Kario Kazuomi, Ogawa Hisao, Okumura Ken, Okura Takafumi, Saito Shigeru, Ueno Takafumi, Haskin Russel, Negoita Manuela, Shimada Kazuyuki
Department of Cardiovascular Medicine, Jichi Medical University School of Medicine.
Circ J. 2015;79(6):1222-9. doi: 10.1253/circj.CJ-15-0150. Epub 2015 Apr 24.
SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal artery denervation (RDN) with standard pharmacotherapy for treatment of resistant hypertension (systolic blood pressure [SBP] ≥160 mmHg on ≥3 anti-hypertensive drugs including a diuretic for ≥6 weeks). When SYMPLICITY HTN-3 failed to meet the primary efficacy endpoint, the HTN-Japan enrollment was discontinued before completion. METHODS AND RESULTS: The 6-month change in office and 24-h ambulatory SBP were compared between RDN (n=22) and control (n=19) subjects. Mean baseline office SBP was 181.0±18.0 mmHg and 178.7±17.8 mmHg for the RDN and control groups, respectively. The 6-month office SBP change was -16.6±18.5 mmHg for RDN subjects (P<0.001) and -7.9±21.0 mmHg for control subjects (P=0.117); the difference between the 6-month change in RDN and control subjects was -8.64 (95% CI: -21.12 to 3.84, P=0.169). Mean 24-h SBP was 164.7±18.3 (RDN group) and 163.3±17.2 mmHg (control group). The 24-h 6-month SBP change for the RDN group was -7.52±11.98 mmHg (P=0.008) and -1.38±10.2 mmHg (P=0.563) for control subjects; the between-group difference in SBP change was -6.15 (95% CI: -13.23 to 0.94, P=0.087). No major adverse events were reported.
SYMPLICITY HTN-Japan, the first randomized controlled trial of RDN in an Asian population, was underpowered for the primary endpoint analysis and did not demonstrate a significant difference in 6-month BP change between RDN and control subjects.
“Symplicity HTN - 日本”研究是一项前瞻性、随机、对照试验，旨在比较肾动脉去神经支配术（RDN）与标准药物治疗用于治疗顽固性高血压（使用包括利尿剂在内的≥3种抗高血压药物，收缩压[SBP]≥160 mmHg，持续≥6周）的疗效。当“Symplicity HTN - 3”研究未达到主要疗效终点时，“HTN - 日本”研究在完成前停止了入组。
比较了接受RDN治疗的受试者（n = 22）和对照组受试者（n = 19）在6个月时诊室血压和24小时动态收缩压的变化。RDN组和对照组的平均基线诊室收缩压分别为181.0±18.0 mmHg和178.7±17.8 mmHg。RDN组受试者6个月时诊室收缩压变化为 - 16.6±18.5 mmHg（P<0.001），对照组受试者为 - 7.9±21.0 mmHg（P = 0.117）；RDN组和对照组6个月变化的差值为 - 8.64（95%CI： - 21.12至3.84，P = 0.169）。24小时平均收缩压在RDN组为164.7±18.3 mmHg，对照组为163.3±17.2 mmHg。RDN组24小时6个月收缩压变化为 - 7.52±11.98 mmHg（P = 0.008），对照组受试者为 - 1.38±10.2 mmHg（P = 0.563）；组间收缩压变化差异为 - 6.15（95%CI： - 13.23至0.94，P = 0.087）。未报告重大不良事件。
“Symplicity HTN - 日本”研究是亚洲人群中第一项关于RDN的随机对照试验，其样本量对于主要终点分析而言不足，且未显示RDN组和对照组受试者在6个月血压变化上存在显著差异。
