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Ann Thorac Surg 1999;68:14-20
© 1999 The Society of Thoracic Surgeons

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Original Articles

Coronary bypass and carotid endarterectomy: does a combined approach increase risk? A metaanalysis

^a Division of Cardiovascular Surgery, The Toronto Hospital, Toronto, Ontario, Canada
^b Division of Cardiovascular Surgery, University of Toronto, Toronto, Ontario, Canada
^c Division of Vascular Surgery, The Toronto Hospital, Toronto, Ontario, Canada
^d Institute for Clinical Evaluative Sciences, Sunnybrook and Women’s College Health Sciences Center, University of Toronto, Toronto, Ontario, Canada

Address reprint requests to Dr Fremes, Sunnybrook Health Science Centre, Rm H405, 2075 Bayview Ave, Toronto, Ontario, Canada M4N 3M5

Presented at the Thirty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 25–27, 1999.

	Abstract

Top Abstract Introduction Material and methods Results Comment Appendix References

 
Background. Patients with concomitant carotid and coronary artery disease present a surgical dilemma. We compared the stroke and mortality rates for combined coronary artery bypass grafting and carotid endarterectomy in which both procedures were performed under a single anesthetic, versus a staged approach, in which coronary artery bypass grafting and carotid endarterectomy were performed separately.

Methods. A computerized MEDLINE search supplemented with a manual bibliographic review was performed for all peer-reviewed English language publications that contained both combined and staged coronary artery bypass grafting/carotid endarterectomy patient cohorts. Outcomes of interest were stroke, death, and stroke or death; aggregation of outcome rates was performed with the Mantel-Haenszel method.

Results. Sixteen studies were identified with a total of 844 combined patients and 920 staged patients. None of the studies was completely randomized. The combined surgical group had a higher prevalence of unstable angina; the two groups had a similar prevalence of symptomatic carotid disease and severe carotid stenosis. Metaanalysis revealed a significantly increased risk of the composite end point, stroke or death, for patients undergoing combined procedures (relative risk 1.49; 95% confidence interval 1.03–2.15; p = 0.034). There was also a trend toward increased risk during combined procedures for the end points of stroke (relative risk 1.50; 95% confidence interval 0.97–2.32; p = 0.068) and death (relative risk 1.55; 95% confidence interval 0.94–2.53; p = 0.084) considered separately. The crude event rates for stroke were 6.0% versus 3.2% for combined versus staged procedure, 4.7% versus 2.9% for death, and 9.5% versus 5.7% for stroke or death. Two of the 16 individual studies showed a statistically significant increase in the risk of stroke or death for combined procedure (p < 0.05).

Conclusions. Combined coronary artery bypass grafting and carotid endarterectomy may be associated with a higher risk of stroke or death than staged procedures. A randomized trial needs to be performed to determine the optimal management of patients with concomitant carotid and coronary artery disease.

	Introduction

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The current indications for surgical revascularization of isolated carotid or coronary artery disease are well described. Recent randomized clinical trials demonstrate that carotid endarterectomy (CEA) decreases stroke risk in patients with symptomatic [1, 2] and, to a lesser extent, asymptomatic [3] severe carotid stenosis. The indications for coronary artery bypass grafting (CABG) are well defined in the cardiac surgery literature [4]. However, the optimal management of patients with concomitant coronary and carotid vascular disease is not known. The importance of this clinical problem is accentuated by the finding that patients frequently present with atherosclerosis of both arterial systems: 8% to 14% of CABG patients have significant carotid stenosis [5, 6] and 40% to 50% of CEA patients have coronary artery disease [7, 8].

The treatment options for a patient presenting with concomitant surgical carotid and coronary artery disease include combined CABG/CEA (both procedures performed under a single anesthetic) and staged CABG/CEA (CEA performed before CABG as a separate procedure, or vice versa). Several proponents exist for both types of surgical approaches with published case series proclaiming the safety of each technique. The relative risk associated with either approach is not known, however, because the majority of case series focus on only one treatment modality and because the number of patients in each study is relatively small. The purpose of this study, therefore, is to determine the relative risk of stroke and mortality for combined versus staged CABG/CEA using a systematic review of the literature.

	Material and methods

Top Abstract Introduction Material and methods Results Comment Appendix References

 
A comprehensive literature review was undertaken using a MEDLINE search of "coronary bypass surgery" and "carotid endarterectomy" from 1980 to August 1998, supplemented with manual bibliography reviews. All peer-reviewed studies published in the English language that dealt with concomitant carotid and coronary artery procedures were identified and reviewed. Studies containing data that was duplicated in latter publications from the same institution [9–11] and studies that did not separate results for combined and staged CABG/CEA patient cohorts [12–14] were excluded.

Sixty-seven publications were identified that reported results from patients undergoing combined operations and 19 publications reported the results of staged procedures. The median date of publication was 1992 for combined studies and 1987 for staged studies. To minimize temporal bias, as well as interinstitutional variability, studies were included in the metaanalysis only if they contained both combined and staged patient cohorts.

Sixteen studies [15–30] were identified using this literature search technique (Table 1 ). All data were extracted from the studies and entered into a computer file. The prespecified study end points were (1) the composite end point of stroke or death, and (2) the incidence of stroke or death considered separately. Secondary study end points were (1) incidence of myocardial infarction, and (2) incidence of myocardial infarction, stroke, or death. It should be stressed that with one partial exception [24], none of the studies are randomized clinical trials; they are all retrospective observational studies of cohorts of consecutive patients with concomitant carotid and coronary artery disease. The study by Hertzer and colleagues [24] included randomization of a subset of patients to a combined or a staged approach (see below).

	Results

Top Abstract Introduction Material and methods Results Comment Appendix References

 
The 16 studies identified included a total of 844 patients in the combined group and 920 patients in the staged group. Operative techniques for patients undergoing combined operation were similar for all studies, with CEA being performed before CABG under the same anesthetic, except for Ennix and colleagues [19], where the sequence of operations was not stated (Appendix). Operative techniques for patients undergoing staged procedures varied between studies—the sequence of operations consisted of CEA before CABG in eight studies, CABG before CEA in one study, and a mixture of the two approaches in the remaining seven studies (Appendix). No attempt was made to stratify staged patients according to operative technique because of lack of detailed information on outcomes within these groups, and because of the small number of adverse events.

Table 1 summarizes selection criteria for combined and staged groups for each study. Selection criteria were not stated or ambiguously defined in 8 of the 16 studies. Seven studies stated that those patients with severe lesions of both carotid and coronary arterial systems or patients with unstable cardiac symptoms were treated with a combined approach, whereas patients with a severe lesion of only one system were treated with a staged approach. The study by Hertzer and associates [24] randomized 129 patients with asymptomatic carotid stenosis and high cardiac risk into a combined group (n = 71) and a staged group (CABG performed before CEA, n = 58). Also included in this study, however, were three nonrandomized groups: a group of patients with low cardiac risk who underwent staged operation (CEA before CABG, n = 24), and two groups of patients with high cardiac risk and symptomatic carotid disease who underwent either combined (n = 60) or staged operation (CABG before CEA, n = 23). The selection criteria for combined versus staged operation for these last two groups of patients were not defined.

Table 1 also displays the prevalence of known carotid and cardiac risk factors for combined and staged groups for each study. The majority of studies either did not contain risk factor information or reported risk factor prevalence for all patients, without distinguishing between combined and staged groups, thereby making statistical analysis of possible unbalance covariates difficult. In those studies in which detailed reporting was available, however, there was no significant difference in the prevalence of symptomatic carotid disease (47% for combined group versus 46% for staged group) or severe (more than 70%) carotid stenosis (97% for both groups). A significantly higher proportion of patients undergoing combined operation had unstable angina (37% versus 21%, p = 0.001).

Stroke
Table 2 displays the metaanalysis results for each of our primary outcomes. Metaanalysis revealed a trend toward increased risk of stroke during combined surgery (relative risk 1.50; 95% confidence interval 0.97–2.32; p = 0.068). Table 3 displays the crude event rates for all primary outcomes. The incidence of stroke was 6.0% for combined operations versus 3.2% for staged procedures. Figure 1 shows the study-specific relative risks for stroke for each of the 14 studies included in the metaanalysis (as mentioned above, two studies were dropped in the analysis of stroke rates because both treatment groups had zero strokes). Twelve of the 14 studies showed an increased incidence of stroke for combined operations (relative risk > 1.0), but none was statistically significant.

View larger version (21K): [in this window] [in a new window]   Fig 1. Relative risks (vertical lines) ± 95% confidence intervals (horizontal lines) for stroke in combined versus staged coronary artery bypass grafting/carotid endarterectomy. Values greater than 1.0 indicate increased risk for combined procedures. Note that the x-axis is logarithmic.

View larger version (20K): [in this window] [in a new window]   Fig 2. Relative risks (vertical lines) ± 95% confidence intervals (horizontal lines) for death in combined versus staged coronary artery bypass grafting/carotid endarterectomy. Values greater than 1.0 indicate increased risk for combined procedures. Note that the x-axis is logarithmic.

View larger version (22K): [in this window] [in a new window]   Fig 3. Relative risks (vertical lines) ± 95% confidence intervals (horizontal lines) for stroke or death in combined versus staged coronary artery bypass grafting/carotid endarterectomy. Values greater than 1.0 indicate increased risk for combined procedures. Note that the x-axis is logarithmic.

	Comment

Top Abstract Introduction Material and methods Results Comment Appendix References

We identified 16 studies with combined and staged patient cohorts, and in general found a higher risk of adverse outcomes for combined operation. Metaanalysis revealed a statistically significant increase in risk of stroke or death. Examination of each study separately revealed that the majority demonstrated increased risk for combined procedures, two were statistically significant. Crude event rates for each adverse outcome were also higher for combined operation. As expected, these event rates are higher than those associated with isolated CABG or isolated CEA [1, 31].

Before concluding that combined operation results in increased risk, however, it is important to consider that none of the studies analyzed were completely randomized trials. Therefore, selection bias may have resulted in unequal distribution of higher risk patients. Indeed, review of selection criteria for each study revealed that many studies used a combined approach in patients with severe lesions of both arterial systems, which may have resulted in greater atherosclerotic burden in the combined group.

If combined procedure does indeed result in a higher risk of stroke or death compared to staged operation, there are several possible reasons. One reason may be that combined procedures are more technically difficult, from both a surgical and an anesthetic point of view, than staged procedures resulting in more perioperative complications. Another reason may be that combined operations result in excessive "stress" on the cardiovascular and cerebrovascular systems, resulting in large fluctuations in patient hemodynamics during relatively long operative procedures. Finally, differences in coagulation management during combined procedures may increase the risk of thrombosis, particularly as antifibrinolytics are commonly used in CABG.

An important secondary end point of this study was myocardial infarction. We did not find a difference in risk of myocardial infarction for the two groups of patients. It has been traditionally thought that staged procedures (CEA before CABG) may result in a higher risk of myocardial infarction, particularly in the perioperative period of the carotid operation. Our finding of no increased risk of myocardial infarction for staged operation lends further support to the safety of this surgical approach.

It should be noted that the partially randomized study by Hertzer and colleagues [24] demonstrated a higher incidence of stroke during staged procedure in the 129 randomized patients (14% versus 3%). It may be argued that the high incidence of stroke was attributable to the sequence of operations in the staged group, with CABG being performed before CEA. Indeed, a previous review of the literature revealed a very high incidence of stroke in patients undergoing such "reverse-staged" procedures [32]. The optimal surgical approach for staged procedures may be, therefore, CEA before CABG.

To the best of our knowledge, only one previous metaanalysis has examined the issue of combined and staged CABG/CEA [32]. In contrast to our study, Brener and associates demonstrated an increased risk of myocardial infarction and death in patients undergoing staged procedures, with no difference in stroke rates. One large difference exists between the metaanalysis performed by them and our study, which may explain our discrepant findings. Brener and colleagues analyzed all studies that contained patients undergoing either combined or staged CABG/CEA, whereas we examined only those studies that contained both combined and staged patient cohorts from the same institution. A larger proportion of papers examining the results of combined operation has been published in more recent years when compared with staged surgical papers (median date of publication 1992 for combined studies versus 1987 for staged studies). This may result in a temporal bias because of the well documented decreases in morbidity and mortality for cardiac surgery over time [33–35]. We believe the inclusion of papers with both combined and staged patient cohorts will minimize temporal bias, as the time period of operations was the same for combined and staged patients for each individual study. In addition, the inclusion of combined and staged cohorts from the same institution would presumably result in the same surgeons performing each operative strategy, thereby minimizing operator and center-specific effects including differences in case selection and operator skill.

Limitations of study
The main limitation of our metaanalysis is that none of the studies that we analyzed, with the partial exception of one, were randomized clinical trials. Randomized clinical trials would have been obviously preferable to retrospective case series [36], because they allow relatively unbiased within-study estimations of effects that can be aggregated using standard metaanalytic techniques [37, 38].

To determine definitively whether staged operation results in better outcomes than combined procedure, a randomized clinical trial must be performed. Such a study would require a multiinstitutional, multinational effort to achieve the appropriate sample size. For example, using stroke or death as the primary outcome with an expected incidence of 7.5% (the overall incidence of stroke or death was 7.5% for both groups in this comprehensive review), a sample size of 1,500 patients per group would be required to detect a relative risk reduction of 33% with an level of 0.05 and a power of 80%. As patients with concomitant carotid and coronary artery disease represent a high-risk surgical group, the appropriateness of carotid angioplasty and stenting for this population should also be addressed [39]. In accordance with the Hippocratic dictum of primum non nocere, the onus is now on practicing cardiac surgeons to demonstrate conclusively that combined operation does not result in increased morbidity or mortality, particularly given the fact that a safer surgical alternative exists.

	Acknowledgments

 
This study was supported in part by the Heart and Stroke Foundation of Ontario. Michael A. Borger, MD, Vivek Rao, MD, PhD, and Gideon Cohen, MD are Research Fellows; Stephen E. Fremes, MD is a Research Scholar; and Richard D. Weisel, MD is a Career Investigator at the Heart And Stroke Foundation of Ontario. C. David Naylor, MD, DPhil is a Senior Scientist for the Medical Research Council of Canada.

	Appendix

Top Abstract Introduction Material and methods Results Comment Appendix References

 

	References

Top Abstract Introduction Material and methods Results Comment Appendix References

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