Medical Care Costs and Quality of Life after Randomization to Coronary Angioplasty or Coronary Bypass Surgery
Mark A. Hlatky, M.D., William J. Rogers, M.D., Iain Johnstone, Ph.D., Derek Boothroyd, M.S., Maria Mori Brooks, Ph.D., Bertram Pitt, M.D., Guy Reeder, M.D., Thomas Ryan, M.D., Hugh Smith, M.D., Patrick Whitlow, M.D., Robert Wiens, M.D., Daniel B. Mark, M.D., M.P.H., Allan D. Rosen, Katherine Detre, Robert L. Frye, for The Bypass Angioplasty Revascularization Investigation (BARI) Investigators
Background Randomized trials comparing coronary angioplastywith bypass surgery in patients with multivessel coronary diseasehave shown no significant differences in overall rates of deathand myocardial infarction. We compared quality of life, employment,and medical care costs during five years of follow-up amongpatients treated with angioplasty or bypass surgery.
Methods A total of 934 of the 1829 patients enrolled in therandomized Bypass Angioplasty Revascularization Investigationparticipated in this study. Detailed data on quality of lifewere collected annually, and economic data were collected quarterly.
Results During the first three years of follow-up, functional-statusscores on the Duke Activity Status Index, which measures theability to perform common activities of daily living, improvedmore in patients assigned to surgery than in those assignedto angioplasty (P<0.05). Other measures of quality of lifeimproved equally in both groups throughout the follow-up period.Patients in the angioplasty group returned to work five weekssooner than did patients in the surgery group (P<0.001).The initial mean cost of angioplasty was 65 percent that ofsurgery ($21,113 vs. $32,347, P<0.001), but after five yearsthe total medical cost of angioplasty was 95 percent that ofsurgery ($56,225 vs. $58,889), a difference of $2,664 (P = 0.047).The five-year cost of angioplasty was significantly lower thanthat of surgery among patients with two-vessel disease ($52,930vs. $58,498, P<0.05), but not among patients with three-vesseldisease ($60,918 vs. $59,430). After five years of follow-up,surgery had an overall cost-effectiveness ratio of $26,117 peryear of life added, but unacceptable ratios of $100,000 or moreper year of life added could not be excluded (P = 0.13). Surgeryappeared particularly cost effective in treating patients withdiabetes because of their significantly improved survival.
Conclusions In patients with multivessel coronary disease, coronary-arterybypass surgery is associated with a better quality of life forthree years than coronary angioplasty, after the initial morbiditycaused by the procedure. Coronary angioplasty has a lower five-yearcost than bypass surgery only in patients with two-vessel coronarydisease.
Percutaneous transluminal coronary angioplasty was introducedby Grüntzig et al.1 in 1977 as a less invasive alternativeto coronary-artery bypass surgery. Several randomized clinicaltrials of angioplasty and bypass surgery have compared the clinicaloutcomes of these procedures.2,3,4,5,6,7 The Bypass AngioplastyRevascularization Investigation (BARI) was a large trial ofangioplasty and bypass surgery8; the results of five years offollow-up have been reported.9 Although survival among patientswith diabetes improved significantly after bypass surgery, overallrates of survival and survival free of Q-wave myocardial infarctionafter randomization to angioplasty or bypass surgery did notdiffer significantly in the BARI study,9 in any of the otherrandomized trials,2,3,4,5,6,7 or in quantitative overviews.10,11The effect of angioplasty and bypass surgery on quality of lifeand medical costs should therefore also play an important partin the choice between these two techniques of revascularization.
We began the Study of Economics and Quality of Life in 1988as a prospective substudy of the randomized BARI trial, seekingto compare long-term functional status, quality of life, employment,and costs after angioplasty and bypass surgery.
Methods
Study Design
The methods8,12,13,14,15 and major findings9,16 of the BARItrial have been reported previously. In brief, patients wereeligible for that trial if they had angina or objective evidenceof myocardial ischemia severe enough to warrant coronary revascularization,stenosis of 50 percent or more in two or more coronary vessels,technical suitability for both angioplasty and bypass surgery,and no prior coronary revascularization procedure.8
We conducted the present study at 7 of the 18 clinical sitesthat participated in the BARI trial.17 Functional status andquality of life were assessed at study entry and annually duringfollow-up. Use of health care services and employment statuswere documented every three months throughout follow-up.17
Functional status was measured with the Duke Activity StatusIndex, a 12-item scale with total scores ranging from 0 to 58.2(with higher scores indicating better functional status) thatevaluates the ability to perform common activities of dailyliving.18,19 Emotional health was measured with the RAND MentalHealth Inventory, a five-item scale with total scores rangingfrom 0 to 100 (with higher scores indicating better mental health)that assesses anxiety, depression, and positive affect.20,21,22,23The employment status of the patients was ascertained quarterly,including the average number of hours they worked each weekand the amount of time they lost from work because of ill healthor any other reason.
The quarterly documentation of the patients' use of medicalservices included all hospitalizations (regardless of lengthor diagnosis), visits to physicians and other health care providers(studied in 10 categories), and outpatient cardiac tests andprocedures. Hospital bills were obtained for all dischargesoccurring on or after the date of randomization, including thoseat hospitals not participating in this study as well as participatingsites. Charges from each hospital department (such as radiologyor electrocardiography) were converted to costs by multiplyingthe charges by the department-specific ratio of costs to chargesas found in each hospital's Medicare cost report.24 When dataon charges were unavailable (for 452 admissions to VeteransAffairs hospitals and 61 of the 3270 admissions to other hospitals),the 1995 Medicare reimbursement for the diagnosis-related group(DRG) specific to the patient's diagnosis was used. Physicians'charges were obtained from the participating hospitals, andMedicare rates of reimbursement to physicians were assignedto office visits. Costs for cardiac medications were calculatedon the basis of the average wholesale prices in the 1995 RedBook. All costs were adjusted to 1995 dollars with the ConsumerPrice Index.25 To correct for the lower value of dollars spentin the future as compared with the value of those spent in thepresent, costs for follow-up treatment were discounted at arate of 3 percent per year after the date of randomization.26,27
Statistical Analysis
The changes from base line in annual quality-of-life scoreswere compared on an intention-to-treat basis by the Wilcoxonrank-sum test. Only the patients surviving at each follow-upvisit were included in the quality-of-life analyses. Base-linepredictors of improvement in the quality of life were analyzedby multiple linear regression.
Data on costs were totaled quarterly through June 5, 1995, andcumulative costs were compared by the Wilcoxon rank-sum test.The time course of the accumulation of costs during the follow-upperiod was described by an adaptation of the life-table method28in which successive quarterly mean costs were cumulatively totaled,with the surviving patients included through the time of lastcontact and the deceased patients included with the actual costsof their care through their dates of death and then with noadditional cost until their last potential follow-up as of June5, 1995. Variability in cost was assessed by a permutation test.Base-line predictors of cost were assessed by linear regression,with the logarithm of the four-year cumulative cost used asthe dependent variable. The effect on cost of an interactionbetween the number of diseased vessels and the assigned treatmentwas the only prespecified subject of a subgroup analysis inthis study.
The incremental cost effectiveness of bypass surgery as comparedwith angioplasty was calculated as follows:
with cost (t) representing the cumulative medical cost up toa specified time (t) during follow-up, and life-years (t) representingthe area under the survival curve up to that time. In accordancewith standard methods of cost-effectiveness analysis,26,27 anannual discount rate of 3 percent was applied to both follow-upcosts and life-years. The precision of the ratio of costs tothe effectiveness of treatment was assessed by the bootstrapmethod29,30: the patients in the angioplasty and bypass-surgerygroups were each resampled with replacement 1000 times, andfive-year survival, five-year costs, and the resulting cost-effectivenessratio were recalculated in each bootstrap sample.
Results
A total of 1829 patients were randomized in the BARI trial,952 of them (52 percent) at the seven sites participating inthe present study. Nine hundred thirty-four patients (98 percent)agreed to participate in this study, with 465 assigned to angioplastyand 469 assigned to bypass surgery. The mean follow-up periodwas 5.5 years; there were 5 years or more of follow-up for 67percent of patients and 4 years or more of follow-up for 95percent. The clinical characteristics and quality-of-life measuresof the patients at entry into the study were generally wellbalanced between the angioplasty and bypass-surgery groups (Table 1).Event rates during follow-up were similar to those in theoverall trial,9,16 with the patients in the angioplasty grouphaving a slightly higher mortality rate (P = 0.54), significantlymore second or subsequent revascularizations (P<0.001), andsignificantly more angina after one year (P = 0.001) and threeyears (P = 0.01) of follow-up (Table 1).
Table 1. Characteristics of the Patients Randomly Assigned to Angioplasty or Bypass Surgery.
The functional status of all the patients in the study, as assessedby the Duke Activity Status Index, improved by 5.7 units (P<0.001)after one year. The improvement in functional status among thepatients undergoing bypass surgery was significantly greaterthan that among those undergoing angioplasty after one year(7.0 vs. 4.4 units, P = 0.02), two years (5.5 vs. 3.0 units,P = 0.02), and three years (5.6 vs. 3.2 units, P = 0.04) offollow-up, but the difference was not significant after four(4.3 vs. 2.6 units, P = 0.17) or five (3.6 vs. 2.0 units, P= 0.26) years (Figure 1).
Figure 1. Changes in Scores on the Duke Activity Status Index from Base Line to the Annual Follow-up Evaluations in Patients Randomly Assigned to Bypass Surgery or Angioplasty.
The "whiskers" at the top and bottom of each box indicate the 95th and 5th percentiles of the distribution, respectively; the top and bottom of each box, the 75th and 25th percentiles; and the line through the box, the median (the 50th percentile). The solid circle in the box indicates the mean, and the notches in the sides of the box indicate ±2 SE.
Emotional health, as measured by the RAND Mental Health Inventory,also improved significantly after coronary revascularization(mean change in all patients after one year, 1.8 units; P<0.001),with no significant difference between the groups throughoutfollow-up.
The proportion of patients who were initially employed and whocontinued to work either full time or part time declined to83 percent after six months, to 73 percent after one year, to57 percent after three years, and to 45 percent after five years,with no significant differences between the groups. The patientsin the angioplasty group returned to work significantly earlierafter randomization than those in the bypass-surgery group (median,6 vs. 11 weeks; P<0.001), but after their return the numberof hours spent on the job did not differ significantly betweenthe groups.
The initial cost of coronary revascularization was significantlylower in the angioplasty group than in the bypass-surgery group(P<0.001), with mean hospital costs and physicians' feesof $21,113 as compared with $32,347 (Table 2). The differenceof $11,234 in the initial cost (a 35 percent difference) narrowedprogressively over the next three years, but the cost of angioplastyremained significantly lower than that of bypass surgery throughoutfollow-up (Figure 2). The total cost after five years of follow-upwas $2,664 less (5 percent lower) in the angioplasty group thanin the bypass-surgery group ($56,225 vs. $58,889, P = 0.047).The higher cost of subsequent hospitalizations and cardiac medicationsaccounted for most of the increase in cost during follow-upin the angioplasty group (Table 2). The variation in cost wassignificantly greater among the patients assigned to angioplastythan among those assigned to bypass surgery (Figure 2) afterone and three years (P<0.001 for both), but not after fiveyears (P = 0.15).
Figure 2. Cumulative Costs at Quarterly Intervals during Follow-up of Patients Randomly Assigned to Bypass Surgery or Angioplasty.
The thick curves indicate mean cumulative costs calculated by a modification of the life-table method. The lighter curves at the top indicate the 75th percentile of the cumulative cost, and the lighter curves at the bottom the 25th percentile, among the patients remaining in the follow-up cohort. The bars at the bottom of the figure indicate the mean (+2 SE) follow-up costs accrued in the previous year among patients followed throughout that year.
Predictors of Outcome
The improvement in scores on the Duke Activity Status Indexand the RAND Mental Health Inventory varied significantly accordingto the patients' clinical characteristics at entry into thestudy (Table 3). Patients who had heart failure at entry improvedsubstantially less in physical function, and men improved morethan women in both physical and emotional function. Older patientsimproved significantly less than younger patients in physicalfunction, but improved significantly more in emotional function.The degree of improvement in physical function was similar amongpatients with and without diabetes after one year, but therewas significantly less improvement among the diabetic patientsby four years. There were no significant interactions betweenbase-line variables and group assignments with respect to eitherthe Duke Activity Status Index or the RAND Mental Health Inventory.
Table 3. Multivariable Predictors of Improvement in Quality-of-Life Scores.
Four-year cumulative costs were significantly higher in patientswith heart failure (29 percent higher, P<0.001), patientswith diabetes (21 percent higher, P = 0.001), and patients withmore coexisting conditions (10 percent higher per unit of theCharlson comorbidity index,31 P<0.001), after adjustmentfor clinical site (P<0.001) and the length of hospitalizationbefore randomization (P<0.001). The number of diseased vesselswas the only base-line clinical factor that had a significantinteraction with the group assignment with respect to four-yearcumulative costs (P<0.001). The lowest cost was among patientsin the angioplasty group who had two-vessel disease; in theremaining patients, costs were 17 to 22 percent higher.
Cost-Effectiveness Analyses
Over the five years of follow-up, the patients assigned to bypasssurgery incurred higher overall costs (by $2,664) than thoseassigned to angioplasty, but they also had slightly better averagesurvival rates (0.10 life-year), leading to an overall cost-effectivenessratio of $26,117 per year of life added. The cost-effectivenessratio for bypass surgery became considerably more favorableover the course of follow-up: $478,609 per year of life addedat one year, $97,032 at two years, $37,876 at three years, $29,740at four years, and $26,117 at five years.
The cost-effectiveness ratio at five years for bypass surgeryas compared with angioplasty was relatively imprecise when assessedby the bootstrap method. There was a 71 percent probabilitythat the ratio would be $50,000 or less per added year of life,but a 13 percent probability that it would exceed $100,000 peradded year.
Five-year analyses of cost effectiveness were performed separatelyin the patients with two-vessel disease and those with three-vesseldisease and in the patients with and without diabetes, becauseof the significant interaction between these factors and study-groupassignment with respect to either cost or survival (Table 4).In patients with two-vessel disease, surgery had a cost-effectivenessratio of $60,057 per year of life added, whereas among patientswith three-vessel disease there was a trend toward lower costand better survival with surgery (Table 4). Among the patientswith diabetes, surgery led to lower costs and longer life expectancythan did angioplasty, whereas among the remaining patients surgeryhad higher costs and an equal life expectancy (Table 4). Posthoc analysis suggested that angioplasty was associated witha higher cost than surgery only among patients with diabetesand three-vessel disease (Table 4), but this trend was not statisticallysignificant because of the small size of the subgroups.
Table 4. Cost and Life Expectancy over the Five Years of Follow-up, According to Clinical Characteristics.
Discussion
We found that coronary bypass surgery improved physical functionmore than angioplasty during the first three years of follow-up.The five-year cumulative cost of angioplasty was 5 percent lowerthan that of surgery. Angioplasty was significantly less expensiveonly among patients with two-vessel disease; among patientswith three-vessel disease, the five-year costs of the two procedureswere similar.
Quality of Life
A major goal of coronary revascularization is to relieve symptomsof myocardial ischemia. Bypass surgery32,33,34 and angioplasty35both reduce angina and exercise-induced myocardial ischemiabetter than medical therapy. In the BARI trial as well as inother randomized trials,10,11 a larger proportion of patientsassigned to bypass surgery had no angina for the first threeyears of follow-up. In accordance with the greater relief fromangina noted early after bypass surgery, functional status asassessed by scores on the Duke Activity Status Index improvedmore during the first three years in the patients assigned tobypass surgery. The increased scores on the Duke Activity StatusIndex after one year in the bypass-surgery group as comparedwith the angioplasty group were clinically meaningful: an increaseof 2.7 units, for example, was the equivalent of being ableto do light work around the house or walk for a block or twoon level ground as compared with being unable to perform theseactivities.18 The improvement in physical function expectedafter angioplasty and bypass surgery varies substantially amongpatients, however, so clinical recommendations should be tailoredto the condition of the individual patient.
Employment
Since angioplasty is less invasive than bypass surgery and isassociated with a shorter convalescence, it was hoped that patientsundergoing angioplasty would be more likely to maintain theiremployment. Our findings confirm that these patients returnedto work faster, as reported in nonrandomized studies,36 butafter the first three months the proportion of patients employedand the number of hours they spent on the job were equivalentin the angioplasty group and the bypass-surgery group. Relieffrom angina and improved functional status do not appear sufficientto preserve long-term employment among patients with coronarydisease.37
Medical Costs
Angioplasty has lower initial costs than bypass surgery,38,39,40but because of restenosis the costs are increased over one yearof follow-up.41 In this study, the cost of the initial revascularizationwas 35 percent ($11,234) lower in the angioplasty group thanin the bypass-surgery group, but the patients undergoing angioplastyincurred considerably higher costs for hospitalization and medicationsduring follow-up, so that the long-term cost advantage was reducedto 5 percent ($2,664) after five years. Nevertheless, the meancumulative cost of angioplasty remained significantly lowerthroughout follow-up. Further follow-up will be needed to determinehow failure of saphenous-vein grafts after bypass surgery andprogression of disease in the native circulation affect costand clinical outcome.
Our findings about the costs of angioplasty and bypass surgeryconfirm and extend the results of other randomized trials. TheRandomized Intervention Treatment of Angina trial found thatthe two-year cumulative cost of angioplasty was 79 percent to84 percent lower than the cost of bypass surgery.42 The ArgentineRandomized Trial of Percutaneous Transluminal Coronary Angioplastyversus Coronary Artery Bypass Surgery in Multivessel Diseasefound that the three-year cost of angioplasty was 57 percentless than that of bypass surgery.43 The Emory Angioplasty versusSurgery Trial found that the three-year cost of angioplastywas 94 percent that of bypass surgery.44 This study extendsthese observations in several ways. Most important, the five-yearfollow-up period is considerably longer than those of previousstudies, allowing us to show that the steady increase in thecost of angioplasty as compared with bypass surgery halted afterroughly three years of follow-up. In addition, our study includeda more comprehensive accounting of costs than did previous studies;these costs included the costs of outpatient visits, cardiacmedications, nursing home admissions, and all hospital admissionsfor any cause during follow-up.
Cost Effectiveness
With the persistent concern about the cost of health care, afrequently asked question is whether a therapy provides enoughvalue to the patient to justify its added cost. We found thatthe overall cost-effectiveness ratio for bypass surgery as comparedwith angioplasty after five years ($26,117) was in the rangeof the ratios for generally accepted therapies, such as renaldialysis ($30,000) and captopril treatment in patients withreduced ejection fractions after myocardial infarction ($28,400).45The cost-effectiveness ratio for bypass surgery should be interpretedcautiously, however, for several reasons. Estimates of costeffectiveness in this study were relatively imprecise, becauseof the considerable variation in long-term costs among patientsand the relatively small difference in overall mortality atfive years. The data are consistent with an acceptable overallcost-effectiveness ratio for bypass surgery (there is a 71 percentprobability that this ratio would be $50,000 or less per yearof life added), but the possibility of an unacceptable ratiocannot be ruled out (that is, there is a 13 percent probabilitythat the ratio would be $100,000 or more per year of life added).Furthermore, the cost-effectiveness ratio for bypass surgeryas compared with angioplasty changed substantially from earlyin the follow-up period ($478,609 after one year) to late inthat period ($26,117 after five years). Longer follow-up ofthe cohort will be important for making the estimates of costeffectiveness more precise and for determining whether, on average,surgery is more or less cost effective beyond five years.
The cost-effectiveness ratio of a particular therapy may varysubstantially according to the characteristics of patients,since the effectiveness of therapy or its cost, or both, mayvary considerably among populations of patients.45 Despite therelative uniformity of the patients enrolled in the BARI study,the cost-effectiveness ratios found in this study varied considerablyaccording to the clinical characteristics of the patients. Bypasssurgery was quite cost effective in diabetic patients becauseof their significantly better survival, whereas the cost ofangioplasty was lower than that of surgery in patients withtwo-vessel disease, but not in those with three-vessel disease.Multivariable analysis would provide an assessment of the relativeimportance of these and other factors (such as age, sex, andthe presence or absence of congestive heart failure) with regardto cost effectiveness. Methods of performing such analyses ofthe complex relations inherent in a cost-effectiveness ratiohave not yet been established, but the increasing availabilityof primary data on cost and outcome from clinical trials willundoubtedly spur their development.
Conclusions
We found that, on average, functional status was improved morewith bypass surgery than with angioplasty in the first threeyears, whereas in other respects the quality of life was equivalentwith either method of revascularization. The cost of angioplastywas initially $11,234 lower than that of bypass surgery (a 35percent savings, P<0.001), but higher subsequent costs forhospitalization and medication reduced the savings to $2,664at five years (a 5 percent savings, P=0.047). Balloon angioplastyhas a significant cost advantage over bypass surgery in patientswith two-vessel coronary disease, but the costs are similarin patients with three-vessel disease.
Supported by a grant (015151) from the Robert Wood Johnson Foundation,Princeton, N.J., and by a grant (HL38610) from the NationalHeart, Lung, and Blood Institute, Bethesda, Md.
Source Information
From the Stanford University School of Medicine, Stanford, Calif. (M.A.H., I.J., D.B.); the University of Alabama Medical Center, Birmingham (W.J.R.); the University of Pittsburgh Graduate School of Public Health, Pittsburgh (M.M.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); the Mayo Clinic, Rochester, Minn. (G.R., H.S.); Boston University School of Medicine, Boston (T.R.); the Cleveland Clinic Foundation, Cleveland (P.W.); St. Louis University School of Medicine, St. Louis (R.W.); and Duke University School of Medicine, Durham, N.C. (D.B.M.). Other authors were Allan D. Rosen, M.S., and Katherine Detre, M.D., Dr.P.H. (University of Pittsburgh Graduate School of Public Health), and Robert L. Frye, M.D. (Mayo Clinic).
Address reprint requests to Dr. Hlatky at Stanford University School of Medicine, HRP Redwood Bldg., Rm. 150, Stanford, CA 94305-5092.
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Appendix
The following institutions and investigators participated inthe Study of Economics and Quality of Life substudy of the BARItrial: University of Alabama at Birmingham — W. Rogers,W. Baxley, L. Dean, G. Roubin, G. Zorn, G. Duke, S. Brewer,W. Lowe, E. Charles, L. Carr, L. Maske, and A. McCarroll; BostonUniversity — T. Ryan, M. Mazur, J. Brush, D. Faxon, andB. Hankin; Cleveland Clinic Foundation — P. Whitlow, M.Lincoff, E. Topol, K. Comella, B. Healy, A. Rogers, J. Tedrick,E. Griffin, L. Webster, and K. Schaffer; Duke University —D. Mark, R. Califf, D. Fortin, J. Grinnell, M.A. Sellers, L.Drew, V. Bass, D. Frid, E. Hampton, H. Gessner, L. Hicks, T.Daniels, E. Griffin, and B. Bacon; Mayo Clinic — G. Reeder,H. Smith, M. Mock, L. Pierre, F. Nobrega, and R. Vlietstra;University of Michigan — B. Pitt, M. Stock, K. McNeely,P. Fox, K. Burek, H.-L. Shu, L. Belzowski, J. Collins, and T.Johnson; St. Louis University — R. Wiens, B. Chaitman,C. Huffman, P. Thibodeau, and J. Fehl; Coordinating Center —K. Detre, S. Kelsey, K. Tyrell, M.M. Brooks, G. Hardison, A.Rosen, S. Crow, G. Harger, J. Bost, J. Melvin, and A. Steenkiste;Central Laboratory — M. Hlatky, I. Johnstone, D. Boothroyd,C. Winston, C. Kallmann, E. Steel, C. Bacon, K. Gelman, N. Clapp-Channing,C.-K. Kim, K. Lee, S. Wilson, R. Lynn, and A. Heaton; RobertWood Johnson Foundation — L. Sandy and J. Cantor.
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