Role of Adding XXXX and Renal Denervation in True Resistant @entity101 : One-Year Outcomes of Randomized PRAGUE-15 Study.

@entity1 @entity1482 @entity101
UNASSIGNED: This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in @entity1 with true resistant @entity101 and assessed the effect of @entity1482 addition. We present here the 12-month data. A total of 106 @entity1 with true resistant @entity101 were enrolled in this study: 52 @entity1 were randomized to RDN and 54 @entity1 to the @entity1482 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 @entity1 . 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 @entity1482 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 @entity101 with confirmed compliance is not superior to intensified pharmacological treatment. @entity1482 addition (if tolerated) seems to be more effective in blood pressure reduction.
