Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study
Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study
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DOI：
10.1016/s0140-6736(13)62192-3
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发表时间：
2014-02-15
期刊：
影响因子：
168.9
通讯作者：
Esler, Murray D.
中科院分区：
文献类型：
--
作者：
Krum, Henry;Schlaich, Markus P.;Esler, Murray D.
背景：射频消融术联合肾去神经支配（RDN）可显著降低难治性高血压患者的血压。我们评估了长期降压效果和安全性。方法HTN-1是一项开放标签研究，纳入153例患者，其中111例同意随访36个月。符合条件的患者收缩压至少为160毫米汞柱，并以最佳剂量服用至少三种降压药，包括利尿剂。每6个月评估一次办公室收缩压和安全性的变化，每12个月报告一次。本研究已在ClinicalTrials.gov注册，注册号为NCT00483808、NCT00664638和NCT00753285。结果88例患者在36个月时数据完整。基线时平均年龄为57岁（SD 11）， 37例（42%）患者为女性，25例（28%）患有2型糖尿病，平均肾小球滤过率为85 (SD 19) mL/min / 1.73 m(2)，平均血压为175/98 (SD 16/14) mm Hg。36个月时，收缩压（-32.0 mm Hg, 95% CI -35.7至-28.2）和舒张压（-14.4 mm Hg, -16.9至-11.9）发生显著变化。收缩压下降10毫米汞柱以上的患者在1个月时为69%，6个月时为81%，12个月时为85%，24个月时为83%，36个月时为93%。随访期间发生1例新的肾动脉狭窄需要支架植入，3例与RDN无关的死亡。难治性高血压患者RDN后血压变化持续较长时间，安全性较好。
Background 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.Methods 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.Findings 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.Interpretation Changes in blood pressure after RDN persist long term in patients with treatment-resistant hypertension, with good safety.