Monash Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, Australia.
Neurovascular Hypertension and Kidney Disease Laboratory, Baker IDI Heart and Diabetes Institute and Heart Centre, Alfred Hospital, Melbourne, VIC, Australia.
Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.
Renal denervation (RDN) with radiofrequency ablation substantially reduces blood pressure in patients with treatment-resistant hypertension. We assessed the long-term antihypertensive effects and safety.
Symplicity HTN-1 is an open-label study that enrolled 153 patients, of whom 111 consented to follow-up for 36 months. Eligible patients had a systolic blood pressure of at least 160 mm Hg and were taking at least three antihypertensive drugs, including a diuretic, at the optimum doses. Changes in office systolic blood pressure and safety were assessed every 6 months and reported every 12 months. This study is registered with ClinicalTrials.gov, numbers NCT00483808, NCT00664638, and NCT00753285.
88 patients had complete data at 36 months. At baseline the mean age was 57 (SD 11) years, 37 (42%) patients were women, 25 (28%) had type 2 diabetes mellitus, the mean estimated glomerular filtration rate was 85 (SD 19) mL/min per 1·73 m(2), and mean blood pressure was 175/98 (SD 16/14) mm Hg. At 36 months significant changes were seen in systolic (-32·0 mm Hg, 95% CI -35·7 to -28·2) and diastolic blood pressure (-14·4 mm Hg, -16·9 to -11·9). Drops of 10 mm Hg or more in systolic blood pressure were seen in 69% of patients at 1 month, 81% at 6 months, 85% at 12 months, 83% at 24 months, and 93% at 36 months. One new renal artery stenosis requiring stenting and three deaths unrelated to RDN occurred during follow-up.
Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety.
Ardian LLC/Medtronic Inc.
射频消融的肾脏去神经支配（RDN）可显著降低治疗抵抗性高血压患者的血压。我们评估了长期降压效果和安全性。
Symplicity HTN-1 是一项开放性研究，共纳入 153 例患者，其中 111 例同意随访 36 个月。入选患者的收缩压至少为 160mmHg，且正在接受至少三种降压药物治疗，包括最佳剂量的利尿剂。每 6 个月评估一次诊室收缩压和安全性，并每 12 个月报告一次。这项研究在 ClinicalTrials.gov 注册，编号为 NCT00483808、NCT00664638 和 NCT00753285。
88 例患者在 36 个月时有完整数据。基线时的平均年龄为 57（11）岁，37（42%）例患者为女性，25（28%）例患者患有 2 型糖尿病，估计肾小球滤过率的平均值为 85（19）mL/min/1.73m2，平均血压为 175/98（16/14）mmHg。36 个月时，收缩压（-32.0mmHg，95%CI-35.7 至-28.2）和舒张压（-14.4mmHg，-16.9 至-11.9）均有显著变化。1 个月时，69%的患者收缩压下降 10mmHg 或更多，6 个月时为 81%，12 个月时为 85%，24 个月时为 83%，36 个月时为 93%。在随访期间，有 1 例新出现需要支架置入的肾动脉狭窄和 3 例与 RDN 无关的死亡事件。
治疗抵抗性高血压患者的 RDN 治疗后血压变化可长期持续，安全性良好。
Ardian LLC/Medtronic Inc.
