Randomized Comparison of Renal Denervation Versus Intensified
Pharmacotherapy Including Spironolactone in True-Resistant
Hypertension : Six-Month Results From the Prague-15 Study

J 2015

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study

ROSA, Ján; Petr WIDIMSKÝ; Petr TOUŠEK; Ondřej PETRÁK; Karol ČURILA et al.

Základní údaje

Originální název

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study

Název česky

Randomizované srovnání renální denervace versus intenzifikovaná farmakoterapie zahrnující spironolakton u pravé rezistentní hypertenze : 6 - měsíční výsledky ze studie Prague -15

Autoři

Vydání

Hypertension, Philadelphia, Lippincott Williams & Wilkins, 2015, 0194-911X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 6.350

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/15:00082349

Organizační jednotka

Lékařská fakulta

Klíčová slova česky

hypertenze rezistentní ke konvenční terapii; spironolakton; sympatická denervace

Klíčová slova anglicky

hypertension resistant to conventional therapy; spironolactone; sympathetic denervationn

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 18. 5. 2017 14:17, Ing. Mgr. Věra Pospíšilíková

Anotace

ORIG CZ

V originále

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.

Česky

Tato prospektivní randomizovaná multicentrická studie hodnotila účinnost katetrové renální denervace (= RDN) pomocí katetru Symplicity flex oproti intenzifikované farmakologické léčbě zahrnující spironoloakton (v případě jeho tolerance) u pacientů s pravou rezistentní hypertenzi. 106 pacientů bylo randomizováno k RDN (= 52) nebo k intenzivní farmakoterapii (= 54). Po 6 měsících došlo k signifikantní redukci 24 hodinového průměrného systolického tlaku o 8,6 mmHg v denervační skupině a o 8,1 mmHg v skupině farmakologické. Oba poklesy byly tedy srovnatelné. Podobný srovnatelný pokles byl i v poklesu office systolického tlaku (u RDN o 12,4 mmHg, u farmakoterapie o 14,3 mmHg). 6–měsíční výsledky sice potvrdily bezpečnost renální denervace, ale RDN dosáhlo redukci krevního tlaku jen srovnatelného k intenzifikované farmakoterapii.

Citovat

ROSA, Ján; Petr WIDIMSKÝ; Petr TOUŠEK; Ondřej PETRÁK; Karol ČURILA; Petr WALDAUF; František BEDNÁŘ; Tomáš ZELINKA; Robert HOLAJ; Branislav ŠTRAUCH; Zuzana ŠOMLÓOVÁ; Miloš TÁBORSKÝ; Jan VÁCLAVÍK; Eva KOCIÁNOVÁ; Marian BRANNY; Igor NYKL; Otakar JIRAVSKÝ a Jiří WIDIMSKÝ JR. Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study. Hypertension. Philadelphia: Lippincott Williams & Wilkins, 2015, roč. 65, č. 2, s. "407"-"U339", 17 s. ISSN 0194-911X. Dostupné z: https://doi.org/10.1161/HYPERTENSIONAHA.114.04019.

@article{1220459,
   author = {Rosa, Ján and Widimský, Petr and Toušek, Petr and Petrák, Ondřej and Čurila, Karol and Waldauf, Petr and Bednář, František and Zelinka, Tomáš and Holaj, Robert and Štrauch, Branislav and Šomlóová, Zuzana and Táborský, Miloš and Václavík, Jan and Kociánová, Eva and Branny, Marian and Nykl, Igor and Jiravský, Otakar and Widimský Jr., Jiří},
   article_location = {Philadelphia},
   article_number = {2},
   doi = {https://doi.org/10.1161/HYPERTENSIONAHA.114.04019},
   keywords = {hypertension resistant to conventional therapy; spironolactone; sympathetic denervationn},
   language = {eng},
   issn = {0194-911X},
   journal = {Hypertension},
   title = {Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study},
   url = {http://www.tandfonline.com/doi/abs/10.1080/19448953.2015.1094273},
   volume = {65},
   year = {2015}
}

TY  - JOUR
ID  - 1220459
AU  - Rosa, Ján - Widimský, Petr - Toušek, Petr - Petrák, Ondřej - Čurila, Karol - Waldauf, Petr - Bednář, František - Zelinka, Tomáš - Holaj, Robert - Štrauch, Branislav - Šomlóová, Zuzana - Táborský, Miloš - Václavík, Jan - Kociánová, Eva - Branny, Marian - Nykl, Igor - Jiravský, Otakar - Widimský Jr., Jiří
PY  - 2015
TI  - Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study
JF  - Hypertension
VL  - 65
IS  - 2
SP  - "407"-"U339"
EP  - "407"-"U339"
PB  - Lippincott Williams & Wilkins
SN  - 0194911X
KW  - hypertension resistant to conventional therapy
KW  - spironolactone
KW  - sympathetic denervationn
UR  - http://www.tandfonline.com/doi/abs/10.1080/19448953.2015.1094273
N2  - 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.
ER  -

ROSA, Ján; Petr WIDIMSKÝ; Petr TOUŠEK; Ondřej PETRÁK; Karol ČURILA; Petr WALDAUF; František BEDNÁŘ; Tomáš ZELINKA; Robert HOLAJ; Branislav ŠTRAUCH; Zuzana ŠOMLÓOVÁ; Miloš TÁBORSKÝ; Jan VÁCLAVÍK; Eva KOCIÁNOVÁ; Marian BRANNY; Igor NYKL; Otakar JIRAVSKÝ a Jiří WIDIMSKÝ JR. Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension : Six-Month Results From the Prague-15 Study. \textit{Hypertension}. Philadelphia: Lippincott Williams \&{} Wilkins, 2015, roč.~65, č.~2, s.~''407''-''U339'', 17 s. ISSN~0194-911X. Dostupné z: https://doi.org/10.1161/HYPERTENSIONAHA.114.04019.

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