title: The ARTS study (Arterial Revascularization Therapies Study).
abstract: The rising costs of health care 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 multicentre approach (19 countries, 68 sites). 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 day), medium (1 year), and long-term (3 and 5 year) 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% one needs 1200 patients. Between April 97 and June 98, 1205 patients have been randomized with a monthly recruitment of 83 patients. Expected costs, effects and cost-effectiveness ratio (CE ratio) are: Stent high costs 2 VDStent high costs 3 VDStent low costs 2 VDStent low costs 3 VDCABG costs (C)$19.297$24.566$16.638$20.456$21.350 effects (E)81%81%81%81%88% CE ratio$23.876$30.397$20.586$25.322$24.348 Clinically, stenting is not expected to be more effective than CABG, but should be cost effective in both the 2- and 3-VD group when using the lower cost estimate and in the 2 VD group when using the higher cost assumptions.
authors.affiliation: Department of Interventional Cardiology, Heartcenter/Eramus University Rotterdam/Interuniversity Cardiology Institute of the Netherlands. serruys@card.azr.nl
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: F
authors.initials: F
authors.lastname: Unger
authors.forename: B A
authors.initials: BA
authors.lastname: van Hout
authors.forename: M J
authors.initials: MJ
authors.lastname: van den Brand
authors.forename: L A
authors.initials: LA
authors.lastname: van Herwerden
authors.forename: G A
authors.initials: GA
authors.lastname: van Es
authors.forename: J J
authors.initials: JJ
authors.lastname: Bonnier
authors.forename: R
authors.initials: R
authors.lastname: Simon
authors.forename: J
authors.initials: J
authors.lastname: Cremer
authors.forename: A
authors.initials: A
authors.lastname: Colombo
authors.forename: C
authors.initials: C
authors.lastname: Santoli
authors.forename: M
authors.initials: M
authors.lastname: Vandormael
authors.forename: P R
authors.initials: PR
authors.lastname: Marshall
authors.forename: O
authors.initials: O
authors.lastname: Madonna
authors.forename: B G
authors.initials: BG
authors.lastname: Firth
authors.forename: A
authors.initials: A
authors.lastname: Breeman
authors.forename: M A
authors.initials: MA
authors.lastname: Morel
authors.forename: P G
authors.initials: PG
authors.lastname: Hugenholtz
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000191:economics; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000191:economics / Q000601:surgery / Q000628:therapy*; D003362:Cost-Benefit Analysis; D006801:Humans; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015607:Stents / Q000191:economics