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(Circulation. 1996;94:1818-1825.)
© 1996 American Heart Association, Inc.

Articles

Coronary Angioplasty in Diabetic Patients

The National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry

Kevin E. Kip, MSPH; David P. Faxon, MD; Katherine M. Detre, MD, DrPH; Wanlin Yeh, MS; Sheryl F. Kelsey, PhD; Jesse W. Currier, MD; for the Investigators of the NHLBI PTCA Registry

the University of Pittsburgh, Pa (K.E.K., K.M.D., W.Y., S.F.K.), and the University of Southern California, Los Angeles (D.P.F., J.W.C.).

Correspondence to Kevin E. Kip, University of Pittsburgh, Graduate School of Public Health, Epidemiology Data Coordinating Center, 127 Parran Hall, 130 DeSoto St, Pittsburgh, PA 15261. E-mail epidkek@vms.cis.pitt.edu.

	Abstract

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Background Patients with diabetes mellitus are at increased risk of cardiovascular disease. To date, the baseline status and subsequent outcomes of diabetic coronary angioplasty (percutaneous transluminal coronary angioplasty, or PTCA) patients with advanced atherosclerotic disease and with procedures performed across North America have not been well characterized.

Methods and Results Data on baseline clinical and angiographic characteristics and short- and long-term outcomes of 281 diabetic and 1833 nondiabetic PTCA patients in the multicenter National Heart, Lung, and Blood Institute 1985-1986 PTCA Registry were analyzed. Diabetic patients were older, were more likely to be female, and had more comorbid baseline conditions, triple-vessel disease, and atherosclerotic lesions. Angiographic success and completeness of revascularization did not differ significantly, yet diabetic patients experienced more in-hospital death (women) and nonfatal myocardial infarction. Nine-year mortality was twice as high in diabetic patients (35.9% versus 17.9%). Similarly, 9-year rates of nonfatal myocardial infarction (29.0% versus 18.5%), bypass surgery (36.7% versus 27.4%), and repeat PTCA (43.7% versus 36.5%) were higher in diabetics than in nondiabetics. In multivariate analysis, diabetes remained a significant predictor of decreased 9-year survival and other untoward events.

Conclusions Compared with nondiabetic PTCA patients, diabetic patients have more extensive and diffuse atherosclerotic disease. Despite similar probability of angiographic success, diabetic patients are more likely to suffer in-hospital death (women) and nonfatal myocardial infarction. Long-term survival and freedom from myocardial infarction and coronary revascularization is also reduced in diabetic PTCA patients. Whether PTCA or coronary bypass surgery is more suitable for these patients is currently under investigation.

Key Words: myocardial infarction • diabetes mellitus • cardiovascular diseases • angioplasty • follow-up studies

	Introduction

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Diabetes mellitus is an independent risk factor for the development of and extent of coronary artery disease,^{1 2 3 4} and diabetic patients are at increased risk of cardiovascular disease morbidity and mortality.⁵ There is, however, debate concerning whether coronary atherosclerosis is actually more diffuse in diabetics or is merely associated with a greater number of discrete stenoses.^{4 6 7 8} In coronary bypass patients,^{9 10} diabetes has been shown to be an independent predictor of lesion progression, occlusion, and late cardiac mortality. Similarly, adverse long-term prognosis has been reported in diabetic patients undergoing PTCA.^{11 12 13} In addition, several reports,^{14 15 16} but not all,^{17 18 19 20} suggest that diabetes independently increases the risk of restenosis after successful PTCA.

To date, the short- and long-term outcomes of diabetic PTCA patients have not been well described from a cohort of patients with advanced and complex disease consistent with the present PTCA population and with procedures performed at multiple centers across North America. Therefore, we describe baseline clinical and angiographic characteristics and short- and long-term outcomes of diabetic PTCA patients from the NHLBI 1985 to 1986 PTCA Registry.

	Methods

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Patient Population
Patients from 16 participating NHLBI PTCA Registry sites who underwent first-time PTCA outside the setting of acute MI (within the last 10 days) were considered. Eligibility criteria for the registry and patient characteristics have been described elsewhere.^{21 22 23 24} Briefly, consecutive patients at participating sites were entered in the registry. All subjects gave informed consent for routine annual follow-up after the initial procedure and for reporting intercurrent clinical events. The study protocol was approved by the Institutional Review Board for Biomedical Research at the University of Pittsburgh, the coordinating center for the registry. Patient confidentiality was ensured by the use of alphanumeric codes rather than names to identify patient records. Since previous publications,^{22 23} complete data for 334 consecutive patients from Emory University Hospital became available and were added to the registry database so that the total number of registry patients was 2136. Baseline diabetes status was unknown in 22 patients, thus reducing the cohort to 2114 patients, of whom 281 (13.3%) had a history of diabetes. History of diabetes was ascertained through review of medical records by site coordinators and through patient self-report. Baseline treatment status (insulin or hypoglycemic agent versus diet controlled) was not identified or recorded by site coordinators.

Definitions
Coronary artery lesions were classified as proximal, mid, or distal in accordance with definitions in the Coronary Artery Surgery Study.²⁵ Lesions in vein graft segments, however, were not included in lesion-level analyses despite the fact that 257 patients within the cohort (12%) had prior bypass surgery. This is because diabetic patients in the registry had slightly more prior bypass surgery than nondiabetic patients and because progression of atherosclerotic lesions may occur more rapidly in bypass graft segments.⁹ Thus, the number of angiographically-determined lesions was 3335. Successful dilatation was defined as >20% reduction in luminal diameter stenosis and <50% residual stenosis. This definition is consistent with the recommendation from the Joint International Society and Federation/World Health Organization Task Force on Coronary Angioplasty.²⁶ Partial angiographic success was defined as successful dilation of at least one attempted lesion. Total angiographic success was defined as successful dilation of all attempted lesions.

MIs were documented by at least two of the following: clinical symptoms, ECG evidence (Q-wave criteria of a definite MI according to the Minnesota Code),²⁷ and enzyme changes (more than double the upper normal limits of creatine kinase and/or the presence of creatine kinase–MB). Infarctions after hospitalization for initial PTCA were recorded whether they occurred alone, during a repeated PTCA, or during subsequent CABG. Hospital records were examined to verify that ECG findings, enzyme test results, and clinical symptoms were consistent with the registry definition of MI. Rates and risks of MI described throughout are for nonfatal MIs only. Repeated angioplasty was defined as a procedure performed after discharge from hospitalization for initial PTCA.

Follow-up
At each participating site, annual telephone interviews of the patients were conducted by the site coordinator. Information on hospitalizations for MI or repeated revascularization, angina, and cardiac catheterizations was collected and reported on standard forms. Information on diabetes treatment (insulin or hypoglycemic agent versus diet controlled) was not obtained during follow-up because it was not part of the standard forms and because no a priori hypotheses relative to diabetes were developed. At year 9 of follow-up, 1928 (91.2%) of the baseline cohort of 2114 patients were still providing follow-up information or had died. Of the remaining 186 patients of the total cohort (8.8%), 84 (4.0%) were lost to follow-up, 48 (2.3%) refused to be followed up, and contact was still being attempted in 54 (2.6%) of the patients. Among the 186 patients with incomplete follow-up, 21 (11.3%) were diabetic, and the mean length of follow-up was 5.1 and 5.2 years for diabetic and nondiabetics, respectively. Periodic searches of the National Death Index have been performed during the 9-year follow-up period to identify previously unknown deaths among patients with incomplete follow-up.

Statistical Analysis
The study population was analyzed in two ways. First, patients were categorized by the presence or absence of a history of diabetes. Second, the influence of diabetes was investigated as an independent predictor of morbid events. Differences in mean baseline and angiographic characteristics were analyzed by Student's t tests when continuous variables were normally distributed and by the Wilcoxon rank sum test when nonnormality was present. Differences in proportions of categorical variables were assessed by ² tests. Logistic regression analysis was used to determine the OR of diabetes on in-hospital events while adjustment was made for baseline factors univariately associated with in-hospital outcomes (at P<.10). In-hospital outcomes included death, nonfatal MI, death/MI, abrupt closure, emergency surgery, and death/MI/emergency surgery. Life table analysis by use of the product-limit method was used to estimate short- and long-term morbid event rates by diabetes status. Cox regression analysis²⁸ was used to assess the RR of diabetes on death and other untoward events at 9 years of follow-up. The covariate age was forced to remain in each model, with stepwise selection performed on the baseline factors univariately associated (at P<.05) with the outcome of interest. Graphic and analytic techniques were used to assess the proportional hazards assumption of invariant RR over the follow-up period. All analyses were performed with the use of SAS software (SAS Institute Inc).

	Results

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At baseline (Table 1), diabetic patients were older (mean age of 59.8 versus 57.2 years), more likely to be female (38.4% versus 23.5%), and more likely to be classified as high-surgical-risk patients and have a history of Canadian Cardiovascular Society class III or IV angina, congestive heart failure, severe concomitant noncardiac disease, hypertension, and poorer exercise test performance than nondiabetics. Diabetic patients were, however, less likely to be smokers at the time of PTCA intervention (21.2% versus 29.9%). The significant age difference between diabetic and nondiabetics existed in men only (mean age of 61.1 versus 61.0 years in women; 58.8 versus 56.1 years in men).

View this table: [in this window] [in a new window]   Table 1. Baseline Medical History

Among angiographic characteristics (Table 2), diabetic patients had similar ejection fractions (mean, 59%) but had more triple-vessel disease (27.7% versus 17.7%) and left dominance (21.1% versus 15.8%) than nondiabetics. In addition, diabetic patients had more total and significant lesions (lesions with 50% stenosis), particularly in the left anterior descending and left circumflex coronary arteries and in proximal and distal segments. The number of lesions attempted, pre-PTCA or post-PTCA stenoses, and rates of angiographic success did not differ by diabetes status; however, a slight but nonsignificant excess of incomplete revascularization was seen in the diabetic patients (61.1% versus 55.4% in nondiabetics; P=.08).

View this table: [in this window] [in a new window]   Table 2. Angiographic Characteristics and Initial PTCA Results

Despite relatively similar procedural success, univariate analyses revealed that diabetic patients were significantly more likely to experience in-hospital death, nonfatal MI, and the combined outcomes of death/MI and death/MI/emergency surgery (Table 3). After statistical adjustment, these relations diminished yet remained near or below statistical significance with an estimated risk of in-hospital death nearly three times higher in the diabetic group. The confidence limits for risk estimates of in-hospital outcomes were wide because of the sample size of diabetic patients and the relatively small number of events. Of note, all in-hospital deaths in the diabetic group occurred in female patients, which represents a striking female-specific death rate of 8.3%. A review of death certificate information and procedural comments provided by site operators and coordinators revealed that among these patients, four experienced MI, one experienced renal failure, one died of cardiogenic shock, one suffered left main occlusion with subsequent hypotension and renal insufficiency, and the remaining two patients experienced complications related to mitral value regurgitation/repair.

View this table: [in this window] [in a new window]   Table 3. In-Hospital Event Rates and ORs of Diabetes Versus No Diabetes

Figs 1 through 5 present short- and long-term event rates by diabetes status. The 9-year death rate (Fig 1) in diabetic patients was about double that of nondiabetic patients (35.9% versus 17.9%) and remained consistent across the number of diseased vessels (Fig 2). Roughly 3% of the 18% excess death in the diabetic group occurred within the first 30 days of follow-up. After removing the excess in-hospital MI experienced in the diabetic group, the rate of nonfatal MI (Fig 3) was similar between diabetic and nondiabetic patients up to 2 years of follow-up. During the subsequent 7 years of follow-up, a general increasing divergence in the rate of MI was seen, and at 9 years, the MI rate was about 1.6-fold higher in diabetic patients (29.0% versus 18.5%). Rates of CABG (Fig 4) indicate increasing divergence between diabetic and nondiabetic patients, with diabetics undergoing about one third more CABG by 9 years of follow-up (36.7% versus 27.4%). Finally, rates of repeat PTCA (Fig 5) were similar during the first 2 years, whereas throughout the remaining 7 years of follow-up, diabetic patients maintained an excess rate of repeat PTCA of 5% to 8%.

View larger version (25K): [in this window] [in a new window]   Figure 1. Nine-year mortality curve after angioplasty in diabetic patients compared with nondiabetics. Cum. indicates cumulative.

View larger version (35K): [in this window] [in a new window]   Figure 2. Comparison of 9-year mortality curve after angioplasty in relation to vessel disease and diabetes status. Non-Diab indicates nondiabetic; Diab, diabetic; and VD, vessel disease.

View larger version (24K): [in this window] [in a new window]   Figure 3. Nine-year rate of MI after angioplasty in diabetic patients compared with nondiabetics. Cum. indicates cumulative.

View larger version (24K): [in this window] [in a new window]   Figure 4. Nine-year rate of CABG after angioplasty in diabetic patients compared with nondiabetics. Cum. indicates cumulative.

View larger version (26K): [in this window] [in a new window]   Figure 5. Nine-year rate of repeat PTCA in diabetic patients compared with nondiabetics. Cum. indicates cumulative.

In Cox regression analysis (Table 4), diabetes conferred a >2-fold increased risk of death at 9 years univariately (RR: 2.28; 95% CI: 1.82, 2.85; P<.001) and an 80% increased risk (RR: 1.82; 95% CI: 1.41, 2.34; P<.001) after statistical adjustment for other baseline factors. Similarly, diabetes was a significant independent predictor of the combined outcomes of death/MI, death/MI/CABG, and repeat PTCA/CABG at 9 years of follow-up.

View this table: [in this window] [in a new window]   Table 4. Untoward Event Rate at 9 Years and RR of Diabetes Versus No Diabetes

	Discussion

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This report describes the baseline clinical and angiographic characteristics and short- and long-term outcomes of diabetic and nondiabetic PTCA patients from the 1985 to 1986 NHLBI PTCA Registry. Consistent with a recent report,¹³ diabetic patients in the PTCA registry had an overall worse cardiovascular disease baseline profile than nondiabetic patients. Similarly, the more extensive atherosclerosis in left anterior descending and left circumflex arterial segments seen in diabetic patients in the registry is consistent with a previous report³ ; however, the finding of more lesions in distal segments adds support to the currently debated argument that diabetics tend to possess more diffuse disease.

From differences in baseline and angiographic characteristics, we expected a worse short-term outcome in diabetic patients. The 3.2% in-hospital death rate in diabetic patients is elevated compared with previously reported rates of 0% to 2%^{22 29 30} among PTCA recipients at large. The estimated near-threefold increased risk of in-hospital death among diabetic patients conflicts with a recent report¹³ in which very low rates (<0.5%) of in-hospital death were reported. The inconsistency may reflect cohort differences: in Stein et al,¹³ roughly 71% of patients had single-vessel disease and 2.5% had a history of congestive heart failure; corresponding proportions of 48.5% and 6.3% existed in our cohort. Still, it should be emphasized that no in-hospital-deaths occurred in male diabetic patients. Thus, the striking 8.3% in-hospital death rate in female diabetic patients and the observation that eight of these nine deaths involved cardiovascular complications strongly suggest increased periprocedural risk in female diabetic PTCA patients. However, in an ancillary study of 548 consecutive female PTCA patients treated from 1993 to 1994, no difference in in-hospital mortality was observed between diabetic and nondiabetic patients (2.6% versus 1.6%, respectively).

Diabetes was a borderline significant predictor of nonfatal in-hospital MI. MI as a complication of PTCA often occurs as a result of extensive coronary arterial dissection, intracoronary thrombosis, or both, with resultant vessel occlusion.³¹ In addition, some degree of intimal dissection is frequently observed after successful PTCA.³² Because diabetes is associated with abnormalities of platelet function, coagulation, fibrinolysis, endothelial function, and intraluminal thrombosis,³³ as well as more extensive atherosclerotic disease (and perhaps more incomplete revascularization), diabetic PTCA patients may be predisposed to an elevated risk of in-hospital MI. Indeed, among the 93 patients who experienced nonfatal in-hospital MI, there was an apparent yet nonsignificant trend for diabetic patients to experience more in-hospital coronary dissection (21.6% versus 15.8%) and abrupt closure (31.6% versus 20.3%).

We expected diabetic patients to have more early revascularization because most revascularizations performed within the first 6 months of the index procedure are due to restenosis¹³ and because diabetes may increase the risk of restenosis after PTCA.^{14 15 16} However, rates of CABG and/or repeat PTCA at 6 months in the registry were generally similar across diabetes status. Because these results conflict with Stein et al,¹³ who suggested overall higher restenosis in diabetic patients, we investigated whether sex modified the effect of diabetes on restenosis. Indeed, rates of CABG and repeat PTCA between male diabetics and nondiabetics at 6 months were similar (11.8% versus 10.4% and 15.6% versus 14.7%, respectively); however, female diabetics had considerably higher rates of repeat PTCA than nondiabetic women at 6 months (18.5% versus 10.9%). Moreover, we found that female diabetic patients were more likely to have unstable angina (a feature predictive of restenosis) than nondiabetic women (69.9% versus 58.7%; P=.04), whereas no difference in unstable angina was seen in men (51.5% versus 50.5%; P=NS). In summary, our results suggest that higher restenosis, as inferred by higher rates of revascularization (repeat PTCA) within 6 months of follow-up, occur in female diabetics only.

The unadjusted and adjusted risk of death and combined 9-year outcomes were consistently higher in diabetic than nondiabetic patients, offering further evidence that diabetes adversely influences long-term prognosis after PTCA. Moreover, the excess risk of long-term mortality seen in diabetic PTCA patients is consistent with a recent report³⁴ in which the 5-year PTCA mortality rate among randomized diabetes patients with multivessel disease was 35% compared with 19% in patients undergoing an initial revascularization strategy of CABG.

Study Limitations
This study has limitations. First, all PTCA procedures were performed in 1985 or 1986. Over the past decade, the field of interventional cardiology has experienced technological advances in guiding catheters, balloon catheters, and angioplasty wires; the advent and emergence of atherectomy devices, laser ablation devices, and stents; and increased use of platelet glycoprotein IIb/IIIa inhibitors. Revascularization strategies and procedural outcomes seen today may differ from those experienced by patients treated in 1985 or 1986. In particular, the association of diabetes with abnormalities in intraluminal thrombosis,³³ a condition that may influence restenosis after PTCA³⁵ may motivate more frequent use of stents in diabetic patients.

Second, because routine angiographic follow-up data were not collected for every patient, our conclusion that female diabetic patients are at increased risk of clinical restenosis, as inferred through higher rates of revascularization at 6 months, should be viewed tentatively. The apparently higher restenosis in female diabetic patients may be attributed in part to differential progression of or subsequent treatment for previously untreated lesions, particularly because diabetic patients indicated more diffuse disease. In the registry, angiographic disease was evaluated by PTCA operators and was not based on a central laboratory quantitative assessment of atherosclerotic burden. Therefore, imprecisions may exist in the magnitude of atherosclerotic disease and incidence of restenosis reported. Furthermore, diabetic patients may experience a higher incidence of silent ischemia, and thus, clinical detection of restenosis may be less reliable in diabetic patients.

Third, our ascertainment of diabetes through review of medical records and patient self-reports did not provide for determination of treatment status. Without a uniform, prospective definition of diabetes, some misclassification may have occurred, the probable net effect of which would be bias toward the null. Thus, our findings may reflect underestimates of the true adverse prognosis associated with diabetes in PTCA patients. However, because diabetes was not an a priori hypothesis, the findings herein should not be viewed as hypothesis based or confirmatory.

Finally, funding constraints precluded adjudication of MIs by an independent review committee. Because diabetic patients had a higher incidence of CABG over the follow-up period and because criteria used for discerning MI after CABG may differ from those of patients undergoing PTCA or spontaneous infarction, it is possible that differential criteria were used between diabetic and nondiabetic patients in discerning infarctions. Similarly, because hospital records were reviewed (ie, ECG evidence and enzyme values) in a nonblinded fashion, it is possible that known patient status of diabetes differentially influenced ascertainment of MI.

Conclusions
Compared with nondiabetic PTCA patients, diabetic patients tend to have more extensive and diffuse atherosclerotic disease and more comorbid baseline conditions. Despite similar probability of angiographic success, diabetic patients are more likely to suffer in-hospital death (females) and nonfatal MI. Moreover, the risk of restenosis may be exceptionally high in female diabetic patients. After accounting for more adverse baseline conditions, the risk of long-term mortality and other adverse outcomes in diabetic PTCA patients is significantly higher than in nondiabetic patients. Whether PTCA or CABG is more suitable for diabetic patients is currently under investigation.

	Selected Abbreviations and Acronyms

 

CABG = coronary artery bypass graft MI = myocardial infarction OR = odds ratio PTCA = percutaneous transluminal coronary angioplasty RR = relative risk

	Acknowledgments

 
This study was supported by NIH grant HL-33292.

Received June 19, 1996; revision received July 25, 1996; accepted July 31, 1996.

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