PARTICIPATION OF PATIENTS with coronary heart disease

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1 1915 A Short Course of Cardiac Rehabilitation Program is Highly Cost Effective in Improving Long-Term Quality of Life in Patients With Recent Myocardial Infarction or Percutaneous Coronary Intervention Cheuk-Man Yu, MD, FRCP, Chu-Pak Lau, MD, FRCP, June Chau, Sarah McGhee, PhD, Hon MFPHM, Shun-Ling Kong, BN, MN, Bernard Man-Yung Cheung, MRCP, FRCP, Leonard Sheung-Wai Li, FRCP, FAFRM ABSTRACT. Yu C-M, Lau C-P, Chau J, McGhee S, Kong S-L, Cheung BM-Y, Li LS-W. A short course of cardiac rehabilitation program is highly cost effective in improving long-term quality of life in patients with recent myocardial infarction or percutaneous coronary intervention. Arch Phys Med Rehabil 2004;85: Objective: To evaluate the long-term effect of a cardiac rehabilitation and prevention program (CRPP) on quality of life (QOL) and its cost effectiveness. Design: Prospective, randomized controlled trial. Setting: University-affiliated outpatient cardiac rehabilitation and prevention center. Participants: A total of 269 patients (76% men; mean age, 64 11y) with recent acute myocardial infarction (AMI; n 193) or after elective percutaneous coronary intervention (PCI; n 76) were randomized in a ratio of 2 to 1. Intervention: Patients received either CRPP (an 8-wk exercise and education class in phase 2) or conventional therapy without exercise program (control group). They were followed until they had completed all 4 phases of the program (ie, 2y). Main Outcome Measures: QOL assessments, by using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Symptoms Questionnaire, were performed at the end of each phase. Direct health care cost was calculated, whereas cost utility was estimated as money spent (in US$) per quality-adjusted life-year (QALY) gained. Results: In the CRPP group, 6 of the 8 SF-36 dimensions improved significantly by phase 2 and were maintained throughout the study period. Patients were less anxious and depressed, and felt more relaxed and contented. In the control group, none of the SF-36 dimensions were improved by phase 2, and bodily pain was increased. In phase 4, only 4 dimensions were improved. Symptoms were unchanged except for increased hostility score. There was a significant gain in net time trade-off in the CRPP group after phase 2. The direct health care expenses in the CRPP and control groups were $15,292 From the Department of Medicine and Therapeutics, Prince of Wales Hospital Hong Kong (Yu, Kong); Department of Medicine, Queen Mary Hospital Hong Kong (Lau, Chau, Cheung); Department of Community Medicine, University of Hong Kong Hong Kong (McGhee); and Department of Medicine, Tung Wah Hospital (Li), Hong Kong. Supported by the Health Care & Promotion Fund Committee of Hong Kong (grant no ). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors(s) or upon any organization with which the author(s) is/are associated. Reprint requests to Chu-Pak Lau, MD, Cardiology Division, Dept of Medicine, Queen Mary Hospital, Pokfulam, Hong Kong, cplau@hkucc.hku.hk /04/ $30.00/0 doi: /j.apmr and $15,707 per patient, respectively. Therefore, the cost utility calculated was $640 saved per QALY gained. Savings attributable to CRPP were primarily explained by the lower rate (13% vs 26% of patients, 2 test 3.9, P.05) and cost of subsequent PCI (P.01). Conclusions: In an era of managing patients with coronary heart disease, a short-course CRPP was highly cost effective in providing better QOL to patients with recent AMI or after elective PCI. In addition, the improvement of QOL was quick and sustained for at least 2 years after CRPP. Key Words: Costs and cost analysis; Exercise therapy; Myocardial ischemia; Quality of life; Rehabilitation by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation PARTICIPATION OF PATIENTS with coronary heart disease in cardiac rehabilitation and prevention programs (CRPP) has gained acceptance in the last decade. 1,2 Although improvement in hard endpoints such as morbidity and mortality was only supported by meta-analysis, 3,4 CRPP was shown to increase patients exercise capacity. 5,6 In a comprehensive CRPP, psychosocial function is another important aspect that rehabilitation physicians and cardiologists should focus on, and the assessment of quality of life (QOL) is a major objective parameter commonly used by researchers. 7,8 Previous uncontrolled studies have found that CRPP improves QOL dimensions in patients with acute myocardial infarction (AMI) or revascularization procedures for up to 1 year. 6,9 However, randomized controlled trials (RCTs) of CRPP, comprised of exercise training, behavioral counseling, and risk factor modification, had controversial effects on QOL beyond phase 2, although early benefits were consistently present. 10,11 Oldridge et al 10 reported that, in patients with AMI, improvement in QOL and exercise tolerance at 1 year was no different for those who received an 8-week CRPP and for the control group. On the other hand, Dugmore et al 11 found that those participating in an intensive 1-year exercise program had better long-term psychologic well-being and QOL scores than did matched controls; the value of that study, however, was limited by the unusually long period of the program. In our era, with limited health care resources but many new dimensions of disease therapy, whether the provision of a new service is cost effective needs to be considered carefully. Information from a meta-analysis 12 of CRPP found that its long-term effect on the number of life-years saved is cost effective, provided that the cost-containing principles are applied in comprehensive programs. Nevertheless, improving the QOL of patients with coronary heart disease in a cost-effective manner may be equal to or may

2 1916 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu even outweigh the importance of the mortality benefit, because the magnitude of the latter benefit is relatively small. An RCT 13 performed in the early 1990s found that the cost-utility ratio of CRPP was US$9200 per quality-adjusted life-year (QALY) gained during 1 year of follow-up. With the rapid shifts in the treatment paradigm toward aggressive management of coronary heart disease, such as the use of thrombolytic therapy after AMI, early and more complete coronary revascularization, and use of new medications such as angiotensin-converting enzyme (ACE) and statins, 14,15 the cost utility of CRPP needs to be readdressed. The aims of this RCT were to investigated (1) whether an 8-week course of exercise training and education program improved long-term (2y) QOL, and (2) whether the CRPP was cost effective in the provision of better QOL in patients with recent AMI or after percutaneous coronary intervention (PCI). METHODS Setting and Patients This unblinded RCT included 269 consecutive patients who were referred to a university-affiliated cardiac rehabilitation center. The largest rehabilitation facility in Hong Kong, this center is situated in the west of the Hong Kong Island and serves a population of about half a million. All patients recruited were either transferred from regional hospitals or attended the outpatient cardiac clinic. Once they were received in the rehabilitation center, consecutive patients within 6 weeks of an AMI or PCI performed for angina pectoris were randomized into the cardiac rehabilitation group (CRPP group) or the control group, at a ratio of 2 to Exclusion criteria included coronary heart disease but without revascularization procedures, significant mitral stenosis (defined as a mitral valve area of 1cm 2 ) or aortic stenosis (defined as an aortic valve gradient of 50mmHg), active pericarditis or myocarditis, severe uncontrolled hypertension (systolic blood pressure 200mmHg and/or diastolic blood pressure 100mmHg), physical problems that precluded exercise, cognitive impairment or unwillingness to join the program, malignancies that limited life span to less than 1 year, and refusal to participate in the study. Age itself was not an exclusion criterion. All study subjects were regularly followed up in the CRPP and cardiac clinics in both study groups. Morbidity and mortality data were obtained through medical records or clinic follow-ups. The hospitalization events were further confirmed by the interhospital computer record and network system. The number and days of hospitalization for all causes (cardiac and noncardiac) that occurred during the rehabilitation program were evaluated. The reason for deaths of patients during the 2-year study period was also ascertained by reviewing the hospital record or death certificate; and the circumstances associated with the event were also obtained from the family members or a witness. The study protocol was approved by the ethics committee, and informed written consent was obtained by every patient. Cardiac Rehabilitation and Prevention Programs The CRPP consisted of 4 phases, as described elsewhere 16,17 Phase 1 was an inpatient ambulating program, which lasted from 7 to 14 days. Phase 2 was a twice-weekly outpatient education and exercise program, lasting 8 weeks. In each session, there was a 1-hour education class focusing on prevention and treatment of coronary heart disease and risk factor modification, such as smoking cessation, controlling cholesterol and blood pressure, reducing weight, managing stress, and treating contributing medical illnesses such as diabetes and hypertension. This was followed by 2 hours of aerobic exercise training. The first hour was conducted by a physiotherapist, who concentrated on aerobic cardiovascular training until the subject was within 65% to 85% of age-adjusted heart rate reserve. 18 This included treadmill, ergometry, rowing, stepper, arm ergometry, and dumbbell and weight training. In the next hour, an occupational therapist conducted home domiciliary or vocational training. Telemetry was used to monitor electrocardiographic changes only for those considered high risk. Phase 3 was a community-based home exercise program lasting 6 months. Phase 4 was a long-term maintenance period, which lasted until the end of the second year after recruitment. After the phase 1 ambulatory phase, the control group received conventional therapy without undergoing the outpatient exercise training program. They received advice from their cardiologists concerning secondary prevention. In addition, antiplatelet medications, -blockers, and statins (if low-density lipoprotein 3.1mmol/L) were prescribed as clinically indicated. The control group also attended a 2-hour talk that explained the disease, the importance of risk-factor modification, and the potential benefits of physical activity. Although the control group did not undergo the exercise program and supervised exercise, the 2 groups underwent the same assessments at the same time-points, that is, at baseline (phase 1) and at the end of phases 2, 3, and 4, inclusive of exercise testing evaluation. QOL Evaluation The QOL assessments were performed on all patients in all 4 phases by a trained social worker (JC) who was unaware of the randomization. QOL was assessed by conducting interviews by using 3 questionnaires: the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the Symptom Questionnaire, and the time trade-off questionnaire. 10,13 The SF-36 is a generic questionnaire measuring 8 dimensions of health: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The highest score for each parameter of SF-36 is 100, and the lowest is 0. The Symptom Questionnaire is a psychologic questionnaire meant to evaluate the level of anxiety, depression, hostility, relaxation, contentment, and friendliness of subjects. The best scores for anxiety, depression, and hostility are 0, and the worst scores are 22. For relaxation, contentment, and friendliness, the best scores are 6 and the worst are 0. The time trade-off involves a single question, which estimates health-related QOL (HRQOL) by asking patients the maximal proportion of life that they would be willing to retain in order to live in full health rather than in their present state of illness. This is expressed in the range from 0 (where one would trade off all of life, theoretically) to 1 (where one would not be willing to trade off any time at all). The QALY was calculated by the following formula 22 : QALY age projected remaining life expectancy (in years) time trade-off score. The net change in QALY between phases was calculated for the CRPP and control groups, respectively, and was then analyzed for differences in all phases between the 2 groups. 22 Cost Estimations Tung Wah Hospital is a heavily subsidized public hospital in Hong Kong. Patients need to pay only a nominal fee to participate in the program. We estimated the total health care costs of

3 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu 1917 the rehabilitation program (in US$) for all 4 phases for the first 150 patients based on the costs published by the hospital. These included costs of staff salary, equipment, investigations, interventions, hospitalizations, scheduled and unscheduled clinic visits, casualty visits, and drugs. Staff salary costs were calculated according to the hourly rates of each discipline in the rehabilitation center, by dividing the annual midpoint salary by the total working hours in a year. The cost of staff salary was then determined in relation to the hours devoted by a staff person to each patient. The equipment cost was calculated by using a straight-line amortization of 10 years, and the amount of time each patient used equipment was then translated to a dollar value. Costs of hospitalizations, investigations, interventions, and clinic visits were based on a local official publication on hospital charges. Investigations were performed at baseline and after phases 2, 3, and 4. They included echocardiography, 24-hour electrocardiographic monitoring, exercise tolerance test, and blood tests. The blood tests involved examination of full-lipid profile, complete blood counts, creatine phosphokinase, glucose, liver and renal function tests, uric acid, and glycosylated hemoglobin for those with diabetes. Coronary angiogram and revascularization procedures after AMI were determined by the cardiologist in charge according to his/her clinical justification. The latter included PCI and coronary artery bypass surgery (CABS). Drug costs for each participant were estimated according to a currently published local drug formulary. These data were supplemented by the patient s self-reported direct medical expenses if private practitioners were consulted. The difference in mean costs between the study and control groups was calculated (the incremental cost), and the cost utility of the CRPP was then calculated as incremental cost per QALY gained per patient. 22 Formal analysis cost effectiveness was not performed, because the present RCT was not designed to measure mortality and there was no incremental mortality rate available from the local population in patients with heart disease attributable to lack of cardiac rehabilitation. Statistics The continuous variables were compared by paired or unpaired t test, where appropriate. Categorical parameters were compared by the Pearson chi-square test. Cost evaluation between groups was compared by using the unpaired t test. QOL scores were evaluated by the Wilcoxon test for phase-to-phase comparisons. The comparison of morbidity and mortality was performed using the Kaplan-Meier survival analysis in a univariate model, with the differences between groups estimated by log-rank test. Data were expressed as mean standard deviation (SD). A P value of less than.05 was considered statistically significant. RESULTS Patient Characteristics Of the 269 Chinese patients recruited, 193 were recruited after recent AMI and 76 after elective PCI (fig 1). The mean age was years, and 204 (76%) were men. One hundred eighty-one patients were randomized into the CRPP group and 88 into the control group. There was no difference in age, sex, and other clinical parameters between the CRPP and control groups (table 1). In the CRPP group, 40% of patients were current smokers, 46% had hypertension, 27% had diabetes, and 47% had a history of hyperlipidemia; in the control group, the corresponding percentages were 42%, 43%, 30%, and 45%, respectively. The overall prescription rate of ACE inhibitors Fig 1. Flow of subjects enrolled in the study. and statins were 64% and 62%, respectively. Forty-three percent of the patients with AMI received thrombolytic therapy. QOL Assessment In the study group, 6 of the 8 SF-36 dimensions improved significantly after phase 2 of the program; these were all maintained when reassessed at the end of phases 3 and 4. These dimensions were physical functioning, physical role, vitality, social functioning, emotional role, and mental health. On the other hand, the bodily pain was increased at the end of phase 2 in the control group and remain so through the study period. At the end of phase 4, 4 dimensions were improved in the control group when compared with phase 1, namely, physical functioning, physical role, vitality, and emotional role (fig 2). Moreover, patients after attending the CRPP became more contented and relaxed at the end of phase 2 and were less anxious and depressed throughout the study period (fig 3). However, none of these psychologic improvements were observed in the control group at the end of the study. Instead, they had increased hostility scores in phases 2 and 3 (figs 2, 3). Costs Costs analysis is shown in table 2. The total health care cost was calculated as $15,707 per patient for the study group and as $15,292 per patient for the control group, which was not significantly different. The incremental cost for the rehabilitation program over the usual cost of care was calculated as $415 per patient, which was primarily attributed to the lower number (13% vs 26%, 2 test 3.9, P.05) and hence lower cost for subsequent PCI ($1100 $2860 vs $2877 $4395, P.01) in the CRPP group after the commencement of the exercise program.

4 1918 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu Table 1: Comparison of Patient Characteristics at Baseline for Patients Who Underwent CRPP and for the Control Group Characteristics CRPP Group (%) Control Group (%) 2 P Mean age SD (y) NA NS Sex, n (%) 0.05 NS Male 138 (76) 66 (75) Female 43 (25) 22 (23) Reason to join CRPP, n (%) Myocardial infarction 129 (71) 64 (73) 0.06 NS PCI 52 (29) 24 (27) Thrombolytic therapy for AMI, n (%) 61 (49) 22 (36) 3.14 NS Smokers, n (%) 72 (40) 36 (42) 0.76 NS Hypertension, n (%) 84 (46) 37 (43) 0.36 NS Hyperlipidemia, n (%) 85 (47) 39 (45) 0.11 NS Diabetes, n (%) 49 (27) 26 (30) 0.23 NS Regular exercise habit, n (%) 57 (57) 29 (58) NS Mean BMI SD (kg/m 2 ) NA NS Mean ejection fraction SD (%) NA NS Medications, n (%) Antiplatelet drugs 179 (99) 87 (99) 0.00 NS -blockers 129 (71) 66 (75) 0.72 NS Calcium antagonists 36 (20) 14 (16) 0.38 NS Nitrates 106 (59) 57 (65) 1.73 NS Statins 119 (66) 49 (56) 0.21 NS ACE inhibitors 119 (64) 53 (60) 0.62 NS Diuretics 38 (21) 11 (13) 2.43 NS Antidiabetic drugs 69 (69) 39 (78) 0.51 NS Abbreviation: BMI, body mass index; NA, not applicable; NS, not significant. Time Trade-Off, QALY, and Cost-Utility Analysis The net change of mean time trade-off scores at the end of phases 2, 3, and 4 for the CRPP and control groups were.03.03,.05.03, and and.05.03,.01.04, and.01.04, respectively, when adjusted for the differences at phase 1 and the mean time trade-off score was significantly improved in the CRPP group when compared with the control group at phase 2 (P.005) (fig 4). The absolute differences in net changes of mean time trade-off scores between the CRPP and control groups were then calculated as.08,.01, and.05, for phases 2, 3, and 4, respectively. Therefore, the mean gain in time trade-off throughout the 2-year rehabilitation program was.0458 per patient. The QALYs calculated for each of the phases, based on the time trade-off and life expectancy in the CRPP and control groups, were 13.1, 13.7, and 13.5 and 11.8, 11.3, 12.4, and 11.7, respectively. Similarly, the net QALYs of the 2 groups, gained in phases 2, 3, and 4, were 0.8, 0.3, and 0.8, respectively, when adjusted for the difference at phase 1. Therefore, the mean gain in QALY at the end of the 2-year program was 0.6. The incremental health care cost for the CRPP group over the control group was $416 per patient; therefore, the cost-utility ratio attributable to the rehabilitation program was $650 per QALY gained per patient. In other words, the health care cost was reduced by the provision of CRPP in the long-term management of patients with coronary heart disease. Clinical Endpoints One hundred thirty-two patients (73%) in the CRPP group completed all 4 phases of the program, and data on 72 patients (82%) in the control group were available at the end of 2 years ( 2 test 3.02, P not significant [NS]). At the end of phase 4, there was no significant difference in mortality (3% vs 5%, log-rank 2 test.05, P NS) or in hospitalization (26% vs 22%, log-rank 2 test 1.07, P NS) between the 2 groups. DISCUSSION Long-Term Improvement of QOL by CRPP Early studies 5,21,23-25 of CRPP based on small patient number and nonrandomized or uncontrolled trials reported that QOL was improved in both young and elderly subjects with recent AMI Although the use of questionnaires to assess HRQOL in patients with coronary heart disease has been validated in large populations, 19 the improvement in psychologic aspects cannot be confidently attributed to CRPP itself, because patients not undergoing CRPP may also have gradual recovery of psychologic function. There are few large RCTs of such design that have investigated the beneficial effect of CRPP on QOL. 10,11,26 Stahle et al 26 found that, in elderly patients with recent acute coronary events, QOL was more improved with CRPP than without it. This result was supported by Dugmore et al, 11 who reported higher QOL scores and psychologic profiles in those who underwent CRPP than in those who did not. However, the generalizability of the latter study is limited, because CRPP was conducted at an unusually high intensity of 3 times a week for 1 year, 11 even though the usual duration of the phase-2 training program is 6 to 12 weeks. 1,4 The study conducted by Oldridge et al 10 more than a decade ago observed that an 8-week CRPP did not improve QOL at 1 year when compared with the control group. However, patients with AMI and after PCI in our study were treated aggressively by various agents that improve the prognosis, such as thrombolytic therapy, 27 ACE, 14,28 and statins, which were used in 43%, 64%, and 62%, respectively. 15 With such rapid change in the treatment paradigm, it is not known

5 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu 1919 Fig 2. Changes in scores of individual SF-36 dimensions in patients who underwent cardiac rehabilitation ( ) and controls ( ). *Significant difference when compared with baseline in patients who underwent cardiac rehabilitation; significant difference when compared with controls.

6 1920 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu Fig 3. Changes in scores of individual Symptoms Questionnaire psychologic symptoms in patients who underwent cardiac rehabilitation ( ) and controls ( ). *Significant difference when compared with baseline in patients who underwent cardiac rehabilitation; significant difference when compared with controls. whether a short-course CRPP for 8 weeks would consistently improve long-term QOL. We found that the improvement in QOL after CRPP was maintained for at least 2 years, including the physical, mental, and social aspects. Such benefits were faster and more sustained than conventional therapy. Therefore, in view of the positive impacts on psychologic well-being, CRPP should be recommended as a standard adjunct therapy. The reasons for the improvement in QOL by CRPP is multifactorial. The positive impact of aerobic training on physical fitness and exercise capacity has been well reported. 5,29 Both the gain in physical functioning and the psychologic support provided by rehabilitation specialists and family members are likely contributing factors. However, the benefits of the 8-week outpatient CRPP alone are difficult to maintain for 2 years. Therefore, the acquisition of a regular home-based exercise routine in the CRPP group throughout the study period may further reinforce the sense of well-being and capability of these patients. Cost Effectiveness of CRPP in the Improvement of QOL Apart from the effect on QOL, the cost effectiveness of CRPP also needs to be considered, especially with the rising financial demand on health care administrators. To determine the cost effectiveness of CRPP in the improvement of QOL, cost utility as incremental cost per QALY gained was assessed. 13,30 Only 1 RCT 13 has evaluated the cost utility of CRPP in anxious or depressed post-ami patients. This work, done nearly a decade ago, found that the cost utility was US$9200/QALY gained in favor of CRPP. 13 Although this evaluation did not distinguish between affordability and the worth of alternative health care services, Oldridge et al concluded that CRPP represents an efficient use of health care resources and was economically justified. Two other less rigorous, nonrandomized controlled studies 31,32 reported that the cost of health care in patients participating in the CRPP after AMI was lower than conventional therapy, in those both older

7 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu 1921 and younger than 65 years. This benefit was explained by the lower cardiovascular rehospitalization charges. In our study, there was no difference in rehospitalization rate in the 2 treatment arms. We believe that there is a need to revisit the cost utility of CRPP, because most of the new therapies introduced in the last decade improved cardiovascular rehospitalization rate. 15,27 Our study found that there was a significant net gain in mean time trade-off in the CRPP group after phase 2, and a larger gain in mean QALY after the 2-year CRPP than elsewhere stated. 13 The mean health care cost in the CRPP group was lower after 2 years, which was explained by the significantly lower rate and expenditure in subsequent PCI that offset the money spent in the program. The lower rate of subsequent PCI may be related to the beneficial effect of exercise training on ischemic preconditioning. 33,34 In animal studies, exercise training restored ischemic preconditioning of senescent hearts by improving myocardial norepinephrine release. 33 In addition, the magnitude of this warm-up response in patients with coronary heart disease was positively related to the intensity of exercise training. 34 Therefore, in some patients with mild and even moderate coronary lesions, the need for elective PCI after exercise training may be obviated. In addition, the psychologic benefit of CRPP on QOL might also contribute to the reduction of the psychosomatic effect on the precipitation of ischemic symptoms, especially anxiety and depressive symptoms. 13,24,35 Because our study was performed without any selection bias on subgroups such as age, sex, baseline psychologic status, or clinical risk factors, the results could be generalized into nearly all patients with recent AMI or PCI. Limitations The sample size and the duration of follow-up did not allow us to determine the potential benefit of mortality and morbidity of CRPP over conventional care. Because of the heavily subsidized health system, patients only contributed a nominal portion of the total costs. Therefore, we could not use billing statistics to accurately assess the cost of CRPP versus control, and some hidden costs may be underestimated. However, this Table 2: Comparison of Mean Costs of Medical Expenses per Patient (in US$) for Patients Who Underwent CRPP and for the Control Group Item CRPP Group (US$) Control Group (US$) Staff salary Equipment Hospitalizations Investigations Coronary angiogram Echocardiography Holter Exercise test Electrocardiogram Blood tests Chest radiogram Revascularization procedures PCI CABS Private clinic visits Public cardiac clinic visits Public noncardiac clinic visits Casualty visits Drugs Mean total costs per patient 15, ,707.4 Fig 4. Changes in time trade-off scores after adjusting for baseline differences in patients who underwent cardiac rehabilitation and in controls. *P<.005 when the 2 groups were compared. is compensated, in part, by using the difference in costs between the 2 intervention arms rather than the actual cost itself. However, there was no significant difference in baseline demographics between the defaulters and those analyzed patients, and we believe that the effect of loss to follow-up, if any, would be small. CONCLUSIONS This RCT found that patients with AMI or after elective PCI who underwent an 8-week course of CRPP had early and sustained improvement in QOL for at least 2 years. CRPP was highly cost effective, with a net gain in QALY, whereas direct health care expenses were reduced, which was primarily related to the reduction of the subsequent need for PCI. The information provided in this study supports the adoption of CRPP in addition to the contemporary regimen of managing patients with coronary heart disease. References 1. Balady GJ, Ades PA, Comoss P, et al. Core components of cardiac rehabilitation/secondary prevention programs: a statement for healthcare professionals from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation Writing Group. Circulation 2000;102: Pollock ML, Franklin BA, Balady GJ, et al. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: an advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation 2000;101: Pashkow FJ. Issues in contemporary cardiac rehabilitation: a historical perspective. J Am Coll Cardiol 1993;21: Oldridge NB, Guyatt GH, Fischer ME, Rimm AA. Cardiac rehabilitation after myocardial infarction. Combined experience of randomized clinical trials. JAMA 1988;260: Lavie CJ, Milani RV. Effects of cardiac rehabilitation programs on exercise capacity, coronary risk factors, behavioral characteristics, and quality of life in a large elderly cohort. Am J Cardiol 1995;76: Packa DR, Branyon ME, Kinney MR, Khan SH, Kelley R, Miers LJ. Quality of life of elderly patients enrolled in cardiac rehabilitation. J Cardiovasc Nurs 1989;3: Wenger NK, Mattson ME, Furberg CD, Elinson J. Assessment of quality of life in clinical trials of cardiovascular therapies. Am J Cardiol 1984;54: Oldridge NB. Outcome assessment in cardiac rehabilitation. Health-related quality of life and economic evaluation. J Cardiopulm Rehabil 1997;17:

8 1922 CARDIAC REHABILITATION IS COST EFFECTIVE, Yu 9. Wahrborg P. Quality of life after coronary angioplasty or bypass surgery. 1-year follow-up in the Coronary Angioplasty versus Bypass Revascularization investigation (CABRI) trial. Eur Heart J 1999;20: Comment in: Eur Heart J 1999;20: Oldridge N, Guyatt G, Jones N, et al. Effects on quality of life with comprehensive rehabilitation after acute myocardial infarction. Am J Cardiol 1991;67: Dugmore LD, Tipson RJ, Phillips MH, et al. Changes in cardiorespiratory fitness, psychological wellbeing, quality of life, and vocational status following a 12 month cardiac exercise rehabilitation programme. Heart 1999;81: Perk J. Need cardiac rehabilitation be cost-effective? J Cardiovasc Risk 1996;3: Oldridge N, Furlong W, Feeny D, et al. Economic evaluation of cardiac rehabilitation soon after acute myocardial infarction. Am J Cardiol 1993;72: Pfeffer MA, Braunwald E, Moye LA, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med 1992;327: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) [see comments]. Lancet 1994;344: Yu CM, Li LS, Ho HH, Lau CP. Long-term changes in exercise capacity, quality of life, body anthropometry, and lipid profiles after a cardiac rehabilitation program in obese patients with coronary heart disease. Am J Cardiol 2003;91: Yu CM, Lau CP, Cheung BM, et al. Clinical predictors of morbidity and mortality in patients with myocardial infarction or revascularization who underwent cardiac rehabilitation, and importance of diabetes mellitus and exercise capacity. Am J Cardiol 2000;85: American College of Sports Medicine. ACSM S guidelines for exercise testing and prescription. Baltimore: Williams & Wilkins; Jette DU, Downing J. Health status of individuals entering a cardiac rehabilitation program as measured by the medical outcomes study 36-item short-form survey (SF-36). Phys Ther 1994; 74: Morrin L, Black S, Reid R. Impact of duration in a cardiac rehabilitation program on coronary risk profile and health-related quality of life outcomes. J Cardiopulm Rehabil 2000;20: Beniamini Y, Rubenstein JJ, Zaichkowsky LD, Crim MC. Effects of high-intensity strength training on quality-of-life parameters in cardiac rehabilitation patients. Am J Cardiol 1997;80: Torrance GW, Feeny D. Utilities and quality-adjusted life years. Int J Technol Assess Health Care 1989;5: Lavie CJ, Milani RV. Disparate effects of improving aerobic exercise capacity and quality of life after cardiac rehabilitation in young and elderly coronary patients. J Cardiopulm Rehabil 2000;20: Maines TY, Lavie CJ, Milani RV, Cassidy MM, Gilliland YE, Murgo JP. Effects of cardiac rehabilitation and exercise programs on exercise capacity, coronary risk factors, behavior, and quality of life in patients with coronary artery disease. South Med J 1997;90: Trzcieniecka-Green A, Steptoe A. Stress management in cardiac patients: a preliminary study of the predictors of improvement in quality of life. J Psychosom Res 1994;38: Stahle A, Mattsson E, Ryden L, Unden A, Nordlander R. Improved physical fitness and quality of life following training of elderly patients after acute coronary events. A 1 year follow-up randomized controlled study. Eur Heart J 1999;20: The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. The GUSTO Angiographic Investigators [published erratum in: N Engl J Med 1994;330:516]. N Engl J Med 1993;329: Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000;342: Marchionni N, Fattirolli F, Valoti P, et al. Improved exercise tolerance by cardiac rehabilitation after myocardial infarction in the elderly: results of a preliminary, controlled study. Aging (Milano) 1994;6: Oldridge NB. Cardiac rehabilitation and risk factor management after myocardial infarction. Clinical and economic evaluation. Wien Klin Wochenschr Suppl 1997;2: Bondestam E, Breikss A, Hartford M. Effects of early rehabilitation on consumption of medical care during the first year after acute myocardial infarction in patients or 65 years of age. Am J Cardiol 1995;75: Levin LA, Perk J, Hedback B. Cardiac rehabilitation a cost analysis. J Intern Med 1991;230: Abete P, Calabrese C, Ferrara N, et al. Exercise training restores ischemic preconditioning in the aging heart. J Am Coll Cardiol 2000;36: Kay P, Kittelson J, Stewart RA. Relation between duration and intensity of first exercise and warm up in ischaemic heart disease. Heart 2000;83: Fleg JL, Pina IL, Balady GJ, et al. Assessment of functional capacity in clinical and research applications: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association. Circulation 2000;102:

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