CLINICAL STUDY: ACUTE CORONARY SYMDROME
The prognostic value of troponin in patients with non-ST elevation acute coronary syndromes: a meta-analysis
Paul A. Heidenreich, MD, MS, FACC*   ,
Thomas Alloggiamento, MD* ,
Kathryn Melsop, MS,
Kathryn M. McDonald, MM ,
Alan S. Go, MD  and
Mark A. Hlatky, MD, FACC
* Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA
Departments of Health Research and Policy and Medicine, Stanford University, Stanford, California, USA
Division of Research, Kaiser Permanente Medical Care Program (Northern California), Oakland, California, USA
Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA
Manuscript received December 1, 2000;
revised manuscript received March 19, 2001,
accepted April 12, 2001.
Reprint requests and correspondence: Dr. Paul Heidenreich, VA Palo Alto, 111C Cardiology, 3801 Miranda Avenue, Palo Alto, California 94304
heiden{at}stanford.edu
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Abstract
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OBJECTIVES
This study was designed to compare the prognostic value of an abnormal troponin level derived from studies of patients with non-ST elevation acute coronary syndromes (ACS).
BACKGROUND
Risk stratification for patients with suspected ACS is important for determining need for hospitalization and intensity of treatment.
METHODS
We identified clinical trials and cohort studies of consecutive patients with suspected ACS without ST-elevation from 1966 through 1999. We excluded studies limited to patients with acute myocardial infarction and studies not reporting mortality or troponin results.
RESULTS
Seven clinical trials and 19 cohort studies reported data for 5,360 patients with a troponin T test and 6,603 with a troponin I test. Patients with positive troponin (I or T) had significantly higher mortality than those with a negative test (5.2% vs. 1.6%, odds ratio [OR] 3.1). Cohort studies demonstrated a greater difference in mortality between patients with a positive versus negative troponin I (8.4% vs. 0.7%, OR 8.5) than clinical trials (4.8% if positive, 2.1% if negative, OR 2.6, p = 0.01). Prognostic value of a positive troponin T was also slightly greater for cohort studies (11.6% mortality if positive, 1.7% if negative, OR 5.1) than for clinical trials (3.8% if positive, 1.3% if negative, OR 3.0, p = 0.2)
CONCLUSIONS
In patients with non-ST elevation ACS, the short-term odds of death are increased three- to eightfold for patients with an abnormal troponin test. Data from clinical trials suggest a lower prognostic value for troponin than do data from cohort studies.
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Abbreviations and Acronyms
| | ACS | = acute coronary syndromes | | CI | = confidence interval | | ECG | = electrocardiogram | | MI | = myocardial infarction | | OR | = odds ratio | | TIMI | = Thrombolysis In Myocardial Infarction |
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Patients with acute coronary syndromes (ACS) have varying levels of risk for suffering unfavorable outcomes such as death, myocardial infarction (MI) or other major cardiac complications. Despite development of various diagnostic approaches, the evaluation of patients with chest pain suggestive of acute myocardial ischemia remains a common, costly problem, with approximately five million people undergoing evaluation in emergency departments annually in the U.S. at an estimated cost of more than $6 billion (1). Patients with chest pain and ST-segment elevation on a standard electrocardiogram (ECG) can be quickly identified as having substantially increased risk and be considered for immediate reperfusion therapy based on current guidelines (2). Patients without ECG evidence of ST elevation or new, pathologic Q-waves are more difficult to assess, especially concerning the risk of short-term adverse events. This uncertainty can lead to unnecessary hospital admissions (often for intensive monitoring) as well as a few inappropriate discharges from the emergency department of patients with a high risk of MI or death (3). Indeed, among patients diagnosed with unstable angina, only 6% to 15% have a short-term risk of cardiac events low enough to be discharged home safely, on the basis of recent guidelines (4).
Prospective studies of troponin assays in ACS have demonstrated that troponin T and I have diagnostic accuracy comparable with, if not better than, creatine kinase-MB (5–7) and also predict long-term risk for adverse cardiac events (8–13). However, interpretation of the aggregate data to date is hampered by heterogeneity in the patient populations to which the tests have been applied. To provide a better overall assessment of the prognostic values of cardiac troponin T and I, we systematically reviewed published studies evaluating these markers in patients with non-ST elevation ACS. We wished to compare prognostic value of an abnormal troponin obtained from clinical trials with the prognostic value obtained from cohort studies enrolling consecutive patients.
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Methods
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Data sources and study selection.
We searched MEDLINE (1966 to 1999) and reviewed cited references of retrieved articles to identify relevant published studies. Our search criteria were: 1) the text word "troponin," and 2) the text words "angina," "unstable," "myocardial infarction" or "ischemia." We also performed a search of the EMBASE database from 1990 to 1998, but did not find any additional articles fulfilling the study criteria. We contacted experts in the field of cardiac markers to identify large unpublished cohort studies.
We restricted our review to clinical trials and cohort studies that evaluated patients with suspected myocardial ischemia. We excluded studies that included only patients with MI. We also excluded case-control studies, articles that did not report mortality and studies published in a language other than English. We excluded studies that included patients with ST-elevation MI unless the studies reported separate data on patients with non-ST-elevation MI (13).
Study selection was performed initially by title review (P.A.H.). Candidate abstracts were then reviewed and selected for data retrieval. Two independent reviewers abstracted data for each article on standardized electronic data forms. A third reviewer compared their results and settled any differences. In general, at least one reviewer of the pair had clinical cardiology expertise and one had experience in critical appraisal. We recorded the outcome of death for all studies, and the combined end point of death or MI for studies including patients with unstable angina. If outcomes at more than one time period were reported, we used the value closest to 30 days following presentation.
We prespecified comparisons of studies enrolling patients with suspected ischemia versus studies enrolling patients in whom MI had already been excluded (unstable angina). We also compared studies of troponin T versus studies of troponin I, studies of troponin T using early-generation tests (threshold 0.2 ng/ml) and those using a more recent test (threshold 0.1 ng/ml) for troponin positivity. We chose to examine cohort studies and clinical trials separately because the included patients are often different. Cohort studies typically include consecutive patients, whereas clinical trials include a more defined population.
Statistical analysis.
We used standard random (DerSimonian-Laird) and fixed (Peto) effects methods to estimate summary odds ratios (ORs) for the outcomes of death and MI (14,15). Because both fixed and random-effects summary estimates were similar, we report only the random-effects results. For studies with no events in a patient group, we substituted 0.5 in place of 0 for the random effects calculation. We tested homogeneity of study effect size using the Q statistic (15). We examined differences between study subgroups using analysis of variance (16). Data are presented as summary ORs with 95% confidence intervals, with two-tailed p values and statistical significance set at p < 0.05.
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Results
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Study selection.
A total of 33 articles were identified by the MEDLINE search and citation review. We excluded four studies that may have fit the inclusion criteria but were not written in English (17–20). Two studies (21,22) were excluded because they reported duplicate information included in other studies. The remaining 27 articles from 26 studies (one study reported troponin T [13] and I [23] in separate reports) were abstracted (9–13,23–44). Eight reports from seven clinical trials (9,13,23,24,27,35,36,42) and 19 cohort studies (10–12,23,25,26,28–34,37–41,43,44) of consecutive patients included a total of 5,360 patients with a troponin T test and 6,603 with a troponin I test.
Patient and study characteristics.
The mean age of enrolled patients was 63 years; 67% were men and 36% had a history of MI. A history of hypertension was noted in 42%, diabetes in 17% and smoking in 41% (Table 1). The included studies had a median follow-up of 12 weeks (mean 24 weeks). Five of 26 studies compared troponin T and I directly. Thus, there were 31 evaluations of troponin T or I. Seventeen studies of troponin T (Table 2) and 10 studies of troponin I (Table 3) reported mortality. There were an additional two studies of troponin T and two of troponin I that reported only the combined end point of subsequent MI or death (Tables 2 and 3).
Overall, patients with a positive troponin (I or T) had significantly worse outcomes than patients with a negative troponin. The mortality in patients with a positive troponin was 5.2%, compared with the mortality in patients with a negative troponin of 1.6%, yielding an OR for death of 3.1 (95% confidence interval [CI]: 2.3 to 4.1). Because the overall mortality was low the OR approximates the relative risk for mortality. A positive troponin was also associated with a significantly greater risk of death or MI: 13.5% versus 5.9%, OR 2.5 (95% CI 2.0 to 3.1).
Clinical trials versus cohort studies.
The proportion of troponin-positive patients was higher in clinical trials than in cohort studies, but their mortality rate was significantly lower (Table 4). In contrast, the mortality rate of troponin-negative patients was similar in the clinical trials and cohort studies. Consequently, a positive troponin was associated with a higher summary OR for mortality (Figs. 1 and 2) in the cohort studies, both for troponin I (p = 0.01) and for troponin T (p = 0.2)
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Figure 1 The odds ratio for increased mortality with a positive troponin I for clinical trials and cohort studies. Data are displayed for each study with at least one death in both positive and negative troponin T subgroups. The summary odds ratio assumes random effects. Error bars represent 95% confidence intervals.
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Figure 2 The odds ratio for increased mortality with a positive troponin T for clinical trials and cohort studies. Data are displayed for each study with at least one death in both positive and negative troponin T subgroups. The summary odds ratio assumes random effects. Error bars represent 95% confidence intervals.
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Two clinical trials (both of platelet glycoprotein IIb/IIIa receptor antagonists; one examined troponin I [27]; and the other troponin T [35]) reported separate troponin data for control and intervention groups. The summary OR for mortality with a positive troponin (T or I) for patients receiving placebo was 2.9 (1.6 to 5.12). This was significantly higher than the OR with a positive troponin for patients receiving the intervention (1.0, 95% CI 0.4 to 2.1, p = 0.03).
Troponin T versus I.
When we limited the analysis to the two trials (23,42) and two cohort studies (10,44) that directly compared troponin T and I, there was no significant difference between the summary OR for mortality with troponin T (5.2, CI 3.1 to 8.5) and troponin I (3.9, CI 2.3 to 6.6, p = 0.8).
Early troponin prognostic value.
Four clinical trials (9,13,24,35) and four cohort studies (10,32,37,39) examined the association of an early positive troponin result (within 6 h of presentation) and subsequent mortality. All treating clinicians were blind to the troponin results. There were 2,116 patients in clinical trials with a negative early troponin result, of whom 29 (1.4%) died during a mean follow up of 9 ± 10 (median 5) weeks. Mortality was lower among the cohort patients (0.4%, 4/917) despite a longer mean follow-up time of 20 ± 22 (median 12) weeks. The summary OR for mortality with an early positive troponin was greater for the cohort studies (23.7, 95% CI 6.6 to 85.6) than for the clinical trials (3.0, 95% CI 1.8 to 5.0, p = 0.003 for difference between trial and cohort studies).
The mortality rate for patients with a negative initial troponin test was greater in studies that included a high fraction of patients with evidence of ischemia on the ECG (Fig. 3). For the two studies including only patients with ischemic ECG changes, the mortality for patients with an initial negative troponin ranged from 1.6% (at 24 weeks) (35) to 4.4% (at 4 weeks) (23).
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Figure 3 The association between the mortality rate for patients with an initial negative troponin test (within 6 h of presentation) and the proportion of patients in each study with electrocardiogram (ECG) evidence of ischemia. The higher risk cohorts (more ECG ischemia) had a higher mortality rate. Evidence of ischemia was defined separately for each trial but usually consisted of ST depression or transient ST elevation. Data from patients with persistent ST elevation are not included. Squares = negative TnI (troponin I); circles = negative TnT (troponin T).
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Short versus long-term follow-up time.
The odds of death for patients with a positive troponin test were higher for cohort studies with follow-up of <12 weeks (11.4, 95% CI 4.5 to 28.9) than for cohort studies with longer term follow-up (3.2, 95% CI 1.8 to 5.5).
Rapid bedside tests.
There were four studies of rapid bedside tests (10,24,32,44). The mortality rate was 0.57% (8/1398) for a negative bedside test and 7.3% (26/357) for a positive test, yielding an OR for mortality of 7.8 (95% CI 2.6 to 23.1).
Troponin T test type.
We compared cohort studies that used older generation quantitative troponin T tests with those using newer generation tests. The mortality rate for the seven cohort studies using the older generation test (threshold 0.2 ng/ml) was 14.6% (31/213) for a positive test and 3.9% (23/585) for a negative test at a median 12 weeks of follow-up. Mortality rates were lower for both positive (2.8%, 3/108) and negative (1.0%, 4/405) troponin results for the three cohort studies using a newer generation test (threshold 0.1 ng/ml). All clinical trials used the new generation quantitative troponin T test. No studies were published using a threshold of 0.01 ng/ml.
Troponin and death or MI in unstable angina.
The prognostic value of troponin in predicting the combined end point of death or nonfatal MI for patients with unstable angina was greater in the cohort studies than in the randomized trials. In the seven cohort studies (n = 700), death or MI occurred in 28% of troponin-positive patients compared with 5.4% of troponin-negative patients during a mean 11 weeks of follow-up. In the trials (n = 3,693), death or MI occurred in only 11.7% of troponin-positive patients compared with 6.0% of troponin-negative patients during a mean 16 weeks of follow-up.
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Discussion
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This overview found that measurement of serum troponin provides significant information about the short-term risk of death for patients with non-ST segment elevation ACS. Patients with a positive troponin test had a short-term risk of death three- to eightfold higher than patients with a negative test. However, the magnitude of risk associated with a positive troponin was greater in cohort studies of consecutive patients than in clinical trials. These results were consistent across studies using troponin I or T and those using a combined end point of death or MI.
Clinical trials versus cohort studies.
There are several possible explanations for the discrepancy in the prognostic value of troponin between clinical trials and cohort studies. First, the patients recruited for trials are likely to be more highly selected than patients from cohort studies of consecutive patients. Unselected patient populations are more heterogeneous and, therefore, may have greater potential for variation in underlying prognosis than would the more homogeneous population enrolled in a clinical trial.
Another possible explanation for the lower risk with a positive troponin in clinical trials is that the interventions attenuated the prognostic value of a positive troponin by lowering the risk of the treated patients. This is suggested by data from c7E3 Fab Antiplatelet Therapy in Unstable Refractory Angina (CAPTURE) (35) and Platelet Receptor Inhibition in Ischemic Syndrome Management (PRISM) (27) where the combined OR for a positive troponin was 1.0 for the intervention group. The Thrombolysis In Myocardial Infarction (TIMI) risk score for unstable angina/non-ST elevation MI (8) developed using cardiac marker data from TIMI 11B (45) was also more predictive of events for patients receiving control (unfractionated heparin) than for those receiving low-molecular-weight heparin.
One implication of our findings is that the prognostic ability of traditional risk factors or markers may vary considerably between trial and non-trial studies. The relative prognostic value of different patient characteristics (such as age or ST depression) may also differ between trial and cohort populations. Data from CAPTURE (35), PRISM (27) and TIMI 11B (45) indicate that the prognostic value of troponin and other risk factors depends on the treatment provided. Further studies are needed to determine the prognostic value of risk factors in both trial and non-trial settings.
Troponin versus other risk factors.
The available data do not establish the degree to which troponin testing adds to the prognostic information conveyed by the ECG and other clinical factors (such as diabetes, age and gender). Most studies have examined each clinical factor in isolation rather than in a multivariable analysis. Three recent trials (8,9,13) and one cohort study (22) compared ECG findings, clinical data and troponin values in predicting outcome in patients with unstable angina or non-Q-wave MI. ST depression was a significant predictor of cardiac events in all studies, and troponin was an independent predictor in three studies. The TIMI risk score (8) noted that cardiac markers (including troponin) were independent of age, risk or severity of coronary artery disease, recent angina, use of aspirin and ST-segment deviation in predicting death, MI or need for urgent revascularization. Although these studies indicate that troponin testing provides independent prognostic information, further analyses are needed to confirm these findings in less selected patients, and to establish the value of this information in clinical decision making.
One of the potential benefits of risk assessment in patients with ACS is the ability to identify candidates for aggressive anti-ischemic therapy. Aspirin, heparin and beta-blockers are known to be effective in patients with unstable angina (4). Recently, new generation antiplatelet therapy (IIb/IIIa receptor inhibitors) (46) and anticoagulants (low-molecular-weight heparin) (45) have been shown to be more effective than usual care. Substudies of randomized trials have reported that patients with a positive troponin benefit more from low-molecular-weight heparin (47), and the platelet glycoprotein IIb/IIIa receptor inhibitors abciximab (35) and tirofiban (27) than those with a negative troponin test. These studies suggest that the troponin level can be used to guide therapy for patients with non-ST elevation ACS. However, a strategy of waiting for a positive troponin test before starting an intervention has not been evaluated in clinical trials.
One potential use of the troponin test is to identify low-risk patients in the emergency department who could be safely discharged home. In a study by Hamm et al. (10), patients with negative troponin tests had low 30-day event rates (0.3% for troponin I and 1.1% for troponin T). Our findings suggest that any risk assessment cannot rely solely on the troponin level. In studies of patients with suspected ACS, patients with a negative troponin test had an overall mortality between 0.7% (troponin I, cohort studies) and 2.1% (troponin I, trial studies). In patients with ECG changes suggestive of ischemia, the short-term mortality rates were higher, ranging from 1.6% (at 24 weeks) to 4.4% (at 4 weeks). These results suggest that troponin test results should be integrated with information from clinical history and ECG results to identify low-risk patients.
Study limitations.
Several limitations of our review should be noted. Because there is no standard troponin I assay, we could not compare threshold values across studies. In addition, we could not determine which troponin I assay was most predictive of outcome. The definition of unstable angina varied across studies, which limited the ability to compare results. Finally, potential under-reporting of negative studies may have increased the strength of the relationship between elevated troponin levels and outcome.
Conclusions.
In summary, our study found that among patients with possible cardiac ischemia or diagnosed unstable angina, an elevated troponin T or I indicates a significantly higher short-term risk of cardiac events including death and MI. The prognostic value of troponin was lower in clinical trials than in cohort studies. Additional studies enrolling consecutive patients (non-trial data) are needed to determine the independent value of troponin data when added to prognostic information from the history, physical examination and ECG.
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Footnotes
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This study was funded by the Agency for Healthcare Research and Quality, Rockville, Maryland, contract #290-97-0013 to UCSF-Stanford Evidence-Based Practice Center. Dr. Heidenreich is supported by a Career Development Award from the Veterans Affairs Health Services Research and Development Service.
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Top
Abstract
Methods