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J Am Coll Cardiol, 2002; 40:1961-1967
© 2002 by the American College of Cardiology Foundation
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CLINICAL STUDY

Association between CK-MB elevation after percutaneous or surgical revascularization and three-year mortality

Sorin J. Brener, MD, FACC*,*, Bruce W. Lytle, MD, FACC{dagger}, Jakob P. Schneider, RN*, Stephen G. Ellis, MD, FACC* and Eric J. Topol, MD, FACC*

* Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio USA
{dagger} Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio, USA

Manuscript received February 26, 2002; revised manuscript received May 7, 2002, accepted July 15, 2002.

* Reprint requests and correspondence: Dr. Sorin J. Brener, Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F- 25, Cleveland, Ohio 44195, USA.
breners{at}ccf.org


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 References
 
OBJECTIVES: The goal of this study was to assess the long-term impact of creatine kinase-MB isoform (CK-MB) elevation after percutaneous or surgical revascularization.

BACKGROUND: The long-term impact of CK-MB elevation after coronary artery bypass grafting (CABG) is not as well characterized as that following percutaneous coronary intervention (PCI).

METHODS: The three-year cumulative survival of consecutive patients who underwent their first percutaneous or surgical revascularization procedure between January 1, 1995 and August 31, 2000 and had CK-MB determination was assessed using the Social Security Death Index.

RESULTS: The 3,812 patients undergoing CABG had a less favorable coronary risk profile than the 3,573 patients undergoing PCI. The incidence of CK-MB elevation above normal range was 90% and 38% for the CABG and PCI groups (p < 0.001). In 6% and 5%, respectively, the elevation surpassed 10x the upper limit of normal (ULN). At an average follow-up of three years, there were 712 deaths, 83 of which occurred within 30 days of procedure. The cumulative survival was 92% and 90% for CABG and PCI, respectively (p = 0.003). Chronic renal insufficiency (adjusted hazard ratio [HR] 3.8, [95% confidence interval 3.1 to 4.6]), age (HR 1.5 per decade [1.3 to 1.6]), ejection fraction <40% (HR 1.3 [1.1 to 1.5] and PCI (HR 1.6 [1.3 to 1.9]) were the main predictors of increased mortality. Creatine kinase-MB isoform elevation only above 10 x ULN was independently predictive of mortality in the CABG (HR 1.3 [1.1 to 1.5]) and PCI (HR 1.1 [1.0 to 1.2]) groups, p < 0.001.

CONCLUSIONS: Creatine kinase MB isoform elevation after revascularization is very common, particularly in CABG patients. When extensive, it is independently correlated with increased mortality over a three-year period. Identification and aggressive management of patients with high levels of CK-MB after revascularization may improve their outcome.

Abbreviations and Acronyms
  ARTS
  Arterial Revascularization Therapy Study
  CABG
  coronary artery bypass grafting
  CAD
  coronary artery disease
  CI
  confidence interval
  CK-MB
  creatine kinase-MB isoform
  HR
  hazard ratio
  MI
  myocardial infarction
  PCI
  percutaneous coronary intervention
  SSDI
  Social Security Death Index
  ULN
  upper limit of normal

Routine surveillance of creatine kinase-MB isoform (CK-MB) after percutaneous coronary intervention (PCI) demonstrates periprocedural elevation in 10% to 40% of patients, which is almost always not associated with immediate clinical manifestations. Numerous series have described an adverse long-term effect of this apparently innocuous manifestation of transient vessel closure, profound ischemia, and distal embolization without clearly establishing a causative relationship (1,2). This association has been less well established after coronary artery bypass grafting (CABG). It was generally assumed that CK-MB elevation after cardiac manipulation is expected and, thus, a clear threshold above which elevation in cardiac markers is indicative of significant damage has not been accepted (3,4).

Thus, we sought to address two issues. The first objective was to identify the frequency and magnitude of CK-MB fraction elevation in a large cohort of patients undergoing surgical or percutaneous revascularization, taking advantage of the routine measurement of this parameter at our institution. The second aim was to correlate these findings with long-term mortality and evaluate the potential effect of various parameters prospectively collected on this association, in the context of the inherent selection process of referral for either type of revascularization.


   Methods
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 Methods
Results
 Discussion
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Between January 1, 1995 and August 31, 2000, consecutive patients surviving for at least 24 h of their first percutaneous or surgical revascularization procedure at our institution were considered for analysis if they had CK-MB measurement and a valid social security number. We excluded patients who had a myocardial infarction (MI) within 24 h before revascularization, or who had emergency CABG after PCI. The two registries collecting data for the CABG and PCI patients were queried, and an integrated data set was created including similar variables. Patients with repeat procedures were counted only once and indexed according to initial revascularization. The achievement of complete revascularization for each patient was determined by operator according to extent of coronary disease and number of revascularized arteries in separate coronary territories. Creatine kinase-MB isoform was measured routinely 8 and 16 h after PCI, and immediately after and the next morning for CABG. Additional measurements were done for clinical indications. Creatine kinase-MB isoform level was described both as a continuous and as a discrete variable in the following categories of multiples of upper limit of normal for the institution ([ULN] 8.8 ng/ml): ≤1, 1 to 3, 3 to 5, 5 to 10, and >10 x ULN.

Survival was assessed using the Social Security Death Index (SSDI). Duration of follow-up was determined from date of procedure to death or date of SSDI query.

Continuous variables were compared with analysis of variance, and discrete variables were analyzed with chi-square test. Kaplan-Meier survival analysis was used for cumulative survival, and Cox proportional hazards model was used to determine independent predictors of outcomes, using the STATISTICA 5.1 software (StatSoft Inc., 1998, Tulsa, Oklahoma). Family history of coronary artery disease (CAD) before age 55 was populated in less than 75% of cases, while the incidence of hyperlipidemia and current smoking was not reliably recorded; these variables were not entered in multivariate models.


   Results
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Discussion
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We identified 7,385 patients eligible for this analysis, 3,812 in the CABG and 3,573 in the PCI cohorts, among 17,567 total procedures. Main reasons for exclusion were for lack of CK-MB measurement (41%) or repeat procedures (34%). Their baseline characteristics are shown in Table 1. Most of the variables indicated a higher risk profile in the CABG group with the expected exception of prior CABG.


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  		Table 1 Baseline Characteristics of the Study Population

 
The procedural details are shown in Table 2. There was significantly more complete revascularization in the CABG group in conjunction with a greater extent of coronary artery disease (CAD), more than a quarter of whom (n = 1,002) had >50% left main coronary stenosis.


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  		Table 2 Angiographic and Procedural Details in the Study Population

 
The average follow-up was approximately three years (1,159 ± 480 days) for the whole cohort (1,276 ± 411 vs. 1,035 ± 516 for CABG and PCI, respectively, p < 0.01), and 712 patients died. Among the 362 deaths in the CABG group, the average interval from procedure to death was 648 ± 508 days (median 632 days). In the PCI group, the interval between procedure and death in 350 patients was 552 ± 513 days (median 387 days). In 83 patients (12% of all fatalities, 39 patients in the CABG and 44 patients in the PCI groups), death occurred between two and 30 days from procedure. The majority of the deaths occurred, thus, at substantial intervals from the procedure. There was no correlation between the time to death and level of CK-MB elevation. The interval to death in patients with >10 x ULN CK-MB elevation was lower than that in the other levels both for CABG (528 ± 480 days) and PCI (483 ± 558 days). Nevertheless, even in this group most deaths occurred one to two years after the procedure.

CK-MB elevation and cumulative rates of survival.   The cumulative survival rate in patients according to revascularization strategy is shown in Figure 1. In the whole cohort, compared with PCI, CABG was associated with improved survival (three-year rate of 92% vs. 90%, p = 0.003). In patients with >10 x ULN CK-MB elevation, the three-year survival was not statistically different between the revascularization strategies (p = 0.99, Fig. 2). In this group, the mean CK-MB level was identical in the two revascularization groups (p = 0.99). The cumulative three-year death rates according to level of CK-MB elevation and revascularization strategy are shown in Table 3.



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  		Figure 1 Cumulative survival in coronary artery bypass grafting (dashed line) and percutaneous coronary intervention (solid line) patients.

 


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  		Figure 2 Cumulative survival in coronary artery bypass grafting (dashed line) and percutaneous coronary intervention (solid line) patients with creatine kinase-MB isoform elevation >10 x the upper limit of normal.

 

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  		Table 3 Population At Risk and Cumulative Three-Year Mortality Rates Associated With Ascending Levels of CK-MB Elevation

 
Multivariate regression analysis
As the two cohorts of patients were different in many important aspects, Cox proportional hazards model analysis was performed. The model included: age (continuous), gender, hypertension, diabetes, hyperlipidemia, chronic renal insufficiency, prior MI, prior CABG, ejection fraction <40%, number of diseased vessels, revascularization procedure, CK-MB (continuous or ordinate), and completeness of revascularization. For the whole population, the most significant predictors of increased mortality (at p < 0.001), in order of contribution to the overall model, were chronic renal insufficiency (hazard ratio [HR] 3.8 [95% confidence interval {CI} 3.1 to 4.6]), age (HR 1.5 per decade [1.3 to 1.6]), ejection fraction <40% (HR 1.3 [1.1 to 1.5], and PCI (HR 1.6 [1.3 to 1.9]). Extent of CAD, diabetes mellitus, prior MI, female gender, and absence of complete revascularization were weaker predictors. When examined as a continuous variable, CK-MB elevation is significantly associated with increased mortality, but Figures 3 and 4 clearly show the lack of a consistent relationship between this parameter and mortality. Thus, we analyzed for each revascularization strategy the independent contribution to mortality of each level of CK-MB elevation, compared with no CK-MB elevation, using the same regression model described above. Only in the patients with the highest level of CK-MB elevation (>10 x ULN) was there a significant independent contribution to mortality (HR 1.3 [1.1 to 1.5], p < 0.01 for CABG and HR 1.1 [1.0 to 1.2], p = 0.01 for PCI).



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  		Figure 3 Cumulative survival in coronary artery bypass grafting patients according to level of creatine kinase-MB isoform elevation. ULN = upper limit of normal.

 


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  		Figure 4 Cumulative survival in percutaneous coronary intervention patients according to level of creatine kinase-MB isoform elevation. ULN = upper limit of normal.

 

   Discussion
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 Abstract
 Methods
 Results
 Discussion
References
 
This is the largest and most comprehensive analysis of the association between long-term survival and periprocedural CK-MB elevation after percutaneous or surgical revascularization in unselected patients at a tertiary institution. Unlike in clinical trials comparing the two revascularization techniques (5–11), the patients differ substantially with respect to clinical and angiographic characteristics. The key observations from this study are that 38% of PCI and 90% of CABG patients have some degree of CK-MB elevation after revascularization. In 16% of PCI and 17% of CABG patients, the CK-MB elevation surpassed the threshold utilized for MI adjudication in clinical trials, >3 x ULN and >5 x ULN, respectively. Our analysis demonstrates that these thresholds overestimate the actual independent contribution of CK-MB elevation to mortality, as patients with CK-MB elevation of 7 x ULN and 15 x ULN, for example, would be included in the >5 x ULN group, despite different impact on outcome after multivariable adjustment.

The PCI patients demonstrate a more consistent link between CK-MB elevation and mortality, while in the CABG group this association more resembles a threshold phenomenon surrounding the 10 x ULN value. The mechanism of CK-MB elevation after revascularization may partially explain the difference in impact on outcome. During PCI, it is mostly related to distal embolization of plaque material and usually not associated with procedural failure (12). In contrast, CABG patients with high levels of CK-MB are likely to be affected by early graft failure and/or lack of adequate myocardial protection during bypass (13–16). Furthermore, as CABG patients have more severe native coronary disease (including left main coronary stenosis), the territory jeopardized by graft failure is large. In addition, it is possible that distal embolization plays an important role in CABG patients as well, particularly during anastomosis of grafts in severely diseased native arteries. These patients may benefit from early repeat angiography to identify and reverse graft failure, despite the occurrence of myocardia damage (17–19).

In a recent series of 2,003 CABG patients, 3.5% were found to have CK-MB >80 U/l (equivalent to approximately 10 x ULN in our study). A total of 90% of these patients had documented graft failure, which resulted in considerable mortality (20). Fitzgibbon et al. (21) reported on 1,388 patients with first CABG who underwent systematic angiography. Among the vein grafts, 12% exhibited early closure.

Is CK-MB elevation synonymous with myonecrosis?.   Recently, magnetic resonance scans of patients with peri-PCI CK-MB elevation (median 21 ng/ml) demonstrated discrete areas of hyperenhancement (necrosis) in the PCI territory, which did not occur in patients without CK-MB elevation (22). Likely, this observation would apply to CABG patients as well.

Comparison with previous studies
Only two studies addressed the long-term impact of CK-MB elevation after CABG. In the Arterial Revascularization Therapy Study (ARTS), CK-MB was systemically measured after the procedure in 496 patients. The incidence of any CK-MB elevation was 62%, and the mortality at one year in patients with CK-MB >5 x ULN was 7%, as compared with 6% in our study (23,24). Similarly, in the GUARD during Ischemia Against Necrosis (GUARDIAN) study, patients at high-risk for CABG complications had a six-month mortality of 3.4%, 5.8%, 7.8%, and 20.2% for CK-MB levels of <1 x, >5 x, >10 x, and >20 x ULN, respectively, p = 0.0001 (25). The relationship remained statistically significant after adjustment for ejection fraction, congestive heart failure, cerebrovascular disease, peripheral vascular disease, cardiac arrhythmia, and the method of cardioplegia delivery and demonstrated the best cut-off point for mortality prediction in the 5 to 10 x ULN range. Most of the other series correlated techniques of myocardial protection with incidence of myonecrosis and short-term operative complications (26–28).

Numerous series have evaluated the impact of peri-PCI CK-MB elevation on medium- and long-term survival, as summarized by Califf et al. (1). The incidence of CK-MB elevation in these series is comparable to the one in our report. Abdelmeguid and Topol (29,30) pointed out that even small CK-MB elevations after PCI are associated with increases in mortality over 8.5 years. Kong et al. (31) reported similar data. In randomized clinical trials, CK-MB elevation in the context of PCI with abciximab was associated with 50% to 140% excess mortality over three years, across the range of CK-MB elevation used in the current report (2). Other series from trials of coronary stenting reported an increase in mortality of up to fourfold in patients with large periprocedural enzyme elevation (32–34).

Also of interest is the fact that high-risk characteristics in the population described in this study resulted in worse survival than in patients enrolled in clinical trials comparing the two strategies of revascularization. For example, in the Bypass Angioplasty Revascularization Investigation (BARI) trial, the three-year mortality among 1,829 patients randomized to CABG or PCI was approximately 5% and 6%, respectively (7), as compared with 8% and 10%, respectively, in this report. In the Emory Angioplasty versus Surgery Trial (EAST), at three years the mortality was 6% and 7% in the two groups, respectively (8). In the Randomized Intervention Treatment of Angina (RITA-1) trial, the mortality at 2.5 years was only 3.6% and 3.1%, respectively (10). In a Veterans’ Administration study dedicated to patients at high-risk, mortality at three years was 21% and 20%, respectively (35). Contemporary studies of CABG versus PCI, such as ARTS, feature a mortality rate of only 4% to 5% at three years (5), highlighting the major difference between randomized clinical trials in which patients are eligible and suitable for both procedures and clinical practice, where appropriate triage to one revascularization strategy is based on a multitude of clinical and angiographic parameters, integrated with evidence from clinical trials.

Study limitations
As in any retrospective analysis, important limitations preclude definitive conclusions. We recognize that while peak CK-MB correlates in general with infarct size, this association is far from perfect and may be affected by the mechanism of infarction in the two groups. Moreover, the adherence to guidelines of CK-MB collection could not be verified, allowing for the possibility that the actual peak value was missed and leading to exclusion of many patients. We do not have information on the cause of death and, thus, may overstate the contribution of coronary disease and revascularization to outcome. We also did not have information on previous or subsequent medical management and revascularization, which may have affected the relation between CK-MB elevation and survival.

Conclusions
Despite these limitations, we conclude that CK-MB elevation is extremely common after revascularization, particularly with surgery. The three-year survival is independently affected by the degree of CK-MB elevation and is particularly impaired in patients exhibiting extensive CK-MB elevation. Nevertheless, other clinical parameters are much stronger predictors of mortality than CK-MB elevation. Routine measurement of CK-MB after revascularization is critical in identifying patients at high risk for subsequent death.


   References
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 Methods
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 Discussion
 References
 

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