The ARTS (Arterial Revascularization Therapies Study): Background, goals and methods.
BACKGROUND: The rising costs of healthcare have forced policy makers to make choices, and new treatments are increasingly assessed in terms of the balance between additional costs and additional effects. The recent recognition that stenting has a major and long-lasting effect enhancing balloon PTCA procedure has made it imperative to compare in patients with multivessel disease the standard surgical procedure with multiple stenting in a large-scale multinational and multicenter approach (19 countries, 68 sites). METHODS: Selection and inclusion of patients is based on a consensus of the cardiac surgeon and interventional cardiologist on equal 'treatability' of patients by both techniques with analysis of clinical follow-up (event-free survival) on the short (30 days), medium (1 year), and long term (3 and 5 years) with analysis of cost-effectiveness and quality of life (EuroQol and SF-36). Of the entire trial, the primary null hypothesis which needs to be rejected is that there will be no difference in event-free survival or effectiveness (E), at 1 year and also that the direct and indirect costs (C) per event-free year are not different between surgery or stenting. For this to become significant with a power of 90% requires 1200 patients. Between April 97 and June 98, 1205 patients have been randomized with a monthly recruitment of 83 patients; the one year follow-up will thus be completed in June 1999. Expected costs, effects and cost-effectiveness ratio (CE ratio) for stents are: Stent: high-cost estimate, 2 vessel disease (C 3 $19,297, E 3 81%, CE ratio 3 $23,876); 3 vessel disease (C 3 $24,566, E 3 81%, CE ratio 3 $30,397) low-cost estimate, 2 vessel disease (C 3 $16,638, E 3 81%, CE ratio 3 $20,586); 3 vessel disease (C 3 $20,456, E 3 81%, CE ratio 3 $25,322) Compared with CABG (C 3 $21,350, E 3 88%, CE ratio 3 $24,348) CONCLUSION: Clinically, stenting is not expected to be more effective than CABG, but should be cost-effective in both the 2- and 3-vessel disease groups when using the lower-cost estimate and in the 2 vessel group when using the higher-cost assumptions. (Int J Cardiovasc