Pulmonary Artery Denervation for Pulmonary Arterial Hypertension A Sham-Controlled Randomized PADN-CFDA Trial

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

作者地址："[Zhang, Hang; Kan, Jing; Xie, Dujiang; Chen, Shao-Liang] Nanjing Med Univ, Div Cardiol, Nanjing Hosp 1, Nanjing, Peoples R China; [Wei, Yongyue; Chen, Feng] Nanjing Med Univ, Sch Publ Hlth, Nanjing, Peoples R China; [Zhang, Caojin; Yang, Ziyang] Guangdong Prov Peoples Hosp, Div Cardiol, Guangzhou, Peoples R China; [Yang, Zhenwen; Wang, Zhouming] Tianjin Med Univ, Div Pulm Vasc Dis, Gen Hosp, Tianjin, Peoples R China; [Gu, Heping; Xin, Yu] Zhengzhou Univ, Div Cardiol, Hosp 1, Zhengzhou, Peoples R China; [Fan, Fenling; Wang, Xiaoyu] Xi An Jiao Tong Univ, Div Pulm Vasc Dis, Affiliated Hosp 1, 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 Pulm Vasc Dis, Shenyang, Peoples R China; [Zhang, Gangcheng] Wuhan Univ, Div Pulm Vasc Dis, Zhongnan Hosp, Wuhan, Peoples R China; [Guo, Xiaomei; Zhao, Chunxia] Div Cardiol, Tongji Hosp, Huazhong Univ Sci & Technol, Wuhan, Peoples R China; [Yin, Yuehui] Chongqing Med Univ, Div Cardiol, Hosp 2, Chongqing, Peoples R China; [Jin, Bowen; Zhou, Hongmei] Wuhan Asia Heart Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China; [Sun, Jingping; Zhang, Juan] Nanjing Med Univ, Cardiac Imaging Ctr, Nanjing, 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 10029 USA"

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

来源：JACC-CARDIOVASCULAR INTERVENTIONS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000933394000007

JCR分区：Q1

影响因子：11.3

年份：2022

卷号：15

期号：23

开始页：2412

结束页：2423

文献类型：Article

关键词：6-minute walk distance; pulmonary arterial hypertension; pulmonary artery denervation; pulmonary artery pressure; pulmonary vascular resistance

摘要："BACKGROUND World Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary artery pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial. OBJECTIVES The aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH. METHODS Patients with WHO group 1 PAH not taking PAH-specific drugs for at least 30 days were enrolled in a multicenter, sham-controlled, single-blind, randomized trial. Patients were assigned to receive PADN plus a phosphodiesterase-5 inhibitor or a sham procedure plus a phosphodiesterase-5 inhibitor. The primary endpoint was the between-group difference in the change in 6-minute walk distance from baseline to 6 months. RESULTS Among 128 randomized patients, those treated with PADN compared with sham had a greater improvement in 6-minute walk distance from baseline to 6 months (mean adjusted between-group difference 33.8 m; 95% CI: 16.7-0.9 m; P < 0.001). From baseline to 6 months, pulmonary vascular resistance was reduced by -3.0 +/- 0.3 WU after PADN and -1.9 +/- 0.3 WU after sham (adjusted difference -1.4; 95% CI: -2.6 to -0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation, and decreased N-terminal pro-brain natriuretic peptide. Clinical worsening was less (1.6% vs 13.8%; OR: 0.11; 95% CI: 0.01-0.87), and a satisfactory clinical response was greater (57.1% vs 32.3%; OR: 2.79; 95% CI: 1.37-5.82) with PADN treatment during 6-month follow-up. CONCLUSIONS In patients with WHO group 1 PAH, PADN improved exercise capacity, hemodynamic status, and clinical outcomes during 6-month follow-up. (Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension [PADN-CFDA]; NCT03282266) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc- nd/4.0/)."

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

基金资助正文："This trial was supported by the National Scientific Foundation of China (grants NSFC 91639303, and NSFC 81770441, and NSFC 82121001). Nanjing First Hospital funded this trial, and Pulnovo Medical provided all PADN catheters through the study period. Dr Stone has received speaker honoraria from Medtronic, Pulnovo Medical, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, VWave, Cardiomech, Gore, and Amgen; and has equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone's daughter is an employee at Medtronic. Dr Stone's employer, Mount Sinai Hospital, has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, and V-Wave. Dr S.-L. Chen is the inventor of PADN but not the owner of the PADN patent; has received speaker honoraria from Microport, Pulnovo Medical, Boston Scientific, Medtronic, Sanofi, and BioMed; is a fellow at the Collaborative Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University; and has received grants from the National Scientific Foundation of China. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose."