Abstract：
Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications.
This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.
SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis.
The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients.
There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).
This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.
SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis.
The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients.
There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).
摘要：
背景：在没有抗高血压药物的情况下，去肾神经（RDN）可降低未控制的高血压患者的血压（BP）。
目的：本试验评估了RDN在抗高血压药物存在下的安全性和有效性。
方法：SPYRALHTN-ONMED是一种前瞻性，随机化，假控制，患者和评估者盲法试验招募来自全球56个临床中心的患者。患者被处方1至3种抗高血压药物。患者被随机分配到射频RDN或假对照程序。主要疗效终点是使用贝叶斯试验设计和分析在6个月时组间平均24小时动态收缩压的基线调整变化。
结果：RDN组（n=206；-6.5±10.7mmHg）和假手术对照组（n=131；-4.5±10.3mmHg）从基线至6个月的平均24小时动态收缩压的治疗差异为-1.9mmHg（95％CI：-4.4至0.5mmHg；P=0.12）。在主要疗效分析中，组间没有显着差异，后验优势概率为0.51（贝叶斯治疗差异：-0.03mmHg[95％CI：-2.82至2.77mmHg]）。然而,假对照患者的用药强度有改变和增加.在6个月时，与假对照相比，RDN与办公室收缩压降低相关（校正后的治疗差异：-4.9mmHg；P=0.0015）。夜间BP降低和获胜比率分析也有利于RDN。在253例评估患者中，有1例不良安全事件。
结论：在主要分析中，组间没有显著差异。然而,多个次要终点分析有利于RDN而不是假对照。（SPYRALHTN-ONMED研究[在没有抗高血压药物的情况下，不受控制的高血压患者中使用SymplicitySpyral多电极肾脏去神经系统的肾脏去神经的全球临床研究]；NCT02439775）。
目的：本试验评估了RDN在抗高血压药物存在下的安全性和有效性。
方法：SPYRALHTN-ONMED是一种前瞻性，随机化，假控制，患者和评估者盲法试验招募来自全球56个临床中心的患者。患者被处方1至3种抗高血压药物。患者被随机分配到射频RDN或假对照程序。主要疗效终点是使用贝叶斯试验设计和分析在6个月时组间平均24小时动态收缩压的基线调整变化。
结果：RDN组（n=206；-6.5±10.7mmHg）和假手术对照组（n=131；-4.5±10.3mmHg）从基线至6个月的平均24小时动态收缩压的治疗差异为-1.9mmHg（95％CI：-4.4至0.5mmHg；P=0.12）。在主要疗效分析中，组间没有显着差异，后验优势概率为0.51（贝叶斯治疗差异：-0.03mmHg[95％CI：-2.82至2.77mmHg]）。然而,假对照患者的用药强度有改变和增加.在6个月时，与假对照相比，RDN与办公室收缩压降低相关（校正后的治疗差异：-4.9mmHg；P=0.0015）。夜间BP降低和获胜比率分析也有利于RDN。在253例评估患者中，有1例不良安全事件。
结论：在主要分析中，组间没有显著差异。然而,多个次要终点分析有利于RDN而不是假对照。（SPYRALHTN-ONMED研究[在没有抗高血压药物的情况下，不受控制的高血压患者中使用SymplicitySpyral多电极肾脏去神经系统的肾脏去神经的全球临床研究]；NCT02439775）。
