Background: Renal denervation (RDN) has demonstrated clinically relevant reductions in blood pressure among individuals with uncontrolled hypertension despite lifestyle intervention and medications. The safety and effectiveness of alcohol-mediated RDN has not been formally studied in this indication.Methods: TARGET BP I is a prospective, international, sham-controlled, randomized, patient- and assessor-blinded trial investigating the safety and efficacy of alcohol-mediated RDN. Patients with office systolic blood pressure (SBP) ≥150 and ≤180 mmHg, office diastolic BP ≥90 mmHg and mean 24-hour ambulatory SBP ≥135 and ≤170 mmHg, despite prescription of 2-5 antihypertensive medications were enrolled. The primary endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 3 months post procedure. Secondary endpoints include mean between-group differences in office and ambulatory BP at additional time points.Results: Among 301 patients randomized 1:1 to RDN or sham control, RDN was associated with a significant reduction in 24-hour ambulatory SBP at 3 months (mean ± standard deviation -10.0 ± 14.2 mmHg versus -6.8 ± 12.1 mmHg, treatment difference -3.2 mmHg, 95% confidence interval [CI] -6.3, 0.0 mmHg; P=0.0487). Subgroup analysis of the primary endpoint revealed no significant interaction across predefined subgroups. At 3 months, the mean change in office SBP was -12.7 ± 18.3 mmHg and -9.7 ± 17.3 mmHg (difference, -3.0, 95% CI -7.0, 1.0; P=0.173), for RDN and sham, respectively. No significant differences in ambulatory or office diastolic BP were observed. Adverse safety events through 6 months were uncommon with 1 instance of accessory renal artery dissection in the RDN group (0.7%). No significant between-group differences in medication changes or patient adherence were identified.Conclusions: Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory systolic BP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed.

中文翻译：

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抗高血压药物存在下酒精介导的肾去神经术对血压的影响：TARGET BP I 随机临床试验的主要结果

背景：去肾神经术（RDN）已证明，尽管进行了生活方式干预和药物治疗，但高血压未得到控制的个体的血压仍能得到临床相关的降低。酒精介导的 RDN 的安全性和有效性尚未在该适应症中进行正式研究。方法：TARGET BP I 是一项前瞻性、国际性、假对照、随机、患者和评估者盲法试验，调查酒精介导的 RDN 的安全性和有效性。介导的 RDN。尽管处方了 2-5 种抗高血压药物，但诊室收缩压 (SBP) ≥150 且≤180 mmHg、诊室舒张压≥90 mmHg、平均 24 小时动态 SBP ≥135 且≤170 mmHg 的患者纳入研究。主要终点是术后 3 个月时平均 24 小时动态收缩压的基线调整变化。次要终点包括额外时间点诊室血压和动态血压的组间平均差异。 结果：在 301 名患者中，按 1:1 随机分配至 RDN 或假对照组，RDN 与 3 个月时 24 小时动态收缩压显着降低相关（平均值±标准差 -10.0 ± 14.2 mmHg 与 -6.8 ± 12.1 mmHg，治疗差异 -3.2 mmHg，95% 置信区间 [ CI ] -6.3，0.0 mmHg ；主要终点的亚组分析显示，预定义的亚组之间没有显着的相互作用。 3 个月时，RDN 组和假手术组的诊室收缩压平均变化分别为 -12.7 ± 18.3 mmHg 和 -9.7 ± 17.3 mmHg（差异，-3.0，95% CI -7.0，1.0；P = 0.173）。动态或诊室舒张压没有观察到显着差异。 6 个月内的不良安全事件并不常见，RDN 组中有 1 例副肾动脉夹层（0.7%）。未发现药物变化或患者依从性方面存在显着的组间差异。 结论：与假手术对照组相比，酒精介导的 RDN 与 24 小时动态收缩压适度但具有统计学意义的降低相关。未观察到各组之间诊室血压或 6 个月主要不良事件存在显着差异。