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PURPOSE: Presently, reliable estimates on the impact of secondary cardiovascular events on health status in patients treated for cardiovascular disease are unavailable. However, precise estimates are obligatory to reduce uncertainty about the impact of secondary events, particularly for health economic modeling. METHODS: We gathered individual patient data on health status (EQ5D, range 1 to -0.6) and secondary cardiovascular events (death, myocardial infarction (MI), cerebral infarction, amputation, extracranial bleeding) during follow-up from several completed clinical trials comparing surgical interventions for patients with cardiovascular disease. Included were three trials on patients requiring coronary revascularisation, comparing bypass grafting, balloon angioplasty with stenting and minimally invasive bypass grafting (total n=1405), and one trial on patients with intermittent claudication comparing angioplasty with or without stenting (n=245). Re-interventions were not included or accounted for in this analysis. A random coefficients model on the utility scores, correcting for time and event, was fitted using S-plus. RESULTS: This analysis included 1650 patients, with follow-up ranging from 12 to 36 months. Patients without secondary events improved after intervention (+0.05, p<0.001). 285 patients died. Significant effects were found for myocardial infarction (n=220, impact score -0.03, p=0.005), cerebral infarction (n=60, impact score -0.05, p=0.02) and extracranial bleeding (n=25, impact score -0.05, p=0.01), but not for amputation (n=15). Patients who get an event, except for MI, start substantially (but not significantly, p between 0.15 and 0.22) lower than patients without secondary events. Possible heterogeneity was ignored as the heterogeneity-tests F-max and ICC were negative. CONCLUSIONS: Subsequent cardiovascular events have significant impact in terms of utility. Impact of secondary events is in the same range as improvement due to surgery. Adding additional trial data and similar analyses performed on SF-36 domains will further increase the precision and validity of the results. These estimates on the impact of secondary cardiovascular events will be useful in reducing the uncertainty in long-term economic modelling. Supported by Netherlands Heart Foundation grant 2002B45.
See more of Poster Session - CEA: Methods and Applications; Health Services Research
See more of The 26th Annual Meeting of the Society for Medical Decision Making (October 17-20, 2004)