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(Circulation. 1997;95:868-877.)
© 1997 American Heart Association, Inc.
Articles |
the Divisions of Cardiology and Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Ga.
Correspondence to William S. Weintraub, MD, Division of Cardiology, Emory University Hospital 1365, Clifton Rd NE, Atlanta, GA 30322. E-mail bill@hp3.eushc.org.
| Abstract |
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Methods and Results The surgical and angioplasty procedures and statistical methods were standard. Data were collected prospectively and entered into a computerized database. Follow-up was by letter, telephone, or additional events resulting in readmission. In the angioplasty group, 2.9% required in-hospital CABG. Hospital mortality was 1.2% after angioplasty versus 6.8% after repeat CABG (P<.0001). Recurrent angina was noted frequently at about 4 years and was more common after angioplasty. One-, 5-, and 10-year mortalities were 11%, 24%, and 49% after CABG versus 6%, 22%, and 38% after angioplasty. Survival corrected for baseline differences did not vary with the choice of procedure. There were more additional procedures after angioplasty. Patients undergoing angioplasty may be divided into those with procedures only in native coronary arteries (n=1545), only in vein grafts (n=869), and a mixture (n=199), with respective 10-year survivals of 66%, 56%, and 65% (P<.0001).
Conclusions These patients have a high incidence of events both in-hospital and in the long term. Although initial mortality was higher after CABG, after baseline differences were accounted for, there was no difference in the long term. Patients more frequently have additional procedures after angioplasty. Choice of therapy should consider clinical and angiographic suitability and patient preference.
Key Words: bypass angioplasty surgery
| Introduction |
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8 years, leading to an increased incidence of additional procedures.1 Reoperative CABG was first described within a few years of the first coronary surgical procedures.2 Furthermore, reoperative CABG has been shown to be an increasing part of current surgical practice.3 4 Similarly, vein graft angioplasty was described early after the first description of angioplasty.5 6 7 The present study examines and compares the in-hospital and long-term outcomes of reoperative CABG and angioplasty in patients who have had previous CABG. | Methods |
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Definitions
Single-vessel disease was defined as
50% diameter luminal narrowing in either the left anterior descending, left circumflex, or right coronary artery or a major branch or branches. Double-vessel disease was the presence of
50% diameter luminal narrowing in two of the three major epicardial vessel systems. Three-vessel disease was the presence of
50% diameter luminal narrowing in all three major epicardial vessel systems or in the left anterior descending and proximal circumflex arteries in left-dominant patients. Left main disease was the presence of
50% diameter luminal narrowing in the left main coronary artery. Angiographically successful angioplasty was that all lesions attempted improved >20% in diameter stenosis and were dilated to <50% residual diameter stenosis. Clinically successful angioplasty was angiographic success without the complications of myocardial infarction, coronary surgery, or death during the same hospitalization. An urgent procedure was a procedure thought by the operator to be required within 24 hours. An emergent procedure was a procedure performed in the setting of acute ischemia or infarction. Complications were a postprocedure myocardial infarction determined by the development of new Q waves. A stroke was a neurological event with persistent change in neurological function, including disorientation, persisting for several days. Variables defined by patient history were hypertension, diabetes, severity of angina, prior myocardial infarction, and myocardial infarction during follow-up. Angina was defined by the Canadian Cardiovascular Society Classification.8 Congestive failure was defined by the New York Heart Association criteria.
Angioplasty and CABG Procedures
All angioplasty procedures were performed by standard techniques that have been described previously.9 Angioplasty procedures included balloon dilatations, stent implantation, and the use of other new devices. For CABG, standard surgical techniques, extracorporeal circulation, and myocardial protection methods were used.10
Data Collection
Baseline and restudy demographic, clinical, angiographic, and procedural data, including complications, were recorded prospectively on standardized forms and entered into a computerized database. All fields were defined in a data dictionary. Angiographic success was assessed by quantitative coronary arteriography performed by experienced angiographers involved in the procedure but other than the primary operator.
Patient Follow-up
Follow-up information was obtained from the patients or their referring physicians. Follow-up status for each end point is also assessed at each subsequent hospital admission. Patients not readmitted were contacted by telephone or letter. Follow-up was available on 4107 of the 4174 patients (98%). The mean length of follow-up was 4.2±3.1 years. Information obtained included occurrence of myocardial infarction since the initial angioplasty, subsequent need for an additional revascularization procedure (angioplasty or CABG), death (cardiac plus noncardiac), and recurrent angina. All follow-up information was recorded on standardized forms and entered into the computerized database. All repeat procedures performed at Emory University Hospitals were confirmed from the database. Myocardial infarctions during follow-up were ascertained largely from the patients, and thus there may be both underreporting and overreporting.
Statistical Analyses
Data are expressed as proportions or as mean±SD. Differences in categorical variables were analyzed by
2 (or Fisher's exact test), and differences in continuous variables were analyzed by Student's t tests. The clinical, angiographic, and procedural characteristics of each group were determined. Overall survival (cardiac plus noncardiac) and event-free survival were determined by the Kaplan-Meier method,11 and the estimated probability is shown together with the SEE. Overall survival and event-free survival analyses were performed on the total population, as well as on the subgroups. End points analyzed included (1) survival, (2) freedom from myocardial infarction, (3) freedom from additional CABG, (4) freedom from additional angioplasty, and (5) event-free survival, defined as freedom from the events of death, myocardial infarction, additional CABG, or additional angioplasty. Comparisons of total and event-free survival were made with the Mantel-Cox method.12 Multivariate correlates of survival were analyzed with Cox model analysis,13 with repeated analyses with variables that were frequently missing eliminated to determine the impact of missing data (and consequently fewer patients in the model) on the analyses. Collinearity between variables was examined.
| Results |
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Outcomes are reviewed in Table 2
. Q-wave myocardial infarctions were noted more frequently after CABG (1.4% versus 5.4%, P<.0001), as were strokes. In the angioplasty group, 2.9% crossed over in the hospital and required CABG. Hospital mortality was 1.2% in the angioplasty group versus 6.8% in the CABG group. Recurrent angina was noted in a large minority at an average of about 4 years and was slightly more common after angioplasty. Length of stay was naturally longer in the CABG patients.
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Survivals in the two groups are shown in Fig 1
. Note that the two groups separate initially because of the higher hospital mortality in the CABG patients. One-year mortality was 11% after CABG versus 6% after angioplasty. Five-year mortality was 24% after CABG versus 22% after angioplasty. Ten-year mortality was 49% after CABG versus 38% after angioplasty. However, there were large differences in baseline variables. Thus, the variables from Table 1
were considered potential correlates of long-term mortality in Table 3
. The univariate and multivariate correlates of long-term mortality were lower ejection fraction, greater age, congestive failure, diabetes, hypertension, urgent or emergent procedure, and time from the previous CABG. The therapy chosen, repeat CABG versus angioplasty, and number of vessels diseased were univariate correlates only. Thus, the effect of the choice of therapy on survival could be entirely accounted for by the differences in baseline covariates. When the Cox model analysis was repeated without a stepwise procedure and the group was forced into the model, the hazard ratio for the surgical group was only 1.01. This is plotted graphically in Fig 2
. The two curves are superimposed. Because of recent concern over the choice of revascularization in diabetes, this subgroup is considered in Fig 3
. Although no difference in survival was noted, mortality was high in both groups. Survival in insulin-dependent diabetics divided by choice of therapy was similar (data not shown). The multivariate correlates of long-term mortality in diabetes were greater age, lower ejection fraction, hypertension, congestive failure, and time from previous CABG.
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There was little difference in myocardial infarction after the initial hospitalization (data not shown). One-, 5-, and 10-year freedom from myocardial infarction was, respectively, 0.92, 0.81, and 0.71 after angioplasty versus 0.87, 0.81, and 0.69 after CABG (P=.03). The incidence of an additional CABG is noted in Fig 4
. The curves have quite different shapes, and there is a large separation. This may reflect, to a variable degree, less-complete revascularization as well as restenosis after angioplasty. The angioplasty curve is nearly linear. In the CABG group, in contrast, only a few additional patients required CABG within
6 years, after which this becomes more common. The incidence of additional angioplasty is examined in Fig 5
. Again, a large difference between the curves is noted. The curves also have a different shape; although the incidence of additional angioplasty after repeat CABG is low for
7 years, additional angioplasty is most commonly needed after angioplasty within the first 6 months, coincident with the restenosis process. Thus, the shapes of the curves yield the greatest difference over the first several years, and then the curves gradually start to come toward each other, although with a large difference still remaining. Freedom from the composite of additional angioplasty or CABG is shown in Fig 6
. Although the incidence of additional procedures in all survivors is high, the composite is higher after angioplasty. Freedom from the composite of death, myocardial infarction, angioplasty, or CABG (event-free survival) is shown in Fig 7
. The incidence of events in both groups is high, reflecting the seriousness of the underlying disease process, such that by 10 years, few patients are free of cardiovascular events. The differences in the curves reflect the differences in event rates, with more in-hospital events after CABG. Thereafter, and especially during the first 6 months, there are more events after angioplasty, such that between 6 months and 7 years there is lower freedom from all events after angioplasty. Thereafter the curves overlap.
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The patients undergoing angioplasty may naturally be broken down into those who have procedures performed only in native coronary arteries (n=1545), those with only vein graft procedures (n=869), and those with a mixture (n=199). The clinical and angiographic characteristics of these patients are shown in Tables 4
and 5.
There was little difference between groups in any of these clinical characteristics. Somewhat greater differences are noted in the procedure. There were more multisite procedures in pure native-vessel procedures than in graft procedures. Stents and directional atherectomy were used much more commonly in grafts. There was little variation in hospital complications or angina at follow-up. Hospital stay was somewhat shorter for native-vessel procedures. Survival in the three groups is presented in Fig 8
. The best survival is noted in the native-vessel group, with a 10-year survival of 66%. It was similar in the mixed group, with a 10-year survival of 65%. In contrast, survival for the vein graft patients was 56% at 10 years. The univariate and multivariate correlates of long-term mortality are low ejection fraction, congestive failure, greater age, diabetes, time from prior CABG, graft procedure, hypertension, and a trend for emergent or urgent procedures (Table 6
). Similarly, the univariate and multivariate correlates of long-term mortality in the CABG group are greater age, lower ejection fraction, hypertension, diabetes, congestive failure, and emergent and urgent procedures. The failure to use an internal mammary artery graft and number of native vessels diseased were univariate risks only. The primary differences between the CABG and angioplasty groups are that time from prior CABG is a correlate in the angioplasty group only, and vessels diseased is a correlate in the CABG group only. Lower ejection fraction, greater age, congestive failure, diabetes, and hypertension were strong correlates of mortality in both groups, none of which are procedure related, suggesting that the underlying disease rather than the procedure is the determining factor in long-term survival.
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| Discussion |
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In a series of randomized clinical trials, angioplasty has been compared with CABG in patients who have not had prior CABG.14 15 16 17 18 19 In all of these trials, there was little difference in hospital outcome. At follow-up several years after the procedure, there was also little difference in death or myocardial infarction, but more repeat revascularization was consistently noted after angioplasty than after CABG. Not surprisingly, there is higher mortality after repeat revascularization than after a first procedure. Thus, at 5 years, the survival in the EAST study was 91% in the CABG group and 88% in the angioplasty group compared with 76% and 78% in the present series.20 For nonfatal events, there was less difference. At 5 years, the freedom from CABG in EAST was 99% in the CABG group and 75% in the angioplasty group compared with 96% and 76% in the present study. At 5 years, the freedom from additional angioplasty in EAST was 84% in the CABG group and 51% in the angioplasty group compared with 90% and 62% in the present study.
Compared with a wealth of data concerning first-time CABG, the data on reoperative CABG are more modest. Reoperative CABG has been studied in a recent series from Emory and included many patients in the present report.21 Kirklin and Barratt-Boyes22 noted that in-hospital mortality after repeat CABG is approximately twice that of first surgery. In the CASS registry experience, 9086 patients having a first procedure were compared with 283 patients having a reoperative procedure.23 The mortality and myocardial infarction rates after a first procedure were 3.1% and 6.4% versus 5.3% and 5.8% for a reoperative CABG. The patients undergoing reoperation were younger (mean age, 52±9 years) and had less severe anatomic disease in CASS than in the present report. In the largest series, Loop et al24 reported on results in 2509 patients. Mortality ranged from 2% to 5% and new Q-wave myocardial infarctions from 4% to 8%, with improved results toward the end of the series. For hospital survivors, the 10-year survival was 69.3% and event-free survival 41.2%. Loop et al25 noted improved survival in patients with internal mammary artery grafts, although this was not as important as in their study of first surgeries.
The alternative to reoperative CABG for many patients remains catheter-based interventional procedures. In a recent series from Emory of vein graft angioplasty, the in- hospital mortality was 1.2%, Q-wave myocardial infarction rate 2.2%, and need for emergency CABG 3.5%.5 Restenosis in vein grafts is probably a more severe problem than in native vessels, and new devices such as atherectomy and stents may lower the restenosis rate. Comparisons between devices show little difference in outcome.26 Probably the best-described report is from the CAVEAT-II trial.27 In this study of 305 patients randomized to atherectomy or angioplasty of vein grafts, there was a trend toward more nonQ-wave myocardial infarctions with atherectomy, no difference in restenosis, but fewer additional coronary interventional procedures. Recently, numerous reports on stenting of saphenous vein grafts have appeared.26 28 29 30 In a multicenter registry, Wong et al28 presented results in 589 patients undergoing device implantation in saphenous vein grafts. The restenosis rate was 29.7%, 1-year survival was 93.5%, and 1-year freedom from death, myocardial infarction, or additional revascularization was 76.3%. Longer-term outcome in patients treated with new devices may be expected to become available within the next several years. Previously, few data existed comparing angioplasty with reoperative CABG. In a recent preliminary, observational comparison, the long-term results of angioplasty were superior to those of reoperative CABG, but the selection bias could not be accounted for.31
The obvious limitation of the present study is that it was not randomized. No randomized data exist, and as far as we know, no trial is being planned. The present study clearly reveals that patients treated with reoperative CABG are sicker as a group than patients treated with angioplasty. Although this is not surprising, some patients with severe disease also may be referred to angioplasty because they may be thought to be too sick to undergo CABG. Furthermore, in comparing therapies, it is not clear that multivariate analysis can adequately account for the inherent selection bias in nonrandomized data. Thus, there may well be clinical variables that are either not measured at all or not measured sufficiently well that still form part of the decision in selecting therapy. Thus, there is probably a core group of patients who are really eligible for either procedure as well as a group of patients suitable only for angioplasty and a group suitable only for repeat CABG. In addition, there may well be patients who have had additional revascularization after CABG who could have been treated medically without revascularization. An additional limitation is that therapy continues to change, especially with the increasing use of coronary stents. Thus, analyses such as the present one will certainly need to be repeated as data on long-term outcome of patients undergoing coronary stent implantation after CABG become available.
Then how are patients to be cared for after CABG? There are certainly data on increasing incidence of reoperative procedures after a period of years, suggesting progression of native-vessel disease, graft failure, or both that accelerates after
8 years.1 32 33 In patients with recurrent symptoms unresponsive to medical therapy, referral for revascularization is reasonable. How to follow and when to catheterize and then revascularize asymptomatic patients with positive noninvasive tests and angiographic evidence of ischemic potential is much more difficult. The decision must be tempered with the knowledge that these patients have severe disease and will continue to have problems after these palliative procedures. Comparative studies, along with multivariate models such as those developed in this study, may be used to more accurately determine both immediate and long-term prognosis and to help define the most appropriate therapy. Finally, the fact that neither therapy was clearly superior to the other suggests that choice of additional revascularization for recurrence after coronary surgery may be made on the basis of clinical criteria and angiographic suitability as well as patient preference.
Received May 15, 1996; revision received September 27, 1996; accepted October 7, 1996.
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