1-Year Outcomes of a Multicenter Randomized Controlled Trial of the Ankura II Thoracic Endoprosthesis for the Endovascular Treatment of Stanford Type B Aortic Dissections
单位：[1]Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha, China,[2]Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China,[3]Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China,[4]Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, China,[5]Department of Vascular Surgery, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China,浙江大学医学院附属第一医院[6]Department of Vascular Surgery, Wuhan General Hospital of Guangzhou Military Region, Wuhan, China,[7]Department of Vascular Surgery, Kunming General Hospital of Chengdu Military Region, Kunming, China,[8]Department of Vascular Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China,临床科室心血管中心血管外科首都医科大学附属北京友谊医院[9]Department of Vascular Surgery, Hainan Provincial People’s Hospital, Haikou, China,[10]Department of Vascular Surgery, The First Affiliated Hospital of the Fourth Military Medical University, Xi’an, China,[11]Department of Vascular Surgery, Xiangya Hospital, Central South University, Changsha, China,[12]Department of Vascular Surgery, General Hospital of Tianjin Medical University, Tianjin, China,[13]Department of Vascular Surgery, Wuhan University People’s Hospital, Wuhan, China,[14]Medical Research and Statistics Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China,[15]Drug Clinical Research Center, Shanghai University of Traditional Chinese Medicine, Shanghai, China
BackgroundThe Ankura II Thoracic Stent Graft System (Lifetech, Shenzhen, China) is an evolution of the Ankura stent graft. This study reports one-year outcomes of the Ankura II Thoracic Stent Graft System for endovascular treatment of Stanford type B aortic dissections. MethodsThe Ankura II Thoracic Aortic Endovascular Trial was a randomized, single-blinded, clinical trial conducted at 12 Chinese institutes. The enrolled patients diagnosed with Stanford type B aortic dissections (TBADs) were randomly assigned to the Ankura group or Ankura II group. Standard follow-up examinations were performed at 1, 6, and 12 months. Safety and efficacy data were analyzed. Results132 patients with TBADs were enrolled. The outcomes for the primary safety end points revealed that the Ankura II stent graft was statistically non-inferior compared to the Ankura stent graft. The 1-month device-related major adverse events (1.6 vs. 0%; p = 0.48), 1-month all-cause mortality (1.7 vs. 4.5%; p = 0.621), 12-month survival rate (95.2 +/- 2.7% vs. 94.1 +/- 2.9%; p = 0.769), and major adverse event (MAE) rate (5.1 vs. 4.7% at 1 month; p = 0.73 and 5.8 vs. 8.9% at 12 months; p = 0.718) of Ankura II group are all comparable to Ankura group. The two groups showed similar primary effectiveness and true lumen expansion effect, and false lumen remodeling was improved in Ankura II group (-100.0 vs. -48.5%; p = 0.08). ConclusionsThe one-year outcomes from this prospective, randomized, multicenter study demonstrate that Ankura II stent graft shows comparable results to Ankura for treating TBADs, resulting in low mortality rates, MAEs and reintervention rates.
第一作者单位：[1]Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha, China,[2]Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China,
共同第一作者：
通讯作者：
通讯机构：[1]Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha, China,[2]Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China,
推荐引用方式(GB/T 7714)：
Chang Shu,Hao He,Weiguo Fu,et al.1-Year Outcomes of a Multicenter Randomized Controlled Trial of the Ankura II Thoracic Endoprosthesis for the Endovascular Treatment of Stanford Type B Aortic Dissections[J].FRONTIERS in CARDIOVASCULAR MEDICINE.2022,9:doi:10.3389/fcvm.2022.805585.
APA：
Chang Shu,Hao He,Weiguo Fu,Wei Guo,Ming Li...&Feng Gu.(2022).1-Year Outcomes of a Multicenter Randomized Controlled Trial of the Ankura II Thoracic Endoprosthesis for the Endovascular Treatment of Stanford Type B Aortic Dissections.FRONTIERS in CARDIOVASCULAR MEDICINE,9,
MLA：
Chang Shu,et al."1-Year Outcomes of a Multicenter Randomized Controlled Trial of the Ankura II Thoracic Endoprosthesis for the Endovascular Treatment of Stanford Type B Aortic Dissections".FRONTIERS in CARDIOVASCULAR MEDICINE 9.(2022)
