doi: 10.1161/CIRCULATIONAHA.104.526780
(Circulation. 2005;112:I-351 – I-357.)
© 2005 American Heart Association, Inc.
Surgery for Coronary Artery Disease |
The Impact of Preoperative Thrombolysis on Long-Term Survival After Coronary Artery Bypass Grafting
From the Department of Cardiac Surgery (I.K.T., C.E.A, J.J.D, D.G.S.), College of Physicians and Surgeons of Columbia University, St Luke’s–Roosevelt Hospital Center, New York, NY; the Department of Cardiac Surgery (I.K.T., C.E.A.), University of Athens School of Medicine, Attikon Hospital Center, Athens, Greece; and the Department of Cardiology (D.G.K.), Athens Euroclinic, Athens, Greece.
Correspondence to Dr Constantine E. Anagnostopoulos, St. Luke’s–Roosevelt Hospital Center at Columbia University, 45 E 89th St, New York, NY 10128. E-mail cea8{at}columbia.edu
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Abstract |
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Background— Coronary artery bypass grafting (CABG) is frequently used after thrombolytic therapy. However, there is little information regarding long-term survival in this setting. The purpose of the present study was to compare the long-term survival of patients subjected to CABG after thrombolysis to those without thrombolysis.
Methods and Results— We studied 3760 consecutive patients with isolated CABG between 1992 and 2002. CABG patients without thrombolysis were compared with those who were treated with thrombolysis within 7 days before CABG. Groups were compared by Cox proportional hazard models and Kaplan-Meier survival plots. The propensity for thrombolysis was determined by logistic regression analysis, and each patient with thrombolysis was then matched to 5 patients without thrombolysis. One hundred ninety-six patients (5.2%) were treated with thrombolysis. Patients with thrombolysis were more likely to be male, younger, and with higher rates of unstable angina, emergency operation, recent or transmural myocardial infarction, preoperative intraaortic balloon pump, hemodynamic instability, shock, intravenous nitroglycerine, left-ventricular hypertrophy, sustained ventricular arrhythmia, and higher EuroSCORE. There were no differences in early outcome between matched groups, but the 5-year actuarial survival was higher in patients with thrombolysis (90.3±2.2% versus 78.5±1.6%; P=0.0007). After adjustment for all factors, the hazard ratio of long-term mortality for patients with thrombolysis was 0.54 (95% CI, 0.36 to 0.81; P=0.003) and, if deaths during the first 12 months were excluded, 0.46 (95% CI, 0.27 to 0.76; P=0.003).
Conclusions— Patients subjected to CABG within 7 days after thrombolysis demonstrated increased long-term survival.
Key Words: thrombolysis • coronary artery bypass grafting • long-term mortality
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Introduction |
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Rapid restoration of coronary flow is the major goal of all available strategies for the treatment of myocardial infarction.1,2 Because of the relatively limited availability of primary percutaneous coronary intervention (PCI) at the time of acute myocardial infarction, even in countries with advanced medical systems, most patients with acute myocardial infarction are treated with thrombolysis.3,4 The usefulness of this therapy is limited by its failure to restore full patency of the infarct-related artery in up to 40% of cases.1,2 Furthermore, the incidence of bleeding complications, such as intracranial hemorrhage after thrombolysis, is estimated between 0.26% and 2.17%, depending on preexisting risk factors.5
Studies in the 1980s demonstrated that coronary artery bypass grafting (CABG) performed after acute myocardial infarction treated with thrombolysis was safe, and the risk for early mortality did not appear to be different than that of elective operation performed at a time remote from an acute myocardial infarction.6–8 However, there is limited published data on long-term survival rates in this subgroup of patients. The purpose of the present study was to compare the long-term survival of patients who were treated with thrombolysis within 7 days before CABG with CABG patients without prior thrombolysis.
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Methods |
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Patient Population and Data Collection
A total of 3760 consecutive patients, who underwent isolated CABG at St. Luke’s–Roosevelt Hospital Center, a University Hospital of Columbia University, from January 1992 to March 2002, were included in this analysis. Data were prospectively collected during admission as part of routine clinical practice and entered into the New York State adult cardiac surgery report for the variables shown in Table 1. Risk stratification was performed according to EuroSCORE.9 All of the patients who were treated with thrombolytic therapy, such as streptokinase, urokinase, or tissue plasminogen activator, for the purpose of treating an acute myocardial infarction within 7 days before surgery comprised the thrombolysis-CABG group. Indications for CABG were based on standard clinical and angiographic criteria. Complete revascularization was the policy of our institution, and reliance on echocardiography, particularly transesophageal echocardiography, in addition to anatomy, determined the number of anastomoses.
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Data Analysis
Long-term patient mortality data were obtained from the US Social Security Death Index database. The sensitivity of the National Death Index to identify deaths is between 92% and 99%, depending on which identifiers are available.10 Social Security number alone has the best accuracy of any combination of other identifiers (first initial, last name, day of birth, month of birth, year of birth, etc.), with a sensitivity of 97% and a specificity of 99%.10 In this study we used only Social Security numbers, which were available for most patients (99.1%), and this allowed us to avoid the use of patient names. In addition, patients without a Social Security number (n=34, none in the thrombolysis group) were censored at the time of discharge from the hospital. The index was queried in September 2002, and patients not found in the index were assumed to be alive at that date.
Ethical Issues
The need for informed consent was waived, because the data used in this study had already been collected for clinical purposes. Furthermore, the present study did not interfere with the treatment of patients, and the database was organized in a way that makes the identification of an individual patient impossible.
Statistical Methods
Numerical variables were presented as the mean±SD, whereas discrete variables were summarized by percentages. Discrete variables were compared using the Fisher’s exact test or the 
2 test, where appropriate. The length of stay before discharge, the Canadian Cardiovascular Society angina class, the EuroSCORE, and the total number of distal anastomoses were compared using the nonparametric Mann-Whitney U test. The Kaplan-Meier survival curves were compared with the log-rank test.11
The propensity for thrombolysis before CABG was determined using logistic regression analysis.12 All of the available preoperative, intraoperative, and postoperative variables were entered into the model. Variables were evaluated first using univariate and then multivariate analysis. The model selection was done with a backward stepwise method starting from all variables with P<0.05 in univariate analyses. This model was then used to calculate a propensity score. This propensity score represented the probability that a patient would receive thrombolysis before CABG. The C statistic (equivalent to the area under the receiver operating characteristic curve) and the Lemeshow-Hosmer goodness-of-fit statistic were calculated to assess the performance and the calibration of the model, respectively.12,13 A C statistic >0.70 indicates a reasonable ability to discriminate between patients who were treated with thrombolysis and those who were not. For the Lemeshow-Hosmer goodness-of-fit statistic, P>0.05 indicates acceptable calibration of the model. Each patient who was treated with thrombolysis was then matched to 5 patients without thrombolysis using propensity scores identical to within 1%. Matched groups were compared for early outcome, as well as for long-term survival with the Kaplan-Meier method.
Finally, the impact of preoperative thrombolysis on long-term mortality after CABG was analyzed by Cox regression analysis.14 Cox proportional hazard models were applied separately to: (a) all patients (n=3760); (ii) only those patients surviving 
6 months (n=3583); and (iii) only those patients surviving 1 year (n=3522). In either case, the model selection was done with a backward stepwise method starting from all of the variables with P<0.05 in univariate analyses. The model was then confirmed using forward stepwise selection. The thrombolysis parameter was forced to remain in each multivariate model, and hazard ratios (HRs) and 95% CIs were calculated. All of the analyses were performed in SPSS 11.0 (SPSS, Inc), and all of the P values are 2-tailed.
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Results |
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Patient and Disease Characteristics, Early and Late Outcome
The mean age within the study sample (n=3760) was 64.1±10.4 years, and 30.9% (n=1162) were women. During the 19,335 person-years of follow-up (mean follow-up, 5.2±3.2 years), 764 deaths (20.3%) were recorded. One hundred ninety-six patients were treated with thrombolysis within 7 days before CABG. The comparison of patients who were treated with thrombolysis with patients without thrombolysis is shown in Table 1. Thrombolysis-CABG patients were younger, less likely to be female, but with lower ejection fraction, higher EuroSCORE, and higher rates of unstable angina, myocardial infarction, emergency or urgent operations, hemodynamic instability, shock, current congestive heart failure, preoperative intraaortic balloon pump, IV use of nitroglycerine, left-ventricular hypertrophy, and malignant ventricular arrhythmia. There were no differences between the 2 groups in early mortality, length of stay, and major postoperative complications. Freedom from all-cause mortality in thrombolysis-CABG patients at 1, 5, and 10 years after surgery was 95.2±1.6%, 91.0±2.3%, and 79.0±4.1% respectively, compared with 93.2±0.4%, 82.4±0.7%, and 66.3±1.4%, respectively, for patients without thrombolysis (P=0.0046) (Figure 1).
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Multivariate Logistic Regression Analysis and Matched Groups
Multivariate logistic regression analysis determined that thrombolysis-CABG patients had more emergency [odds ratio (OR), 4.2; 95% CI, 2.0 to 9.0; P<0.001] or urgent operations (OR 3.8; 95% CI, 2.0 to 7.2; P<0.001), higher rates of unstable angina (OR, 3.2; 95% CI, 1.7 to 6.0; P<0.001), previous (the most recent) myocardial infarction (OR, 2.8; 95% CI, 1.8 to 4.3; P<0.001), transmyocardial infarction (OR, 1.7; 95% CI, 1.2 to 2.5; P=0.003), shock (OR, 4.5; 95% CI, 1.4 to 14.3; P=0.010), intravenous nitroglycerine (OR, 2.9; 95% CI, 2.1 to 4.2; P<0.001), and preoperative intraaortic balloon pump (OR, 1.9; 95% CI, 1.2 to 3.1; P=0.011), as well as higher EuroSCORE (OR, 0.7; 95% CI, 0.5 to 0.8; P=0.001). EuroSCORE was considered as a categorical variable: group 1, EuroSCORE 0 to 3; group 2, EuroSCORE 4 to 6; and group 3, EuroSCORE >6. The discriminatory ability of the logistic model as measured by C statistic was 0.83 (95% CI, 0.80 to 0.86), and the Lemesow-Hosmer goodness-of-fit test was not statistically significant (P=0.614), indicating excellent discriminative power and good calibration of the model, respectively.
Of the 196 patients who were treated with thrombolysis before CABG, 151 (77.0%) were matched with 755 CABG patients without thrombolysis. The matched groups (thrombolysis-CABG versus CABG without thrombolysis) had similar mean EuroSCOREs (6.12 versus 6.04; P=0.684), preoperative and intraoperative characteristics, and no differences in 30-day mortality (2.6% versus 3.6%; P=0.806), in length of stay (9.9 versus 12.4 days; P=0.190), and in major postoperative complications (Table 2). The Kaplan-Meier curves of the matched groups are shown in Figure 2. Freedom from all-cause mortality in thrombolysis-CABG patients at 1, 5, and 10 years after surgery was 95.9±1.6%, 90.3±2.7%, and 81.0±4.5% respectively, compared with 89.2±1.8%, 78.5±1.6%, and 61.2±2.8%, respectively, for patients without thrombolysis (P=0.0007).
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In an attempt to additionally investigate the superiority of the thrombolysis-CABG group, we compared thrombolysis-CABG patients (n=107) with CABG patients (n=397) who had acute myocardial infarction within 7 days before CABG. These 2 subgroups of patients had a similar preoperative risk according to EuroSCORE (6.1 versus 6.2, respectively; P=0.625), and 5-year and 10-year actuarial survival was not significantly increased in thrombolysis-CABG patients (89.0% versus 82.3% and 75.3% versus 60.2%; P=0.058), because of inadequate power of the number of patients in these subgroups. This observation reached statistical significance in the larger matched groups (Figure 2).
Cox Proportional Hazard Models
The crude HR of long-term mortality for CABG patients who were treated with thrombolysis was 0.57 (95% CI, 0.38 to 0.84; P=0.005). After adjustment for preoperative, intraoperative, and postoperative factors, the adjusted HR was 0.54 (95% CI, 0.36 to 0.81; P=0.003). The adjusted HR of long-term mortality for CABG patients who were treated with thrombolysis and survived the first 6 months postoperatively was 0.46 (95% CI, 0.28 to 0.76; P=0.002), and for patients who survived the first year postoperatively, it was 0.46 (95% CI, 0.27 to 0.76; P=0.003).
In our database, there were 22 patients with emergency transfer to operating room after PCI and 77 patients who underwent CABG while they had had a PCI during the same admission. The adjusted HR in the first subgroup was 0.53 (95% CI, 0.17 to 1.68; P=0.277) and in the second subgroup was 1.27 (95% CI, 0.77 to 2.07; P=0.348), indicating that there was no benefit in long-term survival in patients submitted to CABG either immediately after PCI or after PCI during the same admission.
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Discussion |
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Previous studies6,8,15–18 have reported on the safety and efficacy of CABG after thrombolysis for acute myocardial infarction. However, little has been published with respect to long-term survival in this subgroup of patients. We showed that thrombolysis within 7 days before CABG had a beneficial effect on patient survival in a series of CABG patients with a mean follow-up of 5.2 years. After multivariate adjustment for all of the preoperative, intraoperative, and postoperative differences in patient characteristics, thrombolysis before CABG was associated overall with an
50% reduction in mortality, and this finding was also confirmed in CABG patients who survived for 1 year after CABG.
The long-term survival benefits offered by CABG after thrombolysis for acute myocardial infarction have also been reported by other investigators. CABG during hospitalization is associated with a lower risk of recurrent myocardial infarction and a lower risk of 2-year mortality.19 In a series of 191 patients who underwent CABG within an average of 4 days after thrombolysis, and who were followed-up for 27 months, Petrovich et al17 reported a late cardiac mortality of 1%. Messmer et al,20 in a series of 70 patients in whom CABG was undertaken in an average of 4.5 days after thrombolysis, reported an 8-year actuarial survival of 88%. Similarly, in our study, actuarial 5-year and 10-year survival in the thrombolysis-CABG group were 91% and 79%, respectively. In addition, the preoperative mean EuroSCORE surgical risk of 6.15 was accompanied by an overall 30-day mortality of 3.1%, and this is well in accordance with other studies, which have reported 30-day mortality rates between 1.4% and 4.2%.8,15,17,20
The mechanism of this beneficial effect of thrombolysis cannot be deduced from our data. However, several speculations can be made. It has been shown recently that thrombolysis followed by PCI within the next 24 hours offers considerable advantages compared with an ischemia-guided conservative approach for acute myocardial infarction with ST-segment elevation.21 Furthermore, the potential benefits of facilitated angioplasty, that is, combinations of thrombolytic drugs, IIb/IIIa inhibitors, and PCI, are currently being studied.2 One might assume that thrombolysis before PCI, apart from achieving early vessel patency, might also prevent acute vessel thrombosis after PCI. We believe that a similar explanation might also apply to CABG patients; the anticoagulant status created by heparin usually coadministered with thrombolytic therapy may be responsible for the prevention of intraoperative or immediate postoperative CABG thromboses. In our database, despite the high use of arterial grafts (93% of patients with single internal thoracic artery and 55% of patients with 2 arterial grafts), there was 1 vein graft used in 87% of patients, and these vein grafts were subject to early thrombosis. Patients without previous thrombolysis may lack this beneficial effect, with corresponding reduced long-term survival. Also, the possibility that patients who were deemed suitable for an operation early after a myocardial infarction might comprise a cohort of lower overall risk cannot be ruled out.
Interestingly, previous studies22,23 have reported that angina occurring within 48 hours before myocardial infarction had a beneficial effect on the size of the infarct and the hospital outcome in patients treated with thrombolysis, although it has been suggested that this benefit is determined by ischemic preconditioning.22,23 In addition, Andreotti et al24 showed that patients with acute myocardial infarction who had intermittent infarct-related pain or unstable angina in the 7 days preceding the infarction had faster coronary artery reperfusion and smaller infarcts after thrombolytic therapy than patients without preinfarction angina. The thrombolysis- CABG group in our study had high rates of unstable angina (93.9% in unmatched group and 92.1% in matched group). Therefore, the subsequent treatment with thrombolysis may result in smaller myocardial infarction and higher postoperative left-ventricular ejection fraction in this group compared with the CABG-only group. The groups were appropriately matched for preoperative left-ventricular ejection fraction; however, we had no data regarding postoperative evaluation of ejection fraction in these groups.
Limitations of the Study
This is a retrospective study. Nevertheless, the collected information on preoperative, intraoperative, and postoperative factors has been collected with highly standardized methods for the New York State audited database. The cause of death in these patients is not documented and is not necessarily cardiac-related, whereas survival in relation to graft patency was unknown. However, for practical purposes, the estimation of overall mortality is probably more important than the estimation of cardiac deaths alone after a long-term follow-up period. We had no follow-up data on reintervention after the operation, which is a valuable parameter and affects long-term mortality. This study refers to a single-center regional database, and it is likely that selection of patients for thrombolysis and CABG versus CABG alone may be an important determinant, which varies widely among cardiac units. A multi-institutional approach is certainly needed to overcome this limitation. Finally, we were not able to compare the long-term survival of patients operated within the first day after thrombolysis, between 2 and 7 days, or between 7 and 28 days, nor were we able to compare the effect of specific fibrinolytic agents on long-term outcome.
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Conclusions |
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Patients who were treated with thrombolysis for acute myocardial infarction before CABG appear to have had less relative risk for long-term mortality when compared with matched CABG patients without thrombolysis. The beneficial effect of thrombolysis on patient survival post-CABG extends far beyond the 30-day, 1-year, and 5-year mortality time periods. Thus, these data suggest that the CABG operation, when indicated early after a myocardial infarction, should not be delayed because of the use of thrombolytic therapy. Similarly, early thrombolysis for impeding myocardial infarctions should not be deferred in view of a required or anticipated CABG operation within the next few days. A randomized trial comparing long-term outcome in early versus late CABG after thrombolysis seems warranted.
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Footnotes |
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Presented at the 2004 Scientific Sessions of the American Heart Association, New Orleans, La, November 7–10, 2004.
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