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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

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).

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Fig. 1: Flow diagram of study participants.
Fig. 2: Change in BP from baseline to 1 month, 3 months, and 6 months.
Fig. 3: Office SBP forest plots of prespecified subgroups.
Fig. 4: Percentage of patients at target office SBP.
Fig. 5: Hourly plots comparing 24 h BP at baseline and 6 months.
Fig. 6: Change from baseline in plasma aldosterone exposure, renin, and ARR over the study treatment period and at the end of treatment.
Fig. 7: Change from baseline in morning serum cortisol, plasma ACTH, and serum potassium over the study treatment period and at the end of treatment.

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Data availability

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

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Funding

This work was supported by grants from Key Project of Sichuan Natural Science Foundation (No.2024NSFSC0051), National Natural Science Foundation of China (No. 82300333), the CMC Excellent-talent Program (No. 2024kjTzn05), Central Funds Guiding the Local Science and Technology Development of Sichuan Province (No. 2024ZYD0148), Innovation Team Project of Sichuan Provincial Health Commission (No. 24CXTD01), National Key Clinical Specialties Construction (No. 2024GXNKG002), and Sichuan Science and Technology Program (No.24PYXM0578).

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Authors

Contributions

YZ, SL, and GJ contributed equally to the study design, data analysis, and interpretation of the results. CY, LZ, and TL were responsible for patient recruitment and management. FH and ZC provided technical support for the Bi-AAE procedures. HX and PW supervised the study, ensured data integrity, and provided critical revisions to the manuscript. All authors reviewed and approved the final version of the manuscript.

Corresponding authors

Correspondence to Jixin Hou or Peijian Wang.

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The authors declare no competing interests.

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The study was approved by the First Affiliated Hospital of Chengdu Medical College Ethics Committee. Informed consent was obtained from all participants.

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Consent for publication was obtained from all participants.

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Zhou, Y., Liu, S., Ji, G. et al. 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. J Hum Hypertens 39, 489–499 (2025). https://doi.org/10.1038/s41371-025-01032-6

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