG than with PTCA. In this trial in which the use was compared of PTCA and CABG for revascularization in patients with multivessel CAD, 5-year survival rates among medically treated diabetic patients who underwent PTCA was significantly lower than for those receiving CABG (65.5% versus 81.6%, P=.003). These results prompted a National Heart, Lung, and Blood Institute clinical alert in September 1995 stating that CABG should be the preferred initial revascularization choice for patients with medically treated diabetes and multivessel CAD.16
Subsequent analysis of outcomes among small numbers of diabetic patients enrolled in other randomized trials of revascularization have provided conflicting results.17 18 In addition, recent observational comparisons of PTCA and CABG in diabetic patients with multivessel disease19 20 have not confirmed the BARI findings. Therefore, in an effort to provide additional information about these important concerns and the generalizability of these findings, we undertook this analysis to evaluate the relationship between diabetes and survival after revascularization with either PTCA or CABG in a large prospective cohort of patients with multivessel disease.
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Methods |
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Patient Population
Demographics, clinical characteristics, and coronary angiography data on patients undergoing cardiac catheterization at Duke University Medical Center have been prospectively collected and entered into a computerized database since 1971. The population for the present study was selected from a parent population of 17 309 consecutive patients with suspected ischemic heart disease who were entered into the Duke database between March 1984 and August 1990.21 22 Our goal was to examine patients from this population with characteristics making them suitable for randomization in recent multivessel revascularization trials (Fig 1
). To include only subjects from the
parent population suitable for either PTCA or CABG, patients were
excluded for the absence of any significant (
75% diameter)
coronary artery stenosis (n=5817), significant (50%)
left main stenosis (n=691), previous CABG (n=527) or PTCA
(n=253), severe ischemic mitral regurgitation
(n=422), or presence of a primary valvular or congenital
disease or cardiomyopathy. We also excluded
patients with myocardial infarction within 24 hours of
catheterization (n=469) or one-vessel CAD (n=3564) and
those deemed to be treated primarily with medical therapy and not
receiving PTCA or CABG within 30 days of
catheterization (n=1887). The final study population
consisted of 3220 patients with symptomatic multivessel CAD
suitable for either CABG or PTCA who had had an initial
revascularization procedure within 30 days of their
diagnostic catheterization.
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Variable Definitions
We identified patients with the comorbid conditions of diabetes
mellitus, peripheral vascular disease, cerebrovascular
disease, chronic obstructive pulmonary disease, cancer, renal
dysfunction, and liver dysfunction through database questionnaires and
through a retrospective review of discharge diagnoses. For purposes of
data collection, diabetes was defined by a previous physician diagnosis
of diabetes mellitus with treatment with insulin or oral hypoglycemic
agents or with diet. A diagnosis of diabetes was possible at the time
of hospitalization with a fasting glucose of >140 mg/dL on at
least two occasions. Database questionnaires were completed at the time
of cardiac catheterization on the basis of patient
reports, medical records, and physical examination.
Follow-up
Patients were contacted for follow-up by mail and telephone at 6
months, 1 year, and annually from the date of initial
revascularization procedure as previously
described.11 Survival data were 95% complete, with a mean
follow-up of 6.1±2.1 years. Myocardial infarction and
revascularization end points were determined
through medical records and by self-report at follow-up. Cause of
death was divided into cardiovascular and
noncardiovascular categories by a blinded adjudication
committee.21 23
Data Analysis
Baseline characteristics and outcome measures among
patients with (n=770) and without (n=2450) diabetes mellitus were
analyzed after stratification on
revascularization strategy (Fig 1
). For this study,
patients were assigned a treatment variable according to the first
revascularization procedure (either PTCA or CABG)
within 30 days of the index cardiac
catheterization.
Baseline characteristics were summarized with medians and interquartile ranges for continuous variables and percentages for discrete variables. Kaplan-Meier survival curves were used to describe unadjusted survival patterns among groups.24 All-cause mortality was the predetermined primary outcome measure examined in this study. Other outcomes investigated were procedural success, cardiovascular mortality, myocardial infarction during follow-up, and repeat revascularization. To more accurately reflect event rates, repeat revascularization rates are reported in two ways: censored on death and as a composite event of death or repeat revascularization.
To control for potential imbalances in baseline prognostic variables between subgroups related to the nonrandomized nature of this analysis, we adjusted for all identified prognostic factors. Factors included CAD severity, as measured with a previously derived CAD index11 (values 0 to 100); left ventricular ejection fraction; congestive heart failure severity (New York Heart Association functional class I through IV); age; sex; mitral insufficiency severity (0 to 4); other comorbid conditions that might adversely affect prognosis on the basis of a scaled index of factors (modified Charlson comorbidity score,25 values 0 to 6): peripheral vascular disease, cerebrovascular disease, chronic obstructive pulmonary disease, cancer, and renal or liver dysfunction. To evaluate whether outcome differences between the two revascularization strategies differed significantly based on the presence of diabetes, an interaction term for treatment by diabetes was included in the Cox regression model. A statistically significant interaction term would imply that the effect of a given revascularization strategy (PTCA or CABG) was different among patients with diabetes compared with patients without diabetes.
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Results |
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Study Population
The group of study patients with diabetes (n=770) had a higher percentage of women, more hypertension, more heart failure, more mild (1+ or 2+) mitral regurgitation, and more three-vessel CAD (Table 1
). Patients with diabetes
also tended to be slightly older and to have a lower left
ventricular ejection fraction. Patients without diabetes
were more often smokers. In both the diabetic and nondiabetic groups,
men underwent CABG more frequently than PTCA, as did patients with a
history of heart failure and patients with three-vessel CAD. Patients
with a history of myocardial infarction, however, received PTCA more
often. Time from initial cardiac catheterization to
revascularization was greater for patients
undergoing CABG than for those undergoing PTCA. Measures of comorbidity
and ejection fraction were equally distributed.
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Revascularization Procedures
Among patients undergoing PTCA, the average number of lesions
attempted was similar for patients with and without diabetes (1.5
lesions per patient), whereas most diabetic and nondiabetic patients
had at least one lesion successfully dilated (<50% residual
stenosis; 94% and 92%, respectively) (Table 2). The average number of grafts placed
in patients undergoing CABG was also similar among patients with (3.5
grafts per patient) and without (3.4 grafts per patient) diabetes. Of
patients undergoing CABG, 86% received an IMA conduit. There was no
difference in IMA use between patients with or without diabetes.
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Unadjusted Outcome Measures
Unadjusted 5-year survival for diabetics undergoing PTCA was 76%,
whereas for nondiabetics, the rate was 88%. Similarly, in the group of
patients undergoing CABG, 5-year survival was 74% in diabetics and
86% in patients without diabetes mellitus (Table 3, Fig 2).
Cardiovascular mortality and follow-up death or
infarction was greater in diabetic patients undergoing either PTCA or
CABG. The need for repeat revascularization during
follow-up was greater in patients undergoing PTCA than CABG (Table 3).
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Adjusted Survival Outcomes
In the study population, six factors were independently associated
with increased all-cause mortality: age, comorbid illness, left
ventricular ejection fraction, diabetes history, heart
failure severity, and CAD index (Table 4). The interaction between diabetes and
type of revascularization (PTCA or CABG) was not
significant (P=.91); that is, although diabetes is strongly
associated with a worse long-term prognosis, this increased mortality
is not significantly different between diabetic patients treated with
PTCA and those treated with CABG.
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After adjustment for imbalances in baseline characteristics,
diabetes remained a significant predictor of poorer survival in
patients undergoing revascularization
(P<.0001). Diabetic patients receiving PTCA had an adjusted
5-year survival rate of 86%, whereas in PTCA patients without
diabetes, the rate was 92%. Similarly, after CABG, diabetics had a
lower 5-year survival rate compared with nondiabetic patients (89%
versus 93%) (Fig 3).
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Discussion |
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Over the past decade, clinical trials and large cohort analyses have attempted to define optimal treatment strategies for patients with CAD. Whether these treatment strategies need to be individualized for particular subgroups of patients, such as diabetics, has increasingly been a matter of debate.4 15 26 We attempted to evaluate the potential differential effects of revascularization strategy on outcome among diabetic patients in a large prospective cohort of patients with multivessel CAD.
While the recent revascularization trials did not demonstrate a significant survival advantage of CABG over PTCA in the general population of eligible patients with multivessel CAD,14 15 27 28 29 30 BARI did report a 15% decrease in 5-year survival among diabetic patients who underwent PTCA compared with diabetics who had CABG.15 Data from other randomized controlled trials of revascularization offer conflicting results. The 59 diabetic patients in the Emory Angioplasty Versus Surgery Trial (EAST)17 had no significant difference in 5-year survival after PTCA compared with CABG. However, with a total diabetic population of 122 patients, the Coronary Angioplasty versus Bypass Revascularization Investigation (CABRI)18 demonstrated improved survival at 2 years in the diabetic patients undergoing CABG. This improved outcome in CABG-treated diabetic patients was reported to be comparable to that noted in BARI.15 Additional evidence from the preliminary analyses of other large datasets19 20 of patients with CAD have not shown a significantly different effect of these revascularization strategies in diabetic patients. Thus, currently available evidence concerning the effect of revascularization strategy on outcome in diabetic patients does not offer a clear mandate.
The greater morbidity and mortality from CAD in patients with diabetes mellitus are well known,31 32 33 34 35 and diabetic patients appear to have poor outcomes after either PTCA or CABG. In fact, diabetic patients have been shown to have greater morbidity than their nondiabetic counterparts after several modes of revascularization, including CABG,5 6 7 8 9 10 11 12 13 atherectomy,3 percutaneous laser angioplasty,36 and balloon angioplasty.1 2 37 38 39 40 41 42 43 44 Even encouraging therapies for acute coronary syndromes45 and new adjuncts for revascularization, such as abciximab46 and intracoronary stents,47 have failed to improve outcome in diabetics to levels approaching those found in nondiabetics, and diabetic-specific interventions for CAD have only recently come under investigation.34 48 49
Our analysis confirmed that diabetes is a marker of poor prognosis and is associated with worse long-term outcome in patients with multivessel CAD. Even after adjustment for important prognostic characteristics, patients with diabetes receiving either CABG or PTCA had lower survival rates than nondiabetics receiving those interventions. Unlike some previous findings, however, this long-term analysis demonstrates that a history of diabetes holds a similar risk for both PTCA and CABG patients. The increased mortality associated with diabetes is statistically and clinically equivalent in the CABG- and PTCA-treated patients studied here.
Procedural methods, including extent of revascularization and use of IMA conduits, likely have little bearing on these findings. The extent of revascularization in this cohort is similar to the BARI experience, with an average of 3.1 grafts placed per patient in BARI50 compared with 3.5 grafts per patient in this study population. For patients undergoing PTCA, there were two lesions attempted per patient in BARI,51 which is also comparable to the average of 1.5 lesions per patient attempted in this cohort. Likewise, IMA graft use was similar in BARI (83% of diabetic patients and 82% of patients overall)50 and our study (86% of diabetic and nondiabetic patients). The important benefit of IMA conduits during CABG is well demonstrated, including among diabetics,52 and it is not surprising that the BARI analysis noted a significant association between IMA grafting and improved survival.26 The slightly greater use of IMA grafting in the Duke population does not explain the survival findings of the present study. In fact, this would tend to enhance any advantage of CABG over PTCA in the diabetic population, leading to a more significant difference in outcome between CABG- and PTCA-treated diabetic patients. Patient recruitment for BARI and the Duke cohort occurred during a similar time period, suggesting comparable utilization and skill in the performance of the procedure among groups.
Subsequent repeat revascularization may also affect ultimate mortality after an initial procedure. Among patients enrolled in the BARI trial, 8% of patients who received CABG underwent an additional revascularization procedure during follow-up, whereas 54.5% of those randomized to receive an initial PTCA later underwent further intervention.15 Among diabetics, 25% of the patients randomized to CABG died or had a repeat revascularization during 5-year follow-up compared with 77.9% of the PTCA cohort.26 Analysis of repeat revascularization among patients in the study population indicates a similar strategy as that used in BARI, whereas the lower death or repeat revascularization end point for diabetic patients undergoing PTCA is in keeping with the group's lower mortality rate in this study.
Several limitations of this analysis deserve further comment. First, this is a nonrandomized, single-center comparison. However, this analysis accounted for many of the factors known to affect prognosis in a previously tested and validated mortality model.21 In addition, Muhlbaier and colleagues53 demonstrated the power of this type of observational analysis, replicating the long-term results of the randomized Coronary Artery Surgery Trial (CASS) with a similar retrospective analysis of the Duke database population. This sample is also prospectively collected and significantly larger than previous comparisons, allowing for additional power in performance of this analysis. Second, this is an historical dataset, involving patients undergoing revascularization from 1984 to 1990. Although PTCA and CABG have both been refined since that time, there has been little advancement in the treatment of diabetes; therefore, the relative magnitude of the survival differences among groups is still likely to be generalizable to the patient population of today. An additional factor limiting this data is that it is not possible to describe the details of diabetes management in these patients.
These limitations, however, must be placed in context; the only randomized controlled trials available have not prospectively evaluated patients with diabetes and have limited statistical power. Until further evidence is available, we must make use of all the resources at hand to determine treatment strategies for patients with CAD. Observational databases, such as the one used in this study, are an important resource in the armamentarium of medical decision-making, providing a broad perspective that can complement randomized trials and provide useful information to patients and physicians.
Our results do not support earlier conclusions that diabetes status alone should determine the choice of revascularization strategy. Based on this analysis, when other factors such as CAD severity, technical considerations, and patient preference have been taken into consideration, the presence or absence of diabetes mellitus should not be a major factor in the decision to proceed with either PTCA or CABG. Because no large clinical trial has prospectively addressed the choice of revascularization in patients with diabetes, subgroup analysis of all randomized trials and adequately sized prospective databases are needed to assist the patient and physician in making informed treatment decisions.
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Selected Abbreviations and Acronyms |
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Acknowledgments |
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The authors wish to thank John M. Daniel for editorial assistance in preparation of the manuscript.
Received March 24, 1997; revision received April 30, 1997; accepted May 15, 1997.
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