BACKGROUND:Renal denervation is a recognized adjunct therapy for hypertension with clinically significant blood pressure (BP)-lowering effects. Long-term follow-up data are critical to ascertain durability of the effect and safety. Aside from the 36-month follow-up data available from randomized control trials, recent cohort analyses extended follow-up out to 10 years. We sought to analyze study-level data and quantify the ambulatory BP reduction of renal denervation across contemporary randomized sham-controlled trials and available long-term follow-up data up to 10 years from observational studies.METHODS:A systematic review was performed with data from 4 observational studies with follow-up out to 10 years and 2 randomized controlled trials meeting search and inclusion criteria with follow-up data out to 36 months. Study-level data were extracted and compared statistically.RESULTS:In 2 contemporary randomized controlled trials with 36-month follow-up, an average sham-adjusted ambulatory systolic BP reduction of −12.7±4.5 mm Hg from baseline was observed (P=0.05). Likewise, a −14.8±3.4 mm Hg ambulatory systolic BP reduction was found across observational studies with a mean long-term follow-up of 7.7±2.8 years (range, 3.5–9.4 years; P=0.0051). The observed reduction in eGFR across the long-term follow-up was in line with the predicted age-related decline. Antihypertensive drug burden was similar at baseline and follow-up.CONCLUSIONS:Renal denervation is associated with a significant and clinically meaningful reduction in ambulatory systolic BP in both contemporary randomized sham-controlled trials up to 36 months and observational cohort studies up to 10 years without adverse consequences on renal function.

中文翻译：

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导管肾去神经术后的长期血压降低：系统评价和荟萃分析

背景：去肾神经术是公认的高血压辅助治疗方法，具有临床显着的降血压（BP）作用。长期随访数据对于确定效果的持久性和安全性至关重要。除了随机对照试验提供的 36 个月随访数据外，最近的队列分析将随访时间延长至 10 年。我们试图分析研究水平的数据，并量化当代随机假对照试验和观察性研究中长达 10 年的长期随访数据中肾去神经支配的动态血压降低。 方法：对数据进行系统评价来自 4 项随访长达 10 年的观察性研究和 2 项符合搜索和纳入标准且随访数据长达 36 个月的随机对照试验。提取研究水平的数据并进行统计比较。 结果：在 2 项当代随机对照试验中，随访 36 个月，观察到平均假调整动态收缩压较基线降低 -12.7±4.5 mm Hg（P = 0.05） ）。同样，在平均长期随访 7.7±2.8 年（范围，3.5-9.4 年；P = 0.0051）的观察性研究中发现动态收缩压降低了 -14.8±3.4 mm Hg。在长期随访中观察到的 eGFR 下降与预测的与年龄相关的下降一致。基线和随访时的抗高血压药物负担相似。 结论：在长达 36 个月的当代随机假对照试验和长达 10 年的观察性队列研究中，去肾神经支配与动态收缩压显着且具有临床意义的降低相关。对肾功能产生不良影响。