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J Thorac Cardiovasc Surg 2008;136:500-506
© 2008 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
a Division of Cardiology, the Texas Heart Institute at St Luke's Episcopal Hospital, Houston, Tex
b Division of Biostatistics, the Texas Heart Institute at St Luke's Episcopal Hospital, Houston, Tex
c Division of Cardiovascular Surgery, the Texas Heart Institute at St Luke's Episcopal Hospital, Houston, Tex
d Divisions of Cardiology and Cardiovascular Surgery, Baylor College of Medicine, Houston, Tex
e School of Health Information Sciences, the University of Texas at Houston, Houston, Tex
Received for publication July 11, 2007; revisions received October 26, 2007; accepted for publication November 1, 2007. * Address for reprints: Shun Kohsaka, MD, Division of Cardiology, 622 W 168th St PH 3-137, New York, NY 10032. (Email: sk2798{at}columbia.edu).
| Abstract |
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Methods: We examined in-hospital and long-term follow-up data from consecutive patients with multivessel coronary artery disease who underwent isolated initial revascularization by coronary stenting or coronary artery bypass grafting between 1995 and 2003. Cox proportional hazards modeling with propensity scoring and propensity-based case matching were used to compare long-term survival and correct for baseline differences between the populations.
Results: A total of 6847 patients were studied (stenting 3917, coronary artery bypass grafting 2930). Each patient had 1 to 9 years of follow-up (median 3.5 years). Unadjusted long-term mortalities were similar for coronary artery bypass grafting and stenting (hazard ratio 1.1, 95% confidence interval 0.9–1.2, P = .21). Matched comparison of 3488 patients (1856 in each group) with similar likelihoods of undergoing coronary stenting or coronary artery bypass grafting, however, suggested that coronary artery bypass grafting provided better long-term survival (hazard ratio 0.7, 95% confidence interval 0.6–0.9; P = .004).
Conclusion: During a 9-year period, in physician-selected patients with favorable demographic characteristics for both revascularization procedures, coronary artery bypass grafting was associated with better long-term survival than stent-assisted angioplasty.
| Introduction |
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To examine the impact on survival of first-time revascularization with PCI with coronary stenting instead of elective CABG, we examined long-term mortality among patients with multivessel CAD enrolled in the Texas Heart Institute Research Database (THIRDBase). THIRDBase is a comprehensive, longitudinal clinical registry of outcomes for more than 150,000 patients treated for cardiovascular disease at the Texas Heart Institute at St Luke's Episcopal Hospital. It includes a wide range of data for all patients admitted to our institution with a diagnosis of cardiovascular disease. Standard methods of survival comparison (Cox proportional hazards modeling and propensity-weighted scoring) and a more stringent statistical method (propensity-based case matching) were used to make our results comparable with those of previous studies.
| Materials and Methods |
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Written, informed consent was obtained at hospital admission from all patients registered in THIRDBase. All data we analyzed were stripped of personal identifiers. We obtained approval for this project from the Committee for the Protection of Human Subjects, the institutional review board for the University of Texas Health Science Center at Houston, on November 11, 2004 (HSC-SHIS-04-009).
Patient histories were obtained by interview at hospital or clinic presentation and were entered prospectively into the database. Variables defined were the number of diseased vessels, left ventricular ejection fraction, urgency of the procedure, hypertension (defined as blood >130/90 mm Hg or current use of antihypertensive medications), angina severity (defined according to the Canadian Cardiovascular Society classification system), congestive heart failure severity (classified according to New York Heart Association criteria), family history of CAD, previous MI, renal insufficiency (defined as a serum creatinine level
2 mg/dL), diabetes mellitus (defined as a fasting blood sugar level >125 mg/dL or the use of antidiabetic agents), peripheral vascular disease, transient ischemic attack, cerebrovascular disease, abdominal aortic aneurysm, and chronic obstructive pulmonary disease.
Statistical Analysis
The Pearson
2 test was used to analyze discrete variables, and the Student t test was used to analyze continuous variables. Logistic regression and Cox proportional hazard models that used a forward stepwise variable selection process were developed to determine which clinical and angiographic variables were associated with late mortality. This HR (or odds ratio [OR]) is the ratio of the mortality in the stenting group to that in the CABG group at any given point in time, controlling for differences in patient demographic characteristics or risk factors.
To express survival differences in percentages, long-term mortality was evaluated with Cox proportional hazards modeling, with propensity scoring to adjust for differences in baseline characteristics influencing each patient's likelihood of being treated with stenting versus CABG, and with an analysis that involved stringent case matching according to propensity scores. Propensity scores were computed from as many patient characteristics and early outcome variables as possible. For the case-matched study population, pairs of patients with similar propensity scores were selected from the two treatment groups. This method yielded very similar stenting (n = 1856) and CABG (n = 1856) groups, which were compared in subsequent late-outcome analyses. Analyses were performed with SAS 6.09 software (SAS Institute, Inc, Cary, NC) for the VAX/VMS operating system.
| Results |
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The prevalences of diabetes (33%) and reduced left ventricular systolic function (ejection fraction <50%, 32%) were high in this study population, particularly in the CABG group (
Table 1). The CABG group also had higher prevalences of advanced age, male sex, smoking, previous MI, unstable angina, congestive heart failure, peripheral vascular disease, cerebrovascular accident, and chronic obstructive pulmonary disease. Of the listed variables, only hypercholesterolemia, obesity, and female sex were more common in the stenting group. Most patients in the CABG group (76%) had three-vessel CAD, whereas those in the stenting group had a more variable degree of CAD: 72% had two-vessel CAD, and 27% had three-vessel CAD. Urgent procedures accounted for 5.3% of all cases (5.7% for CABG, 4.9% for stenting, P = .1571).
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Predictors
Several significant predictors of mortality were identified (
Table 2). The multivariable logistic regression model showed that the strongest predictors of mortality in the CABG group were age older than 65 years (OR 2.2, 95% confidence interval [CI] 1.8–2.7) and history of chronic renal insufficiency (OR 1.9, 95% CI 1.5–2.3). The significant predictors of mortality in the stenting group included age older than 65 years (OR 2.8, 95% CI 2.1–3.8) and history of chronic renal insufficiency (OR 2.2, 95% CI 1.6–3.1).
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Long-term Mortality
Unadjusted long-term mortality was similar between the CABG group and the stenting group (OR 1.1, 95% CI 1.0–1.2, log-rank test P = .27). After adjustment with a multivariate model, no difference in mortality was observed between the CABG and stenting groups (OR 0.9, 95% CI 0.7–1.1). Propensity adjustment, however, revealed a rather strongly favorable result for surgically treated patients (HR 0.8, 95% CI 0.7–0.9, P = .0005).
Matched Groups
We matched 3712 patients (1856 from each group) with respect to their likelihood of being assigned to undergo CABG or stenting according to their clinical, angiographic, and demographic characteristics (
Table 3). Between these two groups, there were no significant differences in age, sex distribution, or the prevalences of current smoking, diabetes, hypercholesterolemia, presentation with unstable angina, or history of MI. The angiographic characteristics of both groups of patients were also similar; both groups had large proportions of patients with two-vessel CAD. The average number of totally occlusive lesions was 1.2 in the CABG group and 1.4 in the stenting group (P = .049). Similar to the outcome of adjusting observed values, the matched population without adjustment in observed values revealed a significant difference in favor of surgery at 9 years (HR 0.7, 95% CI 0.6–0.9, P = .004).
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| Discussion |
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Our findings have variable companionship in the literature. The Bypass Angioplasty Revascularization Investigation (BARI) found poorer 7-year survival after angioplasty (65%) than after CABG (80%) in patients being treated for diabetes.3
A separate analysis of BARI registry data4
disagreed with those of randomized trial data with respect to the outcomes of patients with diabetes: patients with diabetes treated percutaneously and those treated surgically had identical survival rates (84%) during 7 years. A review of the characteristics of the percutaneously treated patients in the BARI trial and registry5
found that registry patients treated percutaneously had fewer lesions at baseline and that their lesion characteristics were more favorable for PCI. These observations highlight the impact of patient selection on long-term outcome after a PCI procedure.
During the performance and follow-up of several randomized trials comparing angioplasty with CABG, the coronary stent was introduced and rapidly became a standard of care. Many clinicians assume that stenting is more beneficial for long-term survival than is angioplasty alone, but this assumption has not been tested in a randomized trial. Our data suggest that in an unselected population of patients with multivessel CAD first revascularization with CABG is associated with better survival rates than those associated with coronary stenting. These results are in agreement with those of similarly designed large-scale retrospective studies, despite differences in study design and population (
Table 4). In the Cleveland Clinic,1
New York State Registries,2
Northern New England,6
and Thoraxcenter7
database analyses, CABG was associated with lower long-term mortality than was stenting.
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Moreover, CAD progression during follow-up is a potential adverse outcome of both techniques.11
). Medical therapy, including the routine use of angiotensin-converting enzyme inhibitors, long-term dual antiplatelet therapy, and far more aggressive lipid-lowering therapy, has evolved significantly since the previous registry studies were published. Both saphenous vein grafts and native vessels receive the protection of more aggressive medical therapy. Still, CAD progression does occur. Failure of a percutaneously treated vessel because of lesion progression at an untreated site may have greater impact on the subtended tissue than does lesion progression after CABG, in which two or more vessels may share the responsibility (albeit unevenly). As a result, patients who undergo CABG may receive greater relative benefit from these medical innovations while being less susceptible to catastrophe in the case of CAD progression than those who undergo PCI. Attempts to treat percutaneously patients or vessels in which eventual treatment failure is probable (eg, patients with diabetes mellitus, extensive atherosclerotic burden, small vessels with long lesions, or bifurcations) may highlight this contrast between the two revascularization methods.
Hannan and colleagues2
used the powerful New York State revascularization reporting system to examine outcomes in more than 59,000 patients treated between 1997 and 2000. Patients with previous revascularization procedures and left main coronary artery stenosis were excluded. Survival after 3 years was better in the stenting group than in the CABG group. After adjustment for baseline risk factors, however, CABG was associated with superior survival not only in the population as a whole but, surprisingly, in almost every subgroup examined, including patients with two-vessel CAD without left anterior descending coronary artery involvement.
Brener and associates1
examined the survivals of patients treated surgically or percutaneously at the Cleveland Clinic from 1995 to 1999, excluding patients who had been refused treatment by a cardiac surgeon because of "comorbidity or a lack of appropriate target vessels" and patients who were undergoing primary treatment for acute MI, who died during the procedure, or who had no social security number. Only 70% of the percutaneously treated patients underwent stent implantation. After 5 years, survivals were similar in patients who underwent PCI (16%) and those who underwent CABG (14%), despite the fact that the CABG group had more risk factors at baseline. After propensity matching was used to correct for this difference in baseline risk, the CABG group appeared to have superior survival (OR 2.3, 95% CI 1.9–2.9). We also excluded patients with acute MI in this study, but we included patients with any other high-risk surgical profile, and our PCI population was restricted to those who received stents.
The Thoraxcenter study7
examined a population similar in size and characteristics to that of the Cleveland Clinic study, save that only patients who received a stent in two or more vessels were included. The finding that 8-year survival was marginally better in the CABG group (87.5%) than in the stenting group (82%) (P = .06) was driven almost solely by the inclusion of patients with left main CAD.
Additionally, the Cleveland Clinic1
and Northern New England6
studies included patients treated with balloon angioplasty only (without stenting). In contrast, the New York State Registries2
and Thoraxcenter7
trials restricted their PCI populations to stent recipients; however, these two studies differed substantially in the demographic characteristics of their populations.
Limitations
Even large observational studies such as this one can be biased by baseline differences between treatment groups. The main limitation of this study is that although the observations that prompted physicians to refer patients for coronary revascularization may be important markers of outcome, we could not obtain these data. We have attempted to nullify the effects of these data and other potential confounding variables by using Cox and propensity analysis. The differences in the results of the Cox and propensity analyses are a source of interest. Although it is possible that propensity adjustment overcorrects for differences in baseline variables, this seems unlikely given the results seen in the matched populations. A more probable explanation is that the ability of the proportional hazards model to separate the effects of individual variables may exclude the effect of physician judgment. Propensity adjustment or matching by examining the confluence of variables affecting referral for a given procedure may be a more powerful means of statistical adjustment for a study such as this.
Long-term follow-up data on the need for repeat procedures or control of angina were not available. It is well established, however, that CABG is more reliable than bare-metal stenting in preventing symptom recurrence and the need for repeat procedures. Our goal was to examine the effect of that difference on long-term survival in a nonrandomized population.
A limitation of both our study and all other comparative studies of CABG and PCI is that their findings may quickly be outdated by technologic advances. One such advance is the advent of drug-eluting stents, which dramatically reduce the need for repeat revascularization after stent placement. There is not yet clear-cut evidence, however, that these stents improve survival. We therefore may still draw inferences about comparative survival from populations with bare-metal stents. Additionally, uses of adjunct devices, such as cutting balloon, laser, and rotational atherectomy, although rare in our population, were not recorded, so the influences of such devices on outcome are not known. Further, advances in preoperative evaluation, including more precise coronary artery and myocardial imaging and diagnostic techniques, have allowed more appropriate patient selection and surgical planning. Improvements in cardiopulmonary perfusion and careful myocardial protection, as well as the use of off-pump and on-pump beating-heart techniques in selected cases, have also decreased perioperative morbidity and mortality.
Implications
In this large, longitudinal database study performed during the modern era of percutaneous coronary stenting, physician-selected strategies for first-time revascularization with CABG were associated with better long-term survival than was stent-assisted angioplasty.
| Acknowledgments |
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| References |
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This article has been cited by other articles:
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M. R. Movahed, M. Hashemzadeh, A. Khoynezhad, M. M. Jamal, and R. Ramaraj Sex- and ethnic group-specific nationwide trends in the use of coronary artery bypass grafting in the United States J. Thorac. Cardiovasc. Surg., June 1, 2010; 139(6): 1545 - 1547. [Abstract] [Full Text] [PDF] |
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