title: The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design.
abstract: BACKGROUND
  Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary intervention (PCI)--is limited, mainly confined to a subanalysis of the Bypass Angioplasty Revascularization (BARI) trial, suggesting a mortality benefit of CABG over PCI. No prospective trial has specifically compared these modes of revascularization in patients with diabetes.
  
  
  OBJECTIVE
  The Coronary Artery Revascularisation in Diabetes (CARDia) trial is designed to address the hypothesis that optimal PCI is not inferior to modern CABG as a revascularization strategy for diabetics with multivessel or complex single-vessel coronary disease. The primary end point is a composite of death, nonfatal myocardial infarction, and cerebrovascular accident at 1 year.
  
  
  METHODS
  A total of 600 patients with diabetes are to be randomized to either PCI or CABG, with few protocol restrictions on operative techniques or use of new technology. This gives a power of 80% to detect non-inferiority of PCI assuming that the PCI 1-year event rate is 9%. A cardiac surgeon and a cardiologist must agree that a patient is suitable for revascularization by either technique prior to recruitment into the study. Twenty-one centers in the United Kingdom and Ireland are recruiting patients. Data on cost effectiveness, quality of life, and neurocognitive function are being collected. Long-term (3-5 year) follow-up data will also be collected.
authors.affiliation: Hammersmith Hospital, London, United Kingdom. a.kapur@imperial.ac.uk
authors.forename: A
authors.initials: A
authors.lastname: Kapur
authors.forename: I S
authors.initials: IS
authors.lastname: Malik
authors.forename: J P
authors.initials: JP
authors.lastname: Bagger
authors.forename: J R
authors.initials: JR
authors.lastname: Anderson
authors.forename: J S
authors.initials: JS
authors.lastname: Kooner
authors.forename: M
authors.initials: M
authors.lastname: Thomas
authors.forename: P
authors.initials: P
authors.lastname: Punjabi
authors.forename: J
authors.initials: J
authors.lastname: Mayet
authors.forename: T
authors.initials: T
authors.lastname: Millane
authors.forename: J
authors.initials: J
authors.lastname: Goedicke
authors.forename: K
authors.initials: K
authors.lastname: Jamrozik
authors.forename: M A
authors.initials: MA
authors.lastname: de Belder
authors.forename: R J
authors.initials: RJ
authors.lastname: Hall
authors.forename: K J
authors.initials: KJ
authors.lastname: Beatt
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000150:complications / Q000601:surgery / Q000628:therapy*; D048909:Diabetes Complications; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus