Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study
Abstract
Objectives: This randomised, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data.
Methods: A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomised to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159+-17 and 155+-17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients.
Spironolactone addition, as crossover after one year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in 5 patients. Results: Similar and comparable reduction of 24-hour systolic blood pressure after RDN or spironolactone addition after randomisation was observed, 9.1 mmHg (p=0.001) and 10.9 mmHg (p=0.001), respectively.
Similar decrease of office blood pressure was observed, 17.7 mmHg (p<0.001) versus 14.1 mmHg (p<0.001), while the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed non-significantly better efficacy of spironolactone addition in 24h systolic and office systolic blood pressure reduction than RDN (3.7 mmHg, p=0.27 and 4.6 mmHg in favour of spironolactone addition, p=0.28, respectively).
Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, p=0.001). Conclusions: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in blood pressure reduction over a period of 24 months.
However, by contrast to the 12-month results, blood pressure changes are not significantly greater.