Title | A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial |
Authors | 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 |
Affiliation | Nanjing Med Univ, Nanjing Hosp 1, Div Cardiol, 68 Changle Rd, Nanjing 210006, Peoples R China Peking Univ, Ctr Publ Hlth & Epidem Preparedness & Response, Hlth Sci Ctr, Shanghai, Peoples R China Guangdong Prov Peoples Hosp, Div Cardiol, Guangzhou, Peoples R China Tianjin Med Univ, Gen Hosp, Div Pulm Vasc Dis, Tianjin, Peoples R China Zhengzhou Univ, Hosp 1, Div Cardiol, Zhengzhou, Peoples R China Xi An Jiao Tong Univ, Affiliated Hosp 1, Div Pulm Vasc Dis, Xian, Peoples R China Capital Med Univ, Beijing Anzhen Hosp, Div Congenital Heart Dis, Beijing, Peoples R China Gen Hosp Northern Theater Command, Div Neurosurg, Shenyang, Peoples R China Wuhan Univ, Zhongnan Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China Huazhong Univ Sci & Technol, Tongji Hosp, Div Cardiol, Wuhan, Peoples R China Chongqing Med Univ, Hosp 2, Div Cardiol, Chongqing, Peoples R China Nanjing Med Univ, Sch Publ Hlth, Dept Biostat, Nanjing, Peoples R China Wuhan Asia Heart Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China Peking Univ, Clin Res Inst, Beijing, Peoples R China Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY USA |
Keywords | AMBRISENTAN SURVIVAL |
Issue Date | Oct-2023 |
Publisher | EUROINTERVENTION |
Abstract | 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. |
URI | http://hdl.handle.net/20.500.11897/692026 |
ISSN | 1774-024X |
DOI | 10.4244/EIJ-D-23-00349 |
Indexed | SCI(E) |
Appears in Collections: | 医学部待认领 |