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

作者全名："Kan, Jing; Zhang, Hang; Xie, Dujiang; Wei, Yongyue; Zhang, Juan; Zhang, Caojin; Yang, Zhenwen; Gu, Heping; Fan, Fenling; Gu, Hong; Wang, Qiguang; Zhang, Gangcheng; Guo, Xiaomei; Yin, Yuehui; Wang, Xiang; Jin, Bowen; Zhou, Hongmei; Yang, Ziyang; Wang, Zhouming; Xin, Yu; Zhang, Chen; Meng, Lili; Wang, Xiaoyu; Zhao, Chunxia; Yan, Xiaoyan; Chen, Feng; Yao, Cheng; Stone, Gregg W.; Chen, Shao-Liang"

作者地址："[Kan, Jing; Zhang, Hang; Xie, Dujiang; Zhang, Juan; Chen, Shao-Liang] Nanjing Med Univ, Nanjing Hosp 1, Div Cardiol, 68 Changle Rd, Nanjing 210006, Peoples R China; [Wei, Yongyue] Peking Univ, Ctr Publ Hlth & Epidem Preparedness & Response, Hlth Sci Ctr, Shanghai, Peoples R China; [Zhang, Caojin; Yang, Ziyang] Guangdong Prov Peoples Hosp, Div Cardiol, Guangzhou, Peoples R China; [Yang, Zhenwen; Wang, Zhouming] Tianjin Med Univ, Gen Hosp, Div Pulm Vasc Dis, Tianjin, Peoples R China; [Gu, Heping; Xin, Yu] Zhengzhou Univ, Hosp 1, Div Cardiol, Zhengzhou, Peoples R China; [Fan, Fenling; Wang, Xiaoyu] Xi An Jiao Tong Univ, Affiliated Hosp 1, Div Pulm Vasc Dis, Xian, Peoples R China; [Gu, Hong; Zhang, Chen] Capital Med Univ, Beijing Anzhen Hosp, Div Congenital Heart Dis, Beijing, Peoples R China; [Wang, Qiguang; Meng, Lili] Gen Hosp Northern Theater Command, Div Neurosurg, Shenyang, Peoples R China; [Zhang, Gangcheng] Wuhan Univ, Zhongnan Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China; [Guo, Xiaomei; Zhao, Chunxia] Huazhong Univ Sci & Technol, Tongji Hosp, Div Cardiol, Wuhan, Peoples R China; [Yin, Yuehui] Chongqing Med Univ, Hosp 2, Div Cardiol, Chongqing, Peoples R China; [Wang, Qiguang; Chen, Feng] Nanjing Med Univ, Sch Publ Hlth, Dept Biostat, Nanjing, Peoples R China; [Jin, Bowen; Zhou, Hongmei] Wuhan Asia Heart Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China; [Yan, Xiaoyan; Yao, Cheng] Peking Univ, Clin Res Inst, Beijing, Peoples R China; [Stone, Gregg W.] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY USA"

通信作者："Chen, SL (通讯作者)，Nanjing Med Univ, Nanjing Hosp 1, Div Cardiol, 68 Changle Rd, Nanjing 210006, Peoples R China."

来源：EUROINTERVENTION

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001104079900012

JCR分区：Q1

影响因子：6.2

年份：2023

卷号：19

期号：8

开始页：684

结束页：+

文献类型：Article

关键词：clinical trials; other abdominal; visceral; pulmonary; intervention; hypertension

摘要："Background: Long-term clinical outcomes after pulmonary artery denervation (PADN) in patients with Group 1 pulmonary arterial hypertension (PAH) have not been reported.Aims: We aimed to investigate the effect of PADN on 1-year outcomes in patients with PAH.Methods: 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.Results: 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 (p(interaction)=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.Conclusions: 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."

基金机构："National Scientific Foundation of China [NSFC 91639303, NSFC 81770441, NSFC 82121001]; Nanjing First Hospital"

基金资助正文："<STRONG> </STRONG>This trial was funded by grants from the 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."