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酒精介导的双侧肾上腺动脉栓塞术治疗特发性醛固酮增多症患者的安全性和有效性:一项随机对照试验的6个月随访

Safety and efficacy of alcohol-mediated bilateral adrenal artery embolization in patients with idiopathic hyperaldosteronism: a 6-month follow-up of a randomized controlled trial.

作者信息

Zhou Yaqiong, Liu Sen, Ji Guo, Yang Changqiang, Zhang Lingling, Luo Tao, Huang Fei, Chen Zongling, Hou Jixin, Wang Peijian

机构信息

Department of Cardiology, School of Clinical Medicine, The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China.

Key Laboratory of Aging and Vascular Homeostasis at Chengdu Medical College of Sichuan Province, Chengdu, Sichuan, China.

出版信息

J Hum Hypertens. 2025 Jun 4. doi: 10.1038/s41371-025-01032-6.

DOI:10.1038/s41371-025-01032-6
PMID:40468047
Abstract

Although unilateral adrenal artery embolization (AAE) has emerged as an alternative treatment for patients with primary aldosteronism (PA), it may be insufficient for treating patients with idiopathic hyperaldosteronism (IHA) due to the bilateral nature of their condition. This study aimed to investigate the safety and efficacy of alcohol-mediated bilateral adrenal artery embolization (Bi-AAE) in patients with idiopathic hyperaldosteronism (IHA). A total of 72 patients were randomly assigned in a (1:1) ratio to receive either Bi-AAE or spironolactone (20-60 mg/day). The primary endpoint was the change in office systolic blood pressure (SBP) from baseline to 6 months. Key secondary endpoints included changes in 24 h blood pressure, aldosterone levels, aldosterone-to-renin ratio (ARR), and serum potassium. At 6 months, Bi-AAE significantly reduced office SBP compared to spironolactone (-18.9 ± 16.4 mmHg vs. -11.6 ± 9.3 mmHg; treatment difference: -7.4 mmHg; P = 0.03), with a greater proportion of Bi-AAE patients achieving target SBP (<140 mmHg; 77.1% vs. 51.5%; P = 0.027). Bi-AAE also resulted in significantly greater reductions in 24 h and home SBP at 1, 3, and 6 months (all P < 0.05). Furthermore, Bi-AAE was more effective in correcting biochemical abnormalities, including hyperaldosteronism and renin suppression (all P < 0.05). Importantly, Bi-AAE preserved zona fasciculata function, as evidenced by normal morning serum cortisol levels and intact responses to ACTH stimulation post-procedure. No serious adverse events occurred during the perioperative or 6-month follow-up period. These findings support Bi-AAE as a safe, minimally invasive, and highly effective alternative to medical therapy for managing IHA. Although the findings support Bi-AAE as a safe, minimally invasive, and highly effective alternative to medical therapy for managing IHA, the need for long-term data before drawing definitive conclusions is emphasized. Future studies with extended follow-up are necessary to confirm its long-term benefits and risks. Trial registration: The trial has been registered at ClinicalTrials.gov (NCT05262660).

摘要

尽管单侧肾上腺动脉栓塞术(AAE)已成为原发性醛固酮增多症(PA)患者的一种替代治疗方法,但由于特发性醛固酮增多症(IHA)患者病情的双侧性,该方法可能不足以治疗此类患者。本研究旨在探讨酒精介导的双侧肾上腺动脉栓塞术(Bi-AAE)治疗特发性醛固酮增多症(IHA)患者的安全性和有效性。总共72例患者按1:1比例随机分组,分别接受Bi-AAE或螺内酯(20 - 60mg/天)治疗。主要终点是从基线到6个月时诊室收缩压(SBP)的变化。关键次要终点包括24小时血压、醛固酮水平、醛固酮与肾素比值(ARR)以及血清钾的变化。在6个月时,与螺内酯相比,Bi-AAE显著降低了诊室SBP(-18.9±16.4mmHg对-11.6±9.3mmHg;治疗差异:-7.4mmHg;P = 0.03),达到目标SBP(<140mmHg)的Bi-AAE患者比例更高(77.1%对51.5%;P = 0.027)。Bi-AAE在1、3和6个月时还使24小时和家庭SBP显著降低更多(所有P < 0.05)。此外,Bi-AAE在纠正生化异常方面更有效,包括醛固酮增多症和肾素抑制(所有P < 0.05)。重要的是,Bi-AAE保留了束状带功能,术后早晨血清皮质醇水平正常以及对促肾上腺皮质激素刺激的反应完整证明了这一点。围手术期或6个月随访期间未发生严重不良事件。这些发现支持Bi-AAE作为一种安全、微创且高效的替代药物治疗方法来管理IHA。尽管这些发现支持Bi-AAE作为一种安全、微创且高效的替代药物治疗方法来管理IHA,但强调在得出明确结论之前需要长期数据。有必要进行长期随访的未来研究以确认其长期益处和风险。试验注册:该试验已在ClinicalTrials.gov注册(NCT05262660)。

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本文引用的文献

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Primary Aldosteronism and Risk of Cardiovascular Outcomes: Genome-Wide Association and Mendelian Randomization Study.原发性醛固酮增多症与心血管结局风险:全基因组关联和孟德尔随机化研究。
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Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial.
肾神经交感神经标测与消融治疗高血压的疗效及安全性(SMART):一项随机对照试验的6个月随访
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