From the Hôpital Saint-André-CHU, Bordeaux, France (P.G., A.C.).
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation (A.J.K.).
Hypertension. 2021 Feb;77(2):529-536. doi: 10.1161/HYPERTENSIONAHA.120.16292. Epub 2020 Dec 28.
Renal denervation (RDN) is effective in lowering blood pressure (BP) in patients with hypertension. The issue remains how to best identify potential responders. Ambulatory BP monitoring may be useful. Baseline nighttime systolic BP (SBP) ≥136 mm Hg and its variability (SD) ≥12 mm Hg in DENER-HTN trial or 24-hour heart rate ≥73.5 bpm in SPYRAL HTN-OFF MED Trial were shown to predict the BP response to RDN. We applied these criteria to the patients with hypertension in the sham-controlled RADIANCE-HTN SOLO trial to predict the BP response to ultrasound RDN at 2 months while patients were maintained off medications. BP responders were defined as: clinical with 24-hour SBP <130 mm Hg (RDN: 22/64 versus sham: 7/58); meaningful with 24-hour SBP reduction ≥10 mm Hg (RDN: 24/64, sham: 7/58); and extreme with 24-hour SBP reduction above mean+2 SD of the SBP decrease in the sham group, that is, ≥16.5 mm Hg (RDN: 10/64 versus sham: 2/58). The predictive criteria reported above were tested for sensitivity, specificity, and positive and negative predictive values. The predictive value varied according to the definition of response, with the clinical definition being strongly influenced by regression to the mean. Baseline nighttime SBP and its variability, especially when combined, offered good specificity (>90% irrespective of definition) but low sensitivity (from 9.1% to 30% depending on the definition) to predict responders; the heart rate criterion had insufficient predictive value. This analysis suggests the potential role of nighttime SBP and its variability to predict BP response to RDN in patients with hypertension. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02649426.
肾动脉去神经术（RDN）可有效降低高血压患者的血压（BP）。问题仍然是如何最好地识别潜在的反应者。动态血压监测可能有用。在 DENER-HTN 试验中，基线夜间收缩压（SBP）≥136mmHg 及其变异性（SD）≥12mmHg，或 SPYRAL HTN-OFF MED 试验中 24 小时心率≥73.5bpm，表明对 RDN 的 BP 反应有预测作用。我们将这些标准应用于 sham-controlled RADIANCE-HTN SOLO 试验中的高血压患者，以预测在患者维持停药的情况下，超声 RDN 治疗 2 个月时的 BP 反应。BP 反应者定义为：临床 24 小时 SBP<130mmHg（RDN：22/64 例比 sham：7/58 例）；有意义的 24 小时 SBP 降低≥10mmHg（RDN：24/64 例比 sham：7/58 例）；极端的 24 小时 SBP 降低超过 sham 组 SBP 降低均值+2SD，即≥16.5mmHg（RDN：10/64 例比 sham：2/58 例）。上述预测标准的敏感性、特异性、阳性和阴性预测值进行了检验。预测值根据反应定义而变化，临床定义受回归均值的影响较大。基线夜间 SBP 及其变异性，尤其是两者结合时，特异性较好（无论定义如何，特异性均>90%），但敏感性较低（取决于定义，从 9.1%到 30%），预测反应者；心率标准的预测价值不足。该分析表明，夜间 SBP 及其变异性在预测高血压患者 RDN 血压反应方面具有潜在作用。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT02649426。
