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Treatment strategies in unstable coronary artery disease: economic and quality of life evaluations
Linköping University, Department of Medicine and Care, Cardiology. Linköping University, Faculty of Health Sciences.ORCID iD: 0000-0002-9375-5087
2003 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

During the past few decades two treatment strategies have evolved for patients with unstable coronary artery disease (UCAD). The non-invasive strategy uses clinical investigations and non-invasive stress tests to identify patients who need diagnostic catheterisation. The early invasive strategy uses coronary catheterisation as the diagnostic instrument. The new technologies have consequences not only for the clinical endpoints of death or myocardial infarction (MI), but also in terms of health-related quality of life and costs. The economic evaluations are of great importance due to the high incidence of the disease and high short-term costs of the invasive strategy. The early costly intervention may prevent later complications and thereby partly or completely offset the higher initial treatment costs. Even if longterm costs remain higher, they can be justified by improved survival or quality of life. Such clinical effects in the long-term follow-up need to be seen in relation to the cost of the strategy. In a prospective Scandinavian multi centre trial we examined 3489 patients with UCAD. The purpose of this thesis was to study the treatment strategies in UCAD with respect to cost-effectiveness and patients' health-related quality of life. This purpose was divided into four aims:

The first aim was to evaluate the cost-effectiveness of extended treatment with the low-molecular-weight heparin dalteparin. 2267 patients were randomised. The incremental cost-effectiveness ratio for administering dalteparin treatment for one month was SEK 30,300 per avoided death or MI. Since the resources for early intervention are limited in many countries, extended dalteparin treatment for up to one month is a cost-effective bridge to invasive intervention.

The second aim was to evaluate the short-term costs and cost-effectiveness of the invasive strategy compared to the non-invasive strategy. A total of 2457 patients were randomised. The results were analysed in a societal perspective. The difference in mean total costs after one year was SEK 23,900 (p < 0.001), favouring the non-invasive strategy. The incremental cost-effectiveness ratio for choosing the invasive instead of the non-invasive strategy was SEK 645,000 per avoided death or MI. The high cost at the beginning of the invasive strategy was substantial. For policy discussions concerning implementing the invasive strategy, these positive results should be balanced against the cost-consequences of the strategy.

The third aim was to evaluate the patients' health-related quality of life with respect to the strategies. We used two questionnaires, the generic Short Form 36 (SF-36) and the disease-specific Angina Pectoris Quality of Life Questionnaire (APQLQ), at randomisation and after three, six and 12 months of followup. The invasively treated group showed a significantly better health-related quality of life at the threeand six-month follow-ups (p < 0.01) than the non-invasively treated group. These differences remained at the 12-month follow-up. The disease-specific quality of life results were similar.

The fourth aim was to evaluate the long-term cost-effectiveness and cost-utility of these strategies. Results were analysed in both a societal and a health care provider perspective. The difference in mean total cost SEK 11,400 was not statistically significant. The estimated cost per quality adjusted life year (QALY) gained for the invasive strategy, based on within trial results and projected life expectancy, was SEK 22,900. These results were consistent in most subgroups. The estimated cost per life year gained was SEK 57,700. Compared to other accepted treatments in the cardiovascular field, the cost per QALY gained is very low.

In summary, this thesis shows that the early invasive treatment strategy for patients with UCAD promotes health-related quality of life and is highly cost-effective when compared to many other interventions in the cardiovascular field and should therefore be recommended.

Place, publisher, year, edition, pages
Linköping: Linköpings universitet , 2003. , 176 p.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 811
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-27497Local ID: 12151ISBN: 91-7373-499-3 (print)OAI: oai:DiVA.org:liu-27497DiVA: diva2:248049
Public defence
2003-10-17, Elsa Brändströmsa sal, Universitetssjukhuset, Linköping, 13:00 (Swedish)
Opponent
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2013-09-11Bibliographically approved
List of papers
1. Cost effectiveness of extended treatment with low molecular weight heparin (dalteparin) in unstable coronary artery disease: results from the FRISC II trial
Open this publication in new window or tab >>Cost effectiveness of extended treatment with low molecular weight heparin (dalteparin) in unstable coronary artery disease: results from the FRISC II trial
2003 (English)In: Heart, ISSN 1355-6037, E-ISSN 1468-201X, Vol. 89, no 3, 287-292 p.Article in journal (Refereed) Published
Abstract [en]

Background: In unstable coronary artery disease short term treatment with low molecular weight heparin in addition to aspirin has been shown to be effective.

Objective: To assess the cost effectiveness of extended treatment with dalteparin in patients managed with a non-invasive treatment strategy.

Design: Prospective, randomised, multicentre study.

Setting: 58 centres in Sweden, Denmark, and Norway, of which 16 were interventional.

Patients: After at least five days’ treatment with open label dalteparin, 2267 patients were randomised to continue double blind treatment with either subcutaneous dalteparin twice daily or placebo for three months. The patients’ use of health service resources was recorded prospectively.

Main outcome measure: Death/myocardial infarction.

Results: After one month into the double blind period there was a 47% relative reduction in death or myocardial infarction in the dalteparin group compared with the placebo group (p = 0.002). There was a non-significant mean cost difference, favouring the placebo group, of 849 Swedish crowns (SEK) per patient (equivalent to £58). The incremental cost effectiveness ratio for giving dalteparin treatment for one month was SEK 30 300 (range −78 000 to 139 000) (£2060, range −£5300 to £9400) per avoided death or myocardial infarct. At three months, the decrease in death or myocardial infarction was not significant, precluding cost effectiveness analyses.

Conclusions: There is a marginal and non-significant increase in costs for one month of extended dalteparin treatment compared with placebo. Extended dalteparin treatment lowers the risk of death or myocardial infarction in patients with unstable coronary artery disease. While in many countries the resources for early intervention are limited, extended dalteparin treatment up to one month is a cost effective bridge to invasive intervention.

National Category
Social Sciences
Identifiers
urn:nbn:se:liu:diva-26280 (URN)10.1136/heart.89.3.287 (DOI)10794 (Local ID)10794 (Archive number)10794 (OAI)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2013-09-11Bibliographically approved
2. Cost-effectiveness of an invasive strategy in unstable coronary artery disease: results from the FRISC II invasive trial
Open this publication in new window or tab >>Cost-effectiveness of an invasive strategy in unstable coronary artery disease: results from the FRISC II invasive trial
2002 (English)In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 23, no 1, 31-40 p.Article in journal (Refereed) Published
Abstract [en]

Aims The utilization and timing of revascularization in unstable coronary artery disease varies, which could have important consequences for patients and for treatment costs. The FRISC II invasive trial compared an early invasive strategy vs a non-invasive strategy with respect to the composite end-point of death and myocardial infarction as well as costs.

Methods and Results A total of 2457 patients, median age 66 years, comprising 70% men, were randomized. We prospectively recorded the patients' use of the health service. The results were analysed in a societal perspective. There was a significant 1·7% absolute reduction in deaths and a 3·7% absolute reduction in deaths and myocardial infarctions in the invasive compared to the non-invasive group after 12 months. During the initial hospitalization a patient in the invasive group spent on average 3·9 more days in hospital than a patient in the non-invasive group. Opposite results were found for rehospitalizations. The difference in mean total costs is SEK 23 876 (P<0·001). The incermental cost-effective ratio for choosing the invasive instead of the non-invasive strategy is SEK 1 404 000 per avoided death and SEK 645 000 per avoided death or myocardial infarction

Conclusion The high cost at the beginning of the invasive strategy is substantial. The clinical results of the FRISC II study provided evidence that the invasive strategy reduces the rate of death and myocardial infarction in patients with unstable coronary artery disease. For policy discussions concerning whether or not to implement the invasive strategy, these positive results should be balanced against the cost-consequences of the strategy.

Keyword
Unstable angina, non-Q wave myocardial infarction, unstable coronary artery disease, costs, cost-effectiveness, revascularization
National Category
Social Sciences
Identifiers
urn:nbn:se:liu:diva-26279 (URN)10.1053/euhj.2001.2695 (DOI)10793 (Local ID)10793 (Archive number)10793 (OAI)
Available from: 2009-10-08 Created: 2009-10-08 Last updated: 2013-09-11Bibliographically approved
3. Invasive treatment in unstable coronary artery disease promotes health-related quality of life: results from the FRISC II trial
Open this publication in new window or tab >>Invasive treatment in unstable coronary artery disease promotes health-related quality of life: results from the FRISC II trial
2004 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 148, no 1, 114-121 p.Article in journal (Refereed) Published
Abstract [en]

Background

Treatment strategies, either invasive or noninvasive, for patients with unstable coronary artery disease still vary. There are no published studies comparing the strategies for health-related quality of life.

Methods

A total of 2457 patients with unstable coronary artery disease were randomized. We prospectively recorded the patients' health-related quality of life using 2 questionnaires, the generic Medical Outcomes Study Short Form 36 (SF-36) and the disease-specific Angina Pectoris Quality of Life Questionnaire (APQLQ), at randomization and after 3, 6, and 12 months of follow-up.

Results

There was a high response rate (92%) at randomization, with 2251 respondents. The invasively treated group showed a significantly better quality of life in all 8 scales and both component scores at the 3- and 6-month follow-up (P <.01) than the noninvasively treated group. These differences remained at the 12-month follow-up, with significance in 7 of the scales and in the physical component score. The disease-specific quality of life results were similar until the 6-month follow-up. At randomization, the unstable population showed a remarkably lower quality of life in all 8 scales and the component scores compared with an age- and sex-matched normative population.

Conclusions

Patients receiving early invasive intervention after an unstable episode had substantial improvement in health-related quality of life until the 1-year follow-up, compared with patients receiving noninvasive treatment. Health-related quality of life in an unstable coronary artery disease population is remarkably lower than in a matched normative population.

National Category
Social Sciences
Identifiers
urn:nbn:se:liu:diva-23965 (URN)10.1016/j.ahj.2003.11.026 (DOI)3515 (Local ID)3515 (Archive number)3515 (OAI)
Available from: 2009-10-07 Created: 2009-10-07 Last updated: 2013-09-11Bibliographically approved
4. Long-term cost-effectiveness of invasive strategy in patients with unstable coronary artery disease: results from the FRISC II invasive trial
Open this publication in new window or tab >>Long-term cost-effectiveness of invasive strategy in patients with unstable coronary artery disease: results from the FRISC II invasive trial
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background The use of coronary catheterisation and revascularisation in unstable coronary artery disease (UCAD) varies, which could have important consequences for patients as well as for health care costs. Our objective was to examine the total two-year costs and the long-term cost-effectiveness and cost-utility of these strategies.

Methods All 2457 patients in the FRISC II invasive trial, randomised to an early invasive strategy with coronary catheterisation and revascularisation if appropriate or to a non-invasive strategy with coronary catheterisation only for recurrent ischemic symptoms or a positive stress test, were included in the economic evaluation. The patients' use of health services as well as productivity losses were recorded prospectively. Health state scores were obtained five times during the two-year follow-up. Health effects and costs appearing after two years were modelled.

Findings The mean total cost was Swedish kronor (SEK) 11 386 (£ 850) higher in the invasive group. 1bis difference was not statistically significant. The estimated cost per quality adjusted life year (QALY) gained for the invasive strategy, based on within trial results and projected life expectancy, was SEK 22 873 (£ 1 707). These results were consistent in most subgroups. The estimated cost per life year gained was SEK 57 651 (£ 4 302). If costs for added life years were included, the cost per QALY was SEK 78 077 (£ 5 827) for invasive strategy.

Interpretation Invasive strategy in patients with unstable angina or non-ST-segment elevation myocardial infarction was shown to be highly cost-effective in the long term.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-84650 (URN)
Available from: 2012-10-16 Created: 2012-10-16 Last updated: 2013-09-11Bibliographically approved

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