Published online before print November 24, 2008, doi: 10.1161/CIRCULATIONAHA.107.727099
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(Circulation. 2008;118:2374-2381.)
© 2008 American Heart Association, Inc.
Interventional Cardiology |
Nonrandomized Comparison of Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention for the Treatment of Unprotected Left Main Coronary Artery Disease in Octogenarians
From the Departments of Cardiology and Cardiac Surgery, Quebec Heart Institute, Laval Hospital, Quebec, Canada.
Reprint requests to Josep Rodés-Cabau, MD, FESC, Quebec Heart Institute, Laval Hospital, 2725 Chemin Ste-Foy, G1V 4G5 Quebec, Canada. E-mail josep.rodes{at}crhl.ulaval.ca
Received July 19, 2007; accepted September 9, 2008.
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Abstract |
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Background— The objective of the present study was to compare the midterm follow-up results of percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG) for the treatment of unprotected left main coronary artery disease in octogenarians.
Methods and Results— A total of 249 consecutive patients 
80 years of age diagnosed with left main coronary artery disease underwent coronary revascularization in our center between January 2002 and January 2008; 145 patients underwent CABG, and 104 patients had PCI. Major adverse cardiac and cerebrovascular events (MACCE [cardiac death, myocardial infarction, cerebrovascular event, revascularization]) were evaluated at a mean follow-up of 23±16 months. Patients who underwent PCI were older; had higher creatinine levels, lower ejection fraction, and higher EuroSCORE; and presented more frequently with an acute coronary syndrome. Drug-eluting stents were used in 48% of PCI patients. A propensity score analysis was performed to adjust for baseline differences between the 2 groups. Survival free of cardiac death or myocardial infarction (PCI, 65.4%; CABG, 69.7%) and MACCE-free survival (PCI, 56.7%; CABG, 64.8%) at follow-up were similar between the groups (adjusted hazard ratio for survival free of cardiac death or myocardial infarction, 1.28; 95% CI, 0.64 to 2.56; P=0.47; adjusted hazard ratio for MACCE-free survival, 1.11; 95% CI, 0.59 to 2.0; P=0.73). The EuroSCORE value was an independent predictor of MACCE regardless of the type of revascularization (hazard ratio, 1.17 for each EuroSCORE increase of 1 point; 95% CI, 1.09 to 1.25; P<0.0001).
Conclusions— In this single-center, nonrandomized study, there were no significant differences in cardiac death or myocardial infarction and MACCE between CABG and PCI for the treatment of left main coronary artery disease in octogenarians after a mean follow-up of 2 years. Baseline EuroSCORE was the most important predictor of MACCE regardless of the type of revascularization. Randomized studies comparing both revascularization strategies in this high-risk coronary population are warranted.
Key Words: aged, 80 and older • angioplasty • bypass • coronary artery bypass • coronary artery disease • stents
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Introduction |
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An increasing number of octogenarian patients are undergoing coronary artery bypass graft surgery (CABG).1 Despite recent improvements in postoperative outcomes resulting from advances in technology, pharmacotherapy, and perioperative management, octogenarians remain at higher risk of morbidity and mortality after CABG compared with younger patients.2,3 Furthermore, the prevalence of left main coronary artery (LMCA) disease is higher in this subset of patients.4,5
Editorial p 2326
Clinical Perspective p 2381
Percutaneous coronary intervention (PCI) has emerged as an alternative to CABG for the treatment of unprotected LMCA in the stent era.6 Recently, some studies have suggested similar results or even a reduction in cardiac events with PCI compared with CABG for the treatment of unprotected LMCA, mainly because of a lower rate of cardiac death and myocardial infarction (MI) during the peri-intervention period.7–9 However, no studies to date have evaluated the results of PCI for the treatment of LMCA disease specifically in octogenarians, although this high-risk population could benefit the most from a potential reduction in early morbidity and mortality. In many centers, in fact, a growing number of octogenarian patients estimated to be at high surgical risk are currently being proposed for PCI treatment in the belief that the latter is a lower-risk alternative to CABG.10 However, no studies have compared the 2 revascularization strategies for the treatment of unprotected LMCA in this high-risk population. This has led to a case-by-case clinical decision scenario without well-established criteria for identifying patients, if any, more likely to benefit from PCI treatment than from CABG. The objectives of this study were to compare the midterm results of PCI and CABG for the treatment of LMCA disease in octogenarians and to determine the risk factors associated with midterm cardiovascular events in these 2 revascularization strategies.
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Methods |
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The study included all patients
80 years of age who had undergone revascularization (either CABG or PCI) for the treatment of unprotected LMCA in our center from January 2002 to January 2008. Patients within the first 24 hours of an ST-elevation MI and those undergoing concomitant valve surgery were excluded. The decision to perform PCI instead of surgery depended on the physician responsible for the patient, the cardiac surgery team, and the patient’s preference. Clinical baseline and perioperative data were entered prospectively into a database registry for patients undergoing CABG and were obtained retrospectively by a review of the medical records for patients undergoing PCI. PCI procedures were performed by the radial or femoral approach, and the LMCA PCI technical strategy, including whether to use glycoprotein IIb/IIIa inhibitors, intraaortic balloon pump, and drug-eluting stent implantation, was at the discretion of the interventional cardiologist performing the procedure. Intravascular ultrasound was not used to guide the procedure. PCI was considered angiographically successful if residual stenosis <30% with coronary Thrombolysis in Myocardial Infarction grade 3 flow was obtained at the end of the procedure. Serial cardiac enzyme determination was performed systematically after intervention. All patients received aspirin (80 mg/d) indefinitely and clopidogrel (75 mg/d) for at least 1 month (bare metal stents) or 6 months (drug-eluting stents). CABG procedures were performed using standard on-pump or off-pump bypass techniques, including a left internal mammary artery for revascularization of the left anterior descending artery whenever possible, and serial cardiac enzymes were measured in all cases after intervention. Patients were followed up by clinical visits and/or phone contact. Patients did not undergo systematic control coronary angiography at follow-up. If an event occurred during the follow-up period, the medical file at the center taking care of the patient was consulted, and the patient’s primary care physician and/or the cardiologist were consulted if any further information was needed. The study protocol was performed in accordance with the institutional ethics committee, and all patients gave informed consent for the procedures.
All cardiac and noncardiac complications occurring within 30 days after the intervention were evaluated. Major cardiac and cerebrovascular events (MACCE), analyzed 30 days after the intervention and at the last follow-up, included cardiac death, MI, repeat revascularization or urgent cardiac reintervention, and cerebrovascular event (stroke or transient ischemic attack). Any death was considered cardiac unless proven otherwise. Periprocedural MI (within the 7 days after intervention) was defined as an elevation of serum creatine kinase-MB isoenzyme that was 5 times the upper limit of normal after CABG and 3 times the upper limit of normal after PCI. In case of elevated creatine kinase-MB levels at baseline, MI was defined as an increase >50% over baseline values after intervention in both groups. MI after the periprocedural period was defined as any typical rise above the upper range limit and fall of biochemical markers of myocardial necrosis (either creatine kinase-MB or troponin) with at least one of the following: cardiac symptoms, development of Q waves on the ECG, or ECG changes indicative of ischemia. In PCI patients, stent thrombosis occurrence was classified as definite, probable, or possible according to the Academic Research Consortium criteria.11
Statistical Analysis
Qualitative data are presented as percentages; quantitative data are given as mean±SD or median (25% to 75% interquartile range [IQR]). Comparisons between groups were restricted to those variables in which there was 80% power to detect a hazard ratio (HR) of 2.0 with the number of patients included in the study. Differences between PCI and CABG regarding cardiac death or MI and MACCE were evaluated at follow-up. A continuous propensity score analysis was performed to adjust for the intergroup clinical differences caused by the selection bias inherent to the nonrandomized nature of the study. A propensity score representing the likelihood of having PCI was calculated for each patient by use of a logistic regression analysis that identified variables independently associated with PCI. Variables included in the logistic regression analysis were age, sex, body mass index, current smoking, hypertension, hypercholesterolemia, diabetes, prior MI, prior PCI, prior stroke, peripheral arterial disease, creatinine level, creatinine level 200 µmol/L, left ventricular ejection fraction, clinical indication for coronary revascularization (stable angina pectoris versus acute coronary syndrome), urgent procedure, vessels with 70% diameter stenosis, EuroSCORE, and EuroSCORE 6. The variables used to build the propensity score analysis were age, creatinine level, left ventricular ejection fraction, clinical indication for coronary revascularization, and EuroSCORE. Patients were grouped into quartiles based on propensity scores to create 4 cohorts of similar risk factor profiles. Cardiac death or MI and MACCE at follow-up were analyzed with a Cox regression analysis adjusted for propensity score and were compared among the quartiles of the propensity score. Non-MACCE 30-day complications were analyzed with a logistic regression analysis adjusted for propensity score. Comparisons regarding the 30-day number of complications per patient and hospitalization length were analyzed with Student’s t test and the Wilcoxon rank-sum test, respectively. A multivariate Cox regression analysis was used to determine the variables predictive of cumulative MACCE at follow-up for the entire study population and for the CABG and PCI groups, including all variables with values of P<0.2 in univariate Cox analysis. The variables included in this analysis were left ventricular ejection fraction, creatinine level, female sex, diabetes, history of MI, history of cerebrovascular accident, urgent procedure, distal LMCA lesion location, and EuroSCORE. The area under the receiver-operating characteristics curve was used to assess the discriminating power of the independent predictors. MACCE-free survival curves were constructed with the use of Cox regression analysis adjusted for propensity score. Differences were considered statistically significant at values of P<0.05.
The authors had full access to and take full responsibility for the integrity of the data. All authors have read and agree to the manuscript as written.
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Results |
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A total of 249 consecutive patients were included in the study; 145 patients (58%) had CABG, and 104 patients (42%) underwent PCI. The reasons for performing PCI rather than surgery were distributed as follows. Twenty-eight patients (27%) were considered nonsurgical candidates because of advanced age in association with at least one of the following: renal failure (8 patients), very low left ventricular ejection fraction (11 patients), chronic pulmonary obstructive disease (5 patients), recent stroke (2 patients), active cancer (1 patient), and frailty (12 patients); 14 patients (13%) refused surgery; and 62 patients (60%) were evaluated as high-surgical-risk candidates (median EuroSCORE, 10; IQR, 8 to 12) by the physician responsible for the patient and the surgical team, and a decision to perform PCI was finally taken by consensus. Baseline clinical characteristics of the study population grouped according to the type of revascularization (CABG versus PCI) are shown in Table 1. Patients who underwent PCI were older; had higher creatinine levels, lower ejection fraction, and higher EuroSCORE; and presented more frequently with an acute coronary syndrome. Fifty-five of the 93 PCI patients (59%) with an acute coronary syndrome had an MI, and the median time between MI and LMCA PCI was 3 days (range, 4 hours to 18 days), with 42% of these patients undergoing PCI within the first 24 hours of a non-ST segment elevation MI. The main procedural characteristics of the CABG and PCI procedures are shown in Table 2.
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All complications occurring within 30 days after the intervention are shown in Table 3. Seven patients in the PCI group (6.7%) and 12 patients in the CABG group (8.3%) died within 30 days after the intervention (Table 4). A total of 25 patients who underwent CABG (17.2%) and 13 patients who underwent PCI (12.5%) had an MI within 30 days. There was 1 case of definite subacute stent thrombosis 8 days after PCI at the level of a bare metal stent implanted in the mid segment of the right coronary artery. MACCE rate at 30 days was 18.3% in the PCI group and 27.6% in the CABG group. CABG patients had complications more frequently, including new-onset atrial fibrillation (adjusted odds ratio [OR], 9.7; 95% CI, 3.2 to 28.7; P<0.0001), acute renal failure (adjusted OR, 8.6; 95% CI, 2.1 to 35.7; P=0.002), and any bleeding requiring blood transfusion (adjusted OR, 17.5; 95% CI, 7.9 to 40; P<0.0001). Overall, CABG was associated with a higher number of complications per patient (2.1±1.7 versus 0.8±1.3; P<0.0001) and a longer hospital stay (8 days [IQR, 6 to 12 days] versus 5 days [IQR, 3 to 8 days]; P<0.0001).
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MACCE occurrences after the first 30 days and during a mean follow-up of 23±16 months are shown in Table 5. Cardiac death occurred in 10 patients (10.3%) who had undergone PCI and in 6 patients (4.5%) who had undergone CABG (Table 6). The PCI patients who had a cardiac death during the follow-up presented a significantly higher EuroSCORE (11±2.1 versus 8.5±2.5; P=0.01) and lower left ventricular ejection fraction (40±11% versus 53±17%; P=0.02) compared with those patients who survived the follow-up period. MI occurred during the follow-up period in 11 patients (11.3%) who underwent PCI and in 3 patients (2.3%) who had CABG. There were 3 cases of possible stent thrombosis in patients who had LMCA bare metal stent implantation and died suddenly at the 3-, 15-, and 31-month follow-up. Ten patients (10.3%) in the PCI group underwent revascularization (7 because of LMCA restenosis and 3 as a result of the progression of coronary disease). The MACCE rate during the follow-up period was 30.9% in the PCI group and 9% in the CABG group. At 23±16 months of follow-up, the cumulative cardiac death or MI rate was 34.6% in the PCI group and 30.3% in the CABG group (unadjusted HR, 1.15; 95% CI, 0.74 to 1.78; P=0.55; adjusted HR, 0.78; 95% CI, 0.39 to 1.55; P=0.47; Figure 1). MACCE-free survival rates at follow-up were similar between groups (PCI, 56.7%; CABG, 64.8%; unadjusted HR, 0.83; 95% CI, 0.55 to 1.25; P=0.33; adjusted HR, 1.11; 95% CI, 0.59 to 2.0; P=0.73; Figure 1). Cardiac death or MI and MACCE-free survival curves at 24 months of follow-up are shown in Figure 2. During the follow-up period, 17 patients (8 patients in the CABG group, 9 patients in the PCI group) died of noncardiac causes (Table 6).
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Cox logistic regression analysis identified the EuroSCORE value as the only independent predictor of cumulative MACCE at follow-up for the entire study population (HR, 1.17 for each EuroSCORE increase of 1 point; 95% CI, 1.09 to 1.25; P<0.0001), the PCI group (HR, 1.29 for each EuroSCORE increase of 1 point; 95% CI, 1.16 to 1.43; P<0.001), and the CABG group (HR 1.12 for each EuroSCORE increase of 1 point; 95% CI, 1.02 to 1.23; P=0.023). A EuroSCORE 9 was identified as the cutoff point with the best sensitivity and specificity for the prediction of MACCE, with an area under the receiver-operating characteristics curve of 0.65 (95% CI, 0.51 to 0.77; P<0.001) for the entire study population, 0.67 (95% CI, 0.54 to 0.81; P=0.01) for the PCI group, and 0.65 (95% CI, 0.52 to 0.74; P=0.01) for the CABG group. The sensitivity and specificity of a EuroSCORE 9 for the prediction of MACCE were 68% and 65%, respectively, for the entire study population, 71% and 62% for the PCI group, and 61% and 69% for the CABG group.
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Discussion |
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This is the first study evaluating the results of revascularization with either CABG or PCI for the treatment of LMCA disease in octogenarians. The main finding of this study is that, in the current era, PCI and CABG were associated with comparable outcomes for the treatment of unprotected LMCA disease in this high-risk population after a mean follow-up of 2 years. Furthermore, baseline EuroSCORE was identified as the independent predictor of MACCE regardless of the type of revascularization.
Consistent with our results, previous studies carried out in younger and lower-risk patients comparing CABG and PCI for the treatment of unprotected LMCA7–9 showed equivalent results of the 2 revascularization strategies for the composite end point of MACCE at midterm (6 months to 1 year) follow-up. However, the 30-day death rates associated with PCI (6.7%) and CABG (8.3%) in the present study were higher than those previously reported, likely reflecting the higher-risk profile of our study population. It is well known that elderly patients have a higher prevalence of cardiac and noncardiac comorbidities, and higher mortality rates associated with coronary revascularization, either PCI or surgery, have been shown in these patients compared with younger patients.2,3,12–14 Importantly, nearly all PCI patients included in our study were evaluated as poor candidates or noncandidates for surgery, and all had a EuroSCORE value 6. In-hospital mortality rates up to 6% to 13% have been reported for LMCA PCI in similar high-risk patients.6,15 Interestingly, mortality rates associated with both PCI and CABG were much lower than the >10% predicted mortality rate on the basis of the mean EuroSCORE values of the study population, probably because of the significant advances in the procedural management of high-risk coronary patients undergoing revascularization in the current era. Previous studies of PCI in octogenarians have demonstrated a higher in-hospital complication rate in these patients, including an incidence of periprocedural MI of up to 20% in the setting of acute coronary syndromes.12–14,16 In addition, both the higher coronary atherosclerotic burden, leading to PCI of lesions other than LMCA in more than half of patients, and the complexity of LMCA lesions (frequently heavily calcified bifurcation lesions) in these patients might have increased the periprocedural MI rate. On the other hand, the paucity of data on the safety of glycoprotein IIb/IIIa inhibitor use in very old patients and the higher contraindication rate for these agents in this population17 could have accounted for their use in fewer than one third of our PCI patients despite the fact that most of them were diagnosed with an acute coronary syndrome. This also might have contributed to the high rate of MI after PCI in the present study. In any case, PCI was associated with a lower rate of in-hospital complications, and the length of hospital stay was significantly shorter after PCI compared with CABG. Previous reports have already shown the higher costs associated with CABG in octogenarians compared with younger patients,2,3 and future studies should determine whether both the lower complication burden and hospital stay associated with PCI translate into a more cost-effective revascularization strategy compared with CABG in these patients.
Previous studies comparing PCI and CABG for the treatment of multivessel coronary disease have shown a higher cardiac event rate associated with PCI during the follow-up period, mostly because of a higher revascularization rate.18,19 Similar differences in cardiac events at midterm follow-up favoring the surgical strategy also have been observed in the studies comparing PCI and CABG for the treatment of LMCA despite the use of drug-eluting stents.7–9 Interestingly, the PCI group had a revascularization rate of 9.6% and a target lesion revascularization rate as low as 6.7%. The use of drug-eluting stents in half of the patients and, more important, the absence of systematic follow-up coronary angiography (all coronary angiographies and revascularizations were clinically driven) might explain the low revascularization rate in our PCI study population, especially in view of the fact that LMCA angiographic restenosis occurs mostly at the ostium of the left circumflex artery and is asymptomatic in most cases.20 The need for systematic coronary angiography at follow-up for patients undergoing PCI of LMCA on the basis of the potential risk of sudden death associated with LMCA restenosis21 has recently been established as a class IIA recommendation by the American College of Cardiology/American Heart Association guidelines for PCI,22 even though no prospective studies have yet demonstrated the benefits of such a strategy. Sudden death occurred in 3 patients at 3, 15, and 31 months after PCI in the present study; all of these patients had received bare metal stents in the LMCA. We cannot exclude the possibility of stent restenosis or late stent thrombosis as the cause of sudden death in these 3 cases. In addition, the potential risks of double antiplatelet therapy for the prevention of late stent thrombosis should be taken into account and might be an important limitation for the use of drug-eluting stents in this very old population. PCI patients had a high cardiac death rate during the follow-up period (10.3%, ie, >2-fold higher than the CABG group), which likely was due to the advanced age (mean, 85 years) and very high-risk characteristics of the PCI population, with those patients who died at follow-up exhibiting a higher EuroSCORE (median, 11) and a lower left ventricular ejection fraction (mean, 40%) compared with those who survived. The MI rate also was high in the PCI group during the follow-up period (11.3%), probably related to the diffuse and complex coronary disease of these patients combined with a high rate (43%) of incomplete revascularization in this group. On the other hand, CABG was associated with favorable outcomes after the perioperative period; this finding was consistent with the results of previous studies showing that octogenarians who survived to CABG have a midterm and long-term survival similar to that of the general population of octogenarians.23,24
The present study found the EuroSCORE to be the most powerful predictor of MACCE at midterm follow-up after LMCA revascularization in octogenarian patients regardless of revascularization modality. This suggests that, in this very old and high-risk population, an estimation of the global patient risk with the EuroSCORE might be superior for the prediction of cardiovascular events to procedural and anatomic factors that have previously been recognized as prognostic factors in the setting of LMCA revascularization.1,25 Kim et al26 have already shown that the EuroSCORE value was the most important independent predictor of death and nonfatal MI after LMCA PCI. We identified a EuroSCORE cutoff point of 9 as the best predictor of MACCE for both the PCI and CABG groups. Therefore, octogenarians with a very high surgical risk also have a very high risk of major adverse cardiovascular events associated with PCI; this should be considered when PCI is offered as an alternative to CABG for the treatment of LMCA in these patients. The fact that independent prognostic factors seemed to be similar for both revascularization strategies precluded the possibility of identifying specific factors that might help us to decide what revascularization therapy would be the most appropriate for a specific octogenarian patient with LMCA disease.
Study Limitations
The main limitation of this study was its nonrandomized and retrospective nature. This might have introduced a significant bias in patient selection, with a PCI population with a higher-risk profile, even though it was partially compensated for by the propensity score analysis. Importantly, the decision of whether to perform PCI was individualized and taken by consensus of the referral physician, interventional cardiologist, and cardiac surgeon in all cases. Thus, our study reflects the contemporary "real-world" scenario currently found in many centers regarding the revascularization treatment of very old patients with LMCA disease. Although this study represents the largest series with the longest follow-up evaluating different strategies of LMCA disease revascularization for octogenarian patients, an important limitation remains the limited number of patients. Comparisons between groups were restricted to those outcomes with 80% power to detect an HR of 2.0 with the number of patients included in this study, which was the reason that comparisons were limited at cumulative events (cardiac death or MI and MACCE) at follow-up and not performed for 30-day outcomes. Finally, the relatively limited duration of the follow-up (2 years) might have led to bias against the surgical revascularization strategy. Randomized studies with a larger number of patients and longer follow-up are needed to confirm whether LMCA PCI is equivalent to CABG for the treatment of this high-risk coronary population. Pending such a trial, the present study provides important information on the clinical management of LMCA disease in octogenarian patients and suggests that PCI is a reasonable strategy for the treatment of this highly challenging subset of patients.
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Acknowledgments |
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We would like to thank Serge Simard, MSc, and M’Hamed Lajmi, PhD, for statistical analysis; Brigitte Dionne, RN, and Stéphanie Dionne, RA, for database completion; and Dr Philippe Pibarot, from the Quebec Heart Institute-Laval Hospital, and Dr Marc Ruel, from the Ottawa Heart Institute, for their useful review of this manuscript.
Disclosures
None.
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CLINICAL PERSPECTIVE
Percutaneous coronary intervention (PCI) has emerged as an alternative to coronary bypass graft surgery (CABG) for the treatment of unprotected left main coronary artery (LMCA) disease in the stent era. However, no studies to date have evaluated the results of PCI for the treatment of LMCA in octogenarians despite the fact that a growing number of octogenarian patients with LMCA disease estimated to be at high or prohibitive surgical risk are being proposed for PCI in the belief that it is a lower-risk alternative to CABG. This study included 249 consecutive patients 80 years of age with LMCA disease who underwent coronary revascularization (PCI, 104 patients; CABG, 145 patients) in our center. Major adverse cardiac and cerebrovascular events were evaluated at 23±16 months of follow-up. Patients who underwent PCI were older (85 versus 82 years of age) and exhibited higher-risk baseline characteristics (mean EuroSCORE, 9.5) than CABG patients. A propensity score analysis was performed to adjust for baseline differences between groups. CABG was associated with a higher rate of perioperative complications (atrial fibrillation, major bleeding, acute renal failure) and longer hospital stay. At follow-up, there was no statistical difference in the occurrence of cardiac death or myocardial infarction (CABG, 30.3%; PCI, 34.6%) and major adverse cardiac and cerebrovascular events (CABG, 35.2%; PCI, 43.3%) between CABG and PCI patients. In this single-center, nonrandomized study, there were no significant differences in cardiac death or myocardial infarction and major adverse cardiac and cerebrovascular events between CABG and PCI for the treatment of LMCA in octogenarians after a mean follow-up of 2 years. This study provides relevant information on the clinical management of LMCA disease in octogenarian patients and suggests that PCI is a reasonable strategy for the treatment of this highly challenging subset of patients. Randomized studies comparing both revascularization strategies in this high-risk coronary population are warranted.
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