Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Universität des Saarlandes, Homburg, Germany (D.V., L.L., M.B., F.M.).
Department of Cardiology, University Heart Center, University Hospital Basel, Switzerland (L.L., F.M.).
Circulation. 2024 Nov 12;150(20):1599-1611. doi: 10.1161/CIRCULATIONAHA.124.069709. Epub 2024 Oct 2.
Several sham-controlled trials have investigated the efficacy and safety of catheter-based renal denervation (RDN) with mixed outcomes. We aimed to perform a comprehensive meta-analysis of all randomized, sham-controlled trials investigating RDN with first- and second-generation devices in hypertension.
We searched MEDLINE and the Cochrane Library for eligible trials. Outcomes included both efficacy (24-hour and office systolic [SBP] and diastolic blood pressure [DBP]) and safety (all-cause death, vascular complication, renal artery stenosis >70%, hypertensive crisis) of RDN. We performed a study-level, pairwise, random-effects meta-analysis of the summary data.
Ten trials comprising 2478 patients with hypertension while being either off or on treatment were included. Compared with sham, RDN reduced 24-hour and office systolic blood pressure by 4.4 mm Hg (95% CI, 2.7 to 6.1; <0.00001) and 6.6 mm Hg (95% CI, 3.6 to 9.7; <0.0001), respectively. The 24-hour and office diastolic blood pressure paralleled these findings (-2.6 mm Hg [95% CI, -3.6 to -1.5]; <0.00001; -3.5 mm Hg [95% CI, -5.4 to -1.6]; =0.0003). There was no difference in 24-hour and office systolic blood pressure reduction between trials with and without concomitant antihypertensive medication ( for interaction, 0.62 and 0.73, respectively). There was no relevant difference in vascular complications (odds ratio, 1.69 [95% CI, 0.57 to 5.0]; =0.34), renal artery stenosis (odds ratio, 1.50 [95% CI, 0.06 to 36.97]; =0.80), hypertensive crisis (odds ratio, 0.65 [95% CI, 0.30 to 1.38]; =0.26), and all-cause death (odds ratio, 1.76 [95% CI, 0.34 to 9.20]; =0.50) between RDN and sham groups. Change of renal function based on estimated glomerular filtration rate was comparable between groups ( for interaction, 0.84). There was significant heterogeneity between trials.
RDN safely reduces ambulatory and office systolic blood pressure/diastolic blood pressure versus a sham procedure in the presence and absence of antihypertensive medications.
多项假手术对照试验对第一代和第二代导管射频消融去肾交感神经术（RDN）治疗高血压的疗效和安全性进行了评估，但结果不一。本研究旨在对所有使用第一代和第二代导管 RDN 治疗高血压的随机、假手术对照试验进行综合荟萃分析。
我们检索了 MEDLINE 和 Cochrane 图书馆中符合条件的试验。结局指标包括 RDN 的疗效（24 小时和诊室收缩压[SBP]和舒张压[DBP]）和安全性（全因死亡、血管并发症、肾动脉狭窄>70%、高血压危象）。我们对汇总数据进行了基于研究的、两两比较的、随机效应荟萃分析。
纳入了 10 项共 2478 例高血压患者的试验，这些患者在试验期间或治疗期间停用或继续使用降压药物。与假手术相比，RDN 降低了 24 小时和诊室收缩压 4.4mmHg（95%CI，2.7 至 6.1mmHg；<0.00001）和 6.6mmHg（95%CI，3.6 至 9.7mmHg；<0.0001）。24 小时和诊室舒张压的变化与这些发现一致（-2.6mmHg [95%CI，-3.6 至 -1.5]；<0.00001；-3.5mmHg [95%CI，-5.4 至 -1.6]；=0.0003）。有或没有同时使用降压药物的试验之间，24 小时和诊室收缩压降低无差异（交互检验，0.62 和 0.73）。血管并发症（比值比，1.69 [95%CI，0.57 至 5.0]；=0.34）、肾动脉狭窄（比值比，1.50 [95%CI，0.06 至 36.97]；=0.80）、高血压危象（比值比，0.65 [95%CI，0.30 至 1.38]；=0.26）和全因死亡（比值比，1.76 [95%CI，0.34 至 9.20]；=0.50）之间无显著差异。基于估算肾小球滤过率的肾功能变化在两组之间无差异（交互检验，0.84）。各试验间存在显著异质性。
与假手术相比，RDN 可安全降低有或无降压药物的情况下的动态和诊室收缩压/舒张压。
