C atheter-based renal denervation (RDN) has been considered as a new hope for patients with resistant hypertension (RH). The first studies published by the same pioneering group of experts 1,2 triggered widespread enthusiasm, and the new method was quickly promulgated. However, this was slowed down in 2014 by publication of trials with negative results for RDN. [3][4][5][6] Apart from exceptions, 7 most of these studies failed to prove the satisfactory efficacy of RDN.3-6 Based on these results, the Czech Society for Hypertension does not recommend implementation of RDN in routine practice.
8This study seeks to evaluate the efficacy of RDN in a prospective multicenter randomized trial with the acronym PRAGUE-15 in patients with true RH. Twenty-four-hour ambulatory blood pressure monitoring, exclusion of secondary hypertension, and evaluation of treatment compliance served as confirmation of true resistance. The efficacy of RDN was compared with intensified antihypertensive treatment, including the use of spironolactone. The 6-month results of the PRAGUE-15 study were previously published. 6 To date, only 1 properly designed study has published 12-month results 9 where RDN was compared with a sham procedure. Here we present the 1-year data, including the evaluation of renal artery changes after RDN and hormonal and hemodynamic parameters.
See Editorial Commentary, pp 278-280Abstract-This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension and assessed the effect of spironolactone addition. We present here the 12-month data. A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable mean 24-hour systolic blood pressure decline of 6.4 mm Hg, P=0.001 in RDN versus 8.2 mm Hg, P=0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic blood pressure decline between complete RDN (6.3 mm Hg, P=0.004) and the subgroup where spironolactone was added, and this continued within the 12 months (15 mm Hg, P= 0.003). Renal artery computed tomography angiograms before and after 1 year post-RDN did not reveal any relevant changes. This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction.