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ACC/AHA 2008 Performance Measures for Adults With ST-Elevation and Non-ST-Elevation Myocardial Infarction

ACC/AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease
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J Am Coll Cardiol, 2003; 42:1535-1543, doi:10.1016/j.jacc.2003.06.001
© 2003 by the American College of Cardiology Foundation
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CLINICAL RESEARCH

Association of creatinine and creatinine clearance on presentation in acute myocardial infarction with subsequent mortality

C. Michael Gibson, MS, MD*,*, Duane S. Pinto, MD{dagger}, Sabina A. Murphy, MPH*, David A. Morrow, MD, MPH*, Hans-Peter Hobbach, MD{ddagger}, Stephen D. Wiviott, MD*, Robert P. Giugliano, MD, SM*, Christopher P. Cannon, MD*, Elliott M. Antman, MD*, Eugene Braunwald, MD* TIMI Study Group

* TIMI Study Chairman's Office, Department of Medicine, Brigham and Women's Hospital, Boston, USA
{dagger} Department of Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
{ddagger} St. Marienkrankenhaus Siegen, Siegen, Germany

Manuscript received April 18, 2003; revised manuscript received June 4, 2003, accepted June 9, 2003.

* Reprint requests and correspondence: Dr. C. Michael Gibson, Director TIMI Data Coordinating Center, 350 Longwood Avenue, First Floor, Boston Massachusetts 02115, USA.
mgibson{at}timi.org


   Abstract
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 Abstract
Methods
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 Discussion
 References
 
OBJECTIVES: We hypothesized that impaired renal function would also be associated with poorer clinical outcomes among patients with ST-segment elevation myocardial infarction (STEMI) treated with fibrinolysis.

BACKGROUND: Previous studies have demonstrated that impaired renal function is associated with poorer clinical outcomes in the setting of unstable angina and non-STEMI and after percutaneous coronary intervention.

METHODS: Data were drawn from the Thrombolysis In Myocardial Infarction (TIMI)-10, TIMI-14, and Intravenous nPA for the Treatment of Infarcting Myocardium Early (InTIME-II) trials.

RESULTS: Within each TIMI risk score (TRS) for STEMI category (0 to 2, 3 to 4, ≥5), 30-day mortality increased stepwise among patients with normal (creatinine [Cr] ≤1.2 mg/dl), mildly (Cr >1.2 to 2 mg/dl), and severely (Cr >2.0 mg/dl) impaired renal function (p < 0.001) and in patients with normal (creatinine clearance [CrCl] ≥90 ml/min), mildly (60 to <90 ml/min), moderately (30 to <60 ml/min), and severely (<30 ml/min) impaired CrCl (p < 0.001). Impaired renal function was associated with increased mortality after adjusting for previously identified correlates of mortality (using Cr: odds ratio [OR] for mild impairment 1.52, 95% confidence interval [CI] 1.30 to 1.77, p < 0.001; OR for severe impairment 3.73, 95% CI 2.55 to 5.45, p < 0.001; using CrCl: OR for mild impairment 1.38, 95% CI 1.10 to 1.73, p = 0.006; OR for moderate impairment 2.06, 95% CI 1.59 to 2.66, p < 0.001; OR for severe impairment 3.81, 95% CI 2.57 to 5.65, p < 0.001).

CONCLUSIONS: In the setting of STEMI, elevated Cr and/or impaired CrCl on presentation is associated with increased mortality, independent of other conventional risk factors and TRS. This association does not appear to be mediated by reduced fibrinolytic efficacy among patients with impaired renal function or by the presence of congestive heart failure on presentation.

Abbreviations and Acronyms
  CHF = congestive heart failure
  Cr(Cl) = creatinine (clearance)
  CTFC = corrected TIMI frame count
  ICH = intracranial hemorrhage
  MI = myocardial infarction
  OR = odds ratio
  PCI = percutaneous coronary intervention
  STEMI = ST-segment elevation myocardial infarction
  TIMI = Thrombolysis In Myocardial Infarction
  TRS = TIMI risk score

Previous studies have demonstrated that impaired renal function is associated with poorer clinical outcomes in the setting of unstable angina and non–ST-segment elevation myocardial infarction (STEMI) and after a percutaneous coronary intervention (PCI) as well as coronary artery bypass graft surgery (1–8). The goal of the present study was to extend these observations to examine the association of baseline creatinine (Cr) and creatinine clearance (CrCl) with subsequent clinical outcomes after fibrinolytic administration among patients with STEMI who received optimal reperfusion therapy. We hypothesized that impaired renal function (elevated Cr and impaired CrCl) would be associated with poorer clinical outcomes after fibrinolytic administration. We also sought to examine the relation between Cr and CrCl with epicardial flow and myocardial perfusion.


   Methods
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Results
 Discussion
 References
 
Clinical and angiographic data were pooled from the Thrombolysis In Myocardial Infarction (TIMI) trial-10A, -10B, and -14 trials. The TIMI-10A trial was a non-randomized, open-label, dose-escalation study of eight ascending doses of tenecteplase, a mutant of recombinant tissue plasminogen activator, in 113 patients (9). The TIMI-10B trial was a randomized trial of 880 patients comparing 30, 40, and 50 mg tenecteplase versus front-loaded recombinant tissue plasminogen activator (10). Data from 1,187 patients enrolled in the TIMI-14 trial comparing fibrinolytic versus abciximab plus a reduced dose fibrinolytic were also included (11,12). Angiography was performed at 60, 75, and 90 min after thrombolytic administration (9–12). Nitroglycerin (intravenous or sublingual) was administered every 15 min if the systolic blood pressure (BP) exceeded 110 mm Hg (9–12). Clinical data were also pooled from the Intravenous nPA for the Treatment of Infarcting Myocardium Early (InTIME-II) trial, which compared the thrombolytics n plasminogen activator versus tissue-type plasminogen activator in 15,078 STEMI patients (13). The distribution of the TIMI risk score (TRS) for STEMI, as previously reported (14), was used to assess the association of Cr and CrCl with mortality in low-risk (TRS 0 to 2), intermediate-risk (TRS 3 to 4), and high-risk (TRS ≥5) patients. Creatinine clearance was divided into four categories: normal (≥90 ml/min) and mildly (60 to <90 ml/min), moderately (30 to <60 ml/min), and severely impaired (<30 ml/min), as defined by the Kidney Disease Outcome Quality Initiative (15).

Angiographic analysis methods.   Angiographic outcomes were assessed at the TIMI Angiographic Core Laboratory by a single observer (Dr. Gibson), who was blinded to the clinical outcomes and drug assignment. The TIMI flow grade (16), corrected TIMI frame count (CTFC) (17–20), and TIMI myocardial perfusion grade (21) were assessed as previously defined. The optimal single-plane projection was selected that identified the stenosis in its greatest severity with minimal foreshortening or overlapping of branches, and end-diastolic frames were chosen for quantitative angiographic analysis (22).

Statistical analysis.   All analyses were performed using Stata version 7.0 (Stata Corp., College Station, Texas). All continuous variables are reported as the mean ± SD. Analysis of variance was used for the analysis of continuous variables. The non-parametric Kruskal-Wallis test was used for the CTFC analysis when data were imputed to an occluded vessel. The chi-square test was used for the analysis of categorical variables. A test for trend across ordered groups was performed for the three Cr groups and four CrCl groups (Stata version 7.0). A multivariate logistic regression model was used for the analysis of 30-day mortality, adjusting for age, pulse, BP, history of congestive heart failure (CHF), Killip class II to IV on presentation, gender, history of diabetes, previous MI, history of hypertension, time to treatment, and anterior myocardial infarction (MI). Kaplan-Meier curves were generated for mortality through two years of follow-up. The log-rank test was used to test the equality of the survivor function across groups, and the test for trend of the survivor function was performed across the ordered groups.


   Results
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Discussion
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Baseline characteristics.   There were 12,377 patients (74.1%) with normal Cr (≤1.2 mg/dl), 4,126 patients (24.7%) with mild renal impairment (Cr >1.2 to 2.0 mg/dl), and 207 patients (1.2%) with severe renal impairment (Cr >2.0 mg/dl). Normal CrCl ≥90 ml/min was present in 6,062 patients (36.4%), mild impairment (60 to <90 ml/min) in 6,795 patients (40.9%), moderate impairment (30 to <60 ml/min) in 3,514 patients (21.2%), and severe renal impairment or failure (<30 ml/min) in 264 patients (1.6%).

There was a stepwise increase in co-morbidities among patients with normal, mildly impaired, and severely impaired renal function (Tables 1 and 2). Patients with mildly and severely impaired renal function were older, and the frequency of previous MI, diabetes, CHF, hypertension, and the incidence of previous coronary artery bypass graft surgery was increased among these patients. Patients with severe renal impairment were more often of a non-white race. Cigarette smoking was less frequent among patients with mild and severe renal impairment. At presentation, patients with mildly or severely impaired renal function were more often tachycardic and in Killip class II to IV heart failure. The duration of symptoms before presentation was longer among patients with severe renal impairment.


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  		Table 1 Baseline Characteristics by Creatinine Group

 

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  		Table 2 Baseline Characteristics by CrCl Group

 
Angiographic findings (TIMI flow grade, TIMI frame count, TIMI myocardial perfusion, minimum lumen diameter, or percent diameter stenosis) after thrombolytic administration in the TIMI-10A, -10B and -14 angiographic trials were not associated with Cr or CrCl (Tables 3 and 4).


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  		Table 3 Angiographic Characteristics by Creatinine Group*

 

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  		Table 4 Angiographic Characteristics by CrCl Group*

 
Clinical outcomes.   There was a stepwise increase in mortality among patients with normal, mildly, and severely impaired renal function (p < 0.0001 for each) and among patients with normal, mildly, moderately, and severely impaired renal function by CrCl (p < 0.001) (Fig. 1). Kaplan-Meier curves show the mortality increased early during the follow-up and continued to separate up to two years of follow-up in the severely impaired renal function group (p < 0.001 for each) (Fig. 2). Within each TRS category (0 to 2, 3 to 4, ≥5), there was a stepwise increase in mortality among patients with normal, mildly, and severely impaired renal function (p < 0.0001 for each) (Fig. 3A) and among patients with normal, mildly, moderately, and severely impaired renal function by CrCl (p < 0.001) (Fig. 3B). Heart failure as a cause of death increased with increasing renal impairment: 24.6%, 35.9%, and 46.2% for normal, mildly, and severely impaired Cr, respectively (p < 0.0001 for trend), and 23.9%, 27.4%, 29.8%, and 48.2% for normal, mildly, moderately, and severely impaired CrCl, respectively (p = 0.0014 for trend).



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  		Figure 1 Mortality at 30 days according to baseline creatinine (Cr) and creatinine clearance (CrCl). OR = odds ratio.

 


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  		Figure 2 Kaplan-Meier survival curves through two years according to baseline Cr and CrCl. Data available through 30 days only in TIMI-10A and TIMI-14. Abbreviations as in Figure 1.

 


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  		Figure 3 Mortality at 30 days according to baseline (A) Cr and (B) CrCl stratified by TIMI risk score (TRS). Abbreviations as in Figure 1

 
In an analysis restricted to patients ≥65 years old, a similar stepwise increase in mortality was observed as renal impairment increased (Fig. 4). Both impaired Cr and CrCl were related to mortality in a stepwise fashion when stratified by the presence or absence of a history of CHF at baseline (Figs. 5A and 5B) and Killip class I and Killip class II to IV at presentation (Figs. 6A and 6B). Mildly and severely impaired renal function were associated with increased mortality in a multivariate model adjusting for age, pulse, BP, history of CHF, Killip class II to IV on presentation, gender, history of diabetes, previous MI, history of hypertension, time to treatment, and anterior MI (odds ratio [OR] for mild impairment 1.52, 95% confidence interval [CI] 1.30 to 1.77; p < 0.001; OR for severe impairment 3.73, 95% CI 2.55 to 5.45; p < 0.001). Likewise, mildly, moderately, and severely impaired renal function by CrCl was associated with increased mortality in a multivariate model (OR for mild impairment 1.38, 95% CI 1.10 to 1.73; p = 0.006; OR for moderate impairment 2.06, 95% CI 1.59 to 2.66; p < 0.001; OR for severe impairment 3.81, 95% CI 2.57 to 5.65; p < 0.001).



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  		Figure 4 Mortality at 30 days according to baseline Cr stratified by TRS in patients over the age of 65 years. Abbreviations as in Figures 1 and 3.

 


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  		Figure 5 Mortality at 30 days according to baseline (A) Cr and (B) CrCl stratified by history (Hx) of congestive heart failure (CHF) at presentation. Abbreviations as in Figure 1.

 


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  		Figure 6 Mortality at 30 days according to baseline (A) Cr and (B) CrCl stratified by Killip class at presentation.

 
Intracranial hemorrhage (ICH) was associated with increased renal impairment: 0.9%, 1.1%, and 2.9% for normal, mildly, and severely impaired Cr, respectively (p = 0.057 for trend); and 0.6%, 0.8%, 1.8%, and 3.0% for normal, mildly, moderately, and severely impaired CrCl, respectively (p < 0.0001 for trend). Although the CrCl group was not significantly associated with ICH in a multivariate model adjusting for known correlates of ICH (age, gender, systolic and diastolic BP), severely impaired Cr tended to be associated with increased ICH (multivariate OR for severe impairment 2.31, 95% CI 0.99 to 5.37, p = 0.053).


   Discussion
Top
 Abstract
 Methods
 Results
 Discussion
References
 
This study extends previous observations regarding the association of renal dysfunction and adverse clinical outcomes among patients with coronary artery disease. In the presence of STEMI, elevated Cr and/or reduced CrCl on presentation are associated with increased mortality, independent of other conventional risk factors and TRS. Heart failure as the primary cause of death increased with increasing renal impairment. Retrospective analyses have demonstrated that renal dysfunction is associated with an increased risk of CHF and mortality after acute MI, and that while reperfusion therapy may improve outcomes, reperfusion therapy is less frequently administered to these patients (23,24). Elderly patients with renal dysfunction are less frequently treated with aspirin, beta-blockers, and fibrinolytic therapy, and they undergo angiography and angioplasty less frequently during the index hospitalization (25).

In contrast to previous observational studies suggesting lower rates of pharmacologic and interventional therapy among patients with renal insufficiency, all patients (regardless of baseline Cr or CrCl) received reperfusion therapy for STEMI in the present study, including fibrinolytic and aspirin therapy within 6 to 12 h of symptom onset in all patients, beta-blocker therapy in a large proportion, and early PCI in many patients. Despite the facts that aggressive pharmacologic treatment was administered to all patients and the epicardial and myocardial reperfusion rates were equivalent, reduced renal function remained associated with impaired survival through up to two years of follow-up. This finding was also observed when the analysis was restricted to patients over the age of 65 years.

Elevated Cr on presentation was associated with increased ICH, independent of age, gender, and BP. Given these findings of increased ICH with increased renal impairment at presentation, physicians should exercise caution in administering fibrinolytics to patients with increased Cr; primary PCI may represent a favorable alternative therapy. However, the risk of ICH in primary PCI patients presenting with renal impairment has not been defined, and likewise may be associated with increased rates of ICH.

Because Cr levels were measured at presentation, which was in general within 3 h of symptom onset, these Cr levels likely reflect renal status near the time of onset of the event and less likely reflect changes in renal hemodynamics due to impaired systemic perfusion (26). Although other biomarkers reflect activation of inflammation (high-sensitivity C-reactive protein, sCD40 ligand, interleukin-6), necrosis (troponin, creatine kinase), the presence of a "metabolic syndrome" (glycosylated hemoglobin, microalbuminuria), or activation of the neuroendocrine system (brain natriuretic peptide), it could be speculated that Cr and CrCl are integrative markers of metabolic abnormalities, neuroendocrine activation, and end-organ damage due to several cardiac risk factors, including hypertension, dyslipidemia, diabetes, and vascular disease in general.

Study limitations.   This analysis is a non-randomized, retrospective analysis, and as such, it is possible that both identified and unidentified confounders may have influenced the outcomes. Strict enrollment criteria are used in clinical trials, and the results observed herein may not be applicable to all patients in clinical practice.

Conclusions.   In the setting of STEMI, elevated Cr and/or impaired CrCl on presentation is associated with increased mortality, independent of other conventional risk factors and TRS. This association does not appear to be mediated by reduced fibrinolytic efficacy among patients with impaired renal function.


   Footnotes
 
This study was supported in part by a grant from Genentech, Inc. and Boehringer-Ingelheim, South San Francisco, California and Rheimberg, Germany (TIMI 10A and B); Centocor and Eli Lilly Inc., Malvern, Pennsylvania and Indianapolis, Indiana (TIMI 14); and Bristol-Myers Squibb, New York, New York (InTIME-II).


   References
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 Results
 Discussion
 References
 

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G. Marenzi, G. Lauri, E. Assanelli, J. Campodonico, M. De Metrio, I. Marana, M. Grazi, F. Veglia, and A. L. Bartorelli
Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction
J. Am. Coll. Cardiol., November 2, 2004; 44(9): 1780 - 1785.
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 J Am Coll CardiolHome page
R. Gupta, Y. Birnbaum, and B. F. Uretsky
The renal patient with coronary artery disease: Current concepts and dilemmas
J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1343 - 1353.
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 NEJMHome page
N. S. Anavekar, J. J.V. McMurray, E. J. Velazquez, S. D. Solomon, L. Kober, J.-L. Rouleau, H. D. White, R. Nordlander, A. Maggioni, K. Dickstein, et al.
Relation between Renal Dysfunction and Cardiovascular Outcomes after Myocardial Infarction
N. Engl. J. Med., September 23, 2004; 351(13): 1285 - 1295.
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 HypertensionHome page
G. F. Mitchell
Increased Aortic Stiffness: An Unfavorable Cardiorenal Connection
Hypertension, February 1, 2004; 43(2): 151 - 153.
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 Journal Watch CardiologyHome page
Renal Impairment Linked with Increased Mortality Risk After MI
Journal Watch Cardiology, January 23, 2004; 2004(123): 4 - 4.
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 JWatch GeneralHome page
Renal Impairment Linked with Increased Mortality Risk After MI
Journal Watch (General), January 6, 2004; 2004(106): 3 - 3.
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 J Am Coll CardiolHome page
A. N. DeMaria, O. Ben-Yehuda, D. Berman, G. K. Feld, B. H. Greenberg, J. D. Knoke, K. U. Knowlton, W. Y. W. Lew, and S. Tsimikas
Highlights of the year in JACC 2003
J. Am. Coll. Cardiol., December 17, 2003; 42(12): 2156 - 2166.
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