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Ann Thorac Surg 2002;74:1526-1530
© 2002 The Society of Thoracic Surgeons

Original article: cardiovascular

A comparison of the recovery of health status after percutaneous coronary intervention and coronary artery bypass

A. Michael Borkon, MDa*, Gregory F. Muehlebach, MDa, John House, MSa, Steven P. Marso, MDa, John A. Spertus, MD, MPHa

a Mid America Heart Institute, Saint Luke’s Hospital and Section of Cardiology, Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA

* Address reprint requests to Dr Borkon, Suite 50-II, 4320 Wornall Rd, Kansas City, MO, 64111, USA
e-mail: mborkon{at}saint-lukes.org

Presented at the Forty-eighth Annual Meeting of the Southern Thoracic Surgical Association, San Antonio, TX, Nov 8–10, 2001.


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
BACKGROUND: Selection of the optimum mode of coronary revascularization should not only be directed by technical outcomes, but should also consider patients’ postprocedural health status, including symptoms, functionality, and quality of life.

METHODS: Health status was analyzed and compared after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using the Seattle Angina Questionnaire (SAQ). The SAQ was administered to 475 patients (252 PCI and 223 CABG) preprocedure and then monthly for 6 months and again at 1 year. Differences in baseline characteristics were controlled by multivariable risk adjustment, and outcomes over time were compared using repeated-measures analysis of variance.

RESULTS: In-hospital, 6-and 12-month clinical outcomes were not different; however, 25% of PCI patients required at least one reintervention during the study period, compared with only 1% of CABG patients (p < 0.001). Although physical function decreased for CABG patients at 1 month (p < 0.001), it improved and was better than the PCI group by 12 months (p = 0.008). Relief of angina was greater for CABG than PCI when analyzed over time (p < 0.001), principally due to the adverse effects of restenosis in the PCI group. Multivariable analysis confirmed that CABG independently conferred greater angina relief compared with PCI (p < 0.001). At 12 months postprocedure, quality of life had improved to a greater extent for CABG than PCI (p = 0.004).

CONCLUSIONS: Over 12 months of follow-up, health status was improved to a greater extent for CABG patients than for PCI patients, primarily due to the adverse influence of restenosis after PCI.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
Refinements in catheter-based technologies and application of endovascular coronary artery stents have forever changed the management of patients with coronary artery disease. Several recent randomized, controlled trials have demonstrated no significant differences in all-cause mortality or event-free survival between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), although a subgroup analysis in the BARI trial suggested improved survival for treated diabetics undergoing CABG [1–4]. However, all trials to date have shown an increased need for antianginal medications and additional revascularization after PCI, even with stent placement [4]. Despite similar clinical outcomes between revascularization techniques, PCI continues to be gaining favor as first-line treatment for most patients with coronary artery disease.

In many instances, when there is an absence of a clear advantage for either CABG or PCI, revascularization strategies are selected based solely upon technical considerations and perceived procedural risks. Nevertheless, patients’ postprocedural health status, including symptoms, functionality, and quality of life, should be equally important considerations in the decision process. Currently, however, few data are available to describe the health status recovery of a patient after either revascularization technique, thus, clinicians are unable to incorporate this information when recommending a treatment strategy to their patients. The purpose of this report is to compare the health status recovery of patients undergoing CABG and PCI.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Acknowledgments
 Discussion
 References
 
Patients
Between February 8, 1999 and July 7, 1999, 495 patients undergoing coronary revascularization were consecutively entered into a study protocol approved by our institutional review board. Details of data collection and potential selection biases have been described previously [5]. Twenty patients from this initial cohort were excluded because the revascularization procedure (PCI) was performed as primary reperfusion for an evolving acute myocardial infarction. Thus, a total of 475 patients were enrolled, 252 of whom underwent PCI (83% received stents) and 223 were treated with CABG.

Baseline sociodemographic and clinical characteristics were noted for each patient. Outcomes, including the need for repeat procedures, death, and rehospitalization, along with Seattle Angina Questionnaires (SAQ) measures of health status, were recorded at the time of the initial revascularization procedure, monthly for the first 6 months, and then at the 1-year anniversary of the initial procedure. At the time of hospital discharge, patients were provided with a packet containing six identical health status surveys to be completed each month during the 6-month recovery period after revascularization and returned by mail. Trained data collectors obtained baseline data before revascularization. Patients were reminded to complete and return the questionnaires before the due date of each packet. One year after their procedure, all patients were contacted by phone and administered the SAQ health status questionnaire. Follow-up was 93% complete.

Health status
Health status assessments were performed with the SAQ. The SAQ is a 19-item, disease-specific measure for patients with coronary artery disease, which measures five relevant clinical domains, including angina frequency, physical function, angina stability, treatment satisfaction, and quality of life [6, 7]. A representative example of SAQ questions and scales are shown in Figure 1. The scales used in these analyses range from 0 to 100, where higher scores indicate fewer symptoms and thus improved clinical functioning. The validity of the SAQ as a quantitative measure of clinical symptoms and quality of life has been previously established [6, 7]. It has also been shown to be predictive of acute coronary syndromes and 1-year mortality in patients with angina [8]. The SAQ was selected as the primary outcome measure of this study due to its greater sensitivity and better interpretability then other generic measures of health status, such as the SF-36 [6]. To maximize the clinical interpretability of these analyses, this study focuses upon the SAQ scales quantifying physical limitation, angina frequency, and quality of life.



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  		Fig 1. Representative sample Seattle Angina Questionnaire (SAQ) questions and scales for angina frequency, physical function, and quality-of-life domains. Higher scores indicate improved function.

 
Statistical analysis
The purpose of these analyses was to compare the recoveries of health status between PCI and CABG. Baseline sociodemographic and clinical characteristics between groups were analyzed using {chi}2 or Fisher’s exact tests for categorical variables and independent t tests for continuous variables. Health status recorded over the period of observation was analyzed with repeated-measures analysis of variance. To control for potentially confounding differences in baseline clinical characteristics, multivariable risk adjustment methods were employed. Baseline differences (p < 0.1) controlled for in the model included age, ejection fraction less than 40%, three-vessel and left main coronary artery disease, unstable angina, diabetes, prior procedure, and any potential baseline differences in SAQ health status score. Baseline SAQ data are reported as unadjusted data. All follow-up data (months 1 to 12) are adjusted for baseline patient characteristics that differed between treatment groups and reported using least-squares means. All analyses were conducted using SPSS version 10.0.7 and SAS version 8.2 (SAS Institute Inc., Cary, NC).


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Acknowledgments
 Discussion
 References
 
Sociodemographic and clinical characteristics are shown in Tables 1 and 2, respectively. Patients undergoing CABG tended to be older (p < 0.01) and had a greater extent of anatomic disease, manifested by increased frequency of three-vessel and left main coronary artery disease (p < 0.0001) and a larger proportion of patients with an ejection fraction less than 40% (p < 0.05). In contrast, the PCI group had an increased proportion of patients with a history of prior PCI or CABG (p < 0.0001) and unstable angina (p < 0.0001).


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  		Table 1. Sociodemographic Characteristics

 

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  		Table 2. Clinical Characteristics

 
In-hospital events including death, stroke, and q-wave myocardial infarction (MI) were not significantly different between groups (Table 3). Although 6- and 12-month mortality did not differ, repeat revascularization was required at least once within the first 6 months for 19% of PCI patients, compared with only 0.5% of CABG patients (p < 0.0001). Over the entire year of observation, 25% of PCI patients had had at least one additional procedure on the same vessel and 8% required a third revascularization, as compared with 1% and 0% of CABG patients (p < 0.0001, for both comparisons). Table 4 summarizes the results of SAQ scores obtained over time for the domains of angina frequency, physical function, and quality of life. Unadjusted baseline SAQ scores were similar for SAQ physical limitation and quality of life domains, but PCI patients had significantly more angina than CABG patients, as measured by the SAQ angina frequency scale.


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  		Table 3. Clinical Outcomes

 

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  		Table 4. Seattle Angina Questionnaire Domain Scores

 
Improvements in angina frequency over time
Patients undergoing both PCI and CABG experienced early significant relief of angina after revascularization (Table 4). After controlling for preprocedural differences between groups, a reported-measure analysis of variance demonstrated that CABG patients had a greater degree of angina relief over time than those treated with PCI (p < 0.005). Multivariable analysis confirmed mode of revascularization to be an independent predictor of angina relief (p < 0.001). This difference was largely explained by the development of restenosis in the PCI group, which was most evident by the third postprocedure month (Fig 2).



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  		Fig 2. Multivariable risk-adjusted Seattle Angina Questionnaire (SAQ) score for angina frequency reflecting the effect of restenosis after percutaneous coronary intervention (PCI). Patients with restenosis had less angina relief over time than PCI without restenosis or coronary artery bypass grafting patients (p < 0.0001).

 
Improvements in physical function over time
The time course of recovery of physical function differed by treatment strategy. Patients undergoing CABG experienced a significant decrease in risk-adjusted physical function during the first postoperative month and then recovered by the second month to ultimately attain a greater level of physical function than patients treated with PCI (Table 4). No postprocedural decrement in physical function was observed for the PCI group. However, patients with restenosis experienced a decrease in physical function, which at 1 month was of similar magnitude to that observed in patients undergoing CABG. Despite reintervention for restenosis, physical function did not improve to the same extent as that observed for patients after successful PCI (p = 0.003) or CABG (p < 0.0001; Fig 3).



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  		Fig 3. Multivariable risk-adjusted Seattle Angina Questionnaire (SAQ) score for physical function for percutaneous coronary intervention (PCI) with and without restenosis compared with coronary artery bypass grafting. Restenosis after PCI led to delayed recovery of physical function (p < 0.0001).

 
Improvements in quality of life over time
Both PCI and CABG facilitated a time-dependent improvement in risk-adjusted quality of life. Patients undergoing CABG achieved greater quality of life at 6 and 12 months after their procedure (Table 4), principally due to the consequences of restenosis in the PCI patients (Fig 4). Subsequent repeat interventions ultimately restored these patients to the same quality of life level experienced by patients undergoing PCI who did not develop restenosis, but less than that achieved by patients undergoing CABG.



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  		Fig 4. Multivariable risk-adjusted Seattle Angina Questionnaire (SAQ) quality-of-life score. Restenosis after percutaneous coronary intervention (PCI) was associated with reduced quality of life over the 12-month duration of study (p < 0.0001). (CABG = coronary artery bypass grafting.)

 

   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Acknowledgments
 Discussion
 References
 
This observational registry demonstrates improved symptom control after CABG as compared with PCI, such that CABG patients were able to attain better physical function and quality of life 1 year after their procedure. This study is unique in that it is the first reported comparison of CABG and PCI to include a disease-specific measure of health status and because it carefully assessed health status throughout the entire year of recovery. The use of the SAQ allowed a sensitive assessment of the impact of coronary disease upon patients’ lives, and contributed to our ability to detect differences between the treatment groups that more general assessments of health status would have missed. Furthermore, the monthly assessments allowed a careful description of the course of recovery after revascularization and allowed us to detect both the 1-month drop in physical function associated with CABG and the impact of restenosis upon the symptom control and quality of life in PCI patients.

The results from this study are consistent with previous randomized trials, which have compared the results of PCI and CABG and shown no significant differences in mortality or event-free survival but an increased use of repeat procedures after PCI [1–4]. These studies similarly have demonstrated better angina control after CABG and a lower use of antianginal medications in this population. Our results not only confirm the better symptom control after CABG, but have also demonstrated the functional and quality of life limitations imposed by greater symptoms in the PCI group, which in most cases was attributed to restenosis.

This present study has several limitations. First, as treatment was not assigned randomly, multivariate risk adjustment models were used to control for baseline differences in the patients selected for each procedure. These statistical steps allowed a fairer comparison of the revascularization techniques. Yet, without treatment randomization, we cannot exclude an unmeasured source of confounding. Unfortunately, given current treatment practices, it would be difficult to recruit patients into randomized trials when interventional cardiologists are able to so easily open narrowed arteries at the time of diagnostic angiography.

A second potential limitation is missing data. Extensive exploration of any potential bias from selectively missing patients with certain characteristics was conducted and no differences in the rates of missing data between treatment groups were detected. Furthermore, multiple imputations were performed to include all patients in the analyses and no differences in the main conclusions of this study were detected.

A third consideration is that we followed patients for only 1 year. It is certainly possible that the health status of patients would be more similar during longer follow-up, especially after the benefits of second and third PCI procedures were realized in patients experiencing restenosis.

The selection of a revascularization strategy should consider multiple factors. Whereas much attention is given to the greater procedural risk of surgery and to the similarity in survival between the procedures, little discussion of health status differences is conducted. This study, using frequent assessments with a sensitive, disease-specific measure of patients’ health status, demonstrates benefits in the control of angina over the year after treatment and a trend towards better function and quality of life 1 year after revascularization with CABG. Much of the benefits of CABG over PCI were attributable to those PCI patients who experienced restenosis. Whether the introduction of coated stents will alter this association will await future investigation. Such future investigations of PCI and CABG, however, should not only focus on anatomic endpoints but should carefully measure patients’ health status outcomes as well.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
Discussion
 References
 
This work was supported in part by an unrestricted grant from Pharmacia and, in part, by grant R-01 HS11282-01 from the Agency for Healthcare Research and Quality.


   Discussion
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
References
 
DR THORALF SUNDT (Rochester, MN): Mike, that is a very nice study and I congratulate you for using a disease-specific tool to measure quality of life. Having done a little bit of work with quality of life analysis, I know that it is easiest simply to use the SF36, but I have learned that this is not an appropriate tool for all disease conditions. I think that your use of an instrument developed and validated for ischemic heart disease is a real strength of the work.

Angina is certainly the appropriate end point, and you have made an excellent attempt to measure it. The trouble, of course, is that angina is a soft end point open to a great deal of interpretation. Nonspecific chest discomfort after cardiac surgery may be mistaken for angina, and a physician wishing to play it safe may choose to treat the symptoms as angina. This is what makes this end point so elusive. I wonder if you have any objective evidence of ischemia in the patients who had recurrent angina such as thalium scans, and if you have information concerning the correlation between such scans and recurrent angina? Thank you for an important contribution to our literature.

DR BORKON: I appreciate your thoughtful comments; they are very insightful. Disease-specific questionnaires are much more helpful to measure a specific treatment response rather than generalized health status questionnaires such as the SF-36. Although these data might be viewed as a relatively soft science, the Seattle Angina Questionnaire is a remarkably sensitive clinical tool with great utility. In the present study, our clinical end points were based upon changes compared with the clinical preprocedure status. We have not correlated objective evidence of ischemia, such as thallium imaging, with recurrence of angina. Patients in the PCI group, however, who had recurrent ischemia, or at least symptomatic ischemia manifested by angina, did undergo repeat study and subsequent repeat revascularization. At least for this population, I believe that we were effectively able to measure recurrent ischemia with the SAQ questionnaire.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 

  1. Writing Group for the Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Five-year clinical and functional outcome comparing bypass surgery and angioplasty in patients with multivessel coronary disease: a multicenter randomized trial. JAMA 1997;277:715-721.[Abstract]
  2. King S.B., III, Lembo N.J., Weintraub W.S., et al. A randomized trial comparing coronary angioplasty with coronary bypass surgery: Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med 1994;331:1044-1050.[Abstract/Free Full Text]
  3. Serruys P.W., Unger F., Sousa J.E., et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med 2001;344:1117-1124.[Abstract/Free Full Text]
  4. Influence of diabetes on 5-year mortality and morbidity in a randomized trial comparing CABG and PTCA in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 1997;96:1707–10
  5. Spertus J.A., Jones P.G., Coen M., et al. Transmyocardial CO(2) laser revascularization improves symptoms, function, and quality of life: 12-month results from a randomized controlled trial. Am J Med 2001;111:341-348.[Medline]
  6. Spertus J.A., Winder J.A., Dewhurst T.A., Deyo R.A., Fihn S.D. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 1994;74:1240-1244.[Medline]
  7. Spertus J., Winder J., Dewhurst T., et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995;25:333-341.[Abstract]
  8. Jones P., Spertus J., McDonell M., Fan V., Fihn S. Health status predicts long term outcome in patients with coronary artery disease. J Am Coll Cardiol 2001;37:491-494.



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