Relationship of Infarct Artery Patency and Left Ventricular
Ejection Fraction to Health-Related Quality of Life After
Myocardial Infarction
The GUSTO-I Angiographic Study Experience
Karin S. Coyne, PhD, MPH; Conor F. Lundergan, MD; Deneane Boyle, MPH;
Samuel W. Greenhouse, PhD; Yasmine C. Draoui, MS; Pamela Walker, BSN; Allan M. Ross, MD;
for the GUSTO-I Angiographic Study Investigators
Downloaded from http://circ.ahajournals.org/ by guest on June 18, 2017
Background—Post–myocardial infarction global ejection fraction and infarct-related artery patency might be expected to
be associated with health-related quality-of-life (HRQOL) outcomes, but this association has not been previously shown.
The GUSTO-I Angiographic Study cohort 2-year follow-up afforded an examination of such potential relationships.
Methods and Results—A total of 1848 patients (87.7% response rate) who were enrolled in the GUSTO-I Angiographic
Study were contacted for a telephone interview regarding their current HRQOL (physical function, psychological
well-being, perceived health status, and social function) 2 years after MI. In multivariable models, left ventricular
ejection fraction (EF) was significantly related to physical (P⫽0.021) and social (P⫽0.014) function, psychological
well-being (P⫽0.042), and perceived health status (P⫽0.024). Infarct-related artery patency was not directly related to
any HRQOL outcome. A decreasing EF was predictive of poorer outcomes in each HRQOL dimension. Men
consistently had better outcomes in all HRQOL dimension with the exception of perceived health status. Increasing age
was predictive of poorer outcomes in all dimensions of HRQOL except for psychological well-being where the inverse
occurred; younger patients experienced greater depression, anxiety and worry than their older counterparts. The
presence of comorbidities increased the likelihood of worse outcomes in all dimensions.
Conclusions—This is the first study to demonstrate a significant relationship between EF and long-term HRQOL
outcomes. This advantage in left ventricular function preservation should be added to the mortality advantage when
considering the impact of treatment strategies for myocardial infarction. (Circulation. 2000;102:1245-1251.)
Key Words: myocardial infarction 䡲 quality of life 䡲 left ventricular function 䡲 patency 䡲 sex
ach year, ⬇1.1 million persons have a myocardial
infarction (MI), with the majority surviving the acute
event.1 Increases in survival after MI can in large part be
attributed to aggressive therapies that limit myocardial damage by achieving infarct-related artery (IRA) patency and
preserving left ventricular (LV) function.2– 4 In addition to the
mortality advantage of patent infarct arteries and preserved
LV function, advantages might also be expected to be seen in
health-related quality-of-life (HRQOL) outcomes, which are
based on the premise that a person’s clinical status affects his
or her quality of life.5,6 Unfortunately, despite the plethora of
HRQOL research on MI survivors, a relationship between
physiological outcome after MI (namely, LV function) and
HRQOL has yet to be demonstrated.7–11 Furthermore, the
effect of patency on HRQOL outcomes has not yet been
reported.
E
The GUSTO-I Angiographic Study, which has a large
single-source angiographic database of acute MI patients,
permits the relationship between physiological outcome and
HRQOL to be fully examined. The purpose of the present
study was to test the hypotheses that (1) patients with patent
arteries at 90 minutes would report higher HRQOL 2 years
after MI than would those with closed arteries and (2) patients
with quantitatively better LV function would report better
HRQOL 2 years after MI than would those with depressed
LV function.
Methods
Patients
Patients from 75 centers in 10 countries were recruited into the
GUSTO-I Angiographic Study12 from June 1991 through February
1993. The eligibility criteria have been previously described.13
Received February 4, 2000; revision received April 6, 2000; accepted April 13, 2000.
From the George Washington University Cardiovascular Research Institute (K.S.C., C.F.L., D.B., Y.C.D., P.W., A.M.R.), Washington, DC; MEDTAP
International (K.S.C.), Bethesda, Md; and The George Washington University Biostatistics Center (S.W.G.), Washington, DC.
Correspondence to Karin S. Coyne, PhD, RN, MPH, MEDTAP International, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814. E-mail
[email protected]
© 2000 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org
1245
1246
Circulation
September 12, 2000
Patients were contacted for telephone interviews during the
follow-up period from February 1994 through July 1995. Patients
randomized into the GUSTO-I Angiographic Study were contacted
by clinical site personnel 2 years after their GUSTO-recorded MI.
For sites at which patients could not be contacted for follow-up
interviews, trained interviewers at central facilities in Leuven,
Belgium, and Washington, DC, interviewed patients. When patients
could not be interviewed due to extraneous factors (eg, no translation
available, incarceration), vital status was obtained. To standardize
the interview process, all interviewers were trained and given
detailed scripts to read during the interview. The follow-up study
was either approved or exempted by the institutional review board or
ethical committee of all participating hospitals. Patients provided
verbal consent at the start of the telephone interview. All patients
were given the opportunity to refuse participation, to not answer
specific questions, or to terminate the interview at any time.
Angiographic Core Laboratory
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The assessments of LV function and coronary artery patency were
described previously.12 Patients were randomized to 1 of 4 treatment
regimens13 and to 1 of 4 angiographic time periods (90 or 180
minutes, 24 hours, or 5 to 7 days). Patency was assessed according
to Thrombolysis in Myocardial Infarction (TIMI) flow grade14; only
the 90-minute patient cohort was used for the patency analysis. Left
ventriculograms were obtained in a 30° right anterior oblique
projection within a relatively narrow time window after MI (median
4.9 days after MI [25th/75th percentiles 0.185, 6.48 days]). All
ejection fractions (EFs) were calculated in a standardized manner
with the area-length method15 with ventriculographic silhouettes
being acquired digitally at end systole and end diastole and the
borders defined by a core laboratory angiographer.
HRQOL Assessment
HRQOL was defined as a multidimensional concept that reflects a
person’s perception of their physical, psychological, and social
function and health status.16,17 A battery approach, which combines
previously validated generic and disease-specific questionnaires to
create a multidimensional profile, was used to capture HRQOL.18
Each questionnaire was translated into Dutch, French, German, and
Spanish through forward-backward methodology with an expert
review of the final translation.19
The “physical function” dimension of HRQOL was assessed with
the Duke Activity Status Index,20 which was developed specifically
to evaluate physical activities in cardiac populations. “Psychological
well-being” was measured with the emotional component of the
Minnesota Living With Heart Failure Questionnaire21 (modified in
wording only to “living after a heart attack”). “Social function” was
assessed with 2 questions: 1 from the SF-3622 and 1 from the
Minnesota Living With Heart Failure Questionnaire. “Perceived
health status” was assessed with the general health component of the
Medical Outcomes Study SF-36,22 which has been used in a
multitude of clinical settings as a “direct” evaluation of a person’s
personal health.
Symptoms
Cardiac symptoms (dyspnea and angina) were treated as an antecedent or a contributing factor to HRQOL, with the incidence of each
reported descriptively. Symptoms were assessed according to the
Rand Dyspnea Severity Scale23 and the Rose Angina Questionnaire.24 The Rand Dyspnea Severity Scale was scored by creating a
Guttman Scalogram with 5 levels (from 0 for no dyspnea to 4 for
severe dyspnea).23 Angina was scored dichotomously.
All selected questionnaires have previously demonstrated reliability and validity.8,9,11,20 –28 The occurrence of repeat hospitalizations
during the 2-year period and current medication use were also
assessed. Test-retest reliability was assessed by contacting a subset
of patients for a second interview within 10 to 20 days after the first
interview.
Statistical Analysis
Descriptive statistics for continuous end points are presented as
median and interquartile range values and as percentages for discrete
variables. To facilitate subgroup analyses by country, all participating European countries were analyzed as 1 country, resulting in the
following groups: Australia, Canada, Europe, and United States.
Test-retest reliability was assessed with intraclass correlations for
continuous variables and Cohen’s ␬ for discrete or ordinal data.29
The internal consistency of each dimension was assessed using
Cronbach’s ␣.30 Group differences were evaluated with contingency
tables for categorical variables and ANOVA for continuous variables. The Student-Newman-Keuls procedure was applied a posterior to identify differences in continuous group mean values.31
Responses from this fairly healthy patient sample were not
normally distributed; thus, multivariate logistic regression was used
to further test the study hypotheses. Outcome variables were made
dichotomous with patients who scored in the worst 25th percentile of
each dimension considered to represent an “event”; patients outside
of the worst 25th percentile were considered to represent a nonevent.32 TIMI and EF models were conducted separately with the
same covariates in each model. The Hosmer and Lemeshow
goodness-of-fit test was used to evaluate model fit, with a nonsignificant P value indicative of adequate fit.33 Covariates placed in all
models were age, sex, body mass index, treatment group, location of
infarction, previous MI, previous CABG, diabetes, hypertension,
hyperlipidemia, and a composite score of in-hospital events. The
in-hospital event score was created as an index of the patient’s
severity of illness during acute hospitalization and was calculated by
summing the occurrence of the following events: major bleeding,
stroke, congestive heart failure/pulmonary edema, reinfarction, recurrent ischemia, atrial fibrillation, defibrillation, permanent pacemaker insertion, and CABG. Patients with incomplete data were
excluded from multivariable modeling. All probability values reported were 2-tailed; a level of P⬍0.05 defined statistical
significance.
Results
Of the original 2431 patients, 323 died before the 2-year
follow-up. Of the remaining 2108 patients, a total of 1848
patients responded to the telephone interview (response rate
87.7%), 56 (2.6%) were lost to follow-up, 86 (4.1%) refused
to be interviewed, and 118 (5.6%) were unable to be
interviewed. Of the 1848 interviews, 17 were obtained via
proxy and subsequently excluded from analysis. The median
time to contact patients was 2.2 years (mean 2.3 years). Table
1 displays the baseline characteristics of the interviewed
patients versus those who were not interviewed. Deceased
patients had been significantly older with more comorbidities
and lower EFs than the other patients. Each instrument of the
HRQOL battery demonstrated high internal consistency and
test-retest reliability. Tables 2 and 3 display the scores for
each dimension of HRQOL and the frequency of dyspnea and
angina by patency grade and EF. There were no differences in
HRQOL outcomes by initial patency grade except patients
with closed arteries (TIMI 0 or 1) reported significantly more
angina (P⫽0.03) at 2 years than did those with patent arteries.
When the final IRA patency grade was assessed in patients
who had emergent PTCA (15.4%), there were no significant
differences in HRQOL outcomes or symptoms. For descriptive purposes only, EF was dichotomized at 40% to emphasize differences in HRQOL according to good versus poor
LV function. EFs of ⱕ40 were associated with poorer
function in each dimension, more dyspnea and angina, and a
greater rehospitalization rate at 2 years after MI. Significant
differences also existed between men and women, with
Coyne et al
TABLE 1.
GUSTO-I Angiographic Experience
1247
Baseline Characteristics
Interviewed
(n⫽1848)
Characteristic
Refused
(n⫽86)
Alive, No
Interview
(n⫽118)
Lost
(n⫽56)
Deceased
(n⫽323)
Age, mean y
59.5
62.4
54.4
53.5
68.8
Body mass index, mean
kg/m2
26.8
26.8
27.7
27.4
26.5
EF, mean, %
58.9
55.7
57.2
56.0
46.6
TIMI 3 flow grade at 90
min, %
40.3
34.1
28.3
53.3
25.7
Composite in-hospital event
score (range 0–10), mean
0.71
0.81
0.48
0.61
1.79
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White (n⫽1997), %
92.4
83.6
88.2
73.5
90.3
Female, %
21.0
17.4
16.1
14.3
35.0
Diabetes, %
11.6
15.1
11.0
20.0
18.4
Hypertension, %
34.2
50.0
29.7
29.1
47.5
Hyperlipidemia, %
35.2
25.3
38.6
32.1
31.0
Previous MI, %
11.5
16.3
11.9
12.5
26.5
Previous CABG, %
3.9
2.3
1.7
3.6
9.3
Previous angina, %
32.9
46.5
32.2
33.9
46.7
women reporting significantly poorer HRQOL in each dimension and experiencing more dyspnea than men. There
were no sex differences in rehospitalization rates. No differences were noted in HRQOL scores across country or
treatment groups.
To further examine the effects of patency and EF on
HRQOL, multivariable models were performed. TIMI flow
was not a significant predictor in any of the HRQOL
dimensions examined in the present study. In contrast, EF (as
a continuous variable) was a significant predictor of all
HRQOL outcomes (Table 4). Female sex was predictive of a
poorer HRQOL outcome in 3 of 4 dimensions. Increasing age
was a significant predictor in each HRQOL dimension with
the exception of psychological well-being, where the inverse
occurred. The calculated probabilities of poor physical function and poor psychological well-being given the effects of
EF, sex, age, and comorbidities are displayed in Figures 1 and
2, respectively. Women consistently had higher probabilities
of poorer outcomes than men, and the presence of comorbidities additionally compounded the probability of a poorer
outcome for both sexes. Important to note (Figure 2), age was
inversely related to psychological well-being, indicating that
younger patients experienced greater psychological distress
(eg, depression and worry) after MI. A 50-year-old patient
with no comorbidities has essentially the same probability of
a poor psychological well-being as a 70-year-old patient with
comorbidities. The effects of EF and comorbidities on the
probability of “poor” social function and perceived health
status were similar to those displayed in Figure 1.
Repeat hospitalizations were predicted with the in-hospital
event score and the presence of anterior infarction and diabetes.
The occurrence of angina at the 2-year time point was predicted
by younger age, female sex, anterior infarction, and the presence
of diabetes; TIMI flow and EF were not related to angina. The
occurrence of severe dyspnea (score ⬎2) was predicted by EF,
female sex, body mass index, and previous MI.
TABLE 2.
TABLE 3.
HRQL and Clinical Outcomes by TIMI Flow
Dimension
TIMI 0, 1
(n⫽256)
TIMI 2
(n⫽225)
TIMI 3
(n⫽324)
P
HRQL profile (range)
Physical function (0 –58.2)*
HRQL and Clinical Outcomes by Ejection Fraction
Dimension
EF⬎40
(n⫽1514)
EFⱕ40
(n⫽167)
P
HRQL profile (range)
35.1
33.6
34.1
0.63
Physical function (0 –58.2)*
Psychological well-being (5–30)†
8.8
9.0
8.4
0.49
Psychological well-being (5–30)†
8.5
9.6
Perceived health status (5–25)†
12.2
11.7
11.6
0.20
Health perception status (5–25)†
11.7
15.1
0.001
3.4
3.5
3.3
0.57
Social function (2–12)†
3.3
3.9
0.002
Dyspnea, % reporting dyspnea
score ⬎2
33.5
36.9
34.5
0.30
Dyspnea, % reporting dyspnea
score ⬎2
12.4
21.8
0.001
Angina, % reporting symptom
31.2
24.8
21.8
0.03
Angina, % reporting symptom
23.4
33.7
0.003
Rehospitalization, % with event
44.8
47.6
46.1
0.88
Rehospitalization, % with event
43.8
51.8
0.05
Social function (2–12)†
Clinical outcomes
*High score indicates better function.
†High score indicates worse function.
35.0
30
0.0003
0.006
Clinical indicators
*High score indicates better function.
†High score indicates worse function.
1248
Circulation
September 12, 2000
TABLE 4.
Results of Multivariate Logistic Regressions:
Factor
Parameter
Estimate
Wald
␹2
P
OR
95% CI
Physical function†
Female
0.928
44.3
0.0001
2.5
1.92, 3.32
Age, per 10 y
0.238
17.5
0.001
1.26*
1.13, 1.41
Previous MI
0.616
10.96
0.009
1.9
1.28, 2.66
Hypertension
0.360
8.0
0.005
1.4
1.12, 1.84
Diabetes
0.483
7.55
0.006
1.6
1.14, 2.28
Hyperlipidemia
⫺0.316
5.94
0.015
0.7
0.56, 0.94
EF, per 10 units
⫺0.102
5.31
0.021
0.90*
0.83, 0.985
Psychological well-being‡
Female
0.614
19.33
0.0001
1.85
1.40, 2.43
Age, per 10 y
⫺0.180
11.55
0.0007
0.84*
0.75, 0.93
EF, per 10 units
⫺0.128
8.78
0.003
0.88*
0.81, 0.96
0.374
4.11
0.042
1.45
1.01, 2.08
Previous MI
0.617
12.35
0.024
1.85
1.31, 2.6
Diabetes
0.458
7.31
0.007
1.58
1.13, 2.2
Hypertension
0.322
7.11
0.008
1.4
1.09, 1.75
5.1
0.024
0.91*
0.84, 0.99
0.277
4.23
0.04
1.03
1.0, 1.06
Female
0.610
20.15
0.0001
1.34
1.14, 2.4
Body mass index
0.046
12.43
0.004
1.05
1.02, 1.07
Previous MI
0.482
7.33
0.0068
1.62
1.14, 2.29
Previous MI
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Perceived health status§
EF, per 10 units
Body mass index
⫺0.097
Social function¶
EF, per 10 units
Age, per 10 y
⫺0.010
0.012
6.02
0.014
0.90*
0.83, 0.98
4.8
0.028
1.12*
1.01, 1.25
*OR and CIs for age and EF are calculated for a 10-year or 10-unit change.
†Hosmer and Lemeshow goodness of fit test⫽4.5 with 8 df, P⫽0.81.
‡Hosmer and Lemeshow goodness of fit test⫽10.97 with 8 df, P⫽0.20.
§Hosmer and Lemeshow goodness of fit test⫽9.61 with 8 df, P⫽0.29.
¶Hosmer and Lemeshow goodness of fit test⫽11.53 with 8 df, P⫽0.17.
Discussion
The long-term mortality benefits of reperfusion, by both IRA
patency and preserved LV function, have been documented.3,34 However, the goal of reperfusion is not only to
decrease long-term mortality rates but also to improve morbidity rates and HRQOL. This is the first study to demonstrate a relationship between EF and HRQOL after MI.
Preserved EF after MI was predictive of HRQOL, specifically
physical function, psychological well-being, perceived health
status, and social function. These results provide additional
information on the long-term benefits of reperfusion.
Previous investigations failed to show such relationships (between EF and HRQOL) after MI or in cardiac populations7–11 but
differed from the present study in many ways. The GUSTO-I
angiographic follow-up study was the only HRQOL study in which
EF was obtained in a standardized manner (left ventriculography)
and during a specific timeframe and analyzed at a central angiographic core laboratory. Previous trials used a variety of EF
measures (eg, echocardiograms, radionuclide imaging) obtained at
various time points before trial entry.35–37 In addition, no central
core laboratory analysis of LV function occurred in prior studies.
The consistency in the measurement and analysis of EF in the
present study minimized measurement error.
This patient population was also considerably healthier than
previous study populations that examined this relationship and
consisted primarily of patients with congestive heart failure. The
mean EF in this sample was 58.2, whereas the other study
populations required EFs of ⬍35 or 40 for patient eligibility,
thereby creating patient samples with uniformly poor LV performance and limited variability in EF.35–37
Furthermore, in the present study, multivariable logistic regressions were used to examine the relative and joint effects of
sociodemographic and clinical factors on HRQOL after MI. Patients at the highest risk for poor HRQOL (ie, those in the worst
25th percentile) were those who had a combination of factors.
Patients with low EF and with comorbidities who were female were
at the highest risk of poor HRQOL, whereas patients with high EF
and with no comorbidities who were male were at the lowest risk.
In this multivariable analysis, IRA patency at 90 minutes was not
related to HRQOL, which is surprising given its strong relationship
to death.2,34 This is likely due to the fact that early IRA patency
Coyne et al
GUSTO-I Angiographic Experience
1249
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Figure 1. Probability of poor physical
function 2 years after MI for men and
women with and without existing
comorbidities for 50-year-olds (A) and
70-year-olds (B).
provides clinical benefits primarily through better preservation of
LV function, which appears to be the final pathway to improved
outcome. In addition, patency rates evolve, and what may have been
documented as patent at 90 minutes may or may not have been
patent at 4 months or 1 year. Although IRA patency is strongly
related to death, it does not appear to independently affect long-term
HRQOL outcomes except through its effects on LV preservation.
The negative impact of long-term comorbidities on HRQOL has
been previously noted.10,22 This analysis was limited in that only
comorbidities that were related to cardiac disease (eg, hypertension,
diabetes, previous MI) were recorded. Other prevalent comorbidities (eg, arthritis, cancer) were not collected at the time of the initial
infarction, so their predictive impact cannot be assessed.
Women consistently reported lower HRQOL than men (with the
exception of perceived health status). This finding was consistent
with previous post-MI research.38–41 Using multiple regression,
Ekeberg et al38 found that age, severity of illness, and previous
medical history did not account for lower HRQOL in women.
Shumacher et al10 found that women had significantly lower scores
in social and physical functioning, life satisfaction, and mental
health and more symptoms than men, despite controlling for age,
EF, comorbidities, perceived stress, country, and other treatment
variables. Interestingly, in a general population health survey,
women also reported lower HRQOL than men,22 which indicates
that sex differences in HRQOL are not particular to post-MI
patients.
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Circulation
September 12, 2000
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Figure 2. Probability of poor psychological well-being 2 years after MI for men
and women with and without existing
comorbidities for 50-year-olds (A) and
70-year-olds (B).
One must speculate whether the sex differences in HRQOL are
biological or methodological. A recurrent explanation of why
women report lower HRQOL is that they have more psychosomatic
complaints and better symptom recall and are more vocal about
their negative feelings.42,43 If this explanation is correct, then a
self-report bias may explain the differences. However, the noted
HRQOL differences may also be attributed to a methodological
bias, because there appears to be an underrepresentation of women
in post-MI HRQOL studies. Alternatively, the differences may be
real, indicating that women do fare worse after MI. This issue
cannot be answered within this analysis but merits further
investigation.
A potential limitation of the present study is the temporal
relationship between the event (the GUSTO MI) and the HRQOL
interview 2 years later. Much can and does happen to individuals
during a 2-year period, including reinfarctions, medication changes,
and major life events. Interim events may have a greater potential
effect on a patient’s current HRQOL status than patency or EF. This
temporal relationship must be considered when reviewing the
findings of the present study. In addition, no baseline HRQOL data
were collected, thereby limiting this analysis to cross-sectional
HRQOL data.
Another potential limitation is that the population in this analysis
was highly selective in that all patients qualified for thrombolytic
therapy and were treated in settings with 24-hour angiographic
capabilities. Thus, the results of this trial may not be generalizable
to the general post-MI population; patients who do not qualify for
thrombolytic therapies may not experience similar outcomes.
Coyne et al
Importantly and despite these limitations, the present study sheds
light on potential predictors of poor HRQOL after MI. Patients with
such attributes may be identified at hospital discharge and targeted
for additional follow-up or interventions to decrease negative
outcomes.
Acknowledgments
This work was funded by a grant from Genentech, Inc (South San
Francisco, Calif). The authors gratefully acknowledge the participation of the GUSTO-I angiographic sites, the patients who participated, and the staff of the George Washington Cardiovascular
Research Institute. The authors would also like to thank Nancy Kline
Leidy, PhD, for her comments on and critique of an earlier version
of the manuscript.
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Relationship of Infarct Artery Patency and Left Ventricular Ejection Fraction to
Health-Related Quality of Life After Myocardial Infarction: The GUSTO-I Angiographic
Study Experience
Karin S. Coyne, Conor F. Lundergan, Deneane Boyle, Samuel W. Greenhouse, Yasmine C.
Draoui, Pamela Walker, Allan M. Ross and for the GUSTO-I Angiographic Study Investigators
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Circulation. 2000;102:1245-1251
doi: 10.1161/01.CIR.102.11.1245
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