Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
25421981
DOI
10.1161/hypertensionaha.114.04019
PII: HYPERTENSIONAHA.114.04019
Knihovny.cz E-resources
- Keywords
- hypertension resistant to conventional therapy, spironolactone, sympathetic denervation,
- MeSH
- Blood Pressure Monitoring, Ambulatory MeSH
- Antihypertensive Agents administration & dosage pharmacology therapeutic use MeSH
- Axotomy methods MeSH
- Adult MeSH
- Hypertension drug therapy physiopathology surgery MeSH
- Catheter Ablation * MeSH
- Drug Therapy, Combination MeSH
- Creatinine blood MeSH
- Kidney innervation surgery MeSH
- Drug Resistance MeSH
- Middle Aged MeSH
- Humans MeSH
- Metabolic Clearance Rate MeSH
- Postoperative Complications epidemiology MeSH
- Prospective Studies MeSH
- Aged MeSH
- Spironolactone therapeutic use MeSH
- Heart Rate drug effects MeSH
- Sympathectomy * adverse effects 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
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Antihypertensive Agents MeSH
- Creatinine MeSH
- Spironolactone MeSH
This prospective, randomized, open-label multicenter trial evaluated the efficacy of catheter-based renal denervation (Symplicity, Medtronic) versus intensified pharmacological treatment including spironolactone (if tolerated) in patients with true-resistant hypertension. This was confirmed by 24-hour ambulatory blood pressure monitoring after excluding secondary hypertension and confirmation of adherence to therapy by measurement of plasma antihypertensive drug levels before enrollment. One-hundred six patients were randomized to renal denervation (n=52), or intensified pharmacological treatment (n=54) with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. A significant reduction in 24-hour average systolic blood pressure after 6 months (-8.6 [95% cofidence interval: -11.8, -5.3] mm Hg; P<0.001 in renal denervation versus -8.1 [95% cofidence interval: -12.7, -3.4] mm Hg; P=0.001 in pharmacological group) was observed, which was comparable in both groups. Similarly, a significant reduction in systolic office blood pressure (-12.4 [95% cofidence interval: -17.0, -7.8] mm Hg; P<0.001 in renal denervation versus -14.3 [95% cofidence interval: -19.7, -8.9] mm Hg; P<0.001 in pharmacological group) was present. Between-group differences in change were not significant. The average number of antihypertensive drugs used after 6 months was significantly higher in the pharmacological group (+0.3 drugs; P<0.001). A significant increase in serum creatinine and a parallel decrease of creatinine clearance were observed in the pharmacological group; between-group difference were borderline significant. The 6-month results of this study confirmed the safety of renal denervation. In conclusion, renal denervation achieved reduction of blood pressure comparable with intensified pharmacotherapy.
References provided by Crossref.org
Should All Patients with Resistant Hypertension Receive Spironolactone?
