Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting in Multivessel Coronary Disease
Edward L. Hannan, Ph.D., Chuntao Wu, M.D., Ph.D., Gary Walford, M.D., Alfred T. Culliford, M.D., Jeffrey P. Gold, M.D., Craig R. Smith, M.D., Robert S.D. Higgins, M.D., Russell E. Carlson, M.D., and Robert H. Jones, M.D.
Background Numerous studies have compared the outcomes of twocompeting interventions for multivessel coronary artery disease:coronary-artery bypass grafting (CABG) and coronary stenting.However, little information has become available since the introductionof drug-eluting stents.
Methods We identified patients with multivessel disease whoreceived drug-eluting stents or underwent CABG in New York Statebetween October 1, 2003, and December 31, 2004, and we comparedadverse outcomes (death, death or myocardial infarction, orrepeat revascularization) through December 31, 2005, after adjustmentfor differences in baseline risk factors among the patients.
Results In comparison with treatment with a drug-eluting stent,CABG was associated with lower 18-month rates of death and ofdeath or myocardial infarction both for patients with three-vesseldisease and for patients with two-vessel disease. Among patientswith three-vessel disease who underwent CABG, as compared withthose who received a stent, the adjusted hazard ratio for deathwas 0.80 (95% confidence interval [CI], 0.65 to 0.97) and theadjusted survival rate was 94.0% versus 92.7% (P=0.03); theadjusted hazard ratio for death or myocardial infarction was0.75 (95% CI, 0.63 to 0.89) and the adjusted rate of survivalfree from myocardial infarction was 92.1% versus 89.7% (P<0.001).Among patients with two-vessel disease who underwent CABG, ascompared with those who received a stent, the adjusted hazardratio for death was 0.71 (95% CI, 0.57 to 0.89) and the adjustedsurvival rate was 96.0% versus 94.6% (P=0.003); the adjustedhazard ratio for death or myocardial infarction was 0.71 (95%CI, 0.59 to 0.87) and the adjusted rate of survival free frommyocardial infarction was 94.5% versus 92.5% (P<0.001). Patientsundergoing CABG also had lower rates of repeat revascularization.
Conclusions For patients with multivessel disease, CABG continuesto be associated with lower mortality rates than does treatmentwith drug-eluting stents and is also associated with lower ratesof death or myocardial infarction and repeat revascularization.
Several studies have compared the long-term outcomes of coronary-arterybypass grafting (CABG) and coronary stenting.1,2,3,4,5 In 2003,drug-eluting stents were introduced for the purpose of reducingrestenosis, which has continued to be a problem associated withthe use of bare-metal stents. Many randomized, controlled trialshave documented lower rates of clinical and angiographic restenosis,target-lesion revascularization, and major adverse cardiac eventswith drug-eluting stents.6,7,8,9,10,11,12,13,14,15,16,17,18,19,20However, recent reports of the danger of late stent thrombosisamong patients with drug-eluting stents21,22 led to a meetingof a Food and Drug Administration (FDA) advisory committee thataddressed the safety of drug-eluting stents.23,24
Consequently, it is not clear whether the relative outcomesreported in earlier studies that compared CABG with coronarystenting are reflective of current practice. The purpose ofthis study is to compare rates of death, death or myocardialinfarction, and subsequent revascularization in patients receivingdrug-eluting stents and those undergoing CABG in New York State.
Methods
Databases
The two primary databases used in the study were the CardiacSurgery Reporting System (CSRS) and the Percutaneous CoronaryIntervention Reporting System (PCIRS) of the New York StateDepartment of Health. These registries were developed in 1989and 1991, respectively, for the purpose of collecting informationon all residents of New York State who undergo CABG and percutaneouscoronary intervention (PCI) in nonfederal hospitals in the state.The registries contain information on demographics, coexistingconditions, left ventricular function, hemodynamic state, diseasedvessels and vessels for which surgery or angioplasty was attempted,hospital and operator identifiers, and in-hospital adverse outcomes.Uniform definitions for these elements are used in the databases.The PCIRS also contains information on the type or types ofdevice used for each patient, including bare-metal stents anddrug-eluting stents. Efforts to ensure the accuracy and completenessof these data have been described elsewhere.5
Information on deaths of residents of New York State after dischargefrom the hospital was obtained by matching the patients in eachof the registries with the state Vital Statistics Death filewith the use of patient identifiers. CSRS and PCIRS were alsolinked with the state administrative acute care discharge-reportingsystem, the Statewide Planning and Research Cooperative System(SPARCS). The SPARCS contains information on patient demographics(age, sex, and race), diagnoses and procedures, admission anddischarge dates, and discharge disposition for all patientsdischarged from nonfederal acute care hospitals in New YorkState. CSRS and PCIRS records were matched with SPARCS recordsby using unique hospital identifiers along with patient identifiersand dates of admission, surgery, and discharge. Subsequent emergencyhospitalizations with myocardial infarction as the principaldiagnosis were then identified.
Study Group and End Points
The study includes patients who were treated with drug-elutingstents (with or without other devices) or CABG from October1, 2003, to December 31, 2004. This strategy was chosen to avoidthe start-up period for drug-eluting stents between April andSeptember 2003.
Patients were excluded if they had previously undergone revascularization(6061 patients), had left main coronary artery disease (3188patients), had had a recent myocardial infarction (within 24hours before treatment) (1768 patients), or were not residentsof New York State (678 patients). The remaining patients, whoincluded 9963 patients receiving drug-eluting stents and 7437patients undergoing CABG between October 1, 2003, and December31, 2004, were followed through December 31, 2005, for myocardialinfarction resulting in readmission, death, and repeat revascularization.
The end points of the study were death in the hospital or within30 days after treatment and death, death or myocardial infarction,and revascularization up to 18 months after treatment. Myocardialinfarctions as complications were defined as either complicationsat the index admission (defined as new Q waves in both the CSRSand the PCIRS) or myocardial infarctions at readmission (definedas an emergency admission with a principal diagnosis of myocardialinfarction).
Statistical Analysis
The main purpose of the study was to compare differences inadverse outcomes between the two procedures. Another purpose,identified at the beginning of the study, was to compare adverseoutcomes in subgroups of patients at high risk (patients withdiabetes, patients 80 or more years of age, and patients withlow left ventricular ejection fractions).
The prevalence rates of risk factors and characteristics (demographicfeatures, left ventricular function, hemodynamics, and coexistingconditions) of the patients in the two treatment groups werecompared by the chi-square test and Fisher's exact test. Kaplan–Meierestimates were used to plot the rates of subsequent revascularization;data from patients who died before subsequent revascularizationwere censored. The risk-adjusted odds ratios for in-hospitaland 30-day mortality were calculated with the use of a stepwiselogistic-regression model with patient risk factors as independentcontrol variables and type of procedure included in the modelas the independent study variable of interest.
Differences in risk-adjusted, long-term rates of death and ofdeath or myocardial infarction between patients undergoing thetwo procedures were investigated by developing stepwise Coxproportional-hazards models after confirmation that the proportional-hazardsassumption was justified.25 Candidate independent variablesincluded left ventricular function, hemodynamics, and coexistingconditions. Treatment type (drug-eluting stent or CABG) wasincluded in each model in order to obtain hazard ratios forCABG as compared with drug-eluting stent after adjustment forcovariates that are significant predictors of adverse outcomes.Separate models were developed for combinations of the two outcomesand four anatomical groups defined by the number of diseasedvessels and by the presence or absence of disease in the proximalleft anterior descending (LAD) coronary artery. Data from patientswith two-vessel disease who had no LAD artery disease and frompatients with two-vessel disease who had nonproximal LAD arterydisease were combined because of sample-size considerationsand similar outcomes. Separate models were developed for eachof the outcomes for all patients with three-vessel disease andall patients with two-vessel disease. Disease was defined asstenosis of at least 70%. Two-vessel disease was defined asdisease in two of the three major epicardial vessels, and three-vesseldisease as disease in all three vessels.
Adjusted Kaplan–Meier survival curves were constructedfor each type of procedure for patients with two-vessel andthree-vessel disease with the use of the Cox proportional-hazardsmodels and methods for calculating adjusted survival.26 Coxproportional-hazards models were also used to test for significanceof the hazard ratios for three subgroups of patients: patientswith diabetes, patients 80 or more years of age, and patientswith left ventricular ejection fractions below 40%.
A propensity model was then used to test for selection bias.27,28The significant predictors of type of procedure (CABG or drug-elutingstent) were identified by fitting a stepwise logistic-regressionmodel with a binary dependent variable representing CABG versusdrug-eluting stent, with candidate variables consisting of thepatient-related predictors of the type of procedure used. Foreach anatomical group, the patients' propensity scores weresubdivided into quartiles, and risk-adjusted hazard ratios forCABG versus drug-eluting stent were computed for each quartile.Hazard ratios were compared across quartiles. All reported Pvalues are two-sided and are not adjusted for multiple testing.All analyses were performed with SAS software (version 9.1).
Results
Table 1 presents the prevalence rates of risk factors amongpatients treated with CABG and among those treated with drug-elutingstents. Patients undergoing CABG were on average older (althoughmore patients over 80 years of age were treated with stentsthan with CABG) and were more likely to be male, to be non-Hispanic,to be white, to have lower ejection fractions, to have had previousmyocardial infarctions, to have other coexisting conditions,and to have three-vessel disease. There were no significantdifferences between the two groups in the risk-adjusted ratesof in-hospital or 30-day mortality (adjusted odds ratio, 1.29;95% confidence interval [CI], 0.92 to 1.81; P=0.15).
Table 1. Risk Factors in Patients Treated with CABG or Drug-Eluting Stents.
Figure 1 shows that the rate of revascularization within 18months after the initial procedure was higher for patients receivingdrug-eluting stents. Of patients who received drug-eluting stents,28.4% underwent repeat PCI (e.g., stenting or balloon angioplasty)and 2.2% underwent CABG within 18 months. The respective ratesfor patients undergoing CABG were 5.1% and 0.1%; both differencesare statistically significant (P<0.001). Of patients whoreceived drug-eluting stents, 12.5% underwent repeat PCI within30 days and 18.3% underwent repeat PCI within 60 days. Manyof these patients may have undergone planned PCI associatedwith incomplete revascularization during the index admission.Of the 28.4% of patients who underwent repeat PCI during thestudy period, only a little more than one quarter (7.0%) underwenttarget-vessel revascularization.
Figure 1. Rates of Revascularization within 18 Months after Initial Procedure.
CABG denotes coronary-artery bypass grafting, and PCI percutaneous coronary intervention.
The mean follow-up times were 19.1 months for patients undergoingCABG and 18.7 months for those receiving drug-eluting stents.Table 2 presents follow-up times according to treatment andanatomical group. Table 2 also presents adjusted hazard ratios(CABG vs. drug-eluting stent) for mortality among patients insix anatomical groups: all patients with three-vessel disease,those with three-vessel disease including proximal LAD arteryinvolvement, those with three-vessel disease without proximalLAD artery involvement, all patients with two-vessel disease,those with two-vessel disease including proximal LAD arteryinvolvement, and those with two-vessel disease without proximalLAD artery involvement. Figure 2 and Figure 3 present the 18-monthunadjusted and adjusted rates of survival and survival freefrom myocardial infarction for patients with three-vessel diseasetreated with drug-eluting stents or CABG and for those withtwo-vessel disease treated with drug-eluting stents or CABG.
Table 2. Hazard Ratios for Death and for Death or Myocardial Infarction after CABG and after Treatment with a Drug-Eluting Stent, According to Number of Diseased Vessels.
Figure 3. Adjusted Curves for Long-Term Survival and Survival Free from Myocardial Infarction According to the Number of Diseased Vessels.
Panels A through D show survival curves adjusted for age; sex; ejection fraction; hemodynamic state; history or no history of myocardial infarction before the procedure; the presence or absence of cerebrovascular disease, peripheral arterial disease, congestive heart failure, chronic obstructive pulmonary disease, diabetes, and renal failure; and involvement of the proximal left anterior descending (LAD) artery. CABG denotes coronary-artery bypass grafting.
As indicated in Table 2 and Figure 3, CABG was associated withlower 18-month rates of death and of death or myocardial infarctionthan treatment with a drug-eluting stent for patients with three-vesseldisease and for patients with two-vessel disease. Among patientswith three-vessel disease who were treated with CABG, as comparedwith those who received stents, the adjusted hazard ratio fordeath was 0.80 (95% CI, 0.65 to 0.97), and the adjusted survivalrate was 94.0% versus 92.7% (P=0.03); the adjusted hazard ratiofor death or myocardial infarction among this group of patientswas 0.75 (95% CI, 0.63 to 0.89), and the adjusted rates of survivalfree from myocardial infarction were 92.1% versus 89.7% (P<0.001).
Among patients with two-vessel disease treated with CABG, theadjusted hazard ratio for death was 0.71 (95% CI, 0.57 to 0.89)and the adjusted survival rates were 96.0% versus 94.6% (P=0.003);the adjusted hazard ratio for death or myocardial infarctionamong this group of patients was 0.71 (95% CI, 0.59 to 0.87),and the adjusted rates of survival free from myocardial infarctionwere 94.5% versus 92.5% (P<0.001). CABG was also associatedwith significantly lower mortality in patients with two-vesseldisease either with involvement of the proximal LAD artery (adjustedhazard ratio, 0.71; 95% CI, 0.53 to 0.96) or without involvementof the proximal LAD artery (adjusted hazard ratio, 0.69; 95%CI, 0.48 to 0.98).
Table 3 presents the rates of death and of death or myocardialinfarction for three subgroups of patients treated with drug-elutingstents or CABG who were chosen at the outset of the study. Therewere no significant differences in mortality among any of thesubgroups. However, the rate of death or myocardial infarctionwas significantly lower for those treated with CABG among patientswith ejection fractions below 40% (adjusted hazard ratio, 0.67;95% CI, 0.53 to 0.84) and patients who were at least 80 yearsold (adjusted hazard ratio, 0.74; 95% CI, 0.56 to 0.96).
Table 3. Hazard Ratios for Death and for Death or Myocardial Infarction after CABG and after Treatment with a Drug-Eluting Stent, According to Selected Subgroups of Patients.
Significant covariates in the propensity analysis included age;sex; race; ethnic group; ejection fraction; history or no historyof myocardial infarction; presence or absence of peripheralvascular disease, hemodynamic instability, congestive heartfailure, chronic obstructive pulmonary disease, and diabetes;and anatomical group (number of diseased vessels and the presenceor absence of proximal LAD artery disease). For each of the12 combinations of anatomical group and outcome (six anatomicalgroups and two outcome measures), the advantage of CABG wasquite consistent, with only 11 of the 48 quartiles having adjustedhazard ratios that were larger than 1 and nonsignificant.
Discussion
The two primary interventions for patients with multivesselcoronary artery disease are CABG and PCI. Several randomized,controlled trials and observational studies have compared thelong-term outcomes of these two interventions, but these studiesall preceded the introduction of drug-eluting stents.1,2,3,4,5Consequently, the findings of these studies are outdated andmay no longer reflect current relative outcomes. For instance,many studies have compared the outcomes of drug-eluting andbare-metal stents, and the majority of these studies have concludedthat drug-eluting stents compare favorably with bare-metal stentswith regard to target-lesion stenosis, target-vessel stenosis,or both, or repeat-revascularization rates.6,7,8,9,10,11,12,13,14,15,16,17,18,19,20Conversely, two reports have warned about the danger of latestent thrombosis among patients with drug-eluting stents,21,22leading to an FDA meeting that addressed the safety of drug-elutingstents.23,24 Thus, it is unclear how the long-term outcome ofdrug-eluting stents compares with that of CABG.
The purpose of this observational study was to compare ratesof death and repeat revascularization among patients treatedwith CABG and among those treated with drug-eluting stents inNew York State between October 1, 2003, and December 31, 2004,and in follow-up observations, to compare rates of death, deathor myocardial infarction, and repeat revascularization in thesetwo groups of patients through December 31, 2005. The majorfindings of the study were that among patients with three-vesseldisease or two-vessel disease, those treated with CABG had significantlylower adjusted rates of death and of death or myocardial infarctionthan those treated with drug-eluting stents; that CABG was associatedwith lower rates of death or myocardial infarction for all subgroupsof patients with multivessel disease defined by the presenceor absence of proximal LAD artery disease; that for the mortalityoutcome, there were no significant differences between drug-elutingstents and CABG for patients with three-vessel disease, withor without proximal LAD artery disease, but there was a trendin favor of CABG; and that in three high-risk subgroups of patients(patients with diabetes, patients with left ventricular ejectionfractions below 40%, and patients 80 years of age or older),there were no significant differences in adjusted mortalityrates between those undergoing CABG and those receiving drug-elutingstents, but patients with ejection fractions below 40% and patientswho were at least 80 years old who underwent CABG had significantlylower rates of death or myocardial infarction. A caveat of thefindings for the three high-risk subgroups is that there maybe unmeasured confounding in the data. For example, data onthe severity of diabetes and insulin dependence were not available,and to the extent that one treatment (e.g., CABG) is associatedwith more severe diabetes, the risk-adjustment process was unableto control for those differences.
Our earlier study conducted in New York State compared the outcomesof CABG and bare-metal stents.5 That study, which examined therate of death but not the rate of death or myocardial infarction,found that the adjusted mortality rates were lower for CABGthan for bare-metal stents in all subgroups of patients definedon the basis of the number of diseased vessels and the presenceor absence of proximal LAD artery disease. The hazard ratiosranged from 0.64 for patients with three-vessel disease includingthe proximal LAD artery to 0.76 for patients with two-vesseldisease without involvement of the proximal LAD artery.5
The primary difference between the findings of this earlierstudy and the present study is that the earlier study foundsignificantly lower death rates after CABG than after stentingin all subgroups of patients defined on the basis of locationof disease, whereas we report here that two of these subgroupsdid not have lower death rates after CABG than after stenting.However, the current study did find lower rates of death ormyocardial infarction after CABG than after stenting in allsubgroups of patients.
An important caveat of the present study and the earlier oneis that both were observational studies and are therefore subjectto potential bias with respect to the relative preproceduralseverity of illness among patients treated with CABG and drug-elutingstents. There are a few ways to test for and to minimize thisbias, including propensity analyses and instrumental variablesin conjunction with adjustments to account for differences inmeasures of underlying preprocedural risk.29 As in our earliercomparison of bare-metal stents versus CABG, we chose to usepropensity analyses, whereby the existence of constant treatmenteffects can be tested for by subdividing patients into propensitygroups on the basis of a score obtained from a logistic-regressionmodel, with predictors of treatment type as independent variablesand treatment type as a binary dependent variable.
Our propensity analyses demonstrate that the relative outcomesassociated with the two procedures remained about the same,regardless of the propensity to choose one procedure over theother, indicating that the results are not likely to be severelycompromised by selection bias. Furthermore, observational studiessuch as ours are of value because they shed light on the useof competing treatment options in current practice and becausethey include patients at high risk who are frequently not representedin clinical trials. Nevertheless, despite our efforts to eliminatebias as much as possible, in an observational study there isno way to eliminate bias caused by the presence of patientswho would not have been in a randomized, controlled trial becausethey would have had contraindications or would have been deemedto be ineligible for one of the procedures, or by the presenceof pairs of patients who differ with respect to unmeasured riskfactors not contained in the registries.
Another caveat is that, as in our previous study, we did nothave access to data on deaths occurring outside of New York.We limited the study to residents of New York State and eliminatedout-of-state patients who underwent the procedures in New Yorkhospitals. However, if a New York resident moved from the stateand died elsewhere, information on the death was not availableto us. Consequently, it must be assumed that the likelihoodof a patient's dying outside of New York was not associatedwith the type of procedure undergone by the patient.
Finally, we would like to have used a longer follow-up period,but more recent mortality data are not available at this time.Nevertheless, it would appear that the advantage of CABG wouldhave persisted over the course of another year or two of follow-up,both because our earlier, longer study5 showed evidence of thattendency and because there is evidence of very late stent thrombosisin patients receiving drug-eluting stents.21
Supported in part by the New York State Department of Health.
Dr. Higgins reports receiving consulting fees from Sanofi-Aventisand Astellas Pharma and receiving lecture fees from Sanofi-Aventis.No other potential conflict of interest relevant to this articlewas reported.
The views expressed are those of the authors and do not necessarilyreflect those of the New York State Department of Health.
We thank Kenneth Shine, M.D., chair of the New York State CardiacAdvisory Committee, and the other members of the committee fortheir encouragement and support of this study, and Paula Waselauskas,Kimberly S. Cozzens, Rosemary Lombardo, Cynthia Johnson, andthe cardiac surgery departments and cardiac catheterizationlaboratories of the participating hospitals for their tirelessefforts to ensure the timeliness, completeness, and accuracyof the registry data.
Source Information
From the University at Albany, Albany, NY (E.L.H., C.W.); St. Joseph's Hospital, Syracuse, NY (G.W.); New York University Medical Center, New York (A.T.C.); Medical University of Ohio, Toledo (J.P.G.); Columbia–Presbyterian Medical Center, New York (C.R.S.); Rush University Medical Center, Chicago (R.S.D.H.); Mercy Hospital, Buffalo, NY (R.E.C.); and Duke University Medical Center, Durham, NC (R.H.J.).
Address reprint requests to Dr. Hannan at the Department of Health Policy, Management, and Behavior, School of Public Health, State University of New York, University at Albany, 1 University Pl., Rensselaer, NY 12144-3456, or at elh03{at}health.state.ny.us.
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Zhao, D. X., Leacche, M., Balaguer, J. M., Boudoulas, K. D., Damp, J. A., Greelish, J. P., Byrne, J. G., the Writing Group on behalf of the Cardiac Surgery,
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