European Heart Journal Advance Access published online on September 27, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm403
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A comparison between coronary artery bypass grafting surgery and drug eluting stent for the treatment of unprotected left main coronary artery disease in elderly patients (aged 
75 years)
1 Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola, Via Massarenti 9, 40 138 Bologna, Italy
2 Dipartimento di Cardiologia, Legnano, Italy
3 Dipartimento di Cardiologia, Rimini, Italy
4 Istituto di Cardiochirurgia, Policlinico S. Orsola, Bologna, Italy
5 Dipartimento Cardiochirurgia, Legnano
Received 5 June 2007; revised 14 August 2007; accepted 23 August 2007.
* Corresponding author. Tel: +39 051 349858; fax: +39 051 344859. E-mail address: tulliopalmerini{at}hotmail.com
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Abstract |
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Aims: In this study, we compared the clinical outcomes of elderly patients with unprotected left main coronary artery (ULMCA) stenosis treated with either coronary artery bypass grafting (CABG) or drug-eluting stent (DES).
Methods and results: From January 2003 to April 2006, 259 patients with ULMCA stenosis and age 
75 years underwent coronary revascularization with either CABG or DES. One hundred and sixty-one patients were treated with CABG and 98 with DES. The cumulative unadjusted rates of 2-year mortality were 17% in CABG-treated patients and 18% in those treated with DES (P = 0.71). The adjusted rates of 2-year survival were 85% for CABG-treated patients and 87% for DES-treated patients (P = 0.74). The incidence of 2-year myocardial infarction was 6% in CABG-treated patients and 4% in DES-treated patients (P = 0.11). The incidence of target lesion revascularization (TLR) was 3% in CABG-treated patients and 25% in DES-treated patients (P < 0.0001). In the multivariable analysis, peripheral vascular disease, left ventricular ejection fraction and acute coronary syndrome were independent predictors of 2-year mortality.
Conclusion: In this study, we could not demonstrate a difference in mortality between CABG-treated patients and those treated with DES. However, the rate of TLR was higher in the DES group.
Key Words: Stents • Bypass • Coronary disease
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Introduction |
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Coronary artery bypass grafting (CABG) surgery is considered the standard of care for the treatment of unprotected left main coronary artery (ULMCA) stenosis.1 This notion is based on some randomized and observational studies performed 3 decades ago, which showed that surgery is associated with a significant improvement in survival when compared with medical therapy.2,3 In these studies, however, elderly patients (aged
75 years) were, in general, not included or represented a small proportion of the general population and therefore whether these results apply also to the elderly has never been determined.
Continued technical evolution of percutaneous coronary intervention (PCI), including the recent introduction of drug-eluting stents (DESs)4–6 and aggressive antiplatelet therapy,7,8 has renewed the interest for the percutaneous treatment of ULMCA stenosis.9–13 PCI of ULMCA stenosis might be particularly suitable for elderly patients,14–18 who represent one of the most rapidly expanding segments of the population in Western countries. Elderly patients, in fact, often present with major contraindications to surgery or have several comorbidities that significantly increase the operative risk. Recently, three observational registries have shown similar incidence of early- and mid-term mortalities between CABG-treated patients and those treated with DES.19–21 In these studies, however, no analysis was performed in elderly patients. Therefore, the relative efficacy of the two strategies of revascularization in this context remains unknown. For these reasons, we examined the outcomes of patients 75 years presenting with ULMCA stenosis treated with either CABG or DES.
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Methods |
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Patients
In the present study, we included patients with a de novo
50% ULMCA stenosis and age 75 years treated consecutively with either CABG or DES at three high volume tertiary care interventional centres in the period between 1 January 2003 and 30 April 2006. We excluded patients with ST-segment elevation acute myocardial infarction, haemodynamic instability, valve repair or replacement, previous CABG, and history of neoplastic condition in the preceding 5 years. Two hundred and fifty-nine patients had the specified requisites and they represented the cohort of the present study. The decision to perform PCI instead of surgery was taken if the anatomy was suitable for stenting and the patient and the referent physician preferred the percutaneous approach or if there were contraindications for surgery. As this was not a randomized trials, to better characterize the patient population in relation to possible strategies of revascularization, we performed a post hoc analysis aimed at evaluating how many patients were suitable for PCI only, how many for CABG only, and how many could have been treated with both strategies. Patients were considered to be suitable for both strategies if PCI of ULMCA was considered technically feasible, if an equivalent degree of revascularization could be provided by the two strategies of revascularization, if a mammary artery could be used to bypass the left anterior descending coronary artery, and if the general condition of the patient was considered suitable for surgical intervention. In each centre, one interventional cardiologist and one surgeon reviewed all the coronary angiography of patients participating in the study and, on the basis of the clinical and anatomic characteristics of patients, an agreement was found on the possible strategies of revascularization. The study was approved by the local institutional Ethics Committees. All patients gave written informed consent for participation in the study.
Procedural characteristics
All surgical and percutaneous procedures were performed in standard fashion by the same interventionalist and surgical team. CABG surgery was performed either ‘on-pump’ or ‘off-pump’.
Mammary artery conduits were used whenever possible. For those patients taking both aspirin and clopidogrel, surgery was delayed 5 days. After the operation, patients received 100 mg aspirin indefinitely. In DES-treated patients, heparin was administered at the start of the procedure at a dose of 100 U/kg in patients not treated with glycoprotein IIb–IIIa inhibitors and at a dose of 70 U/kg in those treated with glycoprotein IIb–IIIa inhibitors. Use of glycoprotein IIb–IIIa inhibitors was left at the operator's discretion. After the procedure, all patients received 100 mg aspirin indefinitely and either 250 mg ticlopidine twice a day or 75 mg/day clopidogrel, for 3, 6 or 12 months depending on clinical and procedural characteristics. Total creatine phosphokinase (CPK) and the isoenzyme muscle–brain MB were collected in all patients after 6 h and the morning after the intervention. In patients with post-procedural CPK elevations, repeat CPK analysis was performed every 6 h until the peak elevation was defined.
During follow-up, in CABG-treated patients, coronary angiography was performed only if clinically indicated, whereas in DES-treated patients, at least one angiographic control was performed within 6 months after the intervention or as clinically indicated by symptoms. Long-term follow-up was performed by means of a telephone interview.
Definitions
Haemodynamic instability was defined as the need to use inotropic drugs or intra-aortic balloon pump to keep the systolic pressure to at least 90 mmHg in the presence of symptoms of low cardiac output. Acute coronary syndrome was defined as either unstable angina or non-ST-segment elevation myocardial infarction. The diagnosis of non-ST-segment elevation myocardial infarction was based on the presence of typical symptoms and an increase in either CPK, with the isoenzyme MB >10% of the total value, or troponin I. The diagnosis of periprocedural myocardial infarction was made if, in the first 7 days after the surgical or the percutaneous intervention, there was documentation of new abnormal Q waves and either a rise in the CPK level to more than twice the upper normal limit with CPK-MB isoenzyme >10% the total value or a CPK-MB value that was five times the upper normal limit for CABG-treated patients and three times for PCI-treated patients. Beginning 8 days after the intervention, an increase in either CPK with MB >10% or troponin I was sufficient for the diagnosis of myocardial infarction. Peripheral vascular disease was defined as the presence of at least one of the following: symptomatic or >50% asymptomatic carotid stenosis, abdominal aortic aneurysm, claudication or previous or planned intervention on the abdominal aorta, limb arteries, or carotids. Renal dysfunction was defined as serum creatinine levels >1.2 mg/dL. In CABG-treated patients, target lesion revascularization (TLR) was defined as the need for PCI or CABG because of failure of grafts for either left anterior descendent artery or circumflex artery. In DES-treated patients, TLR was defined as repeated PCI or CABG for restenosis of the entire segment involving the implanted stent and the 5 mm distal and proximal borders adjacent to the stent. Deaths were classified as either cardiac or non-cardiac. Deaths that could not be classified were considered cardiac.
Statistics and endpoints of the study
The primary endpoint of the study was 2-year mortality. All other comparisons were considered secondary objectives of the study. Given the exploratory nature of the study and the lack of knowledge about effect size, no formal sample size calculations were performed.
Data are presented as mean ± standard deviation or median and range as appropriate.
Continuous data between groups were compared using unpaired Student's t-test or Mann–Whitney rank sum test as appropriate. Categorical variables were compared by 
2 statistics or Fisher's exact test as appropriate. Survival, myocardial infarction-free survival and TLR-free survival were analysed by the Kaplan–Meyer analysis and differences between groups were analysed with the log rank test. Independent predictors of mortality at 2-year follow-up were analysed using the Cox proportional hazard regression model. The Cox multivariable analysis was performed using the following variables as covariates: the method of revascularization (DES vs. CABG), age, gender, diabetes, acute coronary syndrome, renal dysfunction, chronic pulmonary disease, peripheral vascular disease, multivessel disease, and left ventricular ejection fraction (LVEF). The proportional hazard assumptions of the model were assessed by plotting the scaled Schoenfeld residuals against time and the linearity assumption was assessed by plotting the Martingale residuals against continuous covariates. All patients were censored at 2 years. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. Given the non-randomized nature of the study, to minimize any selection bias, a second multivariable analysis was performed using the propensity score as a covariate. The propensity score was determined using a logistic regression model from which the probability of receiving a DES rather than CABG surgery was calculated for each patient. All variables listed in Table 1 were included in the model. Model discrimination was assessed with the c-statistic. Each patient's propensity score was calculated from the sum of the values for all variables in the model multiplied by their respective logistic coefficient. Thereafter, a Cox regression analysis was performed using as covariates the method of revascularization and the propensity score calculated as a simple linear term. Statistical analyses were performed using SPSS 12.0 for Windows (SPSS Inc., Chicago, IL, USA) and STATA/SE 9.2 for Windows (Statacorp, LP, TX, USA). P-values less than 0.05 were considered statistically significant.
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Baseline clinical characteristics and 30-day clinical outcome
Baseline clinical and angiographic characteristics are summarized in Table 1. One hundred and sixty-one patients were treated with CABG and 98 with DES. DES-treated patients were older, were more subject to acute coronary syndrome, and had higher surgical scores than CABG-treated patients. Of the 259 patients, 157 (60%) were believed to be suitable for either PCI or CABG, 68 (26%) for CABG only and 34 (14%) for PCI only. The unadjusted incidence of 30-day mortality was 4.3% in CABG-treated patients and 5.1% in patients treated with DES (P = 0.98). The unadjusted incidence of myocardial infarction was 1.9% in CABG-treated patients and 3% in DES-treated patients (P = 0.84).
Clinical outcome at follow-up
Clinical outcomes at 2-year follow-up are shown in Figure 1. One patient in the PCI group and no patient in the CABG group were lost to follow-up. The cumulative unadjusted rates of 2-year mortality and cardiac mortality were 17 and 12% in CABG-treated patients, respectively, and 18 and 10% in DES-treated patients (for mortality, log rank test: P = 0.71 and for cardiac mortality: P = 0.83). The cumulative unadjusted incidence of myocardial infarction at 2-year follow-up was 6% for CABG-treated patients and 4% for DES-treated patients (P = 0.88).
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As part of the routine follow-up strategy of each centre, most of PCI-treated patients underwent at least one angiographic follow-up within 6 months from the index procedure. Reasons for not performing the angiographic follow-up were very old age (>90 years), poor general conditions, or patient refusal. As a consequence, 79 patients in the DES group (80%) underwent coronary angiography within 6 months after the index procedure. CABG-treated patients underwent coronary angiography only if clinically indicated. The unadjusted incidence of 2-year TLR was 3% in CABG-treated patients and 25% in DES-treated patients (P < 0.0001). Among the 20 DES-treated patients who underwent TLR, 17 were treated with a new PCI and three with CABG. All the three CABG-treated patients who underwent TLR were treated with PCI.
Independent predictors of mortality
In the Cox univariate analysis, acute coronary syndrome, peripheral vascular disease, LVEF, EuroScore,22 and Parsonnet Score23 were significantly associated with 2-year mortality (Table 2). In the multivariable analysis (Table 2), peripheral vascular disease, LVEF, and acute coronary syndrome were the only independent predictors of 2-year mortality. The adjusted rates of 2-year survival were 85% for CABG-treated patients and 87% for DES-treated patients (P = 0.74). To minimize any selection bias, a second multivariable analysis was performed using the propensity score of receiving a DES as a covariate. The c-statistic of the regression model of the propensity score was 0.85. After adjusting for the propensity score, DES-treated patients showed a non-significant trend towards a better survival rate than CABG-treated patients (HR = 0.81, 95% confidence interval: 0.37–1.81; Figure 2).
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Surgical therapy is considered the standard of care for patients with ULMCA stenosis.1 This notion is based on some randomized and observational studies performed 3 decades ago that convincingly showed the superiority of CABG over medical therapy.2,3 Those studies, however, did not recruit elderly patients, and therefore few data are available for this segment of population to guide clinical practice. In fact, in the European study, all patients were men with stable angina, mean ± SD age was 49.9 ± 7, and mean ± SD LVEF was 64.6 ± 10%.3 In the Collaborative Study in Coronary Artery Surgery, the risk spectrum of patients enrolled was broader than that of the European study, but still most patients were not at high risk: mean ± SD age was 56.8 ± 8 and mean ± SD LVEF was 60.0 ± 14.5%.2 In a more contemporary study performed at the Cleveland Clinic, Ellis et al.24 reported the clinical outcome of 1585 patients with ULMCA stenosis consecutively treated with CABG: mean age was 65 years, the operative mortality was 2.3%, 1-year mortality was 11.3%, and 3-year mortality was 15.6%. This study recruited a more complex population presenting with several comorbidities: 20.9% had chronic obstructive pulmonary disease, 29% had peripheral vascular disease, and 7.7% had renal insufficiency. On the whole,
18% of the patients were considered at high risk based on a score model developed on a training cohort of the study which was used to predict in-hospital and 3-year mortality; they had a 40% risk of death within 3 years. In the model constructed to predict mortality, age was the strongest factor associated with the risk of 3-year mortality. Elderly patients present a distinct profile with more frequent comorbidities and a limited life expectancy and therefore extrapolations of modern evidence-based medicine tested in younger patients may be not adequate. Moreover, elderly patients represent one of the most rapidly expanding segments of the population in Western countries, and in the last few years, an increasing number has been referred to both surgical therapy and percutaneous revascularization.17,18,25,26 Therefore, selecting the optimal strategy of revascularization in this complex context represents an issue of public health concern.
PCI might be particularly suitable for elderly patients who often present with chronic pulmonary disease, chronic renal insufficiency, peripheral vascular disease, and other comorbidities, which all increase the operative risk and reduce life expectancy. Moreover, preliminary studies have shown that the use of DES for the treatment of ULMCA stenosis is associated with very favourable mid-term outcome, which is highly competitive with that of surgery, especially for ostial lesions.9,10,12,13 In addition, three recently published observational studies comparing CABG vs. DES for the treatment of ULMCA stenosis have shown similar rates of mortality at mid-term follow-up.19–21 As the clinical impact of surgical therapy in elderly patients with ULMCA stenosis and the relative efficacy of CABG vs. DES in such a complex context has never been the subject of a specific study, we compared the results of surgical therapy vs. percutaneous revascularization performed exclusively with DES in patients aged 75 years and ULMCA stenosis referred for coronary revascularization. Not surprisingly, patients referred to PCI were older, were more subject to acute coronary syndrome, and had higher surgical scores than those of CABG-treated patients, reflecting the common tendency of referring higher risk patients to percutaneous revascularization. However, both unadjusted and adjusted 2-year mortality rates were similar between the two groups. Moreover, after adjusting for the propensity score, DES-treated patients had a non-significant statistical trend towards better survival (HR = 0.81, 95% confidence interval = 0.37–1.81; Figure 2). Similarly, the incidence of 2-year myocardial infarction was 6% for CABG-treated patients and 4% for DES-treated patients. In contrast, DES-treated patients presented a significant increase in the rate of TLR when compared with those treated with CABG. Although this last finding is not surprising because it is in agreement with previous studies,21,27 the magnitude of the difference observed might be due to the different strategies of follow-up chosen for the two populations. In fact, although CABG-treated patients underwent coronary angiography only if clinically indicated, the large majority of DES-treated patients underwent routine coronary angiography within 6 months from the index procedure as part of the follow-up strategy after the procedure. Moreover, most patients had bifurcation stenosis, which still represents a challenge also for DES.28 In a recent study, in fact, in which DESs were used for the treatment of bifurcation stenosis, the rate of restenosis at 6 months was 25.7%.29
In conclusion, in this study, we could not demonstrate a difference in mortality between CABG-treated patients and those treated with DES. However, giving the recent findings on the increased risk of late stent thrombosis associated with DESs, our data should be interpreted with caution and further studies are required to confirm our results.
Limitation
This is not a randomized trial and, therefore, the comparative analysis of CABG vs. PCI performed with DES may be limited by unmeasurable selection bias inherent to physician judgement and preference in selecting the strategy of revascularization. Therefore, judicious patient selection and careful triage to either treatment may have contributed to the results observed. Other studies have, in fact, found a better than expected outcome for patients appropriately selected by physician judgement for one treatment rather than another.30
No patient was treated with bilateral mammary artery and few patients with off-pump surgery. Therefore, we cannot exclude that with these strategies of surgical revascularization, we would have observed a better clinical outcome in the cohort of surgical treated patients.
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This research was supported by Fondazione Fanti Melloni, Bologna, Italy.
Conflict of interest: none declared.
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P. S. Teirstein Percutaneous Revascularization Is the Preferred Strategy for Patients With Significant Left Main Coronary Stenosis Circulation, February 24, 2009; 119(7): 1021 - 1033. [Full Text] [PDF]
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