(Circulation. 1995;91:979-989.)
© 1995 American Heart Association, Inc.
Articles |
Influence of Diabetes Mellitus on Early and Late Outcome After Percutaneous Transluminal Coronary Angioplasty
Presented in part at the American College of Cardiology 41st Annual Scientific Session, Dallas, Tex, April 12-16, 1992.
From the Center For Cardiovascular Epidemiology and the Andreas Gruentzig Cardiovascular Center, Divisions of Cardiology and Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Ga.
Correspondence to William S. Weintraub, MD, Division of Cardiology, Emory University Hospital, 1364 Clifton Rd NE, Atlanta, GA 30322.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background Although patients with diabetes mellitus constitute an important segment of the population undergoing coronary angioplasty, the outcome of these patients has not been well characterized.
Methods and Results Data for 1133 diabetic and 9300 nondiabetic patients undergoing elective angioplasty from 1980 to 1990 were analyzed. Diabetics were older and had more cardiovascular comorbidity. Insulin-requiring (IR) diabetics had diabetes for a longer duration and worse renal and ventricular functions compared with non-IR subjects. Angiographic and clinical successes after angioplasty were high and similar in diabetics and nondiabetics. In-hospital major complications were infrequent (3%), with a trend toward higher death or myocardial infarction in IR diabetics. Five-year survival (89% versus 93%) and freedom from infarction (81% versus 89%) were lower, and bypass surgery and additional angioplasty were required more often in diabetics. In diabetics, only 36% survived free of infarction or additional revascularization compared with 53% of nondiabetics, with a marked attrition in the first year after angioplasty, when restenosis is most common. Multivariate correlates of decreased 5-year survival were older age, reduced ejection fraction, history of heart failure, multivessel disease, and diabetes. IR diabetics had worse long-term survival and infarction-free survival than non-IR diabetics.
Conclusions Coronary angioplasty in diabetics is associated with high success and low complication rates. Although long-term survival is acceptable, diabetics have a higher rate of infarction and a greater need for additional revascularization procedures, probably because of early restenosis and late progression of coronary disease. The most appropriate treatment for these patients remains to be determined.
Key Words: diabetes mellitus • insulin • angioplasty
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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Patients with diabetes mellitus have a marked propensity for cardiovascular morbidity and mortality. Epidemiological data from the Framingham Study1 demonstrated a twofold to threefold increase in atherosclerotic disease in diabetics. The risk of death from cardiovascular causes is three times higher for diabetic than nondiabetic men, even after adjustment for age and the presence of hypercholesterolemia, hypertension, and tobacco use.2 Similarly, the risks of myocardial infarction, peripheral arterial disease, and heart failure and the mortality associated with coronary ischemic events are increased significantly in diabetics.3
Because of the prevalence of extensive atherosclerotic disease, diabetics constitute an important segment of the population undergoing coronary revascularization procedures. Specifically, patients with diabetes mellitus account for approximately 10% to 20% of patients currently undergoing percutaneous transluminal coronary angioplasty (PTCA). Several reports4 5 6 7 8 9 10 11 12 13 have suggested that diabetes mellitus increases the risk of recurrence after successful PTCA, but the short- and long-term outcomes of these patients have not been well characterized. The purpose of this study is to analyze and compare the procedural success rate, risk of in-hospital complications, and long-term fate of a large population of diabetic and nondiabetic patients undergoing PTCA.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Patient Population
From June 1980 through December 1990, 10 433 patients without prior PTCA or coronary artery bypass graft (CABG) surgery underwent elective PTCA at Emory University and Crawford W. Long hospitals. Diabetes mellitus was present in 1133 patients, accounting for 10.9% of the population treated with angioplasty. Included in this analysis were patients who had the procedure done electively for stable or unstable angina or after stabilization following a myocardial infarction. Those who had PTCA (n=821) in the setting of an acute myocardial infarction were excluded.
Definitions
Patients were included in the diabetic group if
they received
active treatment for diabetes mellitus with either insulin or an oral
hypoglycemic agent at the time of the initial PTCA. Diet-controlled
diabetics were included only if documentation of a fasting blood
glucose of 7.77 mmol/L (>140 mg/dL) or a random blood glucose of
>11.1 mmol/L (>200 mg/dL) was available during the hospitalization
for PTCA.14 All other patients who did not fulfill these
criteria were included in the nondiabetic group. Documentation of the
level of glycosylated hemoglobin was available only in a minority of
individuals. Patients were further classified as insulin-requiring (IR)
and non-IR diabetics, depending on whether they were on active insulin
treatment at the time of hospitalization for PTCA. Duration refers to
the time from first diagnosis of diabetes mellitus to hospitalization
for the index PTCA.
Angina was classified according to the Canadian Cardiovascular Society.15 Congestive heart failure was defined according to the New York Heart Association classification.16 Heart failure was considered present in patients with functional class II or greater. Previous myocardial infarction and hypertension were determined from patient histories. Single-vessel disease was present if there was >50% diameter luminal narrowing in any of the major coronary arteries or their main branches. Two- and three-vessel disease was defined as the presence of >50% diameter luminal narrowing in either two or all three major epicardial vessels, respectively. Left ventricular ejection fraction was determined from the pre-PTCA ventriculogram. Angiographic success was defined as a reduction in the diameter stenosis of all lesions dilated to <50% and a decrease in the stenosis diameter by >20%. Clinical success refers to successful angiographic dilation of all lesions attempted with no myocardial infarction, death, or need for in-hospital coronary surgery.
Data Collection and Angiographic Characteristics
Baseline
demographic, clinical, angiographic, and procedural
data including complications were recorded prospectively on
standardized forms by physicians and entered into a computerized
database. The pre- and post-PTCA angiograms were measured with digital
electronic calipers (Sandhill Scientific Inc) by experienced
angiographers other than the primary operator. The narrowing of each
coronary artery lesion was expressed as the percent diameter narrowing
of the stenosis compared with the normal adjacent arterial segment. The
diameter stenosis recorded was the mean value determined in two nearly
orthogonal views.
In-Hospital and Long-term Follow-up Outcome
In-hospital
outcome was determined by means of a discharge form
filled out on all patients at the time of discharge. Long-term
follow-up was done by trained personnel who made telephone contact with
the patients in the study. These individuals were trained in
determining the cause of death, especially if death was cardiovascular
in origin. Patients were asked about the presence of symptoms, all
hospitalizations subsequent to the index angioplasty, the occurrence of
myocardial infarction, and additional angioplasty or coronary surgery.
Clinical follow-up (mean, 4.0±3.2 years) was available in 96% of
cases. All subsequent revascularization procedures at Emory University
and Crawford W. Long hospitals were also captured from the clinical
database. Myocardial infarctions at follow-up were determined from
patient responses; thus, the potential for underreporting and
overreporting exists.
Statistical Analysis
The study population was analyzed in two
separate ways. First,
patients were grouped by the presence or absence of diabetes mellitus.
Second, the population of diabetics was subgrouped by the requirement
of insulin therapy. The resultant groups were compared by
demographic characteristics, symptoms, comorbid factors, angiographic
characteristics, procedural results, and complications. All data are
expressed as proportion or mean±SD. Differences in categorical
variables were analyzed by 
2 test and differences
in continuous variables by unpaired t test. Stepwise
logistic regression analysis was used to determine correlates of
in-hospital events. Overall survival and event-free survival analyses
were performed with the Kaplan-Meier17 method, and
probability was expressed as mean±SEE. End points analyzed included
(1) total survival, (2) freedom from myocardial infarction, (3) freedom
from coronary surgery, and (4) freedom from additional PTCA. Survival
curves are displayed with tables that reveal the number of patients
remaining, survival, and cumulative events at 6-month intervals.
Comparisons of total and event-free survival were made with the
Mantel-Haenszel18 method. Correlates of time-to-events
were determined by Cox19 model analysis. Because
ejection fraction and height were frequently missing, missing values
were extrapolated by linear regression from clinical variables. Models
for stepwise logistic regression and Cox model analysis were
performed with the values missing and with the extrapolated values. All
statistical analyses were performed with BMDP statistical
software.
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Results |
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The total population of patients undergoing first-time PTCA included 1133 diabetics and 9300 nondiabetics. Of the 1133 diabetic patients, 352 (31%) were being treated with insulin at the time of presentation for the index PTCA and constitute the IR group. The other 781 patients (69%) were being treated with oral hypoglycemic agents or diet alone and constitute the non-IR group. Table 1
lists the baseline clinical characteristics of the
patient groups. Compared with nondiabetic patients, diabetics were
older and more frequently women. This group also had more advanced
cardiovascular disease, as manifested by a higher prevalence of
unstable angina pectoris, prior myocardial infarction, a history of
congestive heart failure, and hypertension. Although not statistically
different, there was a trend toward higher creatinine levels in
diabetics than in nondiabetics.
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Within the diabetic group, IR patients were younger, more often were female, had diabetes for a longer duration (13.7 versus 6.4 years), and had worse renal function (serum creatinine of 150 versus 106 µmol/L or 1.7 versus 1.2 mg/dL) compared with their non-IR counterparts. In contrast, body weight and history of hypertension were higher in non-IR patients. Although angina class and history of congestive heart failure were similar in both groups, a trend toward a higher prevalence of prior myocardial infarction was seen in IR patients.
Table 2 gives the angiographic characteristics. Two- and
three-vessel diseases were more prevalent in diabetics. The mean
ejection fraction and the proportion of patients with depressed
ventricular function were similar in diabetics and nondiabetics. Within
the group of diabetics, the left ventricular ejection fraction was more
often depressed (<50%) in IR (22%) compared with non-IR (15.5%)
patients. Other angiographic characteristics, such as multivessel
disease and pre-PTCA stenosis, were similar in both groups.
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Early Outcome
Table 3 gives procedural details
and the
in-hospital outcome. Dilatation of a lesion in the left anterior
descending artery and multisite PTCA were performed with similar
frequency in diabetics and nondiabetics. Angiographic success of 89%
to 90% was similar in both groups. A nonsignificant trend toward
better clinical success (which represents angiographic success
in the absence of major complications) was seen in nondiabetics
(88.5%) compared with diabetics (86.6%). Importantly, no differences
in the acute angioplasty results were seen between IR and non-IR
patients.
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Major complications were infrequent. The incidence of in-hospital coronary surgery and Q-wave myocardial infarction was similar in diabetics and nondiabetics. While mortality was low in both groups, there may not have been sufficient power to show that mortality between the groups was not different. Within the group of diabetics, the need for in-hospital CABG was low (2.3%) and not significantly different between IR and non-IR patients. There was a trend toward increased Q-wave myocardial infarction (1.14% versus 0.38%) and death (0.85% versus 0.26%) in IR diabetics compared with non-IR patients.
Clinical
correlates of in-hospital death were analyzed (Table 4). Data
on ejection fraction and height were missing in
a substantial proportion of patients. Therefore, the multivariate
analysis is presented in two ways: with patients eliminated for
missing data (center) and with patients included with extrapolated
values for missing ejection fraction and height (right). Smaller body
size (represented by shorter stature), older age
(particularly more than 70 years of age), reduced ejection fraction
(<50%), and multivessel disease emerged as strong correlates of
in-hospital death. Female sex was a univariate correlate only, with the
differences accounted for by shorter stature and older age. Diabetics
had only a univariate trend toward increased mortality.
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Late Outcome
Survival at 5 years was 93% for patients without
and 88% for
those with diabetes mellitus (P<.0001) (Fig 1). As
early as 1.5 years after the index PTCA, a
difference in the survival curves between both groups becomes evident,
and the curves continue to diverge throughout the time of follow-up.
Freedom from myocardial infarction at 5 years was substantially higher
for nondiabetic patients (89%) than for diabetic individuals (81%)
(P<.0001) (Fig 2). Again, the difference
between groups is readily apparent 2 years after PTCA and
increases throughout the follow-up. Coronary bypass surgery was
required significantly more often in diabetics. A separation in the
curves was noted 2 years after PTCA and became more evident at the end
of the 5-year follow-up, with 14% of nondiabetics and 23% of
diabetics requiring surgery after initial angioplasty
(P<.0001) (Fig 3). With respect to the need
for additional PTCA, 21% of nondiabetics compared with 25% of
diabetics required an additional angioplasty procedure within the first
year of the initial PTCA (P=.0001) (Fig 4).
During follow-up, a progressively higher number of diabetics required
additional PTCA compared with the nondiabetic cohort. Thus, at the end
of 5 years, 32% of nondiabetics and 43% of diabetics required
additional angioplasty (P<.0001).
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Overall survival and
survival free of adverse coronary events
were higher in nondiabetics than in diabetics. At the end of 5 years,
survival free of myocardial infarction was present in 83% of
nondiabetic and in 73% of diabetic patients (P<.0001).
Survival free of myocardial infarction or surgical revascularization
occurred in 73% of nondiabetics and in 60% of diabetics
(P<.0001). Finally, survival free of myocardial infarction,
coronary bypass surgery, and additional angioplasty was present in
53% of nondiabetic patients and in only 36% of diabetics
(P<.0001) (Fig 5).
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Clinical and angiographic
characteristics were analyzed as correlates
of long-term survival (Table 5). The multivariate
analysis is presented in two ways: with patients eliminated for
missing data (center) and with patients included with extrapolated
values for missing ejection fraction (right). The strongest
multivariate correlates of 5-year survival were, in order of
importance, younger age, preserved left ventricular ejection fraction,
and absence of congestive heart failure and multivessel coronary
disease. Diabetes was also a significant independent correlate of
reduced 5-year survival, with a higher hazard ratio in the analysis
with extrapolated values for missing ejection fractions. Female sex
emerged as a correlate of decreased survival by univariate but not by
multivariate analysis.
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Table 6 gives the correlates of
decreased survival in
diabetics, with the analyses with ejection fractions missing in the
center and with extrapolated ejection fractions on the right. For
diabetic patients, the strongest multivariate correlates of 5-year
survival were the same as for the overall population and included
younger age, the absence of heart failure, preserved left ventricular
function, and the absence of multivessel disease. In addition, the lack
of requirement for insulin therapy emerged as an independent correlate
of survival in the analysis with extrapolated values for missing
ejection fractions where the sample size was greater. Female sex and a
history of myocardial infarction were more marginal multivariate
correlates of decreased survival.
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Diabetic patients younger than 60
years of age had an excellent
long-term survival of 93%. Similarly, 89% of those 60 to 69 years old
were alive at the end of the follow-up. In contrast, only 71% of
diabetics over the age of 70 survived 5 years (Fig 6).
For patients with an ejection fraction 
50%, survival was 90%. In
contrast, for those with an ejection fraction <50%, 3.5-year survival
was only 77% (Fig 7). Long-term survival and survival
free of myocardial infarction were better in diabetics who did not
require insulin at the time of the initial PTCA compared with those on
insulin therapy. As Figs 8 and 9 show,
non-IR diabetics had a 5-year survival of 91% and an infarction-free
survival of 77%, which are substantially higher than the 82% survival
and 64% infarction-free survival rates of IR diabetics. The
differences in survival became apparent within 2 years after the index
PTCA and were more pronounced at the end of the follow-up period.
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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This study presents the early results, complication rate, and long-term outcome of a large group of diabetic patients undergoing angioplasty. These results were compared with those of nondiabetic patients undergoing PTCA in the same institutions during the same period. At baseline, cardiovascular comorbid factors were more common in the diabetic group. Diabetics were older, more often female, with a higher prevalence of unstable angina, hypertension, multivessel disease, history of myocardial infarction, or heart failure. Left ventricular function, however, was similar in both groups. From differences in baseline characteristics, we would have expected a worse early outcome in the diabetic group. However, the major in-hospital complications of Q-wave infarction and in-hospital coronary surgery were virtually identical in both groups. While there was a trend toward higher mortality in diabetics, the low mortality in both groups precludes a definitive statement as to whether diabetes mellitus influences in-hospital mortality.
The influence of insulin requirements on the outcome of patients with diabetes mellitus was assessed in this study. IR patients were younger, were more often female, had diabetes for a substantially longer duration, and had worse baseline left ventricular and renal functions. In addition, trends toward higher prevalence of unstable angina and previous infarction or heart failure were present in IR diabetics. Despite these baseline differences, procedural and clinical successes were similar in IR and non-IR diabetics. While acute complications were infrequent (approximately 3%) and the need for in-hospital coronary surgery was similar in both groups, Q-wave myocardial infarction and death were three times more common in IR patients, with strong statistical trends for both. The small number of in-hospital events precludes definite comparisons between groups, and it is possible that in a larger group of patients, the need for insulin would emerge as an important predictor of in-hospital complications.
Long-term clinical outcome after angioplasty in a large cohort of patients with diabetes mellitus was defined for the first time in this study. For the total population of angioplasty patients, age, ejection fraction, history of congestive heart failure, prevalence of multivessel disease, and diabetes mellitus emerged as multivariate correlates of long-term survival. Although acute mortality after PTCA was low in diabetics and nondiabetics, long-term survival was adversely affected by the presence of diabetes mellitus even after correction for other comorbid factors. Although the 5-year survival after PTCA was acceptable, diabetics frequently experienced recurrent coronary ischemic events and a need for further revascularization procedures.
There were also trends toward higher in-hospital rates of death and acute myocardial infarction in IR patients. Importantly, 91% of non-IR patients were alive after 5 years compared with 82% of IR patients. Furthermore, survival free of myocardial infarction was substantially lower for IR diabetics. The reason for the worse outcome in IR diabetics is not entirely clear. Although IR diabetics had a longer duration of diabetes, worse renal function, worse left ventricular function, and more multivessel disease, insulin requirement was an independent correlate of decreased survival. Thus, the worse outcome in IR diabetics cannot be entirely explained by these adverse characteristics and must also include differences between IR and non-IR diabetics not easily measured, such as diffuseness of their vascular disease.
The higher mortality, greater incidence of myocardial infarction, and more frequent requirements for CABG or additional PTCA during follow-up in diabetics are probably due to multiple factors. First, coronary atherosclerosis is not only more prevalent but more extensive in diabetic than in nondiabetic subjects.20 More than 80% of diabetics without clinically manifest coronary disease were found to have two- or three-vessel involvement in one autopsy study.21 Although our study revealed that only one third of the patients had two- or three-vessel coronary disease, it is well known that angiography underestimates the extent of atherosclerotic involvement. This may be particularly relevant to diabetics who are more prone to diffuse atherosclerotic disease.
Second, diabetics are at higher risk of myocardial infarction.22 It is possible that atherosclerotic plaque fissuring and superimposed thrombosis, which are the most important pathogenic factors in acute myocardial infarction, occur more frequently in diabetic patients.23 Diabetics have increased blood viscosity as a result of elevated plasma proteins, increased red cell aggregation, and/or decreased red cell deformability.24 Hyperviscosity, in turn, may increase shear rate and promote plaque rupture, platelet aggregation, and thrombosis. Diabetics also have a number of hematologic abnormalities that can predispose them to thrombosis. Spontaneous and induced platelet aggregation is increased,25 26 platelet synthesis of thromboxane A is enhanced,27 and measurements of platelet activation (platelet factor 4 and ß-thromboglobulin) can be elevated.25 In addition, procoagulant factors—including fibrinogen, factor VIII, and von Willebrand factor—may be increased in diabetics.25 Mechanisms aimed at reducing intravascular clotting may also be impaired. Synthesis of prostacyclin is reduced,25 and fibrinolysis may be attenuated because of increases in plasminogen activator inhibitor type 1.25 28 29
Third, diabetics may exhibit an accelerated form of intimal hyperplasia and atherosclerosis in response to metabolic factors and to the vascular injury caused by balloon dilatation. Proliferation of smooth muscle–type cells in the mesangium of the kidney in diabetic patients has been seen30 ; this process may have some similarity with the smooth muscle proliferation in restenotic lesions. Hyperinsulinemia, common in non–insulin-dependent diabetics with insulin resistance (and in IR diabetics treated with intermittent subcutaneous insulin), may contribute to the atherogenic process. Insulin may directly promote smooth muscle cell proliferation and cholesterol synthesis, increase the synthesis of growth factors,31 and induce the growth of human vascular smooth muscle cells.32 In addition, the increased procoagulant state in diabetics may contribute directly to the progression of the atherosclerotic disease. Given the potential contribution of insulin to the proliferative vascular response, it is not surprising that some studies of multivessel PTCA have found diabetes mellitus to be a predictor of restenosis in all dilated sites.7 12
The marked attrition in event-free survival in the first 6
months after initial PTCA corresponds to the period of highest risk of
restenosis.33 34 During the first year after the
index
PTCA, additional angioplasty was required in 25% of patients with and
in 21% of those without diabetes mellitus (P=.0001). Within
this period, 80% of additional angioplasties in diabetics and 85% in
nondiabetics were performed at the same site as the original procedure.
This suggests that the majority of repeated angioplasties during the
first year were done because of restenosis. In contrast, two thirds to
three fourths of angioplasty procedures performed more than 1 year
after the index PTCA were done at a site different from the original,
without significant differences between diabetics and nondiabetics.
This suggests that PTCA is repeated after the first year of the initial
angioplasty primarily because of the progression of coronary disease
rather than restenosis. Our data indicate not only that repeated
angioplasty within the first year was more common in diabetics but also
that these patients required more frequent revascularization with
either surgery or PTCA during the 5-year follow-up (Figs 3
and
4). This
suggests that compared with nondiabetics, diabetics are more prone to
restenosis within the first year and to the progression of coronary
disease after the first year. Furthermore, the increased event rate in
IR diabetics may be related to accelerated progression in these
patients.
In agreement with our results, several studies have suggested that diabetic patients are at increased risk of restenosis after the initial PTCA4 5 6 7 8 9 12 13 and of recurrent restenosis after repeated PTCA.10 11 In these studies, recurrence rates in diabetic patients ranged from 35% to 75%, although the number of patients included was generally small. Only one study9 analyzed the relation between insulin requirements and restenosis; a higher restenosis rate was found in IR (62%) compared with non-IR diabetics (39%) or control subjects (36%). Another small study5 suggested that IR diabetics have a restenosis rate as high as 75% and frequently require repeated revascularization procedures. While not all reports have detected an association between diabetes mellitus and increased risk of restenosis,35 36 the number of diabetic patients included in these studies was relatively small, and the power to detect a significant difference between groups was limited. A recent study37 of intracoronary stenting for the prevention of restenosis revealed a higher incidence of restenosis in diabetics compared with nondiabetics (49% versus 32%, respectively). Because stenting eliminates the contribution of elastic recoil or vasospasm to the restenotic process, the greater reduction in luminal diameter after PTCA in diabetics probably reflects a greater predisposition to intimal hyperplasia.37
Study Limitations
This study has several limitations. (1) The
requirement for
insulin was based on the patient's mode of treatment at the time of
PTCA and not on a careful study of whether the patient had type I or
type II diabetes mellitus. (2) Given the retrospective nature of this
review, important baseline data regarding renal function,
anthropometric measurements, and left ventricular function are missing
in a number of patients. In addition, the adequacy of glycemic control
was unavailable. Analysis of the correlation of glycemic control and
long-term prognosis would have been interesting. (3) The in-hospital
model of mortality is based on just 29 deaths and thus will be
relatively unstable, especially considering the large number of
clinical variables analyzed. (4) The clinical follow-up suffers from
variability in time of follow-up. These limitations notwithstanding,
the large number of patients studied with clinical follow-up
contributes to the clinical relevance of study.
Conclusions
Patients with diabetes mellitus constitute an
important segment of
the population undergoing PTCA. The angiographic success of balloon
dilatation and the rate of in-hospital emergency surgery and Q-wave
myocardial infarction are not significantly different from the results
of PTCA in the overall population. While in-hospital mortality is low
and long-term survival acceptable, diabetic patients have a higher rate
of cardiovascular events and a need for additional revascularization
procedures over 5 years. This is probably related to the higher
incidence of early restenosis in diabetics and to the late progression
of coronary disease in other segments. Procedural success was similar
in IR and non-IR diabetics, although there was a trend toward higher
in-hospital Q-wave myocardial infarctions and mortality in IR
diabetics. Even after adverse clinical characteristics are accounted
for, the need for insulin emerged as an independent correlate of
decreased survival.
The most appropriate management of diabetic patients with severe coronary disease cannot be determined from this study. While PTCA is an attractive treatment option with low morbidity and mortality, the high incidence of cardiovascular events during follow-up is troublesome. The patients who will best be served by medical therapy, PTCA, or coronary surgery remain to be determined.
Received May 24, 1994; revision received August 26, 1994; accepted September 23, 1994.
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