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CLINICAL RESEARCH: CLINICAL TRIAL

Randomized Comparison of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Diabetic Patients

1-Year Results of the CARDia (Coronary Artery Revascularization in Diabetes) Trial

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^,_*

^_* London Chest Hospital, Barts and The London NHS Trust, London, England
Imperial College Healthcare NHS Trust, London, England
Norfolk and Norwich University Hospitals, Norwich, England
James Cook University Hospital, Middlesbrough, England
^|| Bristol Heart Institute, Bristol, England
^¶ Royal Sussex County Hospital, Brighton, England
^# Western Infirmary, Glasgow, Scotland
^_** Royal Brompton and Harefield NHS Foundation Trust, London, England
Mayday University Hospital, London, England

Manuscript received June 15, 2009; revised manuscript received October 19, 2009, accepted October 19, 2009.

^_* Reprint requests and correspondence: Dr. Kevin J. Beatt, Mayday University Hospital, London Road, London CR7 7YE, England (Email: dr.beatt{at}heartbeatt.com).

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)

Key Words: coronary revascularization • diabetes • multivesssel disease

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass grafting   CI = confidence interval   DES = drug-eluting stent(s)   HR = hazard ratio   MACCE = major adverse coronary and cerebral events   MI = myocardial infarction   PCI = percutaneous coronary intervention

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