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(Circulation. 1995;92:1710-1719.)
© 1995 American Heart Association, Inc.

Articles

A Comparison of Quality of Life Scores in Patients With Angina Pectoris After Angioplasty Compared With After Medical Therapy

Outcomes of a Randomized Clinical Trial

Presented in part at the 41st Annual Meeting of the American College of Cardiology, Dallas, Tex, April 1992.

William E. Strauss, MD; Terry Fortin, MS; Pamela Hartigan, PhD; Edward D. Folland, MD; Alfred F. Parisi, MD; the Veterans Affairs Study of Angioplasty Compared to Medical Therapy Investigators¹

From the Research and Development Service, Department of Veterans Affairs Medical Center, West Roxbury (W.E.S., T.F., E.D.F., A.F.P.), Mass, and West Haven (P.H.), Conn.

Correspondence to William E. Strauss, MD, Cardiology Section (111A), Department of Veterans Affairs Medical Center, 1400 VFW Parkway, West Roxbury, MA 02132.

	Abstract

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
Background Evaluations of therapy for the treatment of angina have traditionally consisted of a combination of objective measures, such as exercise tolerance, and subjective markers, such as angina attack rate. Recently, the need to assess "how patients feel"—their quality of life (QOL)—has been regarded with increasing importance. Standard instruments are available to assess QOL and its change after therapeutic intervention. Although QOL instruments have been used to assess the efficacy of percutaneous transluminal coronary angioplasty (PTCA), they have not been used previously to compare the impact of PTCA with that of medical therapy in patients with angina pectoris. We report on the changes in self-assessed QOL among patients randomly assigned to treatment by PTCA or medical therapy and relate these measurements to changes in exercise performance and coronary angiograms.

Methods and Results Patients with stable angina, a positive exercise tolerance test, and at least 70% stenosis (index lesion) in the proximal two thirds of one major coronary artery were randomly assigned to receive PTCA or medical therapy. Six months after randomization, each patient underwent repeat exercise testing and coronary angiography. Before randomization and at the 6-month visit, patients completed a self-administered QOL questionnaire that measured physical functioning and psychological well-being. We compared the changes in QOL with changes between the baseline and 6-month exercise tests, stratified by terciles (decrease in duration, 0- to 2-minute increase, and >2-minute improvement). We also stratified patients by whether there was more or less than 2 SD change (18.8%) in diameter stenosis of the index lesion (initial minus follow-up angiogram), and we related these to changes in QOL measures. One hundred eighty-two patients with one-vessel disease completed baseline and 6-month questionnaires. At baseline, there were no differences in any QOL measurements between treatment groups. At the 6-month follow-up visit, there was greater improvement in both physical functioning and psychological well-being scores for patients receiving PTCA (+7.36±15.6, PTCA; +1.98±14.7, medical therapy; P<.02). Improvement in QOL variables was noted only in patients demonstrating an increase in exercise performance. Also, patients assigned to either treatment whose angiograms demonstrated more than 18.8% improvement in index lesion percent stenosis experienced a significant increase in their QOL scores.

Conclusions This was the first study of the relative changes in QOL measures assessed with the use of previously validated and standardized instruments in patients randomly assigned to treatment with PTCA or medical therapy. Patients assigned to PTCA demonstrated a significantly greater improvement in both physical and psychological measures. This improvement was noted in patients whose exercise performance improved and whose angiograms demonstrated an improvement in lesion severity.

Key Words: clinical trials • quality of life • angioplasty • angina

	Introduction

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
Evaluations of therapy for patients with angina pectoris have consisted of a combination of objective measurements (eg, exercise tolerance) and subjective markers (eg, frequency of angina attacks).¹ Notwithstanding the recent interest in the potential benefits of abolishing "silent ischemia," helping patients to feel better is a central goal of treatment, of which overall quality of life (QOL) is an essential element.

The Veterans Affairs Study of Angioplasty Compared to Medical Therapy (ACME Trial) was conducted to compare percutaneous transluminal coronary angioplasty (PTCA) with optimized medical therapy in patients with one-vessel coronary artery disease, objective ischemia by treadmill testing, and stable clinical status. We report the changes in self-assessed QOL among patients randomly assigned to treatment by PTCA or medical therapy and relate these measurements to changes in exercise tolerance and coronary angiograms performed before and 6 months after assignment of treatment.

	Methods

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
Details of patient selection, randomization, and testing procedures have been presented previously.² In brief, patients with stable angina, a strikingly positive exercise test (ETT), or myocardial infarction within the past 3 months and at least 70% stenosis of the proximal two thirds of one major epicardial coronary artery were eligible for inclusion. After written informed consent was obtained, all antianginal medications were discontinued at least 24 hours before a baseline thallium exercise tolerance test. Patients manifesting horizontal or down-sloping ST-segment depression 1.0 mm in one or more leads that occurred during or immediately after treadmill ETT were eligible for inclusion. Patients with no ST-segment depression who had angina during the test could also be included if there was a reperfusing thallium defect in the region of the involved artery. Qualifying patients were randomly assigned to receive PTCA or medical therapy according to a stepped-care approach designed to eliminate angina.² After discharge, all patients were evaluated monthly. Six months after randomization, each patient was readmitted for repeat ETT and coronary angiography. Coronary stenoses at baseline and 6 months were assessed by a blinded observer in a central laboratory with the use of electronic calipers.⁸ The primary end points in this study were the changes from baseline to follow-up in exercise duration, the frequency of angina attacks, and the use of nitroglycerin.

Before randomization and at the 6-month follow-up, patients completed a two-part self-administered QOL questionnaire that measured physical functioning and psychological well-being. Both parts of the questionnaire have been previously validated and published independently.^{3 4 5 6 7} For the physical component, we adopted the appropriate sections of the McMaster Health Index Questionnaire (MHIQ).³ The physical function items in the MHIQ are designed to evaluate the patient's actual performance at the time of the visit rather than perceived capacity at that time, ie, "Did you dress yourself?" rather than "Can you dress yourself"? The questions are not designed to elicit change from some previous time point, and they are, in general, positive in orientation. The MHIQ has been used in a variety of patient populations, some of which are family practice patients, patients at a rehabilitation center, and elderly patients under acute care in a hospital.^{4 5 6} The MHIQ items cover physical activities, mobility, self-care activities, and communication (sight and hearing). We adapted this component by the addition of a question related to sexual function. The physical assessment component of our questionnaire had a range of scores from 0 (poor) to 32 (excellent). The psychological component was assessed with the Psychologic General Well-Being Index (PGWB) developed by Dupey for the National Center for Health Statistics to measure an individual's subjective sense of well-being or distress.⁷ This index has been used in various populations aged 14 to 74 years. It measures the patient's perception of his or her well-being in the month preceding the test. Six categories of psychological well-being were assessed: anxiety, depressed mood, positive well-being, self-control, general health, and vitality. The test consists of 22 questions, the responses to which are graded from 0 (most negative) to 5 (most positive). There are three to five nonoverlapping items or responses that form the subscales with which to measure the six states. For example, a low score in "anxiety" reflects nervousness and tension, and a high score in "self-control" reflects emotional stability. The answers to the 22 questions were summed to yield an overall psychological well-being QOL score (maximum, 110). A sample questionnaire is provided in "Appendix B."

A primary end point of the ACME Trial was the change in exercise tolerance; therefore, we examined the changes in QOL compared with changes between baseline and 6-month ETTs. We divided the changes in exercise duration by terciles using cutoff points in change from baseline to follow-up of 0 and 2 minutes. We thus identified the change in ETT duration for each patient as being worse (<0 minutes), unchanged or a moderate improvement (0 to 2 minutes), or a large improvement (2 minutes). Within these groups, we then compared the changes in QOL scores, both overall and for the subscales.

Previous analysis of our angiographic assessment of coronary artery stenosis showed the standard deviation for repeated measurement of the same stenosis to be 9.4%; 2 SD therefore was equal to 18.8%.⁸ We averaged QOL scores for patients stratified by whether there was 18.8% improvement in percent artery stenosis, 18.8% worsening, or <18.8% change (statistically unchanged) between changes in the initial and 6-month follow-up angiogram.

Statistical Analysis
Comparisons between the treatment groups (medicine and PTCA) were made with a t test or Wilcoxon statistic. Changes within lesion categories have been compared with no change with the use of the t test. The Pearson correlation coefficient was used to devise the correlations between the QOL and other functional outcomes. All analyses were performed using the intention-to-treat principle.

	Results

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
Two hundred twelve patients with one-vessel disease completed the study: 107 were randomized to medical care, and 105 were randomized to PTCA. The primary end points (changes in exercise tolerance, angina attack rate, and nitroglycerin use) and adherence to assigned therapy have been reported previously.² Of these 212, 182 patients completed both baseline and 6-month follow-up questionnaires. Patients in whom paired data were available (182) had values for ETT duration, number of anginal episodes, degree of angiographic stenosis, and QOL scores at baseline that were not significantly different from those of the 30 patients in whom paired responses were not available. For the "not-included" patients, 18 were assigned to PTCA (3 of these patients had coronary artery bypass graft surgery before 6 months), and 12 patients were assigned to medical therapy (4 of these patients had PTCA and 1 died before 6 months). Paired data from both questionnaires, on baseline and 6-month follow-up ETTs, were available in 181 patients; 170 patients had paired data from QOL scores and angiograms. Eighty percent of the questionnaires were completed before the ETT, regardless of the treatment group.

At baseline, there were no differences in the individual QOL categories, overall QOL score, or physical activity scores between the patients randomized to either form of treatment (Fig 1). The overall score for the PTCA cohort was 96.7±20.1 (mean±SD), whereas that of the medical cohort was 96.0±18.6, P=.78. At the 6-month follow-up visit, the mean change in score (follow-up minus baseline) was significantly improved, favoring PTCA for overall psychological status of well-being and for the combined physical function and psychological summed score (+7.36±15.6, PTCA; +1.98±14.7, medical therapy; P<.02) (Fig 2). In addition, each individual component of the PGWB questionnaire showed a trend in favor of PTCA.

View larger version (29K): [in this window] [in a new window]   Figure 1. Bar graph of baseline quality of life (QOL) scores for summed psychological well-being, combined psychological, and physical QOL individual. PGWB indicates Psychologic General Well-Being Index; PTCA, percutaneous transluminal coronary angioplasty.

View larger version (20K): [in this window] [in a new window]   Figure 2. Bar graphs of changes in quality of life (QOL) at 6 months: individual subscales and summed mean values at 6-month follow-up minus baseline score. *P=<0.05. PGWB indicates Psychologic General Well-Being Index; PTCA, percutaneous transluminal coronary angioplasty.

Table 1 demonstrates the relation between a traditional objective marker of functional capacity for patients with angina, the ETT, and the patient's perception of changes in well-being. Changes in summed QOL scores from the baseline to the 6-month evaluation are correlated with changes in exercise duration as measured on the modified Bruce protocol ETT for the patients, divided into terciles. Improvement in overall QOL and its subcategories was noted only in patients demonstrating an increase in ETT duration, being most marked for the PTCA patients with >2.0-minute increase in exercise duration. There was no significant improvement in any of the QOL parameters that correlated with change in exercise duration for the medically assigned patients. The highest tercile (2-minute increase) group had more patients treated by PTCA than those receiving medical therapy (45 versus 20). In addition, the mean increase in exercise duration was 4.8±2.4 versus 3.7±1.3 minutes, with median values of 3.9 and 3.3 minutes, respectively.

View this table: [in this window] [in a new window]   Table 1. Categorizing Patients Based on Terciles of the Change in ETT

At baseline, the total duration of exercise on the treadmill ([mean±SD] 8.46±3.04 minutes, PTCA; 8.77±2.86 minutes, medical therapy; P=NS) and the number of anginal episodes in the past 30 days were both correlated with the physical subscale of the QOL (y+0.26, P<.001; -0.23, P<.001, respectively). Neither, however, was correlated with the psychological component, the PGWB (y+0.09, P=.17; -0.07, P±.29, respectively). At follow-up, the total duration of exercise (10.65±3.55 minutes, PTCA; 9.35±2.93 minutes, medical therapy; P<.01) and number of anginal episodes in the past 30 days were more highly correlated with the physical subscale of the QOL (y=0.41, P<.001; -0.26, P<.001, respectively) and were correlated with the PGWB (y=0.27, P<.001, -0.17, P=.02).

To explore whether self-perceived changes in well-being were related to coronary angiographic changes, we compared the QOL changes for patients demonstrating 18.8% improvement, 18.8% worsening, or no statistical change in coronary stenosis between the baseline and 6-month angiograms. Those patients undergoing PTCA whose angiograms demonstrated >18.8% improvement in lesion severity experienced a significant improvement in overall QOL (P=.0001) in six of its seven subcategories, whereas patients with unchanged angiograms experienced unchanged QOL scores (Table 2). Likewise, the six medically assigned patients who had improved angiograms also noted a significant improvement in their overall QOL scores (P=.04).

View this table: [in this window] [in a new window]   Table 2. Mean Changes in Quality of Life Variables for Each Lesion Severity Category

	Discussion

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
As the need for more rigorous assessment of treatment of angina has been recognized,⁹ comprehensive markers of efficacy have become mandatory.¹ Traditional assessment tools have included objective measures of the amount of ischemia (duration on ETT or extent of ST-segment shift on ambulatory monitoring), generally coupled with a quantification of angina attack rate. During the past decade, the need to assess "how patients feel," ie, QOL, has developed. Although such measures originated in other disciplines, there has been an enhanced interest in applying them to patients with angina¹⁰ as well as other cardiovascular disorders.^{10 11 12 13} "QOL" is a complex, multifaceted term encompassing patients' perceptions of how a disease affects their daily living, or functional capacity, coupled with the absence or presence of symptoms—all filtered through their perceptions of general health and life satisfaction.^{10 12}

Prior evaluations have addressed the issue of QOL in patients with angina by means of surrogate end points such as percentage of patients who are angina free or return to work or by the amount of antianginal medications used.¹³ Examples include evaluations of coronary artery bypass graft surgery, either alone^{14 15 16} or compared with medical therapy.^{17 18} However, during the past decade the need for more reproducible and standardized QOL instruments has been recognized.^{11 12} Methodological issues include method of administration, choice of generic versus disease-specific instruments, and documentation of responsiveness and validity.^{12 19 20} There is no consensus for a single QOL instrument for the patient with angina. It is widely recognized that assessment of QOL is a complex issue that should not simply be represented by the amount of angina or other surrogates.¹⁰ There is a small but increasing body of data gathered by the use of standardized questionnaires to assess QOL in patients with bypass surgery,^{21 22} PTCA,^{23 24} and pharmacological therapy.²⁵

In the ACME study, angina attack rate and nitroglycerin consumption were found to be significantly more improved with angioplasty than with medical therapy.² In addition, the extent of angina-free time during treadmill testing improved to a greater degree in PTCA-assigned patients.²⁶

Patients completed a standardized questionnaire that assessed psychological well-being and physical activity at baseline and at 6 months. Both the PGWB^{27 28} and the MHIQ^{3 4 5 6} have been used extensively and have proved to be sensitive to small changes in QOL.²⁹ The overall QOL scores, summed psychological well-being index, as well as the individual physical and psychological subscales were equal for both the medicine- and PTCA-assigned patients at baseline. The values we found were also within the ranges noted in prior studies of adults with chronic diseases.⁷ The overall correlation at baseline and follow-up of objective measurements of physical functioning (duration of ETT and angina episodes) with elements of the QOL indicates to us that the instrument chosen was a valid one for use in our study population. The increase in the correlations after therapy also indicates that this particular instrument was sensitive to change in patient status.

The present study is the first randomized trial to examine the impact on QOL of PTCA compared with medical therapy. We demonstrated that those who received PTCA showed significant improvements in their overall QOL as measured by the summed psychological well-being and physical activity.

In an attempt to elucidate further a basis for the greater improvement in QOL measures, we correlated the changes in QOL with the interval changes in angiographic appearance. The results demonstrate that the patients who experienced an improvement in QOL were those whose angiograms demonstrated 18.8% improvement in lesion severity. This was true not only for those who underwent PTCA but also for the small number of medical patients whose angiograms improved—presumably due to dissolution of clot.

Although formal, standardized QOL instruments are vital for studies of antianginal therapies, it is unreasonable to expect the practitioner to perform such questionnaires on his or her patients on a routine basis. Therefore, we explored whether the change in exercise duration on standard exercise testing could be used as a surrogate. Previous studies have noted poor correlation between exercise performance and functional status (New York Heart Association functional class) in patients with congestive heart failure³² and angina.³³ The concern was raised that the amount of exertion encountered on a daily basis may not relate to performance on an ETT.³³

The present data reveal an association between the improvement in overall perception of well-being in PTCA patients demonstrating an improvement in exercise performance. A prior study explored the relation between a number of QOL questionnaires, including the PGWB index, and exercise performance.³³ In contrast to our results, they failed to demonstrate an association, perhaps because they evaluated QOL status at a single point in time. In contrast, we evaluated the change in QOL over a 6-month interval in response to an intervention. The construct of QOL instruments is quite different when designing a discriminative instrument (single point in time) versus an evaluative instrument (change over time [20]). However, another assessment of QOL using the Nottingham Health profile did demonstrate a positive correlation with exercise performance.³⁴ Thus, we believe that exercise performance, especially change in exercise tolerance in response to a therapeutic intervention, may serve as a reasonable clinical surrogate for the clinician. However, for the more rigorous scientific assessments of new therapies or comparisons among treatments, more-formal instruments should be used.

	Conclusions

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
In addition to the primary end points of exercise performance and angina attack rate, patients participating in the randomized evaluation of angioplasty compared with medical therapy for the treatment of stable angina completed standardized questionnaires assessing psychological and physical parameters of self-perceived QOL. At the end of the 6-month evaluation period, patients randomized to PTCA had a significantly greater improvement in overall QOL scores. This improvement in QOL was only noted in PTCA-assigned patients demonstrating an increase in exercise performance and only occurred in patients whose angiograms demonstrated at least 18.8% improvement in lesion severity. This is the first randomized study comparing angioplasty and medical therapy to use QOL assessment and to demonstrate the concurrent greater improvement in QOL in patients receiving angioplasty.

View larger version (K): [in this window] [in a new window]   Figure . RECORD NUMBER 2 6 7 2 0 1 121126

	Acknowledgments

 
This work was supported by the Cooperative Studies Program, Research Service, Department of Veterans Affairs, Washington, DC.

	Footnotes

 
¹ Participating investigators are listed in "Appendix A."

	Appendix A

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 
Participating investigators at Veterans Affairs Medical Centers in the ACME Trial were Ann Arbor, Mich: Eric Bates, MD, Judith Mickelson, MD, Peter Verlee, MD; Durham, NC: Frederick Cobb, MD, Kenneth Morris, MD; Lexington, Ky: David Booth, MD, Anthony DeMaria, MD; Los Angeles, Calif: Renaldo Beyer, MD, Martin Josephson, MD, Koonlawee Nadamanee, MD; Memphis, Tenn: David Mirvis, MD, Kadungadi Ramanathan, MD; Palo Alto, Calif: John Giacomini, MD, Helen Gordon, MD; Richmond, Va: Mark Cohen, MD, John Hodgson, MD, John Stroney, MD, George Vetrovec, MD; West Roxbury, Mass: Daniel Pietro, MD, William Strauss, MD.

Received October 4, 1994; revision received February 9, 1995; accepted February 20, 1995.

	References

Top Abstract Introduction Methods Results Discussion Conclusions Appendix A References

 

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