Professor of Medicine, Division of Cardiovascular Medicine, Downstate Medical Center, SUNY Downstate College of Medicine, State University of New York, Brooklyn, NY, USA.
University Hospital Erlangen, Erlangen, Germany.
Clin Res Cardiol. 2022 Nov;111(11):1269-1275. doi: 10.1007/s00392-022-02064-5. Epub 2022 Jul 19.
The SPYRAL HTN-OFF MED Pivotal trial ( https://clinicaltrials.gov/ct2/show/NCT02439749 ) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan-Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control.
SPYRAL HTN-OFF MED 主要试验（临床试验.gov/ct2/show/NCT02439749）表明，与假手术对照相比，在没有抗高血压药物的情况下，肾去神经术（RDN）后血压（BP）显著降低。在 3 个月的主要终点之前，对于符合定义为诊室收缩压（SBP）≥180mmHg 或其他安全问题的逃逸标准的患者，立即重新使用药物。我们的目的是比较 RDN 与假手术对照患者中高血压急症的发生率。患者纳入标准为诊室 SBP≥150 且＜180mmHg，诊室舒张压（DBP）≥90mmHg，平均 24 小时 SBP≥140 且＜170mmHg。患者已被要求停止任何抗高血压药物治疗，并按 1:1 比例随机分为 RDN 或假手术对照组。在这项事后分析中，生成了 RDN 和假手术对照组患者符合逃逸标准的累积发生率曲线和 Kaplan-Meier 估计率。在基线至 3 个月之间，有 16 名 RDN 患者（9.6%）和 28 名假手术对照组患者（17.0%）符合逃逸标准。所有逃逸患者的假手术对照组符合逃逸标准的比例明显高于 RDN（p=0.032），以及诊室 SBP≥180mmHg 的高血压急症患者（p=0.046）。在未测量 BP 超过 180mmHg 的患者中，RDN 和假手术对照组之间的逃逸率相似（p=0.32）。在 SPYRAL HTN-OFF MED 主要试验中，与假手术对照组相比，RDN 患者不太可能发生需要立即使用抗高血压药物的高血压急症。
