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Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study
J. Rosa, P. Widimský, P. Waldauf, T. Zelinka, O. Petrák, M. Táborský, M. Branny, P. Toušek, K. Čurila, L. Lambert, F. Bednář, R. Holaj, B. Štrauch, J. Václavík, E. Kociánová, I. Nykl, O. Jiravský, G. Rappová, T. Indra, Z. Krátká, J. Widimský,
Language English Country England, Great Britain
Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
Grant support
NV16-30345A
MZ0
CEP Register
- MeSH
- Blood Pressure Monitoring, Ambulatory MeSH
- Mineralocorticoid Receptor Antagonists therapeutic use MeSH
- Antihypertensive Agents therapeutic use MeSH
- Adult MeSH
- Hypertension therapy MeSH
- Cross-Over Studies MeSH
- Drug Therapy, Combination MeSH
- Coronary Vasospasm therapy MeSH
- Blood Pressure MeSH
- Kidney innervation physiopathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Aged MeSH
- Spironolactone therapeutic use MeSH
- Sympathectomy * MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
OBJECTIVES: The randomized, 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 randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP 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 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. RESULTS: Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). CONCLUSION: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.
References provided by Crossref.org
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- $a Rosa, Ján $u a3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University bCardiocentre cDepartment of Anaesthesiology, University Hospital Královské Vinohrady and Third Faculty of Medicine, Charles University, Prague dDepartment of Internal Medicine I - Cardiology, Faculty of Medicine and Dentistry, University Hospital Olomouc and Palacký University, Olomouc eCardiocentre, Nemocnice Podlesí, Třinec fDepartment of Radiology gDepartment of Nephrology, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic.
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- $a OBJECTIVES: The randomized, 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 randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP 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 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. RESULTS: Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). CONCLUSION: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.
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