Jung-Min Ahn1, Jae-Hyung Roh1, Young-Hak Kim1, Duk-Woo Park1, Sung-Cheol Yun2, Pil Hyung Lee1, Mineok Chang1, Hyun Woo Park1, Seung-Whan Lee1, Cheol Whan Lee1, Seong-Wook Park1, Suk Jung Choo1, CheolHyun Chung1, JaeWon Lee1, Do-Sun Lim3, Seung-Woon Rha4, Sang-Gon Lee5, Hyeon-Cheol Gwon6, Hyo-Soo Kim7, In-Ho Chae8, Yangsoo Jang9, Myung-Ho Jeong10, Seung-Jea Tahk11, Ki Bae Seung12, Seung-Jung Park13. 1. Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 2. Division of Biostatistics, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 3. Korea University Anam Hospital, Seoul, South Korea. 4. Korea University Kuro Hospital, Seoul, South Korea. 5. Ulsan University Hospital, Ulsan, South Korea. 6. Samsung Medical Center, Seoul, South Korea. 7. Seoul National University Hospital, Seoul, South Korea. 8. Seoul National University Hospital, Bundang, South Korea. 9. Yonsei University Severance Hospital, Seoul, South Korea. 10. Chonnam National University Hospital, Gwangju, South Korea. 11. Ajou University Medical Center, Suwon, South Korea. 12. Catholic University of Korea, St. Mary's Hospital, Seoul, South Korea. 13. Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: sjpark@amc.seoul.kr.
Abstract
BACKGROUND: In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. OBJECTIVES: This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. METHODS: We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. RESULTS: At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). CONCLUSIONS: During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).
RCT Entities:
BACKGROUND: In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. OBJECTIVES: This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. METHODS: We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. RESULTS: At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). CONCLUSIONS: During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).
Authors: Salvatore Cassese; Sebastian Kufner; Erion Xhepa; Robert A Byrne; Johanna Kreutzer; Tareq Ibrahim; Klaus Tiroch; Marco Valgimigli; Ralph Tölg; Massimiliano Fusaro; Heribert Schunkert; Karl-Ludwig Laugwitz; Julinda Mehilli; Adnan Kastrati Journal: Clin Res Cardiol Date: 2015-12-22 Impact factor: 5.460