Esler Murray D, Böhm Michael, Sievert Horst, Rump Christian L, Schmieder Roland E, Krum Henry, Mahfoud Felix, Schlaich Markus P
Baker IDI Heart and Diabetes Institute, Monash University, 75 Commercial Road, Melbourne, Victoria 3004, Australia
Universitätsklinium des Saarlandes, Homburg/Saar, Germany.
Eur Heart J. 2014 Jul;35(26):1752-9. doi: 10.1093/eurheartj/ehu209. Epub 2014 Jun 4.
The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study.
SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone. At 6 months, 37 control subjects crossed over to renal denervation. Office blood pressure measurements, antihypertensive medication use, and safety events were followed every 6 months through 3 years.
Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months. Baseline blood pressure was 184 ± 19/99 ± 16 mmHg in all treated subjects. At 30-month post-procedure, systolic blood pressure decreased 34 mmHg (95% CI: -40, -27, P < 0.01) and diastolic blood pressure decreased 13 mmHg (95% CI: -16, -10, P < 0.01). The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg (95% CI: -40, -25, P < 0.01) and -14 mmHg (95% CI: -17, -10, P < 0.01), respectively. Procedural complications included one haematoma, and one renal artery dissection before energy delivery that was treated successfully. Later complications included two cases of acute renal failure, which fully resolved, 15 hypertensive events requiring hospitalization, and three deaths.
Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns.
NCT00888433.
本研究旨在确定在SYMPLICITY HTN-2研究中，肾动脉去神经术治疗顽固性高血压的长期效果。
SYMPLICITY HTN-2研究将106例顽固性高血压患者随机分为肾去神经术组或单纯药物治疗组。6个月时，37例对照组患者转而接受肾去神经术。在3年的时间里，每6个月随访一次诊室血压测量值、抗高血压药物使用情况及安全事件。
最初接受肾去神经术的52例患者中有40例获得了36个月的随访，6个月时转而接受肾去神经术的37例患者中有30例获得了30个月的随访。所有接受治疗患者的基线血压为184±19/99±16 mmHg。术后30个月时，收缩压下降了34 mmHg（95%可信区间：-40，-27，P<0.01），舒张压下降了13 mmHg（95%可信区间：-16，-10，P<0.01）。最初接受肾去神经术组在36个月时收缩压和舒张压的降低值分别为-33 mmHg（95%可信区间：-40，-25，P<0.01）和-14 mmHg（95%可信区间：-17，-10，P<0.01）。手术并发症包括1例血肿，以及1例在能量传递前发生的肾动脉夹层，后者成功治愈。后期并发症包括2例急性肾衰竭，均完全缓解，15例高血压事件需要住院治疗，3例死亡。
在部分严重顽固性高血压患者中，肾去神经术在3年时可使血压持续降低，且无严重安全问题。
NCT00888433。
