Kandzari David E, Mahfoud Felix, Townsend Raymond R, Kario Kazuomi, Weber Michael A, Schmieder Roland E, Tsioufis Konstantinos, Pocock Stuart, Liu Minglei, DeBruin Vanessa, Brar Sandeep, Böhm Michael
Piedmont Heart Institute, Atlanta, GA (D.E.K.).
Department of Cardiology, University Heart Center, University Hospital Basel, Switzerland. (F.M.).
Circ Cardiovasc Interv. 2025 May 20;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194.
Six-month results from the SPYRAL HTN-ON MED trial demonstrated that renal denervation (RDN) reduced office blood pressure (BP), and not 24-hour ambulatory systolic BP, compared with sham control in hypertensive patients. In this prespecified analysis of the ON MED trial, long-term changes in BP, antihypertensive drug use, and safety outcomes through 24 months are compared between RDN and sham control groups.
SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, blinded trial enrolling 337 patients globally from 56 clinical centers. Eligible patients had an office systolic BP of 150 to 180 mm Hg, a diastolic BP ≥90 mm Hg, and a 24-hour ambulatory systolic BP of 140 to 170 mm Hg. Patients were randomized to RDN or a sham control procedure and were prescribed a stable regimen of 1 to 3 antihypertensive medications through 6 months. After 6 months, patients and physicians were unblinded with permitted changes to antihypertensive therapy, and control patients were permitted to crossover. Crossover patients had their last observations carried forward as part of the control group. Statistical analyses were conducted on the population as a randomized.
At 24 months, the RDN group experienced significantly greater mean reductions in ambulatory systolic BP (-12.1±15.3 mm Hg [n=176] versus -7.0±13.1 mm Hg [n=33]; difference: -5.7 mm Hg; =0.039) and office systolic BP (-17.4±16.1 mm Hg [n=187] versus -9.0±19.4 mm Hg [n=35]; difference: -8.7 mm Hg; =0.0034) compared with sham controls. At 24 months, antihypertensive medications increased significantly more in the sham group (1.7-2.7) compared with the RDN group (1.8 versus 2.4; =0.046). Sensitivity analyses accounting for missing sham patient BP values due to crossover yielded consistent results in favor of RDN for 24-hour ambulatory (=0.023) and office systolic BP (<0.0001). Clinically adverse events were rare, with no instances of renal artery stenosis through 24 months.
RDN produced significantly greater ambulatory and office systolic BP reductions at 24 months compared with sham control, despite higher antihypertensive medication use in the control group.
URL: https://clinicaltrials.gov/study; unique identifier: NCT02439775.
SPYRAL HTN-ON MED试验的6个月结果表明，与假手术对照组相比，肾去神经支配术（RDN）可降低高血压患者的诊室血压（BP），但不能降低24小时动态收缩压。在这项ON MED试验的预先设定分析中，比较了RDN组和假手术对照组在24个月内血压、抗高血压药物使用情况及安全性结果的长期变化。
SPYRAL HTN-ON MED是一项前瞻性、随机、假手术对照、双盲试验，在全球56个临床中心招募了337例患者。符合条件的患者诊室收缩压为150至180mmHg，舒张压≥90mmHg，24小时动态收缩压为140至170mmHg。患者被随机分配接受RDN或假手术对照程序，并在6个月内接受1至3种抗高血压药物的稳定治疗方案。6个月后，患者和医生不再设盲，允许对抗高血压治疗进行调整，对照组患者允许交叉。交叉患者将其最后的观察结果作为对照组的一部分进行结转。对随机分组的人群进行统计分析。
在24个月时，与假手术对照组相比，RDN组的动态收缩压平均降低幅度显著更大（-12.1±15.3mmHg [n = 176] 对比 -7.0±13.1mmHg [n = 33]；差值：-5.7mmHg；P = 0.039），诊室收缩压也是如此（-17.4±16.1mmHg [n = 187] 对比 -9.0±19.4mmHg [n = 35]；差值：-8.7mmHg；P = 0.0034）。在24个月时，与RDN组（1.8对比2.4；P = 0.046）相比，假手术组的抗高血压药物增加显著更多（1.7 - 2.7）。考虑到因交叉导致假手术组患者血压值缺失的敏感性分析，得出了有利于RDN组24小时动态血压（P = 0.023）和诊室收缩压（P < 0.0001）的一致结果。临床不良事件罕见，在24个月内未出现肾动脉狭窄病例。
与假手术对照组相比，RDN在24个月时能显著更大幅度地降低动态和诊室收缩压，尽管对照组使用了更多的抗高血压药物。
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