ASH Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois.
Renal Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
J Am Coll Cardiol. 2015 Apr 7;65(13):1314-1321. doi: 10.1016/j.jacc.2015.01.037.
Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure.
This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group).
Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed.
The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg.
These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
SYMPLICITY HTN-3（难治性高血压患者的肾脏去神经支配）试验的结果证实，肾脏去神经支配治疗抵抗性高血压的安全性，但在术后 6 个月时疗效不佳。
本研究旨在分析 SYMPLICITY HTN-3 试验的 12 个月结果，包括原始去神经支配组、在 6 个月主要终点后接受去神经支配的假手术组（交叉组）和在 6 个月后未接受去神经支配的假手术组（非交叉组）。
符合条件的受试者被随机分为去神经支配组或假手术组，2:1 分配。在确定 6 个月主要终点后，受试者对其治疗组进行盲法；符合条件的假手术组受试者可接受去神经支配。分析随机分组后 12 个月（交叉组为 6 个月）时血压（BP）的变化。
361 例去神经支配受试者中的 319 例和 101 例非交叉受试者中的 48 例可获得 12 个月的随访；101 例交叉受试者中有 93 例可获得 6 个月的去神经支配随访。在去神经支配受试者中，12 个月时诊室收缩压（SBP）的变化大于 6 个月时的变化（-15.5 ± 24.1 mm Hg 比-18.9 ± 25.4 mm Hg，p = 0.025），但 12 个月时 24 小时 SBP 的变化无显著差异（p = 0.229）。非交叉组诊室 SBP 在 6 个月时下降了-32.9 ± 28.1 mm Hg，但在 12 个月时恢复到-21.4 ± 19.9 mm Hg（p = 0.01），增加到 11.5 ± 29.8 mm Hg。
这些数据支持在 1 年随访后诊室或动态血压无进一步降低。非交叉组血压下降的丧失可能反映了药物依从性的降低或其他相关因素。（难治性高血压患者的肾脏去神经支配[SYMPLICITY HTN-3]；NCT01418261）。
