Original Article
A Randomized Trial Comparing Coronary Angioplasty with Coronary Bypass Surgery
N Engl J Med 1994; 331:1044-1050October 20, 1994
- Abstract
Background
The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of these treatments in patients referred for the first time for coronary revascularization, we conducted a three-year prospective, randomized trial comparing the two procedures.
Methods
Revascularization was performed by accepted methods. Follow-up clinical information was collected every six months, and coronary arteriography and thallium stress scanning were performed at one and three years. The primary end point was a composite of death, Q-wave myocardial infarction, and a large ischemic defect identified on thallium scanning at three years. Secondary end points included clinical and angiographic status and the need for additional revascularization procedures. Data were analyzed according to the intention-to-treat principle.
Results
Of the 5118 patients screened for the trial, 842 (16.5 percent) were eligible for enrollment, and 392 (7.7 percent) agreed to participate. A total of 194 patients were randomly assigned to the CABG group, and 198 to the PTCA group. The primary end point occurred in 27.3 percent of the CABG group and 28.8 percent of the PTCA group (P = 0.81). Death occurred in 6.2 percent of the CABG group and 7.1 percent of the PTCA group (P = 0.73 by log-rank test). At three years, the proportions of patients in the CABG group who required repeated bypass surgery (1 percent) or angioplasty (13 percent) were significantly lower than the proportions in the PTCA group (22 and 41 percent, respectively; P<0.001). Angiographic studies at three years showed a greater degree of revascularization in the CABG group. Angina was more frequent in the PTCA group (20 percent) than in the CABG group (12 percent).
Conclusions
We found that CABG and PTCA did not differ significantly with respect to the occurrence of the composite primary end point. Consequently, the selection of one procedure over the other should be guided by patients' preferences regarding the quality of life and the possible need for subsequent procedures.
Media in This Article
Figure 1
Survival of Patients with Multivessel Coronary Disease after Treatment with CABG or PTCA.Figure 2
Proportion of Patients Remaining Free from CABG (Panel A), from PTCA (Panel B), and from CABG or PTCA (Panel C) after the Initial Revascularization Procedure.Article Activity
- Article
Although percutaneous transluminal coronary angioplasty (PTCA) is frequently performed in patients with multivessel coronary artery disease, its value as compared with coronary-artery bypass grafting (CABG) has not been established. In contrast, bypass surgery has been the standard form of revascularization for patients with multivessel coronary disease. Trials comparing surgery with medical therapy have consistently shown greater improvement in angina after surgery, although improved survival has been documented only in certain subgroups of patients with multivessel disease1-5.
PTCA was developed by Gruentzig as a less invasive method of revascularization6-8. The technique was first used in patients with a single obstructed vessel each, but since the mid-1980s the procedure has increasingly been used in patients with multivessel disease9-15. The experience with angioplasty was well documented in a national registry in 1985 and 198616. Patients with multivessel disease made up almost half this registry. In the Emory Angioplasty versus Surgery Trial (EAST), we performed a prospective, randomized comparison of angioplasty with surgery in patients with multivessel disease.
Methods
The EAST investigation, which was performed at a single center, was designed to determine whether initial revascularization with angioplasty in patients with multivessel coronary disease is a viable alternative to bypass surgery, on the basis of the outcome at three years. The primary end point was a composite of death, Q-wave myocardial infarction within the previous three years, and detection of a large ischemic defect on thallium scanning at three years. Secondary end points involved the degree of revascularization at one and three years, ventricular function, exercise performance, the need for subsequent revascularization procedures, the quality of life, and costs. The registry for this trial included all patients referred to Emory University Hospital, Crawford Long Hospital, or the Atlanta Department of Veterans Affairs Hospital for revascularization because of stable or unstable angina or objective signs of ischemia (or both). Patients of any age who had two- or three-vessel disease and had not previously undergone angioplasty or surgery were considered for enrollment.
An independent biostatistical center, located at the Emory University School of Public Health, accepted and verified all data and provided reports to the steering committee and the program office of the National Heart, Lung, and Blood Institute. The data were stored in a computerized data base. The coronary angiography laboratory was located at the University of Washington. Three independent committees (the mortality, electrocardiography, and stroke committees) determined complications. Throughout the trial, all clinical investigators were without knowledge of the outcome data for the two treatment groups. The study was approved by the Emory institutional review board, and the procedure for obtaining informed consent consisted of giving a detailed presentation of the two treatments without recommending one or the other.
PTCA was performed by standard methods17. The degree of revascularization depended on the judgment of the cardiologist performing the procedure, and the aim was to open lesions thought to be contributing to ischemia. In 40 percent of the PTCA group, the procedure was staged (angioplasty was performed in various vessel sites over the course of several days). CABG was performed in a standard fashion, with an effort to provide complete revascularization18.
Screening Procedures
Between July 13, 1987, and April 15, 1990, 5118 patients with multivessel disease who had not previously undergone angioplasty or coronary surgery were screened for eligibility. When any reason for exclusion of a patient was discovered, the search for other reasons was stopped and the patient eliminated from further consideration. The principal angiographic criteria for exclusion (in descending order of frequency) were old (more than eight weeks' duration) chronic occlusions of bypassable vessels serving viable myocardium (1609 patients), left main disease with at least 30 percent stenosis (835 patients), two or more total occlusions (308 patients), and an ejection fraction of 25 percent or less (121 patients). The clinical criteria for exclusion were insufficient myocardium at risk to warrant surgery (318 patients), a myocardial infarction within the preceding five days (125 patients), insufficient symptoms to warrant an invasive revascularization procedure (110 patients), and a noncardiac illness threatening survival (84 patients). In addition, among the patients who were angiographically and clinically eligible for enrollment, 191 were excluded by either the surgeon or the cardiologist because a procedure was thought to be unsafe.
Of the 842 patients (16.5 percent) who met all the inclusion criteria and none of the exclusion criteria, 450 declined the invitation to participate in the study and 392 agreed to participate (198 randomly assigned to the PTCA group and 194 to the CABG group). As initial treatment, one patient in the CABG group underwent angioplasty and two patients in the PTCA group underwent surgery, but the groups were followed according to an intention-to-treat analysis. Randomization was performed on the basis of four angiographic stratums (Table 1Table 1
Treatment of Randomized Patients and Eligible Patients Who Were Not Randomized, According to the Angiographic Stratum.).Data were collected at base line, and the patients were contacted every six months for follow-up information. All patients were followed for the duration of the trial. Repeated angiographic studies were performed in 87 percent of the eligible patients at one year and in 76 percent at three years. Thallium scans were obtained in 88 percent of the patients at one year and in 77 percent at three years.
Ascertainment of Primary End Point
The composite primary end point was chosen to reflect objective adverse outcomes, with the expectation that it would occur frequently enough to have the potential for showing a difference between the groups. The composite end point consisting of death, Q-wave myocardial infarction within three years, and a large ischemic burden detected by thallium scanning at three years met these criteria. Death included mortality from all causes before the 36-month anniversary of randomization. A Q-wave myocardial infarction was judged to be present on the basis of a review of all electrocardiograms obtained as part of the study protocol and other electrocardiograms associated with a cardiac admission. The electrocardiograms were read independently by two electrocardiographers with no knowledge of the study data, who looked for the presence of new pathologic Q waves developing during the course of the trial. Early postoperative electrocardiograms were excluded from the review, and predischarge electrocardiograms in patients undergoing surgery were included.
Thallium stress studies with single-photon-emission computed tomography were performed one and three years after randomization19,20. For the purpose of the primary end point, a large defect was defined as ischemia exceeding one third of the left anterior descending region or half the right or circumflex region with complete or nearly complete redistribution on the three-year scan. This magnitude of ischemia was chosen for three reasons: it is objective, it influences clinical decision making in favor of revascularization, and it prompts a recommendation of reduced activity. All studies were read by the nuclear medicine committee without knowledge of the study data. The reproducibility of the studies was established by the investigators responsible for their interpretation20.
Angiographic Analysis
The angiographic analysis determined the extent of revascularization of obstructed segments of the coronary arteries, which were specified as index segments on the base-line films by a consensus of the surgeon and angioplasty physician. The follow-up angiographic evaluation was based on the stenosis resulting in the largest obstruction in the principal pathway for perfusion to these index segments. Analysis of the severity of the lesions was performed at the quantitative arteriography laboratory at the University of Washington21,22. The percentage of revascularized segments (≤ 50 percent obstruction) per patient on the one- and three-year angiograms was determined for the two treatment groups.
Statistical Analysis
Data were analyzed according to the intention-to-treat principle. Continuous data are presented as means ±SD. The chi-square test or Fisher's exact test was used to determine the significance of differences in categorical variables, and the t-test or Wilcoxon two-sample test was used for continuous variables23. Unadjusted Kaplan-Meier curves are presented with P values calculated according to the log-rank test23. All tests are two-tailed, and a P value ≤ 0.05 was considered to indicate statistical significance. All missing data were assumed to be missing at random24.
Results
Base-Line Variables
The base-line characteristics of the randomized patients did not differ significantly in the two groups (Table 2Table 2
Base-Line Demographic and Clinical Characteristics of the Randomized Patients.). The average age at the time of randomization was 62 years; 74 percent of the patients were men; 60 percent had two-vessel disease, and 40 percent three-vessel disease; the proximal left anterior descending artery was involved in 72 percent of the patients; the ejection fraction was 61 ±12 percent; and 80 percent had Canadian Cardiovascular Society (CCS) class III or IV angina. There were no significant differences in age, sex, extent of disease, or ejection fraction between the randomized patients and those who were eligible but not randomized. The randomized patients had more severe angina and were more likely to have proximal involvement of the left anterior descending artery, but they had slightly fewer lesions per patient than the nonrandomized patients (3.4 ±1.3 vs. 3.7 ±1.6, P = 0.019). The randomized patients were also more likely to be receiving intravenous heparin (32 percent vs. 22 percent of the nonrandomized patients; P = 0.003).Initial Procedure
Angiographic evidence of successful revascularization with PTCA, defined as a reduction of the stenosis by at least 20 percent, resulting in a lesion with a diameter of less than 50 percent, was achieved in 88 percent of the lesions treated with angioplasty. At least one lesion per patient was successfully dilated in 95 percent of the patients, and all treated lesions were dilated in 77 percent. Clinical evidence of successful revascularization, defined as dilation of at least some of the lesions, without death, Q-wave myocardial infarction, or in-hospital surgery, was achieved in 88 percent of the patients in the PTCA group. All treated lesions were dilated, with none of the specified complications, in 74 percent of the patients. Initial revascularization provided pathways for perfusion to all index segments in 98 percent of the patients in the CABG group and in 61 percent of those in the PTCA group. The average percentage of revascularized index segments per patient was 99.1 percent in the CABG group (judged on the basis of the operative report) and 75.1 percent in the PTCA group (judged on the basis of the postprocedure angiogram).
Complications of the initial procedure in the CABG group included death (in 1.0 percent of the patients), Q-wave myocardial infarction (in 10.3 percent), thoracotomy for bleeding (in 1.5 percent), sternal infection (in 2.1 percent), and stroke (in 1.5 percent). Complications in the PTCA group included death (in 1.0 percent of the patients), Q-wave myocardial infarction (in 3.0 percent), bypass surgery (in 10.1 percent), stroke (in 0.5 percent), and repair of the femoral artery (in 1.5 percent) (Table 3Table 3
In-Hospital Complications and Events.). At 30 days, the mortality was still 1 percent in each group.Primary End Point
Death from any cause during the three-year study period occurred in 12 patients in the CABG group (6.2 percent) and 14 in the PTCA group (7.1 percent, P = 0.73) (Figure 1Figure 1
Survival of Patients with Multivessel Coronary Disease after Treatment with CABG or PTCA.). There were eight deaths from cardiac causes in the CABG group and seven in the PTCA group. Q-wave myocardial infarctions occurred in 19.6 percent of the patients in the CABG group and in 14.6 percent of those in the PTCA group (P = 0.21). A large ischemic defect was found on thallium scanning at three years in 5.7 percent of the patients in the CABG group and in 9.6 percent of those in the PTCA group (P = 0.17). The composite primary end point occurred in 27.3 percent of the patients in the CABG group and in 28.8 percent of those in the PTCA group (P = 0.81) (Table 4Table 4
Components of the Primary End Point Three Years after Revascularization.).Further Revascularization
The primary difference between the two groups was in the frequency of further revascularization during the three-year study period (Figure 2Figure 2
Proportion of Patients Remaining Free from CABG (Panel A), from PTCA (Panel B), and from CABG or PTCA (Panel C) after the Initial Revascularization Procedure.). Only one additional operation was required among the patients in the CABG group, whereas 42 operations were needed in the PTCA group. Approximately half these operations occurred during the initial hospitalization, and most of the others occurred over the next 12 months. After three years, 1 percent of the patients in the CABG group and 22 percent of those in the PTCA group had undergone additional surgery (P<0.001) (Figure 2A). Thirteen percent of the patients in the CABG group had undergone subsequent angioplasty at three years, as compared with 41 percent of the PTCA group (P<0.001) (Figure 2B). In the latter group, most of the subsequent angioplasty procedures were performed during the first six months. There was also a clustering of procedures at one year in both groups. Subsequent revascularization with either angioplasty or surgery was required in 13 percent of the CABG group, as compared with 54 percent of the PTCA group (P<0.001) (Figure 2C). Throughout the period of the trial, the patients randomly assigned to surgery underwent a total of 194 operations and 29 angioplasty procedures. The patients randomly assigned to angioplasty underwent a total of 305 angioplasties and 46 operations.Follow-up Angiographic Findings
Initially, 99.1 percent of the index segments per patient were revascularized in the CABG group, whereas 75.1 percent were initially revascularized in the PTCA group. One year after the initial procedure, 88.1 percent of the index segments per patient were revascularized in the CABG group and 58.8 percent were revascularized in the angioplasty group (P<0.001), and by the end of three years the difference between the two groups had narrowed (86.7 percent and 69.9 percent, respectively; P<0.001) (Table 5Table 5
Revascularization of Index Segments Initially and at One and Three Years.). Revascularization of 80 percent or more of the index segments per patient was achieved in 78.8 percent of the CABG group and in 36.1 percent of the PTCA group at one year and in 75.3 percent and 50.7 percent, respectively, at three years, indicating that surgery provided more successful revascularization than did angioplasty. The percentage of revascularized index segments per patient at three years varied according to the randomization stratum. The largest difference between the two treatment groups occurred in the stratum of patients with multiple lesions in one or more of the three arteries involved; the difference favored surgery (Table 5).Follow-up Functional Condition
Even though revascularization was more successful in the CABG group and there were fewer Q-wave infarctions in the angioplasty group, there was no difference in the follow-up ejection fraction, which was 69 percent in both groups at the three-year follow-up evaluation. Angina was more prevalent in the PTCA group at three years, with 20 percent of the patients having CCS class II, III, or IV angina, as compared with 12 percent of the patients in the CABG group (P = 0.039). The patients in the PTCA group were also more likely to be taking antianginal medication (66 percent vs. 51 percent, P = 0.005).
Three years after the initial procedure, the two treatment groups did not differ significantly in terms of activity level or employment status: 44.5 percent of the patients in the CABG group were able to engage in moderate or strenuous activity, as compared with 47.0 percent of the patients in the PTCA group (P = 0.63), and 38.5 percent of the patients in the CABG group were gainfully employed, as compared with 36.5 percent of those in the PTCA group (P = 0.89). More of the patients in the CABG group felt that their recovery was complete (67.8 percent vs. 56.8 percent, P = 0.05), and the patients in the PTCA group expressed slightly more optimism about leading a normal life (84.1 percent vs. 77.1 percent, P = 0.13).
Discussion
We investigated whether coronary angioplasty is a viable alternative to bypass surgery in patients who are in need of revascularization and are suitable candidates for either procedure. The occurrence of the composite primary end point (i.e., death, a Q-wave myocardial infarction, or a large ischemic defect on thallium scanning) did not differ in the two groups. Mortality was also similar in the two groups, although our study did not have sufficient power for a rigorous assessment of mortality.
Other ongoing randomized trials reporting interim data have also shown similar mortality among patients with multivessel disease who are undergoing surgery or angioplasty. These include the Randomised Intervention Treatment of Angina (RITA) trial, with data at 2 1/2 years from over 500 patients25; the German Angioplasty Bypass Surgery Investigation (GABI), with data at 1 year from 359 patients (reported elsewhere in this issue)26; the Coronary Angioplasty Bypass Revascularization Investigation (CABRI), with data at 1 year from 1054 patients (Rickards T: unpublished data); and the Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty versus Coronary Artery Bypass Surgery in Multivessel Disease (ERACI), with data at 1 year from 127 patients27. The Bypass Angioplasty Revascularization Investigation (BARI), which has data from 1829 patients with multivessel disease, is expected to report mortality for an average follow-up of five years in late 199528. So far, the data from these trials have provided reassurance to physicians recommending angioplasty for patients with multivessel disease, but the data should also provide reassurance that surgery is not associated with higher mortality.
The main difference we observed was the need for repeated revascularization. After three years of follow-up, only 13 percent of the patients in the CABG group required additional revascularization, as compared with over half the patients in the PTCA group. Despite the larger number of procedures performed in the angioplasty group, the patients in the surgery group had a greater degree of revascularization at three years and a somewhat more favorable status with respect to symptoms. Other ongoing trials of angioplasty in patients with multivessel disease have also shown a frequent need for bypass surgery in the angioplasty groups: 19 percent in the RITA trial at 2 1/2 years,25 26 percent in the GABI trial at 1 year,26 and 20 percent in the CABRI trial at 1 year.
Limitations of the Study
The size of our study and its three-year duration made mortality an untenable end point. Identification of death, myocardial infarction, or ischemia on thallium stress testing resulted in an adequate number of end points for the analysis, but the clinical usefulness as well as the long-term prognostic value of this composite end point has not been established. Evaluation of total (during initial and subsequent hospitalizations) postoperative Q-wave infarctions in the CABG group was notable in that 16 of 25 Q waves were inferior in location, and the follow-up angiograms showed an average ejection fraction of 66 percent, as compared with 68 percent among the patients without myocardial infarction, indicating that in most cases major myocardial necrosis had not occurred.
Angioplasty techniques have improved in recent years, but the main advances in balloon techniques occurred before this study. Atherectomy devices, lasers, and stents are currently used for 10 to 30 percent of all treated lesions, but there is no evidence that they result in better outcomes in patients with multivessel disease such as those studied in this trial29. Future technical refinements or a solution to the problem of restenosis could, however, influence the outcomes.
Since our study showed no difference between surgery and angioplasty in the primary end point but a large difference in the need for subsequent revascularization, the patient's wishes should be strongly considered in selecting a procedure for revascularization. For patients who wish to avoid surgery, angioplasty is a reasonable alternative with no higher risk of morbidity or mortality than that associated with surgery. Patients must be prepared, however, for the possibility that additional revascularization procedures will be required after angioplasty. Conversely, patients who prefer the more definitive therapy can undergo surgery without fear of increased mortality or morbidity.
Supported by a grant (R01 HL 33965) from the National Heart, Lung, and Blood Institute.
Source Information
From the Divisions of Cardiology (S.B.K., N.J.L., W.S.W.), Radiology (N.P.A.), and Cardiothoracic Surgery (R.A.G.), Emory University School of Medicine, Atlanta; the Division of Biostatistics (A.S.K., H.X.B., M.H.K.), Emory University School of Public Health, Atlanta; and the Division of Cardiology, University of Washington School of Medicine, Seattle (X.-Q.Z.).
Address reprint requests to Dr. King at Emory University Hospital, Suite F606, 1364 Clifton Rd. NE, Atlanta, GA 30322.
Study participants are listed in the Appendix.
Appendix
Participants in the EAST investigation included S.B. King III, N.J. Lembo, W.S. Weintraub, G.S. Roubin, N.P. Alazraki, J.M. Craver, J.S. Douglas, R.A. Guyton, E.L. Jones, D.C. Morris, E.G. DePuey, L.L. Battey, E.G. Krawczynska, J.L. Klein, H.A. Liberman, P. Mauldin, J. Yee-Peterson, F.A. Frerichs, R.R. Mays, S.I. Mead, S.F. Carlin, M. Casey, K. McFarland, S.J. Miller, B.U. Peebles, J. Scott, and C.E. Sutor; Biostatistical Coordinating Center: M.H. Kutner, A.S. Kosinski, H.X. Barnhart, P.J. Griffin, M.J. Lynn, A.G. Sanders, E.C. Hall, P. Jamison, B. Mellon, and R.G. Thomas; Cardiac Data Bank: F.W. Hicks and D.J. Anderson; Program Manager: J.J. Borowski; Financial and Administrative Support: S.S. Hofferber, B. Glasser, and R. Jowers; Emory University Advisory Committee: C.R. Hatcher, R.W. Alexander, W.J. Casarella, J.W. Hurst, J.P. Kokko, and R.C. Schlant; Nuclear Medicine and Exercise Electrocardiography Committee: N.P. Alazraki, R.E. Patterson, R.I. Pettigrew, A. Taylor, J. Ziffer, and E.G. DePuey; Mortality Committee: R.C. Schlant, J.M. Felner, and C. Treasure; Stroke Committee: L.C. Hopkins and J.D. Weissman; Electrocardiography Committee: P.F. Walter, J.W. Hurst, and R.C. Schlant; Angiographic Coordinating Center, University of Washington, Seattle: B.G. Brown and X.-Q. Zhao; National Heart, Lung, and Blood Institute Program Office: P. Desvigne-Nickens, T.L. Robertson, and R.E. Solomon; Safety and Data Monitoring Board: L.S. Cohen, E.L. Alderman, G.C. Kaiser, G. Knatterud, D. Sabiston, H. Smith, L. Walters, and D.O. Williams.
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