• Interventional Techniques & Devices
• Cardiology Clinical Trials

The use of bilateral internal mammary artery (BIMA) grafting is safe according to one-year data from the Arterial Revascularization Trial (ART). David P Taggart, MD, PhD, Professor of Cardiovascular Medicine, University of Oxford and John Radcliffe Hospital, Oxford, UK, presented findings from the one-year analysis of ART, a large international, multicenter, randomized clinical trial of 3102 patients comparing the use of bilateral versus single internal mammary artery grafting in coronary artery bypass grafting (CABG) patients. The study is the largest randomized trial of two surgical procedures ever undertaken in cardiac surgery and is funded for 10 years to determine whether or not BIMA reduces long-term mortality and the need for repeat revascularization. One-year analyses focused on the safety and feasibility of this interventional approach.

For the overall study, the primary endpoint is survival at 10 years and the secondary endpoints include 30 day and cause specific mortality, the need for revascularization, clinical events, quality of life measures, and cost-effectiveness measures. Follow-up analysis at one year included 3069 patients who were randomized to either single internal mammary artery (SIMA) grafting (n=1540) or BIMA (n=1529). Patients were well-matched at baseline. The use of BIMA increased the mean surgery length by 23 minutes and the mean ventilation time by 105 minutes. Outcomes for the preliminary analysis included all-cause mortality, cerebrovascular accident (CVA), myocardial infarction (MI), revascularization, and wound reconstruction at 30 days and at one-year, excluding wound reconstruction for the one-year analysis.

Thirty day and one-year mortality did not increase with the use of BIMA. The rate of all-cause mortality at 30 days was 1.2% for both groups. The rate of CVA, MI, and revascularization at 30 days was also similar between the two groups (1.2% vs 1.0% for BIMA, 1.5% vs 1.4% for BIMA, and 0.4% vs 0.7% for BIMA, respectively). BIMA was associated with a slight increase in the risk of sternal wound reconstruction compared with SIMA (0.6% vs 1.9% for BIMA amounting to a difference of 1.3%). The rate of CVA, MI, and revascularization at one-year were similar for SIMA versus BIMA (1.8% vs 1.5%, 2.0% for both, and 1.3% vs 1.8%, respectively). The rate of all-cause mortality for BIMA was 2.5% compared with 2.3% for SIMA.

Preliminary results from ART are promising with regards to the safety and feasibility of BIMA compared with SIMA. Based on these preliminary data, BIMA appears to be safe for use in CABG patients. Sub-group analyses investigating the effect of diabetes, age, on- versus off-pump, radial artery versus vein grafts, and ventricular function on outcomes will also be evaluated upon completion of the study. ART is expected to be completed in 2015 at which point long-term survival, quality of life, cost-effectiveness, and other analyses will be presented.

• © 2010 MD Conference Express