Eur J Cardiothorac Surg 2005;27:882-886
© 2005 Elsevier Science NL
Health related quality of life after percutaneous coronary intervention versus coronary artery bypass graft surgery in patients with acute coronary syndromes without ST-segment elevation. 12-month follow up
Bozena Szygula-Jurkiewicza,*,
Marian Zembalab,
Krzysztof Wilczeka,
Romuald Wojnicza,
Lech Polonskia
a 3rd Department of Cardiology, Silesian Centre for Heart Diseases, Medical University of Silesia, Szpitalna 2 Street, 41-800 Zabrze, Poland
b Department of Cardiac Surgery and Transplantation, Medical University of Silesia, Zabrze, Poland
Received 20 August 2004;
received in revised form 27 December 2004;
accepted 20 January 2005.
* Corresponding author. Tel.: +48 604 102 999/32 2732316; fax: +48 32 2732679. (E-mail: b.szygula{at}sccs.pl).
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Abstract
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Objective: The efficacy of percutaneous and surgical revascularization in acute coronary syndromes without ST-segment elevation is similar. Therefore, other factors, like health-related quality of life, should play an important role in choosing the revascularization method. Methods: We compared 12-month health-related quality of life for high-risk patients with acute coronary syndromes without ST-segment elevation assigned to percutaneous coronary intervention (group A) versus coronary artery bypass graft surgery (group B). Patients had an episode of rest angina within 24h prior to admission and had to fulfil at least one of the criteria: (1) ST-segment depression (
0.05mV), (2) transient (<20min) ST-segment elevation or T-wave inversion (0.1mV), (3) positive serum cardiac markers. Four hundred and ninety-six (91.34%) of 543 patients alive 12-months after index hospitalization completed a Short Form-36 (SF-36) health status survey. Group A comprised 392 patients and group B comprised 104 patients. We compared mental component summary (MCS) and physical component summary (PCS) scores from the SF-36 survey between analyzed groups. Results: There were no significant differences in MCS scores (47.21±12.30 vs. 46.60±11.3 in group A and group B, respectively, NS). PCS scores were lower in group A (38.30±11.10 vs. 42.64±9.76; p=0.003). Patients of group A had a higher rate of unstable angina (22.45 vs. 5.77%, p=0.0002) and repeated revascularization (12.76 vs. 1.92%, p=0.001) at 1 year. Patients of group A also had higher systolic and diastolic blood pressure during follow-up (138.17±20.41 vs. 133.47±19.21, p=0.04 and 82.48±11.32 vs. 77.25±16.17, p=0.0003, respectively). Systolic blood pressure was inversely associated with PCS scores in group A (Spearman's R= –0.18 p=0.0007). Conclusions: This study has shown that there is a significant difference in health-related quality of life 12-months after percutaneous coronary intervention and coronary artery bypass graft surgery. This difference arises from better physical function (physical component summary) for coronary artery bypass graft surgery patients compared with percutaneous coronary intervention patients. Despite impairment of the physical health status (physical component summary), the mental health status (mental component summary) remained similar in both groups.
Key Words: Acute coronary syndromes without persistent ST segment elevation • Early invasive strategy • Coronary artery bypass grafting • Percutaneous coronary intervention • Health related quality of life • SF-36
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1. Introduction
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Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery have been shown to be effective in the treatment of acute coronary syndromes without ST-segment elevation. Clinical efficacy of these procedures is fairly high and depends mostly on the treatment strategy chosen, patient selection and operator's experience. Decreasing mortality and morbidity requires the search for other clinical criteria that may influence the choice of revascularization method.
There has been growing interest in quality of life as a part of assessment of long-term outcomes in the last few years. The term ‘quality of life’ derives from social sciences, but in medicine it is used in a narrower sense as a health-related quality of life [1–6]. Health-related quality of life has been assessed since, the 1970s, but only recently, it has been recognized as being of major importance. Health-related quality of life is a multidimensional concept based on the patient's perception of his or her health and integrates not only physical functioning, but also psychological status and social dimension. Standardized questionnaires, especially, those self-completed by patients, are a practical, efficacious and inexpensive method of collecting data [7–9].
The aim of this study was to compare 12-month health-related quality of life outcomes for high-risk patients with acute coronary syndromes without ST-segment elevation assigned to PCI versus CABG surgery.
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2. Material and methods
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All patients who underwent revascularization procedure and survived hospitalization were enrolled in the study. A total of 543 consecutive patients with acute coronary syndromes without ST-segment elevation were entered into the study between January 2000 and November 2002.
The patients were high-risk with an episode of rest angina within 24h prior to admission and had to fulfil at least one of the following criteria: (1) ST-segment depression (0.05mV) in at least 2 contiguous leads, (2) transient (<20min) ST-segment elevation (0.05mV) or T-wave inversion (0.1mV) in at least two contiguous leads, (3) positive serum cardiac markers: troponin T (>0.1ng/ml) or CK-MB (>5ng/ml).
Coronary angiography was performed via the femoral artery during the first 4–48h. The decision to perform PCI was left to the discretion of the operator. The aim of the treatment was to achieve normal coronary flow in the culprit vessel with subsequent attempt to obtain complete revascularization. Complete revascularization was defined as dilation of all significant lesions during PCI or revascularization of all diseased major or primary segmental vessels during CABG surgery [10]. Significant stenoses were defined as 50% diameter stenosis or larger in vessels of a reference diameter greater than 2.25mm. Patients disqualified from PCI due to lesion type, anatomy of coronary arteries or severity of coronary artery disease were assigned to CABG surgery. PCI was considered successful if post-procedural stenosis was <30% diameter stenosis and TIMI flow grade three was obtained. CABG was performed by standard methods during the index hospitalisation [11]. In the analyzed group 429 patients underwent PCI and 114 patients were assigned to CABG. All patients alive after 1 year of treatment were sent the Short Form-36 (SF-36) health status surveys and a written questionnaire was utilized to obtain detailed clinical outcomes (death, myocardial infarction, unstable angina, repeated revascularization, hospitalisation) and other clinical information (pharmacological treatment, blood pressure) [5]. If the patient did not respond, a telephone interview was arranged and a second survey was sent. Of the 429 PCI patients 392 (91.4%) completed the SF-36 questionnaire. Of the patients who have not completed SF-36 questionnaire in follow-up 7 (1.8%) patients died, 23 (5.9%) were lost to follow-up and 7 (1.8%) did not show up for their 1-year clinic visit. Of the 114 CABG patients 104 (91.2%) completed the SF-36 questionnaire. In the CABG group 2 (1.8%) patients died and 6 (5.3%) patients were lost to follow-up.
The SF-36 health status survey has been developed during The Medical Outcomes Study (MOS) for the assessment of patients with hypertension and other cardiovascular disorders.
The SF-36 health status survey is a 36-item, standardized, self-administered tool that measures eight health constructs: physical functioning (10 items), physical role functioning (role physical)/role limitation due to physical problems (four items), bodily pain (two items), general perception of health (five items), energy and vitality (four items), social functioning (two items),emotional role functioning (role emotional) (three items) and mental health (five items). Overall physical and mental health status derived from these eight domains is presented as the physical component summary (PCS) and mental component summary (MCS) For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state [7].
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3. Statistical analysis
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Descriptive statistics were presented as means±standard deviations and two-tailed t-test was used for continuous variables. Categorical variables were compared using chi-square or Fisher exact tests. When the assumption of normality was violated the data were compared by the Mann–Whitney test. Correlation was determined with Spearman test. A ‘p’ value of <0.05 was considered significant. The statistical analysis was performed with STATISTICA version 6.0 package (StatSoft Inc.).
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4. Results
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The PCI and the CABG patients had similar baseline profiles (age, gender, diabetes, heart failure, history of myocardial infarction). More PCI patients had arterial hypertension, single-vessel coronary artery disease and non-ST-segment elevation myocardial infarction on admission. The rate of complete revascularization was higher in the CABG group. The patients' baseline characteristics are presented in Table 1.
Both groups had similar mortality rates after discharge (1.63 vs. 1.75%, NS, PCI and CABG, respectively). A similar proportion of the PCI and CABG patients completed the survey (92.9 vs. 92.8%, NS).
The PCS scores were significantly lower in the PCI group (38.30±11.10 vs. 42.64±9.76, p=0.003). This was caused by worse outcomes in all four dimensions of physical health status (physical functioning, physical role functioning/role physical, bodily pain and general health). There were no significant differences in MCS scores. Comparison of the physical and mental health status outcomes between patients assigned to PCI versus CABG surgery is presented in Table 2.
Twelve-month clinical outcomes are listed in Table 3. More PCI patients had episodes of unstable angina. The rate of repeated revascularization and cardiovascular hospitalisation was also higher in the PCI group. Moreover, the PCI patients had significantly higher systolic and diastolic blood pressure. We found a negative correlation between systolic blood pressure and PCS and MCS scores in the PCI group (Table 4). There was no such correlation in the CABG group (Table 5).
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Table 4. Correlation coefficients between elements of SF-36 questionnaire and systolic and diastolic blood pressure in PCI group
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Table 5. Correlation coefficients between elements of SF-36 questionnaire and systolic and diastolic blood pressure in CABG group
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5. Discussion
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The SF-36 health status survey is a standardized and validated instrument recommended by the American Association of Cardiovascular and Pulmonary Rehabilitation used for evaluating health related quality of life in patients with cardiovascular disorders. It enables the assessment of any limitation of patient's physical, psychological and social functioning [7–9].
In this single-centre study we have characterised a group of high-risk patients with acute coronary syndromes without ST-segment elevation and an episode of rest angina within 24h prior to admission. Patients older than 65 years, with ST-segment depression on electrocardiogram, positive troponin levels, diabetes mellitus or prior myocardial revascularization comprised a large proportion of this group. All patients underwent early invasive assessment and treatment (PCI or CABG surgery).
This study has shown a significant difference in health related quality of life 12-months after revascularization. This difference arises due to the better physical health status of the CABG patients. Despite impairment of the physical health status, we found equivalent outcomes of the mental health status for the PCI and CABG patients.
To discuss these differences in health related quality of life between the groups, also the differences of baseline characteristics profile in both study populations need to be recognised. Impairment of the physical health status in the PCI group may be partially associated with a higher rate of hypertensive and elderly patients. During follow-up the PCI patients had more episodes of unstable angina, which appears to be associated with a higher rate of restenosis in follow-up, lower rate of complete revascularization during index hospitalisation and poorly controlled blood pressure after discharge. It resulted in a higher rate of hospitalisation repeated revascularisation and worse physical functioning. Systolic and diastolic blood pressure was negatively correlated with all four dimensions of physical health status in the PCI group. Therefore, accordingly controlled blood pressure and angina relief may improve physical heath in these patients.
Similar results have been observed in ‘The Randomized Intervention Treatment of Angina’ (RITA) study and emory angioplasty versus surgery Trial (EAST) [1,4]. Both studies have shown impaired health related quality of life associated with angina burden in the PCI patients. However, more PCI patients were optimistic about their health compared to CABG patients in the EAST trial. One may speculate that the difference arises due to the more invasive nature of CABG.
One-year, 2-year and 3-year follow-up in ‘The Bypass Angioplasty Revascularization Investigation’ (BARI) trial revealed better physical functioning for CABG patients compared with PCI patients. After the first 3 years health related quality of life outcomes were levelled in both groups. The fact that BARI trial, unlike our study, comprised only patients with stable coronary artery disease is worth mentioning [12].
Other studies have found equivalent health related quality of life outcomes in the PCI and CABG group. ‘The Coronary Angioplasty Versus Bypass Revascularization Investigation’ (CABRI) trial have revealed no differences in health related quality of life evaluated with the ‘Nottingham Health Profile’ [3]. The results of ‘The Angina With Extremely Serious Operative Mortality’ (AWESOME) study are consistent with the CABRI trial, although the AWESOME study enrolled high-risk patients with medically refractory angina and health related quality of life has been assessed with the SF-36 health status survey [2].
Our study population resembled that of the AWESOME trial. They too enrolled the high-risk patients with angina at rest. Moreover, the same SF-36 test was employed in that trial. In the run of 6-month follow-up the CABG and PCI patients did not differ significantly with regard to quality of life [2].
The results of multiple studies on health related quality of life are inconsistent, nevertheless health related quality of life provides a more comprehensive assessment of each revascularization procedure and, therefore, should be taken into consideration in the decision-making process.
One of the limitations of this study is its retrospective design. A duration of the follow-up (1 year) in which a health related quality of life was assessed was chosen to let the patient compare the quality of life to preoperative period, since, in the original SF-36 health survey one of the question refers to the past from 1 year ago [7]. Many authors have reported health-related quality of life in patients assigned to different treatment methods without obtaining pre-treatment quality of life [2,6]. One year is a period in which patient fully recovers to his/her daily activity and social life. It would be interesting to repeat such a health survey after 2, 3 or more years. After a longer follow-up one could expect even worse results for PCI group (more episodes of angina, rehospitalisatons, repeat procedures etc.).
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6. Conclusions
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- • We found better 1-year physical functioning for the CABG patients compared with the PCI patients.
- • Worse physical status in the PCI group may be associated with more frequent episodes of unstable angina and a higher rate of repeat revascularization and hospitalisation during 12-month follow-up.
- • Blood pressure appears to be a potentially reversible factor contributing to worse physical outcome in the PCI group.
- • We found equivalent mental health status outcomes in the PCI and CABG group.
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Appendix A. Conference discussion
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Dr T. Aberg (Umea, Sweden): How have these findings influenced the practice in your own hospital?
Dr Przybylski: These findings did not really influence our practice because our work is concordat with the guidelines which give us information that for single vessel or unstable angina, the PCI is more effective. For NSTEMI tropinin positive patients, still, the cardiological group has a better chance to save lives since early mortality is much lower in PCI than in CABG patients.
Dr T. Wahlers (Jena, Germany): The higher drug treatment in the patients treated by PCI, doesn't that reflect better patient control in the PCI patients as compared to the CABG patients?
Dr Przybylski: First of all, the registry shows the period when drug-eluting stents were unavailable at our institution, and maybe this fact influenced our politics.
Secondly, few years ago patients with NSTEMI troponin positive had been operated on but the mortality was very high. So I think this is very good to control patients with PCI and then decide what to do.
Dr F. Beyersdorf (Freiburg, Germany): Your study found that there is a significantly better physical function in the surgical patients. Do you have any other data explaining or showing why this is the case? I mean, are there any other improvements in the surgical group as compared to the PCI group?
Dr Przybylski: Actually this physical data are much worse. I would like to show 12-month outcome according to fatal MI, nonfatal MI, unstable angina and hospitalization. Can you see the differences between the PCI and CABG group depicted in this slide? This can answer the question why the physical outcome is so bad. Why is not the social outcome different between groups? I don't know, it is very difficult to say.
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Acknowledgments
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The manuscript has been selected by the Programme Committee for Oral Presentation at the 3rd Joint Meeting of the EACTS and ESTS in Leipzig. The details of presentation: Session 1 (08:30–10:00), Monday 13, September 2004, programme number: 002, presentation time: 8:45. AM. Presenting author: Professor Marian Zembala.
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Footnotes
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Presented at the joint 18th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 12th Annual Meeting of the European Society of Thoracic Surgeons, Leipzig, Germany, September 12–15, 2004.
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Abstract
1. Introduction
