A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes

Objective: The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial was designed to evaluate the noninferiority of the saphenous vein (SV) compared with the right internal thoracic artery ([R] ITA) used as a Y-composite graft. Methods: A total of 224 patients who had undergone off-pump revascularization for multivessel coronary artery disease using the SV or RITA as a Y-composite graft based on the in situ left ITA were assigned randomly to the SV Y-composite graft (SV group, n = 112) or free RITAY-composite graft (RITA group, n = 112). The primary endpoint was the 1-year angiographic patency rate of the second limb conduits (SV or RITA). Postoperative 1-year coronary angiograms were performed in 215 patients (SV group, 108; RITA group, 107). Results: The overall graft patency rate was 97.4%(745 of 765) at 1 year (97.9% in the SV group vs 96.9% in the RITA group, P = .362). The primary endpoint of the study, the 1-year patency rate of the SV composite grafts, was 97.1% (238 of 245) and was noninferior to that of the RITA composite grafts (97.1% [198 of 204]) with a 95% lower confidence limit of 2.6%(P < .001 for noninferiority). The graft qualities, evaluated using the FitzGibbon patency grades, were also similar between the 2 groups (P = .948). No statistically significant differences were found in the overall survival rates between the 2 groups at 1 and 4 years (P - .998). Also, no statistically significant differences were found between the 2 groups in the freedom from major adverse cardiac and cerebrovascular event rates at 1 and 4 years (P = .597). Conclusions: The SV composite grafts were noninferior to the RITA composite grafts in terms of the 1-year angiographic patency rates.