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(Circulation. 1997;96:1761-1769.)
© 1997 American Heart Association, Inc.
Articles |
Influence of Diabetes on 5-Year Mortality and Morbidity in a Randomized Trial Comparing CABG and PTCA in Patients With Multivessel Disease
The Bypass Angioplasty Revascularization Investigation (BARI)
From the NHLBI, Bethesda, Md; the Graduate School of Public Health, University of Pittsburgh (Pa); and the BARI Investigative Sites.
Correspondence to Robert L. Frye, MD, University of Pittsburgh, 127 Parran Hall, 130 DeSoto St, Pittsburgh, PA 15261.
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionAppendix 1References |
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Background Patients with diabetes mellitus have increased morbidity and mortality after coronary revascularization. The Bypass Angioplasty Revascularization Investigation (BARI), a trial of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG) in patients with multivessel disease, reported a 5-year survival advantage of CABG over PTCA in patients with treated diabetes mellitus (TDM). This report examines these findings in more detail.
Methods and Results Eighteen clinical centers randomly assigned 1829 patients with multivessel coronary disease to undergo initial CABG or PTCA. Patients were followed an average of 5.4 years. TDM was defined as a history of diabetes with use of oral hypoglycemic agents or insulin at study entry. Nineteen percent of the randomized population (353 patients) met these criteria. TDM patients had more unfavorable baseline characteristics than other patients, but among TDM patients, these characteristics were similar between the CABG and PTCA groups. Better average 5.4-year survival with CABG was due to reduced cardiac mortality (5.8% versus 20.6%, P=.0003), which was confined to those receiving at least one internal mammary artery graft.
Conclusions Patients with TDM assigned to an initial strategy of CABG have a striking reduction in cardiac mortality compared with PTCA. Long-term internal mammary artery graft patency may contribute to this improved outcome by reducing the fatality of follow-up myocardial infarction.
Key Words: angioplasty • bypass • coronary disease • diabetes mellitus • trials
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Patients with diabetes mellitus have a greater incidence of atherosclerotic cardiovascular disease, which, when present, is associated with increased mortality and morbidity compared with nondiabetic patients with cardiovascular disease.1 2 3 4 5 6 Diabetes is an independent risk factor for lesion progression, graft occlusion, and cardiac mortality after CABG.7 8 9 10 11 In two recent studies, a history of diabetes was associated with a twofold increase in mortality over 5 to 8 years after PTCA compared with patients without diabetes.12 13 In addition, diabetes mellitus has been identified as an independent risk factor for the development of restenosis after balloon angioplasty or stent placement.14 15
In 1987, the NHLBI initiated the BARI, a randomized trial to compare the efficacy of CABG and PTCA in patients with multivessel disease.16 17 18 19 20 The primary hypothesis was that an initial revascularization strategy of PTCA did not compromise clinical outcome over a 5-year period compared with an initial strategy of CABG. BARI recently reported no significant difference in survival over a 5-year period between the two strategies.21 Four baseline patient characteristics (clinical presentation, number of coronary vessels diseased, left ventricular function, and American College of Cardiology/American Heart Association lesion type) were prespecified for subgroup analysis. On the basis of findings of an earlier trial,22 the Safety and Data Monitoring Board recommended that diabetes also be monitored. Among patients with TDM, defined as diabetes mellitus treated with oral hypoglycemic agents or insulin at study entry, all-cause mortality was significantly lower in those assigned to CABG than in those assigned to PTCA (19% versus 35%, P=.003).21 The present report extends this comparison to cause-specific mortality and examines CABG efficacy by use of IMA grafts versus SVGs only.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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The trial protocol, including a detailed description of study aims, patient selection, exclusion criteria, procedure guidelines, definitions, and administrative structure, has been published.16 17 18 19 20 Briefly, patients were eligible for BARI if they had angiographically documented multivessel coronary artery disease with either clinically severe angina or objective evidence of marked myocardial ischemia requiring revascularization and were suitable for both PTCA and CABG. Between August 1988 and August 1991, 1829 patients from 18 clinical centers were entered into the trial after providing written informed consent. Patients were followed an average 5.4 years, until June 5, 1995, when 67% had 5 years of follow-up. The primary study end point was all-cause mortality at 5 years. Secondary end points included MI and functional and symptomatic status.
Cause of Death
Cause of death was classified by an independent Mortality and
Morbidity Classification Committee as cardiac, noncardiac but related
to atherosclerotic disease, other noncardiac medical causes (eg,
cancer, pulmonary disease), trauma, suicide, and other or
unknown causes.16 Cardiac death was defined as death <1
hour after onset of cardiac symptoms, within 30 days after documented
or probable MI, or due to intractable CHF, cardiogenic shock, or other
documented cardiac causes. A cardiac cause was defined as contributory
when cardiac malfunction was involved but other direct causes of death
could not be ruled out (eg, chronic CHF with pulmonary
embolism). Documents used for classification included death
certificate; coroner's report if available; report from the clinical
center's principal investigator; surgical and
catheterization laboratory reports if death occurred
within 30 days of a procedure; ECG and enzyme data if measured within
24 hours of death; and the patient's baseline, procedure, and hospital
study data. Each case was reviewed independently by two committee
members, with disagreements resolved by full committee consensus.
Myocardial Infarction
Q-wave MI was determined by central laboratory analysis
of ECGs requiring a two-step worsening of the Minnesota Q-wave
code23 24 or a new left bundle-branch block associated
with a twofold increase in total creatine phosphokinase with a positive
MB fraction. Non–Q-wave MI was diagnosed when cardiac enzymes were
elevated with chest pain for >20 minutes or with the appearance of new
ECG changes. Cardiac enzymes were not used to define an MI within 96
hours after coronary revascularization.
Initial Revascularization Procedures
Left ventricular and coronary arteriographic
findings were analyzed by a central laboratory using a
quantitative arteriographic coding system.25 A successful
dilatation was defined as (1) reduction in luminal diameter narrowing
of 
20%, (2) final lumen diameter narrowing of <50%, and (3) TIMI
grade 3 flow. The details of surgical
revascularization were collected prospectively.
Statistical Methods
Patient group differences were evaluated with the
2 test (or Fisher's exact test) for categorical
data and the Wilcoxon test for continuous or count data. Crude
cause-specific mortality rates for an average 5.4 years of follow-up
were computed as a percentage of the number of patients at baseline.
The Kaplan-Meier estimate26 was used to calculate cardiac
survival (freedom from cardiac mortality) under the assumption that
censoring for incomplete follow-up or noncardiac death was
noninformative. The log-rank statistic, stratified according to
clinical center, was used to compare cardiac survival curves between
treatment groups. A Cox regression model27 was used to
compare cardiac mortality rates, adjusted for baseline differences, in
patients with TDM after PTCA, after CABG with an IMA graft, and after
all other CABG procedures (SVG only). In the Cox model, baseline
differences between the three treatment groups were summarized by a
score that estimated each patient's likelihood of receiving an IMA
graft. The score function was obtained from a logistic regression model
using symptomatic and ischemic status, race, sex,
age 65 years, right-dominant coronary artery system, four or
more significant lesions, significant lesion in the left anterior
descending coronary artery, CHF, and body mass index to predict
which CABG patients received an IMA graft. To assess the influence of
MI on mortality, cardiac mortality rates were computed for patients
with a diagnosed MI and for those without a diagnosed MI in each of
three groups (PTCA, CABG with IMA, and CABG with SVG only).
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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At study entry, 447 patients (24% of the randomized population) had a history of diabetes and 353 (19%) had TDM as defined above. The 94 patients with a history of diabetes but not receiving oral hypoglycemic agents or insulin were included in the 1476 patients classified as not having TDM or "all other" BARI patients.
Baseline Characteristics
BARI patients with and without TDM differed substantially (Table 1
). Patients with TDM were more often
women and blacks and had a lower formal educational level than other
patients. A higher proportion of those with TDM had a history of CHF,
hypertension, chronic renal failure, and peripheral
vascular disease. In addition, TDM patients had higher
triglyceride levels and body mass indexes. The severity of
angina at the time of randomization was similar, but TDM patients were
more likely to report an inactive lifestyle and a lower quality of
life. The extent of coronary disease was also greater in the
TDM group, as reflected by the presence of three-vessel disease and
more distal lesions. Left ventricular ejection fraction was
lower among treated diabetics.
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Among TDM patients, baseline characteristics were equally distributed between treatment arms, with the exception that PTCA patients had higher mean LDL cholesterol.
Initial Revascularization Procedure
Table 2 presents
characteristics of the initial intervention for patients receiving
their assigned treatment. For patients assigned to CABG with and
without TDM, 96% and 98%, respectively, received their assigned
procedures. TDM patients had a higher mean number of significant
lesions and distal sites and a lower proportion with all intended
vessels grafted. IMA grafting, whose use (81% to 82% of all CABGs)
did not differ by TDM status, was usually performed in conjunction with
SVGs. There was a greater use of sequential grafts in the TDM
patients.
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For patients assigned to PTCA, 98% with TDM and 95% without TDM underwent their assigned procedure. TDM patients had more significant stenoses and more distal lesions but a similar number of attempted lesions (2.4 versus 2.3). Among significant attempted lesions, TDM patients had a lower mean reference diameter before and after PTCA, as well as lower mean minimum lumen diameter after PTCA (P<.01 for each comparison).
In-Hospital Events
Within each treatment arm, in-hospital event rates were similar
among patients with and without TDM (Table 3). Among those with TDM, the in-hospital
mortality was 1.2% for CABG and 0.6% for PTCA, and the incidence of
Q-wave MI was threefold greater after CABG compared with PTCA. Among
the TDM patients receiving PTCA, 7.1% required emergency CABG and
2.9% underwent nonemergency CABG during the initial hospitalization,
and 2.4% required emergency PTCA. Other minor complications were
similar between the CABG and PTCA groups.
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All-Cause Mortality During Follow-up
The 5-year survival of TDM patients was significantly worse than
for other patients (73.1% versus 91.3%, P<.0001 for the
log-rank test). For the 94 patients with untreated diabetes at
baseline, the 5-year survival was 93.3% compared with 91.1% for the
1382 patients without a history of diabetes. When the patients with TDM
were analyzed by treatment assignment, the cumulative survival
rates were significantly higher for patients assigned to CABG on the
basis of a stringent prespecified .005 level of significance (80.6 for
CABG, 65.5 for PTCA, P=.003 for the log-rank test). This
treatment difference did not vary significantly by clinical centers
(P=.90).
Cause-Specific Mortality
Cause-specific mortality after an average of 5.4 years of
follow-up is shown in Table 4 for
patients who underwent their assigned
revascularization procedure. Cardiac mortality
rates were 20.6% and 5.8% for PTCA and CABG, respectively, among
patients with TDM, compared with 4.8% and 4.7%, respectively, for
other BARI patients. Rates of noncardiac death related to
atherosclerosis and of death attributed to other
medical causes, while considerably higher for patients with TDM, were
comparable by assigned treatment within both TDM and non-TDM patients.
Thus, among patients with TDM, the excess mortality observed in the
PTCA group in comparison with the CABG group was cardiac and not due to
other causes (P<.01 by Fisher's exact test). As seen in
the Figure, the cardiac survival curves
between TDM and non-TDM patients diverge steadily beginning in the
first year of follow-up, as do the survival curves within the TDM group
by assigned treatment.
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Impact of IMA Use on Cardiac Events
The relation of the presence of an IMA graft to cardiac mortality
was particularly striking (Table 5).
Cardiac mortality with TDM was 2.9% when at least one IMA was used and
18.2% when only SVG conduits were used. The latter rate was similar to
that of patients receiving PTCA (20.6%). Because patients were not
assigned at random to use of IMA graft, this survival advantage could
potentially be due to factors related to patient suitability for IMA
grafts rather than the conduit itself. However, after adjustment for
the selection factors (likelihood of receiving IMA grafts), cardiac
mortality in TDM patients not treated with IMA grafts remained
excessive, with an 8.1 risk ratio for cardiac death with PTCA and a 7.4
risk ratio for SVG alone compared with patients receiving at least one
IMA graft (P<.005 for each comparison). Among patients
without TDM, cardiac mortality rates were similar across the three
treatment groups.
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Postrandomization MI rates were also analyzed among TDM
patients. Although the cardiac death rate in those receiving IMA grafts
was substantially reduced compared with the other two groups,
postrandomization MI rates were comparable for all three groups.
However, when cardiac mortality and MI are cross-classified in the
final two columns of Table 5
, however, it is apparent that IMA use in
diabetic patients was associated with sharply decreased cardiac
mortality with or without MI.
Patients without TDM had nearly identical cardiac mortality and MI rates regardless of treatment or conduit. However, IMA use was once again associated with lower post-MI cardiac mortality. This finding in both nondiabetics and TDM patients suggests that an IMA graft protected patients from high cardiac mortality when an intervening MI was sustained. In the large majority of patients without TDM and without intercurrent MI, cardiac mortality was remarkably similar between CABG and PTCA.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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The BARI Investigators recently reported that patients with TDM at the time of randomization to an initial strategy of PTCA experienced higher mortality over a period of 5 years compared with treated diabetics assigned to CABG.21 To elucidate the mechanisms potentially involved in this observed differential mortality, this report details clinical and angiographic characteristics and specific causes of death of patients with and without TDM.
The hazards of subgroup analysis without a priori defined hypotheses and sufficient sample size to achieve the desired power are well recognized, as is the influence of multiple analyses of the data. We established wide, 99.5% CIs for within-subgroup treatment comparisons, corresponding to a stringent .005 level of significance. Additional support for our findings comes from a recent report from another large multicenter randomized trial, the Coronary Angioplasty versus Bypass Revascularization Investigation (CABRI).28 In contrast, the Emory Angioplasty versus Surgery Trial (EAST) failed to show a survival advantage for CABG.29 The survival rate in the small group of diabetic patients in that study, however, was uncharacteristically similar to the nondiabetic patients.
Investigation of cause-specific mortality rates was critical to our understanding of the significant mortality difference observed between treatment groups in TDM patients. Cardiac mortality was more than three times higher in TDM patients initially revascularized with PTCA, whereas other cause-specific noncardiac death rates, although higher in TDM patients, remained remarkably similar by treatment group. Although patients with TDM are known to have a significantly higher incidence of restenosis and progression of coronary artery disease,1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 we hypothesize that PTCA, rather than leading to increased mortality, may simply fail to alter the natural clinical course in TDM patients with coronary artery disease.
The survival benefit of CABG was limited to use of IMA grafts, and it was particularly striking after postrandomization MI in patients with and without TDM. Although postrandomization MI rates were comparable by assigned treatment and conduit type, the subsequent cardiac mortality was lowest with the placement of IMA grafts. This observation was similar to the substantially lower postinfarction mortality rates reported by Peduzzi et al30 and Alderman31 in the VA study for patients initially randomized to CABG instead of medical treatment. We hypothesize that IMA grafts, being less susceptible to disease progression (accelerated in TDM), may provide better alternative sources of perfusion to maintain ventricular function in regions of hypoperfusion resulting from coronary occlusion.
It is well documented that diabetic patients have a greater incidence of mortality post-MI than nondiabetic patients.32 33 34 35 36 37 38 Among diabetic patients, MIs can more often be painless or atypical, manifesting and diagnosed as sudden CHF, cardiac shock, arrhythmia, or sudden death.39 40 Several basic mechanisms might explain the increased mortality of acute MI in diabetics. The benefits of preconditioning of the myocardium may be inhibited by the influence of hypoglycemic drugs that inhibit the ATPase-sensitive potassium channels.41 A hyperpolarizing mechanism present in endothelial cells of normal arteries may be impaired in diabetics, which may compromise endothelial cell function.42 Insulin resistance may contribute to abnormalities in coronary flow.43 Microvascular abnormalities may lead to myocardial ischemia in diabetics even without epicardial coronary artery disease.44 A higher incidence of silent ischemia, plaque disruption, and thrombosis in diabetic patients may help explain the increased rate of acute coronary syndromes and MI observed in diabetics.35 36 37 38 39 40 41 42 43 44 45 Diabetics have a higher incidence of lipid abnormalities and hypertension, which further increases their risk for coronary artery disease.1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
The results of two recent prospective studies have clearly documented the importance of glycemic control in reducing cardiovascular mortality and morbidity in diabetics.46 47 One-year mortality was also reduced in a randomized trial of diabetics with aggressive insulin and glucose therapy early after MI.48 It has been estimated that in diabetic men, aggressive medical therapy and risk factor modification could reduce mortality from coronary artery disease, which is between three and five times greater than among nondiabetics.49 The importance of control of diabetes cannot be overemphasized.
Limitations and Clinical Implications of the Study
The number of BARI patients with TDM was relatively small (353),
although larger than in other recently reported trials comparing CABG
and PTCA.28 29 Because diabetes was not the original focus
of the BARI trial, we collected no detailed information as to the type,
degree, and duration of diabetes. The BARI diabetic classification,
also used in the diabetes substudy of the MRFIT trial and the Joslin
Clinic follow-up study,6 32 was based on patient history,
strengthened by the objective evidence of insulin or oral hypoglycemic
use. Because BARI was not specifically designed to evaluate TDM, the
adequacy of glucose control is unknown, and differential adherence to
medical therapy cannot be ruled out.
The results for diabetic patients in BARI do not necessarily apply to all patients with diabetes. Treated diabetics in the BARI Registry who refused randomization were selected for treatment with PTCA without apparent compromise in survival compared with CABG.50 These patients, however, do not share the adverse baseline characteristics of those in the randomized trial. This observation suggests that in certain diabetic patients, angioplasty may be a suitable alternative to bypass surgery. In addition, we did not enroll patients with single-vessel disease, and use of the IMA graft was left to the discretion of the operator rather than assigned at random. Interpretation of BARI results must also take into account the fact that the initial procedure was standard balloon angioplasty. The impact on outcomes among treated diabetics is not known for the new revascularization technologies, including the frequent use of stents.51 52 53
The clinical implications of our observations are several. Among TDM patients with the characteristics of those randomized in BARI, CABG with IMA grafts appears to be the preferred initial treatment strategy. However, if only SVGs are used, cardiac mortality is similar to that with PTCA. The advances in catheter-based techniques, surgery, and medical therapy call for further properly controlled randomized clinical trials to determine the best treatment strategy for patients with diabetes mellitus.
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Selected Abbreviations and Acronyms |
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Acknowledgments |
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This study was sponsored by the National Heart, Lung, and Blood Institute.
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Footnotes |
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1 Members of the Writing Group are given in the "Appendix."
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Appendix 1 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Writing Group
This article was prepared by Edwin Alderman, MD, Martial Bourassa, MD, Maria M. Brooks, PhD, Robert Califf, MD, Bernard Chaitman, MD, Katherine Detre, MD, DrPH, David P. Faxon, MD, Frederick Feit, MD, Robert L. Frye, MD, Regina M. Hardison, BS, David Holmes, MD, Richard Holubkov, PhD, Nicholas Kouchoukos, MD, Ronald Krone, MD, William Rogers, MD, Allan D. Rosen, MS, Hartzell Schaff, MD, Leonard Schwartz, MD, Andrea S. Siewers, MPH, George Sopko, MD, MPH, Kim Sutton-Tyrrell, DrPH, and Patrick Whitlow, MD, on behalf of the BARI Investigators. Dr Frye, as study chairman, assumes responsibility for overall content and integrity of this article.
Participants in the BARI Trial
University of Alabama
Principal Investigator: W.J. Rogers. W.A. Baxley, L.S. Dean, G.S. Roubin, J.K. Kirklin, J.W. Kirklin, A. Pacifico, G.L. Zorn, E. Charles, T.D. Paine, S. Brewer, L.C. Carr, G. Duke, L.E. Maske, T.E. Morgan, K. Doss, J.A. Trobaugh, K.W. Anderson, M. Brunner-Scott, D. Bunn, F. Harris. Former participants: T. Bulle, J.B. Cavender, P.J. Garrahy.
Brown University: Rhode Island Hospital
Principal Investigator: D.O. Williams. T.M. Drew, A.K. Singh, G.N. Cooper, B.L. Sharaf, J.L. Wheeler. Former participants: M.E. Grogan, M. Macedo, J. Moran, E.S. Thomas, H. White.
Bellevue Hospital (Satellite to Brown)
Principal Investigators: F. Feit, M.J. Attubato. S.B. Colvin, A.C. Galloway, G. Ribakove, P.F. Pasternack, M. Rey, S. Shapiro.
Boston University
Principal Investigators: A.K. Jacobs, D.P. Faxon. G.R. Garber, N.A. Ruocco, R.S. Shemin, G.S. Aldea, T.J. Ryan, D.A. Weiner, B.R. Hankin, M.E. Mazur. Former participants: J.W. Currier, R.M. Mills, G. Paone, J.E. Brush, J.D. Fonger, M.A. Bettmann, J.A. Rothendler.
Cleveland Clinic Foundation
Principal Investigator: P.L. Whitlow. S. Ellis, I. Franco, R. Raymond, E. Topol, D. Cosgrove, F. Loop, B. Lytle, R. Stewart, P.C. Taylor, A.P. Dimas, A.M. Lincoff, W. Proudfit, G. Williams, M. Lowrie, K. Comella. Former participants: J. Frierson, F. Grigera, B. Healy, J. Hollman, L. Korcuska, B. Robalino, A. Rogers, S. Senick, J. Tedrick, K. Vaska.
Duke University
Principal Investigator: R.M. Califf. R.P. Bauman, V.S. Behar, Y. Kong, M.W. Krucoff, K.G. Morris, R.H. Peter, H.R. Phillips, R. Stack, J.E. Tcheng, R.H. Jones, H.N. Oldham, P. Van Tright, W.A. Baker, T. Bashore, D.F. Fortin, K. Lee, E.M. Ohman, L.A. Drew, M.A. Sellers, V.C. Bass. Former participants: B. Bacon, S.G. Burks, S. Caminiti, T. Daniels, D.J. Frid, H. Gessner, E. Hampton, M.J. Miller, D.B. Pryor, P.J. Quigley, J.S. Rankin, J. Richard, L. Santoro, A. N. Tenaglia.
Harvard University: Beth Israel Hospital
Principal Investigator: D. S. Baim. J. Aroesty, B. Lorell, R. Johnson, R. Thurer, R. Weintraub, M. Flatley. Former participants: M. Cunnion, T. DeFeo-Fraulini, D. Diver, R. McKay, C. McCabe, K. Miller, R. Safian, A. Slater.
Maine Medical Center (Satellite to Harvard)
Principal Investigator: M.A. Kellett Jr. W.D. Alpern, R.A. Anderson, D.J. Cutler, P.W. Sweeney, D.J. Donegan, S. Katz, R.S. Kramer, C.A. Lutes, J.R. Morton, E.R. Nowicki, J.F. Tryzelaar, R.L. White, C.T. Lambrew, S. Bosworth-Farrell, J.C. Kane, N. Tooker.
University of Massachusetts
Principal Investigator: B.H. Weiner. J. Moran, O.N. Okike, A. Pezzella, T.J. VanderSalm, M. Borbone, K. Quist. Former participants: J. Benotti, D. Bitran, J. Dalen, J. Gaca, J. Leppo, M. Pasque, M. Shay, P. Wanta, T. Wisnewski.
Mayo Clinic
Principal Investigator: M. Mock. J. Bresnahan, D. Holmes, G.S. Reeder, C. Mullany, T.A. Orszulak, H. Schaff, P.B. Berger, R. Gibbons, S.L. Kopecky, R.S. Schwartz, H.C. Smith, S. Matheson, L. Kelly, L.A. Pierre. Former participants: D. Bresnahan, B. Gersh, F. Nobrega, M. Peterson, R. Vlietstra.
Medical College of Virginia
Principal Investigator: M.J. Cowley. G. Vetrovec, A. Guerraty, D. Salter, A. Wechsler, K. Kelly Hall. Former participants: C.W. Crandall, D. DeBottis, G. DiSciascio, R.R. Lower, A. Maziarz, A. Nath, B. Sechrist, S. Szentpetery.
University of Michigan
Principal Investigator: B. Pitt. E. Bates, D. Muller, S. Bolling, M. Deeb, M. Kirsh, M.M. Stock, J. Corbett, P. Fox, T. Johnson, K. McNeely, S. Pitt. Former participants: L. Belzowski, D. Bondie, K. Burek, S. Ellis, L. Lee, D. Scarpace, M. Schwaiger, H. Shu, M. Stirling, P. Thomasma, E.J. Topol, J. Walton, S. Werns.
Montreal Heart Institute
Principal Investigator: M.G. Bourassa. R. Bonan, G. Cote, J. Crepeau, P. DeGuise, Y. Leclerc, C. Pelletier, J. Gregoire, G. Hudon, J. Lesperance, J. Trudel, C. Faille. Former participants: A. Arseneault, Y. Castonguay, H. Flageol, D.D. Waters, L. Whittom.
Toronto Hospital (Satellite to Montreal)
Principal Investigator: L. Schwartz. H. Aldridge, D. Uden, T. David, C. Feindel, B. Goldman, I. Lipton, L. Mickleborough, R. Weisel, D. Almond, C. Lazzam, M. McLoughlin, L. Zelovitsky, P. Liu, L. Lazzam, K. Mackie.
New York Medical College
Principal Investigator: M.B. Weiss. R. Moggio, R. Pooley, G. Reed, M. Sarabu, R. Steinberg. Former participants: D. Efstathakis, P. Praeger, M.V. Herman, K. Ryman, Y. Sait, E. Somberg, J.H. Stein.
St Louis University
Principal Investigator: B.R. Chaitman. F.V. Aguirre, M.J. Kern, G. Kaiser, V. Willman, R. Wiens, C. Huffman, T. Stonner, S. Aubuchon, M. Kramer. Former participants: H. Barner, U. Deligonul, J.Fehl, K. Galan, B. Poole, M.G. Vandormael.
Jewish Hospital (Satellite to St Louis)
Principal Investigators: R.J. Krone, N. Kouchoukos. A. Salimi, T.H. Wareing, P. Cole, K. Fischer, R. Kleiger, S. Kovacs, M. Rich, A. Shah, J. Humphrey, C. Benson, D. Bowen, G. Eisenkramer, T. Jones, E. Kelly, L. Kendricks, J. Moore, P. Rice, R. Umstead, J. Waldschmidt, B. Walker, J. Weaver. Former participants: M. Caruso, L. Coulter, L. Spinner.
Parallel Study
Institute of Clinical and Experimental Medicine, Prague, Czech Republic
Principal Investigator: V. Stan
k. A. Belán, J.
Ková
, P. Firt, J. Pirk, V. Koandrle, M.
elízko, R. Jandová, E. Tchernoster.
Former Site
Georgetown University
Principal Investigator: K. Kent. N.M. Katz, R. Wallace, L. Elliott, C. Green, J. Lavelle, C. Rackely, K. Kelly Hall. Former participant: B. Shriver.
Central ECG and Myocardial Infarction Classification Laboratory
St Louis University Medical Center
Principal Investigator: B.R. Chaitman. P. Bjerregaard, I. Gussak, R.D. Wiens, L.T. Younis, K. Stocke, K. Russell, S. Cannon, C. Homeyer, M. Miller. Former participants: D. Kargl, L. Maitus, L. Shaw, B. Takase, A. Terry, S. Zhou.
Central Radiographic Laboratory
Stanford University Medical Center
Principal Investigator: E.L. Alderman. B. Brown, W. Sanders, L. Wexler, B. Hollak. Former participants: T. Beam, R. Moore, G. Shao-Zhou, M. Stadius.
Ancillary Study
Study of Economics and Quality of Life
Stanford University School of Medicine (SEQOL)
Principal Investigator: M. Hlatky. C. Winston, D. Boothroyd, I. Johnstone. Former participants: C. Bacon, K. Cavanaugh, N. Clapp-Channing.
Coordinating Center
University of Pittsburgh (Pa)
Principal Investigators: K.M. Detre, S.F. Kelsey. K. Sutton-Tyrrell, A.D. Rosen, S.W. Crow, K.H. Andrews, M.M. Brooks, R.M. Hardison, G.F. Harger, R. Holubkov, A.E. Siewers, J.P. Martin, J. Greenhouse, A. Sampson, C. Ravotti. Former participants: W.P. Amoroso, L.M. Anderson, H.X. Barnhart, D. Borrebach, J.E. Bost, D.W. Burry, M.A. Carr, M. Cooper, R.L. Hardesty, D.F. Hursh, L. Kamons, J.F. Killinger, T.E. Kuntz, E.A. Maurer, J.E. Melvin, J.A. Metzler, B.L. Naydeck, N.H. Remaley, A. Spadaro, A.R. Steenkiste, B.F. Uretsky, J. Wilson.
Program Office
Cardiac Diseases Branch, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md
Program Administrator: G. Sopko. D. Follmann, M. Horan. Former participants: M.J. Domanski, L. Offen, T. Robertson, R. Solomon, J. Verter, D. Zucker.
Safety and Data Monitoring Board
Chair: J.D. Bristow. J. Childress, T. Gardner, C. Grines, J.W. Kennedy, G. Knatterud, J. Waldhausen, C. White. Former participants: H. Gold, R. Roberts.
Morbidity and Mortality Classification Committee
Chair: R. Prineas. C. Fisch, H.L. Greene, R.B. Karp, S.B. King III, J. Mason, J.L. Titus.
Office of Study Chair
Mayo Clinic Foundation, Rochester, Minn
R.L. Frye, MD
Received February 3, 1997; revision received May 5, 1997; accepted May 15, 1997.
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A. H. Lauruschkat, B. Arnrich, A. A. Albert, J. A. Walter, B. Amann, U. P. Rosendahl, T. Alexander, and J. Ennker Prevalence and Risks of Undiagnosed Diabetes Mellitus in Patients Undergoing Coronary Artery Bypass Grafting Circulation, October 18, 2005; 112(16): 2397 - 2402. [Abstract] [Full Text] [PDF]
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J. Kaehler, R. Koester, W. Billmann, C. Schroeder, H.-J. Rupprecht, T. Ischinger, R. Jahns, A. Vogt, M. Lampen, R. Hoffmann, et al. 13-year follow-up of the German angioplasty bypass surgery investigation Eur. Heart J., October 2, 2005; 26(20): 2148 - 2153. [Abstract] [Full Text] [PDF]
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J.-S. Choi, K. R. Cho, and K.-B. Kim Does Diabetes Affect the Postoperative Outcomes After Total Arterial Off-Pump Coronary Bypass Surgery in Multivessel Disease? Ann. Thorac. Surg., October 1, 2005; 80(4): 1353 - 1360. [Abstract] [Full Text] [PDF]
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S. B. King III, G. Dangas, J. W. Moses, S. B. King III, G. Dangas, and J. W. Moses Surgery Is Preferred for the Diabetic With Multivessel Disease Circulation, September 6, 2005; 112(10): 1500 - 1515. [Full Text] [PDF]
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A. M. Calafiore, M. Di Mauro, G. Di Giammarco, G. Teodori, A. L. Iaco, V. Mazzei, G. Vitolla, and M. Contini Single Versus Bilateral Internal Mammary Artery for Isolated First Myocardial Revascularization in Multivessel Disease: Long-Term Clinical Results in Medically Treated Diabetic Patients Ann. Thorac. Surg., September 1, 2005; 80(3): 888 - 895. [Abstract] [Full Text] [PDF]
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P. Sorajja, P. Chareonthaitawee, N. Rajagopalan, T. D. Miller, R. L. Frye, D. O. Hodge, and R. J. Gibbons Improved Survival in Asymptomatic Diabetic Patients With High-Risk Spect Imaging Treated With Coronary Artery Bypass Grafting Circulation, August 30, 2005; 112(9_suppl): I-311 - I-316. [Abstract] [Full Text] [PDF]
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N. Mercado, W. Wijns, P. W. Serruys, U. Sigwart, M. D. Flather, R. H. Stables, W. W. O'Neill, A. Rodriguez, P. A. Lemos, W. A. Hueb, et al. One-year outcomes of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: A meta-analysis of individual patient data from randomized clinical trials J. Thorac. Cardiovasc. Surg., August 1, 2005; 130(2): 512 - 519. [Abstract] [Full Text] [PDF]
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E. D. Beishuizen, J. W. Jukema, J. T. Tamsma, M. A. van de Ree, J. C. M. van der Vijver, H. Putter, A. C. Maan, A. E. Meinders, and M. V. Huisman No Effect of Statin Therapy on Silent Myocardial Ischemia in Patients With Type 2 Diabetes Without Manifest Cardiovascular Disease Diabetes Care, July 1, 2005; 28(7): 1675 - 1679. [Abstract] [Full Text] [PDF]
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P.-E. Falcoz, S. Chocron, C. Binquet, L. Stoica, D. Kaili, C. Quantin, and J.-P. Etievent Revascularization of the Right Coronary Artery: Grafting or Percutaneous Coronary Intervention? Ann. Thorac. Surg., April 1, 2005; 79(4): 1232 - 1239. [Abstract] [Full Text] [PDF]
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O. Jarvinen, J. Julkunen, T. Saarinen, J. Laurikka, and M. R. Tarkka Effect of Diabetes on Outcome and Changes in Quality of Life After Coronary Artery Bypass Grafting Ann. Thorac. Surg., March 1, 2005; 79(3): 819 - 824. [Abstract] [Full Text] [PDF]
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M. Sabate, G. Pimentel, C. Prieto, J. Corral, C. Banuelos, D. J. Angiolillo, F. Alfonso, R. Hernandez-Antolin, J. Escaned, P. Fantidis, et al. Intracoronary brachytherapy after stenting de novo lesions in diabetic patients: Results of a randomized intravascular ultrasound study J. Am. Coll. Cardiol., August 4, 2004; 44(3): 520 - 527. [Abstract] [Full Text] [PDF]
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F. J.Th. Wackers, L. H. Young, S. E. Inzucchi, D. A. Chyun, J. A. Davey, E. J. Barrett, R. Taillefer, S. D. Wittlin, G. V. Heller, N. Filipchuk, et al. Detection of Silent Myocardial Ischemia in Asymptomatic Diabetic Subjects: The DIAD study Diabetes Care, August 1, 2004; 27(8): 1954 - 1961. [Abstract] [Full Text] [PDF]
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A. Lichtenberg, U. Klima, H. Paeschke, M. Pichlmaier, S. Ringes-Lichtenberg, T. Walles, H. Goerler, and A. Haverich Impact of diabetes on outcome following isolated minimally invasive bypass grafting of the left anterior descending artery Ann. Thorac. Surg., July 1, 2004; 78(1): 129 - 134. [Abstract] [Full Text] [PDF]
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S. R. Wilson, B. A. Vakili, W. Sherman, T. A. Sanborn, and D. L. Brown Effect of Diabetes on Long-Term Mortality Following Contemporary Percutaneous Coronary Intervention: Analysis of 4,284 cases Diabetes Care, May 1, 2004; 27(5): 1137 - 1142. [Abstract] [Full Text] [PDF]
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R. Mehran, G. D. Dangas, Y. Kobayashi, A. J. Lansky, G. S. Mintz, E. D. Aymong, M. Fahy, J. W. Moses, G. W. Stone, and M. B. Leon Short- and long-term results after multivessel stenting in diabetic patients J. Am. Coll. Cardiol., April 21, 2004; 43(8): 1348 - 1354. [Abstract] [Full Text] [PDF]
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G. W. Vetrovec Don't blame the stents J. Am. Coll. Cardiol., April 21, 2004; 43(8): 1355 - 1357. [Full Text] [PDF]
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V. Mathew, B. J. Gersh, B. A. Williams, W. K. Laskey, J. T. Willerson, R. T. Tilbury, B. R. Davis, and D. R. Holmes Jr Outcomes in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention in the Current Era: A Report From the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial Circulation, February 3, 2004; 109(4): 476 - 480. [Abstract] [Full Text] [PDF]
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T. Hirotani, T. Nakamichi, M. Munakata, and S. Takeuchi Risks and benefits of bilateral internal thoracic artery grafting in diabetic patients Ann. Thorac. Surg., December 1, 2003; 76(6): 2017 - 2022. [Abstract] [Full Text] [PDF]
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Z. Zhang, E. M. Mahoney, R. H. Stables, J. Booth, F. Nugara, J. A. Spertus, and W. S. Weintraub Disease-Specific Health Status After Stent-Assisted Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery: One-Year Results From the Stent or Surgery Trial Circulation, October 7, 2003; 108(14): 1694 - 1700. [Abstract] [Full Text] [PDF]
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C. R. Bridges Cardiac surgery in African Americans Ann. Thorac. Surg., October 1, 2003; 76(4): S1356 - 1362. [Abstract] [Full Text] [PDF]
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T. F. Luscher, M. A. Creager, J. A. Beckman, and F. Cosentino Diabetes and Vascular Disease: Pathophysiology, Clinical Consequences, and Medical Therapy: Part II Circulation, September 30, 2003; 108(13): 1655 - 1661. [Full Text] [PDF]
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M. Endo, Y. Tomizawa, and H. Nishida Bilateral Versus Unilateral Internal Mammary Revascularization in Patients With Diabetes Circulation, September 16, 2003; 108(11): 1343 - 1349. [Abstract] [Full Text] [PDF]
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N. Satoh, Y. Ogawa, T. Usui, T. Tagami, S. Kono, H. Uesugi, H. Sugiyama, A. Sugawara, K. Yamada, A. Shimatsu, et al. Antiatherogenic Effect of Pioglitazone in Type 2 Diabetic Patients Irrespective of the Responsiveness to Its Antidiabetic Effect Diabetes Care, September 1, 2003; 26(9): 2493 - 2499. [Abstract] [Full Text] [PDF]
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A. Roguin, W. Koch, A. Kastrati, D. Aronson, A. Schomig, and A. P. Levy Haptoglobin Genotype Is Predictive of Major Adverse Cardiac Events in the 1-Year Period After Percutaneous Transluminal Coronary Angioplasty in Individuals With Diabetes Diabetes Care, September 1, 2003; 26(9): 2628 - 2631. [Abstract] [Full Text] [PDF]
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K.-H. Mak and D. P. Faxon Clinical studies on coronary revascularization in patients with type 2 diabetes Eur. Heart J., June 2, 2003; 24(12): 1087 - 1103. [Abstract] [Full Text] [PDF]
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D. K. McGuire, K. J. Anstrom, and E. D. Peterson Influence of the Bypass Angioplasty Revascularization Investigation National Heart, Lung, and Blood Institute Diabetic Clinical Alert on Practice Patterns: Results from the National Cardiovascular Network Database Circulation, April 15, 2003; 107(14): 1864 - 1870. [Abstract] [Full Text] [PDF]
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F. B. Sozzi, A. Elhendy, J. R.T.C. Roelandt, R. T. van Domburg, A. F.L. Schinkel, E. C. Vourvouri, J. J. Bax, J. De Sutter, A. Borghetti, and D. Poldermans Prognostic Value of Dobutamine Stress Echocardiography in Patients With Diabetes Diabetes Care, April 1, 2003; 26(4): 1074 - 1078. [Abstract] [Full Text] [PDF]
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B. E. Sobel, R. Frye, and K. M. Detre Burgeoning Dilemmas in the Management of Diabetes and Cardiovascular Disease: Rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial Circulation, February 4, 2003; 107(4): 636 - 642. [Abstract] [Full Text] [PDF]
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A. D. Mooradian Cardiovascular Disease in Type 2 Diabetes Mellitus: Current Management Guidelines Arch Intern Med, January 13, 2003; 163(1): 33 - 40. [Abstract] [Full Text] [PDF]
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A. M. Calafiore, M. Di Mauro, G. Di Giammarco, M. Contini, G. Vitolla, A. Lorena Iaco, C. Canosa, and S. D'Alessandro Effect of diabetes on early and late survival after isolated first coronary bypass surgery in multivessel disease J. Thorac. Cardiovasc. Surg., January 1, 2003; 125(1): 144 - 154. [Abstract] [Full Text] [PDF]
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M. Laakso and J. Kuusisto Diabetology for cardiologists Eur. Heart J. Suppl., January 1, 2003; 5(suppl_B): B5 - B13. [Abstract] [PDF]
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L. Schwartz, K. E. Kip, R. L. Frye, E. L. Alderman, H. V. Schaff, and K. M. Detre Coronary Bypass Graft Patency in Patients With Diabetes in the Bypass Angioplasty Revascularization Investigation (BARI) Circulation, November 19, 2002; 106(21): 2652 - 2658. [Abstract] [Full Text] [PDF]
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P.G. Steg and L.J. Feldman Percutaneous coronary intervention in diabetics with prior coronary artery bypass surgery: sweet or sour? Eur. Heart J., September 2, 2002; 23(18): 1411 - 1412. [Full Text] [PDF]
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P F Ludman Percutaneous coronary intervention in diabetics: time to consider "intimal remodelling therapy"? Heart, September 1, 2002; 88(3): 213 - 215. [Full Text] [PDF]
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E. Van Belle, M. Perie, D. Braune, A. Chmait, T. Meurice, K. Abolmaali, E. P. McFadden, C. Bauters, J.-M. Lablanche, and M. E. Bertrand effects of coronary stenting on vessel patency and long-term clinical outcome after percutaneous coronary revascularization in diabetic patients J. Am. Coll. Cardiol., August 7, 2002; 40(3): 410 - 417. [Abstract] [Full Text] [PDF]
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V. Mathew and D. R. Holmes Outcomes in diabetics undergoing revascularization: The long and the short of it J. Am. Coll. Cardiol., August 7, 2002; 40(3): 424 - 427. [Full Text] [PDF]
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L. Gruberg, R. Waksman, A. E. Ajani, H.-S. Kim, R. L. White, E. E. Pinnow, L. F. Satler, A. D. Pichard, K. M. Kent, and J. Lindsay Jr The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1930 - 1936. [Abstract] [Full Text] [PDF]
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J. A. Beckman, M. A. Creager, and P. Libby Diabetes and Atherosclerosis: Epidemiology, Pathophysiology, and Management JAMA, May 15, 2002; 287(19): 2570 - 2581. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, D. Faxon, W. Cascio, H. Schaff, T. Gardner, A. Jacobs, S. Nissen, and R. Stouffer Prevention Conference VI: Diabetes and Cardiovascular Disease: Writing Group VI: Revascularization in Diabetic Patients Circulation, May 7, 2002; 105 (18): e165 - e169. [Full Text] [PDF]
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T. J. Vander Salm, K. E. Kip, R. H. Jones, H. V. Schaff, R. J. Shemin, G. S. Aldea, and K. M. Detre What constitutes optimal surgical revascularization?: Answers from the bypass angioplasty revascularization investigation (BARI) J. Am. Coll. Cardiol., February 20, 2002; 39(4): 565 - 572. [Abstract] [Full Text] [PDF]
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T. Hirotani, S. Shirota, Y. Cho, and S. Takeuchi Feasibility and suitability of the routine use of bilateral internal thoracic arteries Ann. Thorac. Surg., February 1, 2002; 73(2): 511 - 515. [Abstract] [Full Text] [PDF]
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E. Erdmann Cardiovascular events in patients with type 2 diabetes The British Journal of Diabetes & Vascular Disease, January 1, 2002; 2(1_suppl): S4 - S8. [Abstract] [PDF]
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K. M. Detre and R. Holubkov Coronary Revascularization on Balance: Robert L. Frye Lecture Mayo Clin. Proc., January 1, 2002; 77(1): 72 - 82. [Abstract] [PDF]
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S. Giri, L. J. Shaw, D. R. Murthy, M. I. Travin, D. D. Miller, R. Hachamovitch, S. Borges-Neto, D. S. Berman, D. D. Waters, and G. V. Heller Impact of Diabetes on the Risk Stratification Using Stress Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging in Patients With Symptoms Suggestive of Coronary Artery Disease Circulation, January 1, 2002; 105(1): 32 - 40. [Abstract] [Full Text] [PDF]
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S. D. Fihn, S. V. Williams, J. Daley, and R. J. Gibbons Guidelines for the Management of Patients with Chronic Stable Angina: Treatment Ann Intern Med, October 16, 2001; 135(8_Part_1): 616 - 632. [Abstract] [Full Text] [PDF]
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A. M. Calafiore, M. Di Mauro, M. Contini, G. Di Giammarco, M. Pano, G. Vitolla, A. Bivona, R. Carella, and S. D'Alessandro Myocardial revascularization with and without cardiopulmonary bypass in multivessel disease: impact of the strategy on early outcome Ann. Thorac. Surg., August 1, 2001; 72(2): 456 - 462. [Abstract] [Full Text] [PDF]
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A. Abizaid, M. A. Costa, M. Centemero, A. S. Abizaid, V. M.G. Legrand, R. V. Limet, G. Schuler, F. W. Mohr, W. Lindeboom, A. G.M.R. Sousa, et al. Clinical and Economic Impact of Diabetes Mellitus on Percutaneous and Surgical Treatment of Multivessel Coronary Disease Patients: Insights From the Arterial Revascularization Therapy Study (ARTS) Trial Circulation, July 31, 2001; 104(5): 533 - 538. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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A. Elhendy, A. M. Arruda, D. W. Mahoney, and P. A. Pellikka Prognostic stratification of diabetic patients by exercise echocardiography J. Am. Coll. Cardiol., May 1, 2001; 37(6): 1551 - 1557. [Abstract] [Full Text] [PDF]
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K. J. Mather, S. Verma, and T. J. Anderson Improved endothelial function with metformin in type 2 diabetes mellitus J. Am. Coll. Cardiol., April 1, 2001; 37(5): 1344 - 1350. [Abstract] [Full Text] [PDF]
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N. W. Niles, P. D. McGrath, D. Malenka, H. Quinton, D. Wennberg, S. J. Shubrooks, J. F. Tryzelaar, R. Clough, M. J. Hearne, F. Hernandez Jr, et al. Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study J. Am. Coll. Cardiol., March 15, 2001; 37(4): 1008 - 1015. [Abstract] [Full Text] [PDF]
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E. Van Belle, R. Ketelers, C. Bauters, M. Perie, K. Abolmaali, F. Richard, J.-M. Lablanche, E. P. McFadden, and M. E. Bertrand Patency of Percutaneous Transluminal Coronary Angioplasty Sites at 6-Month Angiographic Follow-Up : A Key Determinant of Survival in Diabetics After Coronary Balloon Angioplasty Circulation, March 6, 2001; 103(9): 1218 - 1224. [Abstract] [Full Text] [PDF]
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R. J. Gibbons, D. D. Miller, P. Liu, P. Guo, M. M. Brooks, and M. Schwaiger Similarity of Ventricular Function in Patients Alive 5 Years After Randomization to Surgery or Angioplasty in the BARI Trial Circulation, February 27, 2001; 103(8): 1076 - 1082. [Abstract] [Full Text] [PDF]
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W. A. Hsueh, S. Jackson, and R. E. Law Control of Vascular Cell Proliferation and Migration by PPAR-{gamma}: A new approach to the macrovascular complications of diabetes Diabetes Care, February 1, 2001; 24(2): 392 - 397. [Abstract] [Full Text]
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