State University of New York, Downstate Medical Center, Brooklyn, New York.
Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.
JACC Cardiovasc Interv. 2020 Feb 24;13(4):461-470. doi: 10.1016/j.jcin.2019.10.061.
The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline.
A blood pressure-reducing effect of renal denervation has been difficult to isolate in clinical investigations.
REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial. Patients with office systolic blood pressure (SBP) of 150 to 180 mm Hg and average 24-h ambulatory SBP of 135 to 170 mm Hg after medication washout underwent bipolar radiofrequency renal denervation or a sham procedure. The planned outcome was 8-week change in 24-h ambulatory SBP. Enrollment was terminated for apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Safety assessments included all-cause death, renal failure, severe hypotension or syncope, hypertensive crisis, and renal artery stenosis.
Baseline 24-h blood pressure was 148.3 ± 10.9/85.7 ± 9.1 mm Hg for the denervation group (n = 34, mean age 58.5 ± 10.1 years, 47% women) and 149.1 ± 7.2/86.4 ± 9.8 mm Hg for the control group (n = 17, mean age 58.2 ± 9.8 years, 24% women). At 8 weeks, mean 24-h SBP reductions for the renal denervation and control groups were -5.3 mm Hg (95% confidence interval [CI]: -8.8 to -1.8 mm Hg) and -8.5 mm Hg (95% CI: -13.3 to -3.8 mm Hg), respectively (difference 3.3 mm Hg; 95% CI: -2.8 to 9.3 mm Hg; p = 0.30). Antihypertensive medications could then be added. By 6 months, decreases in SBP were greater for the denervation group, yielding between-group differences of -7.2 mm Hg (95% CI: -15.2 to 0.8 mm Hg; p = 0.08), -9.7 mm Hg (95% CI: -17.7 to -1.7 mm Hg; p = 0.02), and -11.4 mm Hg (95% CI: -19.2 to -3.7 mm Hg; p < 0.01) for 24-h, daytime ambulatory, and office measurements, respectively. Through 12 months, 1 patient (renal denervation group) had a hypertensive urgency requiring immediate management, and 1 experienced progression of renal artery stenosis.
Future studies of radiofrequency renal denervation must anticipate delayed treatment effects. (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension [REDUCE HTN: REINFORCE]; NCT02392351).
本研究旨在探讨基线时未服用药物的高血压患者行双极射频去肾神经术的效果。
在临床研究中，肾去神经术的降压效果一直难以确定。
REINFORCE 试验（使用 Vessix 去肾神经系统治疗高血压的肾去神经术）为一项随机、假对照的多中心试验。研究纳入经洗脱期药物治疗后诊室收缩压（SBP）为 150 至 180mmHg 且平均 24 小时动态 SBP 为 135 至 170mmHg 的患者，行双极射频去肾神经术或假手术。主要终点为 24 小时动态 SBP 的 8 周变化。在纳入足够的有效比较样本量前，因明显无效而提前终止试验。安全性评估包括全因死亡、肾衰竭、严重低血压或晕厥、高血压危象和肾动脉狭窄。
去肾神经术组（n=34）和对照组（n=17）的基线 24 小时血压分别为 148.3±10.9/85.7±9.1mmHg（平均年龄 58.5±10.1 岁，47%为女性）和 149.1±7.2/86.4±9.8mmHg（平均年龄 58.2±9.8 岁，24%为女性）。8 周时，去肾神经术组和对照组的 24 小时 SBP 分别降低 5.3mmHg（95%置信区间：-8.8 至-1.8mmHg）和 8.5mmHg（95%置信区间：-13.3 至-3.8mmHg）（差值 3.3mmHg；95%置信区间：-2.8 至 9.3mmHg；p=0.30）。然后可以添加降压药物。6 个月时，去肾神经术组的 SBP 下降幅度更大，组间差异分别为-7.2mmHg（95%置信区间：-15.2 至 0.8mmHg；p=0.08）、-9.7mmHg（95%置信区间：-17.7 至-1.7mmHg；p=0.02）和-11.4mmHg（95%置信区间：-19.2 至-3.7mmHg；p<0.01），用于 24 小时、日间动态和诊室测量。随访 12 个月时，1 例患者（去肾神经术组）发生高血压急症需要立即治疗，1 例发生肾动脉狭窄进展。
未来的射频去肾神经术研究必须预测延迟的治疗效果。（使用 Vessix 去肾神经系统治疗高血压的肾去神经术[REINFORCE]；NCT02392351）。
