(Circulation. 1997;96:122-127.)
© 1997 American Heart Association, Inc.
Articles |
Impact of an Aggressive Invasive Catheterization and Revascularization Strategy on Mortality in Patients With Cardiogenic Shock in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) Trial
An Observational Study
From the Division of Cardiovascular Diseases (P.B.B., D.R.H.), Mayo Clinic, Rochester, Minn; Division of Cardiology (A.L.S., R.M.C.), Duke Clinical Research Institute, Durham, NC; Division of Cardiology (E.R.B.), University of Michigan (Ann Arbor); and Department of Cardiology (E.J.T.), Cleveland Clinic, Cleveland, Ohio.
Correspondence to Peter B. Berger, MD, Division of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, MN 55905. E-mail berger.peter{at}mayo.edu
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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Background Although retrospective analyses have revealed an association between survival and coronary angiography and angioplasty in patients with acute myocardial infarction complicated by cardiogenic shock, the degree to which bias in the selection of patients to undergo these procedures contributes to this observation remains unclear.
Methods and Results We studied 2200 patients in the Global
Utilization of Streptokinase and Tissue Plasminogen
Activator for Occluded Coronary Arteries (GUSTO-I)
trial with acute myocardial infarction complicated by cardiogenic shock
(systolic blood pressure <90 mm Hg for 
1 hour) who
survived 1 hour after the onset of shock to determine the influence
of an aggressive strategy of early angiography (within 24 hours of
shock onset) and coronary angioplasty or bypass surgery, if
appropriate, on survival. Revascularization was not
protocol mandated but was selected by the attending physicians. Shock
was present on admission in 11% and developed after admission in
89% of shock patients. The 30-day mortality was 38% in the 406
patients who underwent early angiography and were referred within 24
hours for angioplasty (n=175), bypass surgery (n=36), angioplasty and
bypass surgery (n=22), or neither (late or no
revascularization, n=173) compared with 62% in the
1794 patients who did not (P=.0001). However, there were
important differences in the baseline characteristics of the two
groups, including younger age (63 versus 68 years, P=.0001),
less prior infarction (19% versus 27%, P=.001), and a
shorter time to thrombolytic therapy (2.9 versus 3.2
hours, P=.0001) in patients treated with an aggressive
strategy. Using multivariate logistic regression
analysis to adjust for differences in baseline characteristics,
an aggressive strategy was independently associated with reduced 30-day
mortality (odds ratio, 0.43 [confidence interval, 0.34 to 0.54],
P=.0001).
Conclusions An aggressive strategy of early angiography (and revascularization when appropriate) is associated with a reduction in mortality in patients with acute myocardial infarction and cardiogenic shock who receive thrombolytic therapy.
Key Words: angiography • angioplasty • infarction • reperfusion • shock
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Cardiogenic shock is the most common cause of death in hospitalized patients with acute myocardial infarction.1 Although the rapid administration of thrombolytic therapy reduces the occurrence of cardiogenic shock,2 3 the best therapy for patients who present with cardiogenic shock or who develop cardiogenic shock despite reperfusion therapy remains controversial. Although retrospective analyses have indicated that survival in such patients who undergo coronary angioplasty is greater than that in patients who do not undergo angioplasty,4 5 6 7 8 9 selection bias may be a confounding variable.10 Differences in the baseline characteristics of patients who undergo angiography and angioplasty have been reported; these may have a major impact on survival and would tend to overestimate the true benefits of angiography and angioplasty.10 The Global Utilization of Streptokinase and Tissue Plasminogen Activator (TPA) for Occluded Coronary Arteries (GUSTO-I) trial was designed to test the hypothesis that thrombolytic strategies achieving more complete, early, sustained coronary artery patency would lead to further reductions in mortality in patients with acute myocardial infarction.11 In the GUSTO-I trial, patients with cardiogenic shock were identified as a subgroup who would be extensively studied, and a specific ancillary data collection form was prospectively designed for this purpose. We analyzed patients with cardiogenic shock in the GUSTO-I trial to determine whether patients treated with an aggressive strategy of early angiography and revascularization, when appropriate, differed from patients in whom a less aggressive strategy was pursued and whether after accounting for such differences, an aggressive strategy was associated with a reduction in 30-day mortality.
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Methods |
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The details of the GUSTO-I trial have been described in detail.11 Briefly, 41 021 patients with acute myocardial infarction were randomized to one of four thrombolytic regimens: streptokinase with subcutaneous or intravenous heparin, accelerated TPA with intravenous heparin, or a combination of streptokinase plus TPA with intravenous heparin. Eligible patients had ST-segment elevation of
0.1 mV in two
or more limb leads or 0.2 mV in two or more contiguous precordial
leads, onset of ischemic pain within 6 hours of randomization,
and no contraindications to thrombolysis. The primary
outcome of the trial was all-cause 30-day mortality.
In the trial, 2972 patients met the prospectively defined criteria for
cardiogenic shock: systolic blood pressure <90 mm Hg for
1 hour not responsive to fluid administration or the need for
positive inotropic agents to maintain a systolic blood pressure
of >90 mm Hg. Of these, 315 patients had shock on enrollment,
and 2657 developed shock after enrollment in the trial. Patients who
died within 1 hour of the onset of shock (n=155) were excluded from
analysis; the inclusion of patients who did not survive long
enough to undergo coronary angiography as if they were treated
with a "less aggressive strategy" would bias the study in favor
of an aggressive strategy. Patients in whom 30-day survival was not
known (n=4) and in whom data regarding the performance and
timing of angiography were not available (n=606) were also excluded
from analysis. Some patients met more than one exclusion
criterion. After these exclusions, there were 2200 patients for
analysis (Fig 1
).
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Patients were divided into those treated with an "an aggressive strategy" in whom coronary angiography was performed within 24 hours of shock onset (group 1, n=406) and the remaining patients (group 2, n=1794). The primary end point of the study was 30-day mortality in group 1 patients compared with group 2 patients. In the GUSTO-I trial, angiography and revascularization were not protocol mandated but were selected by the primary physicians. A secondary analysis was performed of group 1 patients who underwent early coronary angioplasty to determine whether there was a difference in outcome between patients in whom angioplasty was and was not successful and whether differences in baseline clinical characteristics of patients with successful and unsuccessful angioplasty contributed to a difference in outcome between these two groups.
Statistical Analysis
Continuous variables are presented as mean±1 SD,
and medians are given with the 25th and 75th percentiles in
parentheses. Discrete variables are expressed as frequencies, with
percentages given in parentheses. Differences in continuous
variables between groups were tested using a Wilcoxon
rank-sum test. Differences in discrete variables were examined with
the use of 
2 tests. Results were interpreted as
statistically significant when P<.05.
Multivariate logistic regression analysis was
used to determine whether there was an independent association between
an aggressive strategy of early angiography (and
revascularization if appropriate) and survival,
built on a previously reported model of clinical characteristics
associated with mortality in the entire GUSTO-I patient
population.12 Other variables included in the model
were systolic blood pressure, heart rate, infarct location,
previous infarction, height, time to thrombolysis,
current smoking, history of smoking, diabetes mellitus, weight,
previous bypass surgery, thrombolytic agent received,
history of hypertension, history of cerebrovascular disease,
thrombolytic regimen, and use of an intra-aortic
balloon pump. Cross-validation of the 30-day
multivariate model produced an adjustment of 0.002 to
the operating characteristic area, reducing the value from 0.86 to
0.834. The bootstrapping technique produced exactly the same
correction.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Baseline Characteristics
The mean age of patients with cardiogenic shock in the study population was 67 years; 62% were male (Table 1
). There
were important differences in the clinical characteristics of patients
who underwent early angiography compared with those who did not,
including a younger mean age (63.3 versus 68.4, P=.0001),
less frequent prior angina (38% versus 43%, P=.05) and
prior infarction (19% versus 27%, P=.001), and a shorter
mean time to thrombolytic therapy (2.9 versus 3.2
hours, P=.001). Patients referred for early angiography were
more likely to have a family history of coronary artery disease
(46% versus 35%, P=.0001) and a history of
hyperlipidemia (38% versus 28%,
P=.0001).
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Frequency of Revascularization in Patients
Undergoing Early Angiography
Based on the results of angiography, 255 group 1 patients (63%)
underwent revascularization within 24 hours of
angiography. Coronary angioplasty alone was performed in 175
patients (43%), and bypass surgery alone was performed in 36 patients
(14%); 22 patients underwent both coronary angioplasty and
bypass surgery (5%). One hundred seventy-three patients who underwent
early angiography were not referred for
revascularization within 24 hours (37%). Of these,
45 patients were referred for "late"
revascularization a mean of 6±4 days after
infarction (23 patients to angioplasty, 20 patients to bypass surgery,
and 2 patients to angioplasty followed by bypass surgery).
Clinical Outcome
Adverse cardiovascular events in the 30 days after
enrollment in the trial are shown in Table 2 and Fig 2. Mortality was significantly lower in patients
referred for early angiography (38% versus 62%, P=.0001).
Reinfarction occurred with similar frequency in the two groups (8.9%
versus 8.6%, P=.85), although recurrent ischemia
was more frequent in patients who underwent early angiography (31%
versus 21%, P=.001), as were the development of sustained
ventricular tachycardia (32% versus 26%,
P=.013) and ventricular septal defect (4.9%
versus 1.3%, P=.0001). Asystole occurred less frequently in
patients referred for early angiography (28% versus 44%,
P=.001).
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The mortality difference between patients in whom early angiography was and was not performed remained significant 1 year after enrollment in the trial (44.2% versus 66.4%, respectively; P=.001).
Among patients in the aggressive invasive strategy group in whom
coronary angiography revealed either no severe (50% luminal
diameter) coronary artery stenoses (n=3) or one-vessel
disease (n=106), 30-day mortality was 21.9%. In patients with
two-vessel disease (n=115), 30-day mortality was 38.3%; and mortality
was 41.8% at 30 days in patients with three-vessel disease.
There were 173 patients who underwent early
catheterization in whom
revascularization was not performed within 24 hours
(Fig 2
); the mortality of this group of patients was lower than that of
the group of patients in whom early angiography was not performed (35%
versus 62%, respectively). Forty-five of these patients were referred
for "late" revascularization a mean of 6±4
days after infarction; 5 of the 45 patients died (11%) compared with
56 of the 128 early angiography patients (44%) who did not undergo a
revascularization procedure. However, to
investigate why patients undergoing early angiography without
revascularization had a lower mortality rate than
patients in whom early angiography was not performed and determine what
angiographic findings might have led to a decision not to perform early
revascularization, we analyzed the
available angiographic data from this group of patients. In the 100
patients in whom angiographic data were available for analysis,
the mean luminal diameter stenosis of the infarct-related
artery was 87±20%. Thirty patients had a infarct vessel diameter
stenosis of <80%, 37 patients had normal (TIMI 3) flow in the
infarct artery at the time of angiography, and another 22 patients had
TIMI 2 flow.
Multivariate Analysis
To determine whether the reduction in mortality associated with an
aggressive strategy of early angiography and
revascularization, when appropriate, was due to the
important differences in clinical characteristics,
multivariate logistic regression analysis was
performed. This analysis revealed that an aggressive strategy
was independently associated with a reduction in 30-day mortality, with
an odds ratio of 0.43 (confidence interval, 0.34 to 0.54;
P=.0001).
There was no interaction between thrombolytic treatment
received and the performance of an aggressive strategy
(
2=1.165, P=.28).
Relationship Between Outcome of Coronary Angioplasty
and Mortality
To further assess the importance of coronary angioplasty
in patients with cardiogenic shock, we examined the 30-day mortality
rate in the 197 patients in whom early angioplasty was performed (Fig 2). Angioplasty was successful (<50% residual stenosis) in
148 patients (75%) and unsuccessful in 49 patients (25%). The 30-day
mortality rate of patients in whom angioplasty was successful was 35%
versus 55% in patients in whom it was unsuccessful
(P=.007).
To determine whether the lower mortality associated with successful
angioplasty could be accounted for by differences in baseline
characteristics between patients in whom angioplasty was and those in
whom it was not successful, we compared the clinical characteristics of
the two groups. There were no significant differences between these two
groups in any of the characteristics listed in Table 1 that may have
contributed to the difference in mortality.
Use of an Intra-aortic Balloon Pump
An intra-aortic balloon pump was placed in 302 patients
(74.6%) in the aggressive invasive strategy group and in 141 (7.9%)
of patients in the conservative strategy group. Among patients in whom
an aggressive invasive strategy was performed and in whom an
intra-aortic balloon pump was used, the balloon pump was placed the day
catheterization was performed in 93% of patients,
before the day of catheterization in 3%, and after the
catheterization in 4% of patients. The mortality of
patients in the aggressive invasive strategy group with a balloon pump
was 40.7% (n=123) versus 31.1% (n=32) in patients in the aggressive
invasive strategy group without a balloon pump. The mortality of
patients with an intra-aortic balloon pump in the conservative strategy
group was 56.7% (n=80) versus 61.9% (n=1017) in patients without a
balloon pump in the conservative strategy group. When the placement of
an intra-aortic balloon pump was included in the
multivariate analysis, the results indicated
that the use of an intra-aortic balloon pump was not a predictor of
outcome independent of an aggressive invasive strategy
(2=0.294, P=.59).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The most important finding of this study is that an aggressive strategy of early angiography and revascularization, when deemed to be appropriate by the attending physician, was associated with a significant reduction in 30-day mortality in patients with acute myocardial infarction and cardiogenic shock treated with thrombolytic therapy. The benefit was independent of differences in baseline clinical characteristics between this group and patients treated with a less aggressive strategy. Furthermore, the lower mortality rate in patients in whom angioplasty was successful versus those in whom it was unsuccessful could not be explained by differences in clinical characteristics, further supporting the hypothesis that an aggressive revascularization strategy may reduce mortality in such patients.
Many studies have suggested that angioplasty reduces the mortality of patients with acute myocardial infarction complicated by cardiogenic shock.4 5 6 7 8 9 However, these were retrospective analyses, and it has been shown that significant bias exists in the selection of shock patients referred for coronary angioplasty.10 This raises the possibility that more favorable clinical characteristics might have accounted for the lower mortality in patients referred for angioplasty. Other analyses indicating a lower mortality in shock patients in whom angioplasty was successful compared with patients in whom angioplasty was unsuccessful have also raised questions about the degree to which differences in clinical characteristics contributed to the mortality difference. Some investigators have wondered whether unsuccessful angioplasty might actually increase mortality and account, in part, for the relatively lower mortality in patients with successful angioplasty. These studies have been too small to permit multivariate analysis to adjust for baseline differences, and therefore the degree to which baseline characteristics contributed to the lower mortality associated with angioplasty could not be determined. Therefore, in the present study, the largest cohort of cardiogenic shock patients prospectively identified in a randomized trial, we compared the outcome of the patients who were referred for early angiography (within 24 hours of shock onset) and revascularization (within 24 hours of angiography, if considered to be appropriate by the attending physician) to the remaining patients. This analysis revealed that patients referred for early angiography had significantly fewer risk factors associated with death in the trial, including younger age, less prior infarction, and earlier treatment with thrombolytic therapy. However, after adjustment for these and all other risk factors associated with mortality in GUSTO-I, an aggressive strategy of early angiography and revascularization, if appropriate, was still associated with a lower mortality, with an odds ratio of 0.43 and confidence interval of 0.34 to 0.54 (P=.0001).
An intra-aortic balloon pump was used in many patients with shock in the GUSTO-I trial at the discretion of the clinicians caring for the patient; balloon pumps were used most frequently in patients undergoing an aggressive invasive strategy. Although it is possible that the use of an intra-aortic balloon pump may be beneficial in the treatment of shock patients, and particularly in those patients with shock who are undergoing coronary angiography and angioplasty or bypass surgery, the retrospective nature of this study does not permit an appropriate analysis of whether an intra-aortic balloon pump is useful in such patients.
Potential Bias
In this study, we sought to eliminate three sources of bias that
have characterized prior studies of angioplasty in cardiogenic shock.
One is the failure to exclude patients with cardiogenic shock who died
before angiography could have been performed. This biases a study in
favor of an aggressive strategy, since such patients are considered to
have been treated conservatively. One hour is required in most
hospitals with a catheterization laboratory to perform
emergency angiography; accordingly, in this study, we eliminated from
analysis 155 patients who died within 1 hour of the diagnosis
of shock. However, to determine whether the elimination of deaths
occurring within 1 hour of shock onset was sufficient to avoid bias, we
performed additional analyses to determine whether the
elimination of patients who died within 3 hours of shock onset and
within 6 hours of shock onset changed the results. If all deaths
occurring within 3 hours of shock onset are excluded, an aggressive
invasive strategy was still associated with a lower mortality (155
deaths [38%] versus 1100 deaths [61%]). The lower mortality
associated with an aggressive invasive strategy persisted when deaths
within 6 hours of shock onset were excluded (122 [33%] versus 701
[50%].
A second source of bias is the inclusion of patients who survive the initial phases of cardiogenic shock and who undergo angiography and revascularization late in their hospital course. This also biases a study in favor of an aggressive strategy, since such patients who survive to undergo late angiography cannot be considered to have survived because of the angiography and revascularization procedure. In the present study, 302 of the 1794 patients in the conservative group did ultimately undergo angiography during their initial hospitalization at a median of 4.5 days after shock onset. In this analysis, patients who underwent angioplasty and bypass surgery late in their hospitalization were included in the conservative strategy group.
A third source of bias is the failure to account for differences in the
baseline characteristics of patients who are and those who are not
selected for an aggressive strategy. Such differences did exist in our
study population; failure to adjust for more viable patients being
referred for angiography and revascularization also
biases a study in favor of an aggressive strategy. We adjusted for the
observed significant differences in baseline characteristics and for
all the other nonsignificant differences in the other variables
associated with mortality in the GUSTO-I study and found that an
aggressive strategy was nonetheless associated with a marked reduction
in mortality independent of baseline characteristics. To further
investigate whether selection bias may have contributed to the results
of our study, we compared patients in whom angioplasty was and was not
successful. We found that patients in whom angioplasty was successful
had a significantly lower mortality (35%) than patients in whom it was
not successful (55%), and there were no differences between the two
groups in any of the baseline characteristics listed in Table 1 that
might account for the observed association between successful
angioplasty and improved survival.
Study Limitations
Although patients with cardiogenic shock were prospectively
identified as a subgroup for further analysis and a data form
was specifically designed for this purpose, this study is nonetheless a
retrospective analysis and is subject to the limitations of
such analyses. It is possible that differences in baseline
clinical characteristics that were not identified or differences in
clinical characteristics at the time of angiography that were not
analyzed contributed to the difference in outcome between the
groups. Since the decisions to perform coronary angiography and
revascularization were not protocol mandated but
were made by the patient's attending physician, the possibility exists
that differences in clinical or angiographic characteristics other than
those analyzed in the GUSTO-I trial may have contributed to the
association between an aggressive strategy and a reduced mortality.
Furthermore, there are limitations to the use of
multivariate analysis to adjust for even
recognized differences between groups when many such differences
exist.
Conclusions
In patients with acute myocardial infarction and cardiogenic
shock who receive thrombolytic therapy, an aggressive
strategy of early angiography and
revascularization, if appropriate, is associated
with a marked reduction in 30-day mortality compared with patients who
are treated with a less aggressive strategy independent of differences
in baseline clinical characteristics between the two groups.
Furthermore, the lower mortality in patients whose angioplasty was
successful compared with those in whom it was unsuccessful cannot be
accounted for by differences in clinical characteristics, further
supporting the hypothesis that an aggressive
revascularization strategy reduces mortality in
patients with acute myocardial infarction and cardiogenic shock.
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Acknowledgments |
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The authors gratefully acknowledge Penny Hodgson and Pat Williams for their important editorial contributions.
Received September 9, 1996; revision received January 22, 1997; accepted January 23, 1997.
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E. W. Chen, J. G. Canto, L. S. Parsons, E. D. Peterson, K. A. Littrell, N. R. Every, C. M. Gibson, J. S. Hochman, E. M. Ohman, M. Cheeks, et al. Relation Between Hospital Intra-Aortic Balloon Counterpulsation Volume and Mortality in Acute Myocardial Infarction Complicated by Cardiogenic Shock Circulation, August 26, 2003; 108(8): 951 - 957. [Abstract] [Full Text] [PDF]
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D.R Holmes The final common pathway Eur. Heart J., February 1, 2003; 24(3): 214 - 216. [Full Text] [PDF]
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V. Menon and J. S Hochman MANAGEMENT OF CARDIOGENIC SHOCK COMPLICATING ACUTE MYOCARDIAL INFARCTION Heart, December 1, 2002; 88(5): 531 - 537. [Full Text] [PDF]
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N. S. Kleiman, A. M. Lincoff, G. C. Flaker, K. S. Pieper, R. G. Wilcox, L. G. Berdan, T. J. Lorenz, D. V. Cokkinos, M. L. Simoons, E. Boersma, et al. Early Percutaneous Coronary Intervention, Platelet Inhibition With Eptifibatide, and Clinical Outcomes in Patients With Acute Coronary Syndromes Circulation, February 22, 2000; 101(7): 751 - 757. [Abstract] [Full Text] [PDF]
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D. Hasdai, R. M. Califf, T. D. Thompson, J. S. Hochman, E. M. Ohman, M. Pfisterer, E. R. Bates, A. Vahanian, P. W. Armstrong, D. A. Criger, et al. Predictors of cardiogenic shock after thrombolytic therapy for acute myocardial infarction J. Am. Coll. Cardiol., January 1, 2000; 35(1): 136 - 143. [Abstract] [Full Text] [PDF]
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T. P. Wharton Jr., N. S. McNamara, F. A. Fedele, M. I. Jacobs, A. R. Gladstone, and E. J. Funk Primary angioplasty for the treatment of acute myocardial infarction: experience at two community hospitals without cardiac surgery J. Am. Coll. Cardiol., April 1, 1999; 33(5): 1257 - 1265. [Abstract] [Full Text] [PDF]
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