The objective of this work was to investigate the long-term safety and efficacy of renal denervation in Korean patients from the Global SYMPLICITY Registry (GSR). GSR Korea is a substudy of GSR with additional inclusion and exclusion criteria compared to GSR, including inclusion criteria of office systolic blood pressure ≥160 mmHg, or ≥150 mmHg for type 2 diabetes patients, while receiving 3 or more antihypertensive medications without changes for 2 weeks prior to enrollment. Renal denervation was performed using a Symplicity Flex catheter for ablation in the main renal arteries. Changes in office systolic blood pressure and adverse events were collected for up to 36 months of follow-up for 102 patients in GSR Korea. In addition, adverse events and reductions in office systolic blood pressure were analyzed for patients with and without type II diabetes mellitus. Renal denervation led to mean (± standard deviation) reductions in office systolic blood pressure at 12, 24, and 36 months in GSR Korea (−26.7 ± 18.5, −30.1 ± 21.6 mmHg, and −32.5 ± 18.8, respectively). The proportion of patients with a ≥10 mmHg office systolic blood pressure reduction from baseline was 86.3% at 12 months, 86.5% at 24 months, and 89.7% at 36 months. Adverse events at 3 years were rare. In addition, reductions in office systolic blood pressure were similar for patients with vs. without diabetes mellitus (p > 0.05 at all timepoints). Office systolic blood pressure was safely reduced at up to 36 months post-renal denervation in GSR Korea, and adverse events were rare. In addition, patients with and without diabetes had similar office systolic blood pressure reductions.

这项工作的目的是调查来自全球症状登记 (GSR) 的韩国患者去肾神经支配的长期安全性和有效性。GSR Korea 是 GSR 的一个子研究，与 GSR 相比具有额外的纳入和排除标准，包括诊室收缩压≥160 mmHg 或 ≥150 mmHg 的 2 型糖尿病患者的纳入标准，同时接受 3 种或更多抗高血压药物且 2 次没有变化入学前几周。使用用于主要肾动脉消融的 Symplicity Flex 导管进行肾去神经支配。对 GSR Korea 的 102 名患者进行长达 36 个月的随访，收集办公室收缩压和不良事件的变化。此外，分析了患有和不患有 II 型糖尿病的患者的不良事件和办公室收缩压的降低。去肾神经支配导致 GSR Korea 在 12、24 和 36 个月时办公室收缩压的平均（±标准差）降低（分别为 -26.7 ± 18.5、-30.1 ± 21.6 mmHg 和 -32.5 ± 18.8）。12 个月时诊室收缩压降低 ≥ 10 mmHg 的患者比例为 86.3%，24 个月时为 86.5%，36 个月时为 89.7%。3 年时的不良事件很少见。此外，糖尿病患者与非糖尿病患者的诊室收缩压降低相似（5 ± 18.8，分别）。12 个月时诊室收缩压降低 ≥ 10 mmHg 的患者比例为 86.3%，24 个月时为 86.5%，36 个月时为 89.7%。3 年时的不良事件很少见。此外，糖尿病患者与非糖尿病患者的诊室收缩压降低相似（5 ± 18.8，分别）。12 个月时诊室收缩压降低 ≥ 10 mmHg 的患者比例为 86.3%，24 个月时为 86.5%，36 个月时为 89.7%。3 年时的不良事件很少见。此外，糖尿病患者与非糖尿病患者的诊室收缩压降低相似（p  > 0.05 在所有时间点）。GSR Korea 在去肾神经支配术后长达 36 个月内安全地降低了办公室收缩压，并且不良事件很少见。此外，糖尿病患者和非糖尿病患者的诊室收缩压降低相似。