Research in context
Evidence before this study
We searched PubMed up to April 15, 2018, without time or language restriction with the terms “renal denervation”, “hypertension”, “randomised”, “hypertension”, and various combinations of those words to identify systematic reviews, meta-analyses, and randomised controlled trials of blood pressure lowering efficacy of renal denervation. We identified 11 meta-analyses that included randomised and non-randomised controlled trials of patients with uncontrolled hypertension despite being treated with antihypertensive medications. The 2017 Cochrane Collaboration meta-analysis that included 12 eligible sham and non-sham controlled studies (1149 participants) showed moderate quality evidence that renal denervation did not change office or ambulatory blood pressure compared with standard or intensified antihypertensive therapy. This meta-analysis did not include trials assessing the effect of renal denervation in patients with hypertension in the absence of antihypertensive medications. Since the publication of these meta-analyses, interim analysis of the SPYRAL HTN-OFF MED randomised, sham-controlled trial reported reduction in 24-h ambulatory systolic blood pressure with radiofrequency-based renal denervation compared with a sham procedure at 3 months in the absence of antihypertensive medications.
Added value of this study
The RADIANCE-HTN SOLO trial was designed to show the effect of endovascular ultrasound renal denervation on ambulatory blood pressure compared with a sham procedure in patients with combined systolic–diastolic hypertension who were off antihypertensive medications. This study was powered for efficacy and our results showed a greater reduction in daytime and 24-h systolic ambulatory blood pressure at 2 months in patients who underwent renal denervation than in patients who underwent a sham procedure.
Implications of all the available evidence
The RADIANCE-HTN SOLO and SPYRAL HTN-OFF MED trials enrolled largely similar patient populations, and yielded consistent results, showing that catheter-based renal denervation, using ultrasound or radiofrequency, lowers blood pressure among patients with hypertension who are off antihypertensive medications. The results of both trials will inform the design of future studies in this population to provide additional safety and long-term efficacy data, which will be important to establish the role of renal denervation in the treatment of hypertension.