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A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial

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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. [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. [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. [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.
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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.

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出版当年[2022]版:
大类 | 1 区 医学
小类 | 2 区 心脏和心血管系统
最新[2025]版:
大类 | 1 区 医学
小类 | 2 区 心脏和心血管系统
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出版当年[2021]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
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Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者单位: [1]Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
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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
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