Ki-Bong Kim1, Ho Young Hwang2, Seokyung Hahn3, Jun Sung Kim4, Se Jin Oh5. 1. Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Korea. Electronic address: kimkb@snu.ac.kr. 2. Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Korea. 3. Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea. 4. Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital, Seongnam, Korea. 5. Department of Thoracic and Cardiovascular Surgery, Seoul National University Boramae Hospital, Seoul, Korea.
Abstract
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 RITA Y-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.
RCT Entities:
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 RITA Y-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.