The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design

Am Heart J. 2005 Jan;149(1):13-9. doi: 10.1016/j.ahj.2004.07.001.


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.

Method: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary*
  • Coronary Artery Bypass*
  • Coronary Disease / complications
  • Coronary Disease / surgery
  • Coronary Disease / therapy*
  • Diabetes Complications*
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Multicenter Studies as Topic
  • Myocardial Infarction
  • Randomized Controlled Trials as Topic
  • Research Design
  • Sirolimus / administration & dosage
  • Stents


  • Immunosuppressive Agents
  • Sirolimus