Abstract
OBJECTIVE: To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) and CABG performed with total arterial grafting (TAG). METHODS: Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups. Exclusion criteria included prior CABG, emergent procedure, concomitant procedure, varicose veins and renal dysfunction. The primary endpoints were: enrolment >20% and completion of CT coronary angiography at 6 months >80%. Statistical investigation was performed on an intention to treat analysis. RESULTS: Of 421 eligible patients, 60 were enrolled and 2 withdrew (n = 30 in TAG, n = 28 LIMA+SVG) for 14% enrolment rate. Patient characteristics were similar in each group. No patients died in hospital and adverse events such as MI, stroke and deep sternal wound infection were not significantly different between groups. Clinical follow-up was complete in 100% of patients, with 44/58 (76%) undergoing CT coronary angio at 6 months. Graft occlusion occurred in 2 patients in each group for patency rates of 89% (TAG) and 91% (LIMA+SVG). CONCLUSIONS: We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult. Given the excellent patency results and little difference between groups, our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point. TRIAL REGISTRATION: Randomized Controlled Trial number: ISRCTN80270323 . Few RCT's exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) compared to CABG performed with total arterial grafting (TAG). This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls.