ArticlesOptimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial
Introduction
Endovascular renal denervation with radiofrequency ablation has emerged as a new invasive treatment for patients with resistant hypertension to a multiple antihypertensive drug regimen.1 The first two studies of renal denervation reported 25–30 mm Hg decreases in office systolic blood pressure at 6 months in patients with resistant hypertension, with less than 5% of patients having procedural adverse events.2, 3 Subsequently, the procedure was made available in Europe4, 5, 6 despite uncertainty about both safety and efficacy related to the limitations of most previous studies (no standardisation of blood pressure measurements and antihypertensive treatment, and their single-arm observational study design).7, 8 The indications, risk-benefit ratio, and cost-effectiveness of renal denervation compared with an optimum medical strategy, therefore, still need to be assessed in a setting with a more precise identification of the target population with resistant hypertension.7, 8 We designed this Renal Denervation for Hypertension (DENERHTN) trial to assess the ambulatory blood pressure-lowering efficacy, safety, and cost-effectiveness of renal denervation added to a standardised stepped-care antihypertensive treatment (SSAHT) recommended by UK guidelines9 compared with the same SSAHT alone in patients with confirmed resistant hypertension. We report here the 6-month blood pressure-lowering efficacy and safety results.
Section snippets
Study design and patients
The DENERHTN study is a multicentre, open-label, randomised, controlled trial with blinded endpoint assessment. Between May 22, 2012, and Oct 14, 2013, we recruited participants from 15 French tertiary care centres specialised for hypertension management, which were qualified to do renal denervation. Approval needed both previous expertise of the onsite interventionalist in renal angiography or stenting and training and supervision by the lead interventionalist (appendix). 14 of these
Results
1416 patients with resistant hypertension to three or more antihypertensive drugs on the basis of their office blood pressure were assessed for eligibility. 121 patients (8·5%) with supine office blood pressure of 163·4 mm Hg (SD 23·0)/95·0 mm Hg (12·7) despite being treated with four (IQR 3–5) different antihypertensive drugs (diuretic, 94·2%; renin angiotensin system blockers, 95·9%; calcium channel blockers, 97·5%; β blockers, 35·5%; aldosterone antagonists, 23·1%; centrally acting
Discussion
In patients with confirmed resistant hypertension, renal denervation combined with SSAHT reduced 6-month daytime (primary endpoint), night-time, and 24-h ambulatory systolic blood pressure significantly more (by about 6 mm Hg) than the same SSAHT alone (panel). Subsequently, the 6-month ambulatory blood pressure control rate was higher in the renal denervation group than in the control group. Even though the study was not double-blinded (there was no sham procedure), the need to add-on new
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