Residual Effect of Renal Denervation in Patients With Truly Resistant Hypertension

Persu, Alexandre; Azizi, Michel; Burnier, Michel; Staessen, Jan A.

doi:10.1161/hypertensionaha.113.01632

Cited by 16 publications

(11 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Discrepant results in RDN efficacy have been observed in previous studies. 2,4,6,11,12 Several differences in the methodology of these trials might have contributed to the disparity of results. Currently, the Symplicity HTN-3 study, which was recently published, is considered the most robust RDN study.…”

Section: Discussionmentioning

confidence: 99%

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

et al. 2015

View full text Add to dashboard Cite

T he prevalence of patients with resistant hypertension (RH) varies from 5% to 30%.1 Identification of true-RH, when secondary causes and medication noncompliance are excluded, is becoming more important with the implementation of novel, nondrug therapeutic approaches to RH, such as catheter-based renal-artery denervation (RDN) or baroreflex stimulation. Pilot studies using RDN described the method as feasible, effective, and safe for reducing blood pressure (BP) in the short term. 2-4The interpretation of the results from the majority of these studies was complicated by the lack of 24-hour ambulatory blood pressure monitoring (24-hour ABPM) data, lack of compliance confirmation, or small follow-up sample sizes.This study seeks to evaluate the efficacy of RDN in a prospective multicenter randomized trial with the acronym PRAGUE-15 in patients with true-RH, according to the recommendations for RDN.5 Twenty-four-hour ABPM, exclusion of secondary hypertension and evaluation of treatment compliance served as confirmation of true resistance. The efficacy of RDN was compared with intensified antihypertensive treatment including the use of spironolactone. To date, only 1 study has compared RDN with intensified pharmacological treatment.6 However, only 19Abstract-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. Betweengroup 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.

show abstract

Section: Discussionmentioning

confidence: 99%

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

et al. 2015

View full text Add to dashboard Cite

show abstract

“…For all aforementioned reasons, and in view of the complexity and multifactorial character of hypertension, the failure of RDN to normalize or substantially reduce blood pressure in all patients with apparently TRH was a reasonable working hypothesis for us, even before the Medtronic announcement that Symplicity HTN-3 had failed to meet its primary endpoint ( http://www.tctmd.com/show.aspx?id=123265 ). We (Fadl Elmula et al, 2013 ; Persu et al, 2013a , b ) and others (Azizi et al, 2012 ; Howard et al, 2013 ) had predicted that the true effect of RDN might have been overestimated and may considerably shrink in properly designed studies (Howard et al, 2013 ), and that “one size may not fit all” (Persu et al, 2012 ). In particular, in preliminary analysis of the European Network COordinating research on Renal Denervation (ENCOReD) network (Persu et al, 2014a ) we were struck by the imbalance between the 17.6 mmHg decreases in office blood pressure, vs. only 5.9 mmHg for 24-h ambulatory blood pressure.…”

Section: The Role Of Industry In Promoting Renal Denervationmentioning

confidence: 95%

Renal sympathetic denervation after Symplicity HTN-3 and therapeutic drug monitoring in severe hypertension

et al. 2015

Self Cite

View full text Add to dashboard Cite

Renal sympathetic denervation (RDN) has been and is still proposed as a new treatment modality in patients with apparently treatment resistant hypertension (TRH), a condition defined as persistent blood pressure elevation despite prescription of at least 3 antihypertensive drugs including a diuretic. However, the large fall in blood pressure after RDN reported in the first randomized study, Symplicity HTN-2 and multiple observational studies has not been confirmed in five subsequent prospective randomized studies and may be largely explained by non-specific effects such as improvement of drug adherence in initially poorly adherent patients (the Hawthorne effect), placebo effect and regression to the mean. The overall blood-pressure lowering effect of RDN seems rather limited and the characteristics of true responders are largely unknown. Accordingly, RDN is not ready for clinical practice. In most patients with apparently TRH, drug monitoring and improvement of drug adherence may prove more effective and cost-beneficial to achieve blood pressure control. In the meantime, research should aim at identifying characteristics of those patients with truly TRH who may respond to RDN.

show abstract

“…Doposud vycházely informace o snížení TK po RDN pouze z výsledků vyšetření TK v ordinaci lékaře. Byla však již publikována data, že efekt RDN na snížení 24h ABPM je výrazně nižší [16,21,22]. Bylo také prokázáno, že 24h ABPM má obecně větší senzitivitu k předpovědi závažných kardiovaskulárních příhod v porovnání s TK měřeným v ordinaci lékaře [6].…”

Section: Diskuseunclassified

Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15

et al. 2014

View full text Add to dashboard Cite

Tento článek prosím citujte takto: P. Toušek, et al., Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15, Cor et Vasa 36 (2014) e235-e239, jak vyšel v online verzi Cor et Vasa na SOUHRNKatetrová renální denervace (RDN) byla považována za nadějnou metodu pro léčbu rezistentní hypertenze a počet výkonů se celosvětově stále navyšoval. Doposud byly publikovány s rozdílnými výsledky pouze dvě randomizované studie, které hodnotí efekt této intervence oproti medikamentózní léčbě. Proto jsou nutné další pečlivě designované srovnávací studie. Studie PRAGUE-15 byla navržena jako otevřená prospektivní randomizovaná multicentrická studie srovnávající účinek RDN s intenzifi kovanou medikamentózní léčbou u pacientů s rezistentní hypertenzí. Pacienti randomizovaní do medikamentózní větve budou užívat v léčbě spironolacton, pokud k tomu nebudou žádné kontraindikace. Primární cílový ukazatel studie byl stanoven jako změna hodnot systolického a diastolického tlaku během 24hodinového ambulantního monitorování krevního tlaku (ABPM) mezi vstupní hodnotou a šestiměsíční kontrolou. V tomto článku popisujeme design a metodiku studie. Zásadní pro tuto studii je hodnocení změn krevního tlaku pomocí ABPM, nezávislé hodnocení a užívání spironolactonu v medikamentózní léčbě. ABSTRACTCatheter-based renal denervation (RDN) was considered as a promising method for treatment of resistant hypertension and was increasingly being used worldwide. However, there are equivocal results from only two randomized trials studying the effect of such intervention. Thus, additional data from properly designed long-term comparative trials are needed. The PRAGUE-15 trial is designed as an open, prospective, randomized multicenter trial comparing RDN versus intensifi ed medical treatment in patients with resistant hypertension. Patients randomized to the medical treatment group will receive spironolactone in the absence of contraindications. The primary endpoint will be changes in systolic and diastolic pressure during ambulatory blood pressure monitoring (ABPM) from baseline to 6 months. Herein, we describe the trial design and methodology. The strengths of the trial include ABPM (as the objective endpoint), independent outcomes assessment, and therapeutic use of spironolactone.

show abstract

Residual Effect of Renal Denervation in Patients With Truly Resistant Hypertension

Cited by 16 publications

References 17 publications

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

Randomized Comparison of Renal Denervation Versus Intensified Pharmacotherapy Including Spironolactone in True-Resistant Hypertension

Renal sympathetic denervation after Symplicity HTN-3 and therapeutic drug monitoring in severe hypertension

Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study-PRAGUE-15

Contact Info

Product

Resources

About