Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial

作者：David E. Kandzari, Felix Mahfoud, Raymond R. Townsend, Kazuomi Kario, Michael A. Weber, Roland E. Schmieder, Konstantinos Tsioufis, Stuart Pocock, Minglei Liu, Vanessa DeBruin, Sandeep Brar, Michael Böhm · 发表于：Circulation Cardiovascular Interventions · 年份：2025 · DOI：10.1161/circinterventions.125.015194 · 被引用次数：18 · 研究领域：Blood Pressure and Hypertension Studies、Chronic Kidney Disease and Diabetes、Dialysis and Renal Disease Management

BACKGROUND: Six-month results from the SPYRAL HTN-ON MED trial (SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral Multi-Electrode Renal Denervation System) 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. METHODS: 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 cross over. Crossover patients had their last observations carried forward as part of the control group. Statistical analyses were conducted on the population as randomized. RESULTS: 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 H...