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).