Author + information
- Received June 15, 2009
- Revision received October 19, 2009
- Accepted October 19, 2009
- Published online February 2, 2010.
- Akhil Kapur, MBChB, MD*,
- Roger J. Hall, MD†,‡,
- Iqbal S. Malik, MMBChir, PhD†,
- Ayesha C. Qureshi, MBBS*,
- Jeremy Butts, MBBS†,
- Mark de Belder, MD§,
- Andreas Baumbach, MS∥,
- Gianni Angelini, MD, MCh∥,
- Adam de Belder, MBBS, MD¶,
- Keith G. Oldroyd, MBChB, MD#,
- Marcus Flather, MBBS†,**,
- Michael Roughton, MSc**,
- Petros Nihoyannopoulos, MD†,
- Jens Peder Bagger, MBBS, DSc†,
- Kenneth Morgan, MBChB, BSc† and
- Kevin J. Beatt, MBBS, PhD††,* ()
- ↵*Reprint requests and correspondence:
Dr. Kevin J. Beatt, Mayday University Hospital, London Road, London CR7 7YE, England
Objectives The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease.
Background CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization.
Methods The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available.
Results At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p = 0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p = 0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p = 0.82), respectively.
Conclusions The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154)
Funding for this study was provided by unrestricted research grants from Eli Lilly, Cordis Johnson & Johnson, Bristol-Myers Squibb, Sanofi-Aventis, and the Hammersmith Hospitals Special Trustees. Further support was obtained from Boston Scientific, Medtronic, Guidant, and Jomed. This was an investigator-initiated and independently managed trial. The trial was initially coordinated at the Hammersmith Hospital (now part of Imperial College Healthcare NHS Trust) and from 2005 on at the Royal Brompton Hospital. The study design, data management, coordination, and analysis were all undertaken independent of all funding sources. For full author disclosures, please see the end of this paper.
- Received June 15, 2009.
- Revision received October 19, 2009.
- Accepted October 19, 2009.
- American College of Cardiology Foundation