Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.
Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Hypertens Res. 2022 Feb;45(2):210-220. doi: 10.1038/s41440-021-00761-8. Epub 2021 Oct 17.
The efficacy of renal denervation has been controversial, but recent randomized sham-controlled trials demonstrated significant blood pressure reductions after renal denervation in patients with hypertension. We conducted a systematic review and updated meta-analysis to evaluate the effects of renal denervation on ambulatory and office blood pressures in patients with hypertension. Databases were searched up to 25 May 2021 to identify randomized, sham-controlled trials of renal denervation. The primary endpoint was change in 24 h ambulatory systolic blood pressure with renal denervation versus sham control. The secondary endpoints were daytime and nighttime systolic blood pressure, and office systolic blood pressure. A sub-analysis determined outcomes by medication, procedure, and device. From nine trials, 1555 patients with hypertension were randomized to undergo renal denervation (n = 885) or a sham procedure (n = 670). At 2-6 months after treatment, renal denervation significantly reduced 24 h ambulatory systolic blood pressure by 3.31 mmHg (95% confidence interval: -4.69, -1.94) compared with the sham procedure (p < 0.001). Renal denervation also reduced daytime SBP by 3.53 mmHg (-5.28, -1.78; p < 0.001), nighttime SBP by 3.20 mmHg (-5.46, -0.94; p = 0.006), and office SBP by 5.25 mmHg (-7.09, -3.40; p < 0.001) versus the sham control group. There were no significant differences in the magnitude of blood pressure reduction between first- and second-generation trials, between devices, or with or without medication. These data from randomized sham-controlled trials showed that renal denervation significantly reduced all blood pressure metrics in medicated or unmedicated patients with hypertension, including resistant/uncontrolled hypertension. Future trials should investigate the long-term efficacy and safety of renal denervation.
肾去神经术的疗效一直存在争议,但最近的随机假手术对照试验表明,在高血压患者中,肾去神经术后血压显著降低。我们进行了系统评价和更新的荟萃分析,以评估肾去神经术对高血压患者的动态和诊室血压的影响。数据库检索截至 2021 年 5 月 25 日,以确定肾去神经术的随机、假手术对照试验。主要终点是肾去神经术与假手术对照相比 24 小时动态收缩压的变化。次要终点是白天和夜间收缩压以及诊室收缩压。亚分析根据药物、手术程序和设备确定结果。来自 9 项试验的 1555 名高血压患者被随机分为肾去神经术组(n=885)或假手术组(n=670)。治疗后 2-6 个月,肾去神经术组 24 小时动态收缩压较假手术组显著降低 3.31mmHg(95%置信区间:-4.69,-1.94)(p<0.001)。肾去神经术还降低了白天收缩压 3.53mmHg(-5.28,-1.78;p<0.001)、夜间收缩压 3.20mmHg(-5.46,-0.94;p=0.006)和诊室收缩压 5.25mmHg(-7.09,-3.40;p<0.001),与假手术组相比。第一代和第二代试验之间、设备之间、是否使用药物之间,血压降低幅度没有显著差异。这些来自随机假手术对照试验的数据表明,肾去神经术显著降低了高血压患者(包括难治性/不受控制的高血压患者)的所有血压指标。未来的试验应研究肾去神经术的长期疗效和安全性。