A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial
单位:[1]Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, People's Republic of China.[2]Center for Public Health and Epidemic Preparedness & Response, Health Science Center, Peking University, Shanghai, People's Republic of China.[3]Division of Cardiology, Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.广东省人民医院[4]Division of Pulmonary Vascular Disease, General Hospital of Tianjin Medical University, Tianjin, People's Republic of China.[5]Division of Cardiology, First Hospital of Zhengzhou University, Zhengzhou, People's Republic of China.[6]Division of Pulmonary Vascular Disease, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.[7]Division of Congenital Heart Disease, Beijing Anzhen Hospital of Capital Medical University, Beijing, People's Republic of China.首都医科大学附属安贞医院[8]Division of Pulmonary Vascular Disease, General Hospital of Northern Theater of Command, Shenyang, People's Republic of China.[9]Division of Pulmonary Vascular Disease, Zhongnan Hospital of Wuhan University, Wuhan, People's Republic of China.[10]Division of Cardiology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, People's Republic of China.内科学系心血管内科华中科技大学同济医学院附属同济医院[11]Division of Cardiology, Second Hospital of Chongqing Medical University, Chongqing, People's Republic of China.[12]Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, People's Republic of China.[13]Division of Pulmonary Vascular Disease, Wuhan Asia Heart Hospital, Wuhan, People's Republic of China.[14]Peking University Clinical Research Institute, Beijing, People's Republic of China.[15]The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Long-term clinical outcomes after pulmonary artery denervation (PADN) in patients with Group 1 pulmonary arterial hypertension (PAH) have not been reported.We aimed to investigate the effect of PADN on 1-year outcomes in patients with PAH.In the multicentre PADN-CFDA trial, 128 patients with Group 1 PAH were randomly assigned to PADN plus a phosphodiesterase-5 inhibitor (PDE-5i) versus a sham PADN procedure plus a PDE-5i. The principal endpoint of interest for the present study was clinical worsening at 1 year after randomisation, the composite of worsening of PAH (increase in WHO functional class, need for additional PAH treatments or PAH-related hospitalisation), atrial septostomy, listing for lung transplantation, or all-cause death.One-year clinical follow-up was available in all patients. At 1 year, clinical worsening had occurred in 3 (4.8%) patients in the PADN plus PDE-5i group and in 15 patients (23.1%) in the sham plus PDE-5i group (adjusted hazard ratio: 0.17; 95% confidence interval [CI]: 0.05-0.60; p=0.006), driven by significantly increased rates of PAH-related hospitalisations, worsening functional class and the requirement for additional PAH treatments in the sham group. Results were consistent in high-risk, intermediate-risk and low-risk patients (pinteraction=0.186). Patients treated with PADN plus PDE-5i had an improvement in the between-group change in the six-minute walking distance (6MWD) from baseline to 1 year of 81.2 m (95% CI: 50.3-112.2; p<0.001) compared with PDE-5i treatment alone.In this multicentre sham-controlled randomised trial, PADN treatment for Group 1 PAH significantly reduced clinical worsening and improved the 6MWD during 1-year follow-up in patients treated with a PDE-5i.
基金:
National Scientific
Foundation of China (grant numbers NSFC 91639303, NSFC
81770441 and NSFC 82121001) and Nanjing First Hospital.
Pulnovo provided PADN catheters for use in the study
第一作者单位:[1]Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
共同第一作者:
通讯作者:
通讯机构:[1]Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, People's Republic of China.[*1]Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, 68 Changle Road, Nanjing 210006, People’s Republic of China
推荐引用方式(GB/T 7714):
Kan Jing,Zhang Hang,Xie Dujiang,et al.A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial[J].EUROINTERVENTION.2023,19(8):684-+.doi:10.4244/EIJ-D-23-00349.
APA:
Kan Jing,Zhang Hang,Xie Dujiang,Wei Yongyue,Zhang Juan...&Chen Shao-Liang.(2023).A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial.EUROINTERVENTION,19,(8)
MLA:
Kan Jing,et al."A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial".EUROINTERVENTION 19..8(2023):684-+