Kefei Dou1, Dong Zhang2, Hongwei Pan3, Ning Guo4, Lang Li5, Yue Li6, Qi Zhang7, Bin Liu8, Zhujun Shen9, Bin Zhang10, Jian Liu11, Wei Han12, Yang Wang13, Yanyan Zhao13, Yuejin Yang2, Shaoliang Chen14, Lihua Xie15, Changdong Guan15, Ajay J Kirtane16, Bo Xu17. 1. State Key Laboratory of Cardiovascular Disease, Beijing, China; Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: drdoukefei@126.com. 2. State Key Laboratory of Cardiovascular Disease, Beijing, China; Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. 3. Department of Cardiology, Hunan Provincial People's Hospital, the First Affiliated Hospital of Hunan Normal University, Changsha, China. 4. Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 5. Department of Cardiology, the First Affiliated Hospital of Guangxi Medical University, Nanning, China. 6. Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, China. 7. Department of Cardiology, Shanghai East Hospital, Tongji University, Shanghai, China. 8. Department of Cardiology, the Second Hospital of Jilin University, Changchun, China. 9. Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 10. Department of Cardiology, Guangdong General Hospital, Guangzhou, China. 11. Departments of Cardiology, Peking University People's Hospital, Beijing, China. 12. Department of Cardiology, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China. 13. Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China. 14. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 15. Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 16. Center for Interventional Vascular Therapy, Columbia University Medical Center/NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York. 17. National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: bxu@citmd.com.
Abstract
OBJECTIVES: The aim of this study was to determine whether an active side branch protection (SB-P) strategy is superior to the conventional strategy in reducing side branch (SB) occlusion in high-risk bifurcation treatment. BACKGROUND: Accurate prediction of SB occlusion after main vessel stenting followed by the use of specific strategies to prevent occlusion would be beneficial during bifurcation intervention. METHODS:Eligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score were randomized to an active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs) in a 1:1 ratio stratified by SB vessel size. The primary endpoint of SB occlusion was defined as an angiography core laboratory-assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow in the SB immediately after full apposition of the main vessel stent to the vessel wall. RESULTS:A total of 335 subjects at 16 sites were randomized to the SB-P group (n = 168) and conventional group (n = 167). Patients in the SB-P versus conventional strategy group had a significantly lower rate of SB occlusion (7.7% [13 of 168] vs. 18.0% [30 of 167]; risk difference: -9.1%; 95% confidence interval: -13.1% to -1.8%; p = 0.006), driven mainly by the difference in the small SB subgroup (jailed balloon technique vs. jailed wire technique: 8.1% vs. 18.5%; p = 0.01). CONCLUSIONS: An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions. (Conventional Versus Intentional Strategy in Patients With High Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [CIT-RESOLVE]; NCT02644434).
RCT Entities:
OBJECTIVES: The aim of this study was to determine whether an active side branch protection (SB-P) strategy is superior to the conventional strategy in reducing side branch (SB) occlusion in high-risk bifurcation treatment. BACKGROUND: Accurate prediction of SB occlusion after main vessel stenting followed by the use of specific strategies to prevent occlusion would be beneficial during bifurcation intervention. METHODS: Eligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score were randomized to an active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs) in a 1:1 ratio stratified by SB vessel size. The primary endpoint of SB occlusion was defined as an angiography core laboratory-assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow in the SB immediately after full apposition of the main vessel stent to the vessel wall. RESULTS: A total of 335 subjects at 16 sites were randomized to the SB-P group (n = 168) and conventional group (n = 167). Patients in the SB-P versus conventional strategy group had a significantly lower rate of SB occlusion (7.7% [13 of 168] vs. 18.0% [30 of 167]; risk difference: -9.1%; 95% confidence interval: -13.1% to -1.8%; p = 0.006), driven mainly by the difference in the small SB subgroup (jailed balloon technique vs. jailed wire technique: 8.1% vs. 18.5%; p = 0.01). CONCLUSIONS: An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions. (Conventional Versus Intentional Strategy in Patients With High Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [CIT-RESOLVE]; NCT02644434).