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Ann Thorac Surg 2008;86:29-34. doi:10.1016/j.athoracsur.2008.03.019
© 2008 The Society of Thoracic Surgeons
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Right arrow Coronary disease

Original Articles: Adult Cardiac

Outcome After Surgery and Percutaneous Intervention for Cardiogenic Shock and Left Main Disease

Michael S. Lee, MDa,c,*, Chi-Hong Tseng, PhDb,c, Colin M. Barker, MDd, Venu Menon, MDe, David Steckman, MDd, Richard Shemin, MDc, Judith S. Hochman, MDd

a Division of Cardiology, University of California, Los Angeles Medical Center, Los Angeles, California
b Department of Medicine, University of California, Los Angeles Medical Center, Los Angeles, California
c Department of Cardiac Surgery, University of California, Los Angeles Medical Center, Los Angeles, California
d Division of Cardiology, New York University Medical Center, New York, New York
e Division of Cardiology, Cleveland Clinic, Cleveland, Ohio

Accepted for publication March 7, 2008.

* Address correspondence to Dr Lee, UCLA Medical Center, Adult Cardiac Catheterization Laboratory, 10833 Le Conte Ave, Room BL-394 CHS, Los Angeles, CA 90095-171715 (Email: mslee{at}mednet.ucla.edu).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Limitations
 Conclusions
 Acknowledgments
 References
 
Background: The ideal revascularization strategy (bypass surgery versus percutaneous coronary intervention [PCI]) for patients with cardiogenic shock in the setting of left main coronary artery disease is unknown.

Methods: The Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock Trial and Registry included 164 patients with left main disease who underwent revascularization. Although the standard of care at the time and the trial protocol recommended coronary artery bypass graft surgery for patients with left main disease, the revascularization strategy (79 coronary artery bypass graft surgery and 85 PCI) was individualized for each patient by site investigators.

Results: The median time from myocardial infarction to revascularization was 24.3 hours (interquartile range, 8.7 to 82.5 hours) in the surgical group and 7.4 hours (interquartile range, 3.7 to 19.5 hours) in the PCI group (p < 0.05). Overall 30-day survival with surgery in this setting was 54% (95% confidence interval, 0.43 to 0.69) and was significantly superior to the 14% (95% confidence interval, 0.09 to 0.35) in the PCI group (p ≤ 0.001). When the left main was the infarct-related artery, the 30-day survival rate was 40% in the surgical group (n = 6) and 16% in the PCI group (n = 15; p = 0.03). Coronary artery bypass graft surgery (hazard ratio, 0.41; 95% confidence interval, 0.22 to 0.77; p = 0.006) and age (per 10 years, hazard ratio, 1.04; 95% confidence interval, 1.01 to 1.08; p = 0.02) were independently associated with 30-day survival.

Conclusions: Coronary artery bypass graft surgery appeared to provide a survival advantage over PCI at 30-day follow-up in patients with left main coronary artery disease. The impact of current PCI strategies on this subgroup is undetermined.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Limitations
 Conclusions
 Acknowledgments
 References
 
Cardiogenic shock occurs in approximately 5% to 10% of patients with ST elevation myocardial infarction and is the leading cause of death in these patients [1–3]. Early revascularization improved survival compared with initial medical stabilization and delayed revascularization in patients with myocardial infarction complicated by cardiogenic shock [4–6]. Similar survival rates were observed in patients treated with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) [6, 7].

Left main coronary artery (LMCA) disease represents a significant independent predictor of mortality in patients with myocardial infarction complicated by cardiogenic shock [8]. The revised American College of Cardiology/American Heart Association guidelines indicate that PCI is class IA indication for the management of myocardial infarction complicated by cardiogenic shock and is a class IA indication for CABG if there is suitable coronary anatomy [9]. The standard of care for patients with LMCA disease is CABG [10]. However, PCI has been shown to be a viable alternative in patients with LMCA disease, including high-risk patients [11, 12].

The purpose of this study was to evaluate the 30-day survival with CABG and PCI in patients with LMCA disease to identify the ideal revascularization strategy in patients with myocardial infarction complicated by cardiogenic shock and LMCA disease.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Limitations
 Conclusions
 Acknowledgments
 References
 
Study Population
The Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) Trial and Registry enrolled patients from 36 multinational centers starting from April 1993 and continuing to November 1998 for the trial, and to August 1997 for the registry. The registry required a clinical diagnosis of shock, and the trial inclusion and exclusion criteria have been previously defined [13]. The clinical criteria for cardiogenic shock included hypotension (a systolic blood pressure of <90 mm Hg for ≥30 minutes or the need for inotropic agents or an intraaortic balloon pump to maintain a systolic blood pressure of ≥90 mm Hg) and hypoperfusion of end organs (cool extremities or a urine output of <30 mL/h, and a heart rate of ≥60 beats/min). The hemodynamic criteria for cardiogenic shock included a cardiac index of no more than 2.2 L · min–1 · m–2 of body surface area and a pulmonary capillary wedge pressure at least 15 mm Hg [4]. The prospective, multicenter registry included patients who did not meet all the inclusion criteria for randomization and those who met criteria but were not enrolled in the randomized trial, were outside the specific time windows, were unable or refused to sign consent, or had an exclusion criterion [14]. Of the 302 patients in the trial and 1,190 patients in the registry, the study population included 164 patients who had LMCA stenosis of at least 50% who underwent emergent revascularization (CABG, n = 79; PCI, n = 85). The use of intraaortic balloon pump counterpulsation was protocol-recommended for patients in the trial. There were no recommendations for the management of registry patients. There were protocol recommendations in the trial regarding the choice of revascularization, but the decision was by site investigators, made on an individual basis.

The SHOCK clinical coordinating center at New York University has institutional review board approval to continue to do analyses and publish. Regarding the first author (M.S.L.), the UCLA Institutional Review Board determined that the research does not involve human subjects as defined in the federal regulations because no individual level data were obtained or accessed.

Randomized Trial Protocol Recommendations for Revascularization
Emergency PCI of the infarct-related artery was recommended if patients had single- or double-vessel coronary artery disease, or in patients with single-, double-, or triple-vessel disease in which the stenoses in two non–infarct-related arteries were less than 90% or were located in arteries supplying small branch vessels [7].

Emergency CABG was recommended for patients with LMCA stenosis of at least 50%, a least two total or subtotal occlusions, stenoses of greater than 90% in two non–infarct- related major arteries, disease unsuitable for PCI, or unsuccessful PCI [7]. If PCI was successfully performed only on the infarct-related artery in patients with triple-vessel disease, evaluation for subsequent CABG was recommended during the same hospitalization.

Angiographic Core Laboratory
All angiograms obtained in the trial were analyzed by the Angiographic and Echocardiographic Core Laboratories by two independent, blinded readers. A third reader resolved any discrepancies. In contrast, angiograms obtained in the registry were not analyzed in a core laboratory but rather during central completion of standardized report forms based on local laboratory reports.

Definitions
Complete revascularization with CABG was judged by the surgeon at the time of CABG [4].

Statistical Analysis
Continuous variables were summarized as mean ± standard deviation and were compared using Student's t test. Categorical variables were compared by Fisher's exact test. Thirty-day survival curves were generated by the Kaplan–Meier method, and group differences were assessed by the log-rank test. A multiple Cox regression model with left truncation was used to identify risk factors for 30-day mortality and attempt to correct for the bias that would be attributable to the differential time to revascularization. All statistical tests were two-tailed, and a significance level of 0.05 was used throughout. Statistical analysis was conducted using SPSS version 14.0 (SPSS Inc, Chicago, IL).


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Limitations
 Conclusions
 Acknowledgments
 References
 
Baseline Demographic and Angiographic Characteristics
The study population comprised 164 patients with myocardial infarction complicated by cardiogenic shock and LMCA disease who underwent emergent revascularization (CABG, n = 79; PCI, n = 85). The CABG group had a higher prevalence of triple-vessel disease compared with the PCI group (72.9% versus 87.0%; p = 0.02; Table 1). The LMCA was the infarct-related artery in 24.5% who underwent CABG and 24.4% who underwent PCI. The mean peak creatine kinase level was 2,502 ± 2,593 U/L in the CABG group and 4,203 ± 5,364 U/L in the PCI group (p = 0.011).


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  		Table 1 Baseline Demographic and Angiographic Characteristics
 
Timing and Baseline Hemodynamic Data
The median time from myocardial infarction to revascularization was 24.3 hours (interquartile range, 8.7 to 82.5 hours) in the CABG group and 7.4 hours (interquartile range, 3.7 to 19.5 hours) in the PCI group (p <0.01; Table 2). The median time from the onset of shock to revascularization was 11.3 hours (interquartile range, 3.9 to 77.8 hours) in the CABG group compared with 3.8 hours (interquartile range, 1.9 to 7.6 hours) in the PCI group (p < 0.01). The median time from myocardial infarction to revascularization was 33.2 hours (interquartile range, 8.6 to 113.0 hours) in the CABG registry group compared with 7.1 hours (interquartile range, 4.5 to 14.8 hours) in the PCI registry group (p < 0.01). The median time from the onset of shock to revascularization was 18.1 hours (interquartile range, 2.2 to 100.3 hours) in the CABG registry group compared with 4.8 hours (interquartile range, 2.4 to 9.9 hours) in the PCI registry group (p < 0.01).


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  		Table 2 Timing Data a
 
There were no significant differences in hemodynamic data including systolic blood pressure, cardiac index, wedge pressure, and cardiac power index between the two groups (Table 3).


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  		Table 3 Hemodynamic Data a
 
Coronary Artery Bypass Grafting Procedure
Complete revascularization was achieved in 75 patients (94.8%; Table 4). The mean number of grafts per patient was 3.0 ± 0.2, and 29.0% of patients received a left internal mammary artery conduit to the left anterior descending artery. Intraaortic balloon counterpulsation was used in 92.4%.


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  		Table 4 Procedural Details of Coronary Artery Bypass Grafting
 
Percutaneous Coronary Intervention Procedure
Multivessel PCI was performed in 11.1% (Table 5). Stents were implanted in 26 patients (28.4%). During the course of the study, the rate of stenting increased from 6.7% in 1993 to 1994 to 53.9% in 1997 to 1998 (p < 0.01). Glycoprotein IIb/IIIa antagonists were used in 6.8%. The rate of glycoprotein IIb/IIIa antagonists increased from 0% in 1993 to 1994 to 23.1% in 1997 to 1998 (p < 0.01). Intraaortic balloon counterpulsation was used in 87.1%. Coronary artery bypass graft surgery was performed in 13 patients (15.3%) after initial PCI.


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  		Table 5 Procedural Details of Percutaneous Coronary Intervention
 
Thirty-Day Survival
The estimated 30-day survival is presented in Figure 1. The survival rate in the CABG group was 54% compared with 14% in PCI group (p < 0.001). The survival rate was similar in the trial and registry patients who underwent CABG (58% versus 55%; not significant). When the LMCA was the infarct-related artery, the survival rate was 40% in the CABG group and 16% in the PCI group (p = 0.03). No statistically significant association between survival and the use of stents and glycoprotein IIb/IIIa antagonists was found in this small number of patients during the 2-year time intervals owoing to small strata (p = 0.15).


Figure 1
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  		Fig 1. Kaplan–Meier 30-day survival estimates in the coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) groups.

 
Correlates for Survival
The following variables were entered into a stepwise multivariable Cox proportional hazard model for 30-day survival: age, sex, prior myocardial infarction, hypertension, diabetes, congestive heart failure, renal failure, smoking, prior CABG, prior PCI, multivessel disease, CABG (versus PCI), cardiac index, cardiac power index, systolic blood pressure, and heart rate. Coronary artery bypass graft surgery (hazard ratio, 0.41; 95% confidence interval, 0.22 to 0.77; p = 0.006) and age (per 10 years; hazard ratio, 1.04; 95% confidence interval, 1.01 to 1.08; p = 0.02) were significantly associated with 30-day survival.


   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Limitations
 Conclusions
 Acknowledgments
 References
 
The most important finding in this analysis was that patients with myocardial infarction complicated by cardiogenic shock and LMCA disease treated with CABG had a higher 30-day survival compared with patients treated with PCI. This finding supports current recommendations for the use of CABG as the preferred modality for patients with LMCA disease. However, very few patients undergo CABG for cardiogenic shock complicating myocardial infarction [15]. Acute occlusion of the LMCA can result in severe circulatory decompensation within minutes and often manifests with fatal consequences [16–19].

Wong and associates [20] reported that the mortality was particularly high when the LMCA was the infarct-related artery (78.6%). Quigley and coworkers [21] reported that 8 of 9 patients who presented with myocardial infarction and LMCA disease complicated by cardiogenic shock and underwent PCI or CABG died. In a multicenter registry of 40 patients with myocardial infarction who underwent unprotected LMCA PCI, 93% had cardiogenic shock, and the in-hospital survival rate was 45% [22].

Despite the trial protocol recommending CABG in patients with LMCA disease, nearly half of these patients underwent PCI. This suggests that surgeons may have deemed these patients unsuitable for surgery (eg, patients had poor distal vessels that were not amenable to CABG) and led to an attempt at PCI. Also, it is possible that more stable patients were referred for CABG and unstable patients underwent PCI as it could be performed more expeditiously. Therefore, unmeasured confounders likely amplified the apparent survival benefit of surgery, even in the adjusted analysis. Despite the similar baseline hemodynamic data in the CABG and PCI patients, the longer time from myocardial infarction and cardiogenic shock to revascularization suggests that surgeons selected patients who survived the early, highest risk period, potentially further favoring outcomes in the CABG group. In the PCI group, 11 of 85 patients (13%) were trial patients and 22 of 79 of the CABG patients (28%) were trial patients, which may suggest that CABG patients were more stable and perhaps more likely to be randomized. Those who underwent CABG days after shock onset likely had resolution of shock before surgery, and despite use of statistical adjustment, this bias cannot be completely accounted for. On the other hand, there was a higher prevalence of triple-vessel disease in the CABG group, which was adjusted for in the model. Another possible explanation of the improved survival observed in those who underwent CABG may be attributable to a high proportion of complete revascularization (89%) achieved with CABG. Therefore, CABG may be preferred when LMCA disease with or without severe triple-vessel disease is present or when unsatisfactory and less complete revascularization with PCI is likely [23–26]. Other possible advantages with CABG may be a result of protection of ischemic myocardium with cardioplegia and unloading of the ventricle during cardiopulmonary bypass [7]. The increased mortality observed in the PCI group may have also been caused by larger infarcts compared with the CABG group. The LMCA was more frequently the infarct-related artery in the PCI group compared with the CABG group. The highest mortality in patients with myocardial infarction complicated by cardiogenic shock was observed in those in whom the LMCA was the infarct-related artery [8].

Most PCI patients underwent single-vessel intervention (82%), perhaps because the standard of care was performing PCI only on the infarct-related artery, even though 73% had multivessel coronary disease. Because of the high prevalence of multivessel coronary disease and the possible deleterious effect of ischemia in non–infarct related territories on left ventricular function during the periinfarction period, particularly in LMCA disease, a strategy to provide more complete revascularization with acute PCI of both the infarct-related artery and non–infarct-related stenoses may be beneficial in hemodynamically unstable patients as the LMCA perfuses a large amount of jeopardized myocardium [10, 23, 27, 28].

Zeymer and colleagues [8] reported that mortality was strongly related to the procedural success of PCI in patients with myocardial infarction complicated by cardiogenic shock, with the lowest mortality in patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow. Similarly, the SHOCK registry reported that the presence of TIMI grade 3 flow was associated with improved survival [20]. Although stenting did not result in higher TIMI grade 3 flow rates in two randomized trials of myocardial infarction [29, 30], stenting with adjunctive abciximab increased the likelihood of TIMI grade 3 flow in patients with cardiogenic shock [31]. There was a trend toward lower in-hospital mortality after stenting compared with balloon angioplasty (35% versus 70%; p = 0.1) in patients with myocardial infarction who underwent unprotected LMCA PCI [22]. Although stents and glycoprotein IIb/IIIa antagonists were used increasingly with time in this analysis, the overall rate was not high enough to draw any conclusions regarding survival. It is unknown whether increased use of stents and glycoprotein IIb/IIIa antagonists might have increased survival in the PCI-treated patients.


   Limitations
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Limitations
Conclusions
 Acknowledgments
 References
 
This analysis was limited owing to a small number of patients and the short duration of follow-up. Although protocol recommendations for the trial were available to help investigators select the mode of revascularization for the trial, patient selection bias may have played a role. The decision for CABG versus PCI may have been based on acuity, severity, and technical feasibility. Data were not available on how the investigator's decision corresponded with the protocol recommendations in the trial. The potential impact of better hemodynamic support from percutaneous circulatory assist devices during PCI is unclear and is currently being studied. Data on collateral flow were not available. Data on complete revascularization were not available in all patients in the PCI group.


   Conclusions
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Limitations
 Conclusions
Acknowledgments
 References
 
Despite having more extensive coronary disease, CABG appeared to provide a survival advantage over PCI at 30-day follow-up in patients with LMCA disease. Independent correlates of 30-day survival were performance of CABG and age. Only a randomized clinical trial comparing CABG versus PCI with stents and glycoprotein IIb/IIIa antagonists and possibly left ventricular assist devices can definitely assess the optimal revascularization strategy in the current era of improved surgical and interventional techniques. Until the results of such a trial are available, it is reasonable to recommend CABG for these patients, especially if multivessel disease is present or when complete revascularization with PCI is unlikely to be achieved.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Limitations
 Conclusions
 Acknowledgments
References
 
Supported from research grants R01 HL49970 and R01 HL50020 from the National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, MD.


   References
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 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Limitations
 Conclusions
 Acknowledgments
 References
 

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J. S. Hochman and A. H. Skolnick
Contemporary Management of Cardiogenic Shock: Age Is Opportunity
J. Am. Coll. Cardiol. Intv., February 1, 2009; 2(2): 153 - 155.
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