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Ann Thorac Surg 1995;59:1391-1396
© 1995 The Society of Thoracic Surgeons
Division of Cardiothoracic Surgery, Department of Surgery, and Cardiovascular Division, Department of Medicine, Beth Israel Hospital and Harvard Medical School, Boston, Massachusetts
| Abstract |
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| Introduction |
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Coronary revascularization procedures have increased in number steadily over the past decade as manifest by the aggregate number of percutaneous transluminal coronary angioplasties (PTCAs) and coronary artery bypass graft (CABG) procedures. The shifting proportions of these two procedures has been guided by a drive for less invasive treatment whenever possible, with operative revascularization increasingly being reserved for patients who are ``not candidates'' for further percutaneous revascularization. Only one randomized trial comparing percutaneous revascularization to medical therapy has been published [1], and few prospective trials have compared ``single-vessel'' or ``double-vessel'' disease treated by operation versus angioplasty [2]. Nevertheless, a number of trials comparing percutaneous to operative revascularization for multivessel disease have been reported [24], but these studies were not designed to provide insight into the decision process that selects PTCA as the initial method for revascularization.
Twenty-three to 41% of patients having successful angioplasty for multivessel disease in the randomized trials required subsequent angioplasties over intervals as short as 1 year. Eighteen to 20% of patients with multivessel disease treated with initial PTCA required an operation for revascularization (CABG) within 12 months after an initial, successful PTCA. It is not clear whether PTCA might have been obviated in those patients who required early operative revascularization after a successful PTCA.
In this study, we asked whether there were factors that identified patients who required early operation after an initial successful balloon angioplasty. We tested the null hypothesis that no pre-PTCA characteristics predict the need or timing for subsequent CABG. It was anticipated that, even if no predictive characteristics were identified, this study would provide data on the frequency and interval to CABG, the change in condition before CABG, and the overall survival after multiple procedures. We then hoped to infer whether the therapeutic decision process is appropriate and to suggest any recommendations for changing that selection process.
| Material and Methods |
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Patients were matched solely by the date of angioplasty. Prospective controls who had emergency operations associated with their initial PTCA (35 patients), those who had ``unsuccessful'' angioplasty, and those who had prior CABG were excluded from the controls. If no control PTCAs were available on the date of a case angioplasty or if a potential control patient met exclusionary criteria, the next closest PTCA was matched. In the event of one or more control choices on a given case-date, the match was selected randomly.
Data Collection
Case and control charts were reviewed for the following characteristics before initial PTCA: age, sex, prior myocardial infarction, diabetes, family history of coronary disease, obesity, smoking, hyperlipidemia, and hypertension. Each catheterization report was reviewed for left ventricular ejection fraction, number and location of lesions, percent stenosis of each lesion, the number of lesions dilated, and PTCA complications. Any subsequent admission, myocardial infarction, or death was recorded for all patients. For cases the date of CABG, the number of vessels grafted, associated procedures, postoperative complications, and subsequent revascularizations also were recorded.
The risk of operative revascularization was estimated retrospectively for all patients using a risk assessment tool (Riskmaster; Health Data Research, Inc, Portland, OR) for cases and controls. This estimation was performed again for cases using data contemporary with their CABG. The data required for these determinations included age, sex, body surface area, obesity, diabetes, hypertension, chronic obstructive pulmonary disease, congestive heart failure (or ejection fraction), severe pulmonary vascular disease, prior cerebrovascular accident, prior myocardial infarction (with temporal association), hemodynamic status, prior operation, failed PTCA, left main stenosis (>50%), renal failure, and pulmonary artery pressure.
Surviving cases and controls were followed by telephone interviews. Survivors were asked about the decision for initial PTCA and current symptoms of angina, shortness of breath, exercise limitations, and the use of nitroglycerin. When sufficient data could be ascertained the New York Heart Association class was determined (12.4% of cases and 10.4% of controls could not have their New York Heart Association class definitively determined).
Data for hospital charges were available and tabulated for cases and controls hospitalized after 1983. One hundred twenty in each group had such data available. Evaluation of our institution's Medicare audited data from fiscal years 1987, 1988, and 1989 reveals a consistent cost/charge relationship for PTCA, CABG, and CABG with a diagnostic catheterization. The approximate cost/charge ratio over this period for these procedures was 0.66.
Statistical Methods
Count data were compared by
2 analysis. Means were compared by two-tailed Student's t tests and are expressed as ± one standard deviation. Survival curves of equal-sized groups were constructed and analyzed by Mantel-Cox comparison, and for unequal samples by generalized Wilcoxon comparison. We modeled the occurrence of CABG (cases) as a function of baseline data (before initial PTCA) found to be significantly different from controls by univariate analysis (p < 0.01). These data were analyzed by stepwise multivariate logistic regression analysis (True Epistat; Epistat Services, Richardson, TX).
| Results |
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The baseline operative risk assessment of cases showed a 2.8% mean predicted operative risk compared with the controls' mean of 2.1% (p = not significant).
After Initial PTCA
CASES.
The 128 cases had their CABG performed at a mean of 16.7 months (range, 0 to 116 months) after a mean of 1.7 angioplasties. Sixty-three of the 128 patients had only the initial, single PTCA before CABG at a mean interval of 13.7 months. The other 65 patients had 92 additional PTCAs before operation. Twenty-two patients (17.2%) had CABG performed within 30 days of initial PTCA. Figure 2
shows that more than 80% of patients with four or more coronary stenoses of 70% or greater required operation within 1 year.
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At the time of CABG the estimated operative risk assessment predicted a mean mortality of 4.0%, which was significantly higher than the 2.8% before initial PTCA (p = 0.04). There were three deaths (2.3%) within 30 days or in-hospital after CABG. Six patients (4.7%) had perioperative myocardial infarctions and there were no cerebrovascular accidents.
Revascularization procedures after CABG were required in 12 cases (9.4%). Eight patients had 10 PTCAs, and 4 had a second CABG at a mean interval of 69.7 ± 44 months. One additional patient had a third CABG 5 months after the second one. No further revascularization procedures were performed after CABG in 113 (88.3%).
CONTROLS.
Twenty-four controls (18.8%) had a second PTCA at a mean interval of 11 months. Over the entire period of follow-up the mean number of angioplasties performed in these patients (after their initial one) was 0.25/patient. Over the period of follow-up, severe morbid events occurred in 56 (43.7%) of the controls, including eight myocardial infarctions and nine deaths (one within 30 days of PTCA).
Long-Term Follow-up
The mean survival from initial PTCA was 71.1 ± 27 months for cases and 69.7 ± 28 months for controls. There were 17 late case deaths and 9 control deaths at a mean of 38.6 ± 30 months after initial PTCA. Survival data are shown in Figure 3
. The probability of 5-year survival was greater for controls (94.5%) than for cases (87.9%; p = 0.048). At the time of initial PTCA the cases who experienced late death after CABG were older (63.9 versus 59.3; p = 0.087) and had lower mean LVEF (0.52 versus 0.63; p = 0.017). There was also a statistically significant difference in the estimated operative mortality that was calculated before initial PTCA in those who experienced late death (8.1% versus 1.99%; p = 0.005).
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Multiple Logistic Regression Analysis of the Occurrence of Subsequent CABG
Among the baseline variables entered (diabetes, number of lesions, number of lesions with a greater than 70% stenosis and location of lesions), only diabetes (p = 0.042) and extent of coronary disease (p = 0.007) were found to be predictive of the need for subsequent CABG. The total number of coronary lesions described, regardless of severity, and the total number of lesions with a greater than 70% narrowing were too highly colinear to allow their simultaneous evaluation in the final regression model. Each alone, with diabetes, was highly predictive of an increased risk of subsequent CABG, but the number of lesions with a greater than 70% narrowing was slightly more predictive (odds ratio for ``number of lesions
70%'' = 1.469 [95% confidence interval = 1.1931.809] versus ``number of any lesions'' = 1.193 [95% confidence interval = 1.0501.355]) (Table 3
). The location of lesions was not selected as adding predictive value (p = not significant).
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70% was distinctly different from three or fewer lesions with respect to the interval to CABG, we chose four lesions without diabetes, and the combination of diabetes with three such lesions as parameters for selecting patients to have initial revascularization by CABG. Among the cases and controls there were 59/256 (23.0%) who fit these criteria (28 who had diabetes and three or more coronary lesions and 31 who had no diabetes and four or more lesions). These 59 patients actually had 83 angioplasties. Forty of these 59 patients were cases (31.2% of that group) and actually had CABG, but 19 were control patients who actually had 23 angioplasties, without operation during the period of follow-up. Eighty-eight cases and 109 controls still would have been selected for an initial PTCA.
Hospital Charges
The mean hospital charges per patient for their initial PTCA were not significantly different between controls and cases. The mean charges were $13,085 ± 6,775 for cases and $11,914 ± 5,815 for controls (p = 0.175). The mean charges for a CABG admission were $30,247 ± 14,820 per case. For PTCA plus CABG during the same admission (n = 32), the mean charges were $44,384 ± 41,635 per case (median = $35,056). The total charges for pre-CABG PTCAs among cases were $2.8 million or a mean of $22,095/patient.
| Comment |
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The question of how lower risk patients do with CABG compared with PTCA also has been examined retrospectively. A subset of Coronary Artery Surgery Study Registry patients were considered to have been ideal PTCA candidates (2.8% of the 9,369 patients) based primarily on anatomic considerations. The operative mortality in these patients was 0.4% (1/261), with a perioperative infarction incidence of 2.3% [11]. Both figures compared favorably with published results for PTCA. Hochberg and colleagues [12] retrospectively matched patients who had operation for disease that was anatomically suitable for PTCA (single-or double-vessel disease) with patients who had PTCA. The hospital mortality for CABG was 1% (1/125) compared with 3% 30-day PTCA mortality and a 10% emergency CABG rate. Over 3 years of follow-up another 9% of the PTCA patients required a CABG [12]. These data demonstrated that patients who are selected for PTCA have a similar outcome to those who have CABG, if anatomically matched according to coronary disease. In making the clinical choice, however, the morbidity [3, 4] and expense [13] of CABG necessitate a better than equal outcome if it is to be selected over PTCA as the initial revascularization choice for any group of patients.
Published prospective trials comparing CABG and PTCA for initial revascularization [24] of multivessel disease did not show a significant difference in survival, in spite of the fact that the PTCA group required more subsequent revascularizations and the CABG group had more procedure-related infarcts. Nevertheless, if operative revascularization is required at some early interval after PTCA, and if such patients have a higher morbidity with subsequent CABG, then there are economic and medical arguments that urge triage of such patients to CABG for their initial revascularization.
In this retrospective series we examined only patients who had an initial, successful revascularization by PTCA. In accord with the findings of prior retrospective studies the patients in this study were relatively young and healthy. In spite of the many similarities between the groups (those who never had CABG and those who ultimately required CABG) there were demonstrable differences. The patients who had CABG had a significantly greater incidence of diabetes and significantly more coronary disease.
Assessment of anatomic disease by the traditional one-, two-, or three-vessel disease categories was not as discerning as the total number of lesions (regardless of severity) or the number of lesions more than 70% narrowed. These indices of diffuse or multicentric disease more accurately predicted a short interval to operative revascularization. Importantly, the operative mortality, as estimated by a multifactorial risk assessment program, increased significantly from what it was before the initial revascularization. Furthermore, the long-term survival for those patients who subsequently had CABG differed significantly from that of the PTCA patients who did not require CABG. It is likely that either the mortality of low-risk patients was increased by a delay in operation or the patients in the CABG group were simply at higher risk due to observable factors such as multivessel disease and diabetes. Either explanation suggests a need to identify patients before an initial PTCA who are going to require early operation. There are certainly no data implying that initial PTCA benefited patients who came to subsequent CABG, and indeed the reverse is suggested.
One of the major flaws of this study is the fact that the patients reviewed were treated by an initial PTCA from 1982 to 1989. The judgments made then might differ from contemporary ones, and a broader array of angioplasty techniques exist today. We bear this in mind and ask the readers to do the same. We did not analyze closely the reason for timing of nor decision for operative revascularization. No single-reviewer assessment of the patients' cineangiograms was performed. An objective, independent review of the cineangiograms might have been even more revealing in terms of anatomic stratification of these patients, but in this retrospective study we chose to use angiographic interpretations that were contemporary with the therapeutic decisions. Finally, we only sampled the PTCA group that did not require CABG by obtaining matched controls for the cases from a larger pool of patients who underwent angioplasty. Although we do not doubt the controls' representativeness, our methods precluded our determining the exact incidence of CABG subsequent to successful PTCA.
The factors that we identified can be used to select for initial revascularization by operation, avoiding the cost and morbidity of one or more angioplasties. Diabetes and the number of total lesions, or the number and location of lesions greater than 70% narrowed, should be considered in light of other factors (such as increased age and decreased ejection fraction) in choosing the method of initial revascularization. The traditional ``one-, two-, three-vessel'' disease classification is a poor discriminator in the selection of the appropriate initial revascularization technique. Stratification of patients by predictive criteria should be studied in a prospective manner to validate their ability to improve survival and reduce the total cost of coronary revascularization.
| Acknowledgments |
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We gratefully acknowledge the contributions of Harold G. Roberts, MD, and Mallory Van Horn, BS, in the preparation of the manuscript and the follow-up of the patients in the study.
| Footnotes |
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Address reprint requests to Dr Johnson, Division of Cardiothoracic Surgery, Beth Israel Hospital, 330 Brookline Ave, Boston, MA 02215.
| References |
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