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.
Abstract-There is currently limited data on which drug should be used to improve blood pressure (BP) control in patients with resistant hypertension. This study was designed to assess the effect of the addition of 25 mg of spironolactone on BP in patients with resistant arterial hypertension. Patients with office systolic BP Ͼ140 mm Hg or diastolic BP Ͼ90 mm Hg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled in this double-blind, placebo-controlled, multicenter trial. One hundred seventeen patients were randomly assigned to receive spironolactone (nϭ59) or a placebo (nϭ58) as an add-on to their antihypertensive medication, by the method of simple randomization. Analyses were done with 111 patients (55 in the spironolactone and 56 in the placebo groups). At 8 weeks, the primary end points, a difference in mean fall of BP on daytime ambulatory BP monitoring (ABPM), between the groups was Ϫ5.4 mm Hg (95% CI Ϫ10.0; Ϫ0. R esistant hypertension is a common clinical problem faced by both primary care clinicians and specialists worldwide. It is defined as blood pressure (BP) that remains above goal despite the concurrent use of 3 antihypertensive agents of different classes prescribed at optimal dosages; one of the 3 agents used should be a diuretic. 1 The exact prevalence of resistant hypertension is not known, but it is estimated from large clinical trials to affect at least 10% to 15% of all hypertensive patients. 2,3 If no secondary cause of hypertension is found, the use of multidrug treatment regimens including 3, 4, or more antihypertensive drugs is usually necessary to lower BP and thus prevent future cardiovascular events. 4 Spironolactone is a mineralocorticoid receptor antagonist that was shown to lower BP effectively in both general hypertensive patients and patients with primary aldosteronism. 5-7 A number of small, uncontrolled trials showed the positive effect of small doses of spironolactone in lowering BP in patients with resistant arterial hypertension. 8 -11 In the nonrandomized post hoc analysis of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm, the addition of spironolactone to a triple-drug treatment led, during an average of 1.3 years of follow-up, to a significant decrease of systolic BP of 21.9 mm Hg and diastolic BP of 9.5 mm Hg. 12 However, evidence from randomized trials was lacking, and it was necessary to provide definite proof for the efficacy of spironolactone as an add-on treatment in resistant hypertension. 12,13 Therefore, we designed a prospective randomized trial to evaluate the effect of adding spironolactone in patients with resistant arterial hypertension. We decided to administer a low dose of spironolactone (25 mg/day) in the trial, since the effect of this dose seemed to be substantial
C atheter-based renal denervation (RDN) has been considered as a new hope for patients with resistant hypertension (RH). The first studies published by the same pioneering group of experts 1,2 triggered widespread enthusiasm, and the new method was quickly promulgated. However, this was slowed down in 2014 by publication of trials with negative results for RDN. [3][4][5][6] Apart from exceptions, 7 most of these studies failed to prove the satisfactory efficacy of RDN.3-6 Based on these results, the Czech Society for Hypertension does not recommend implementation of RDN in routine practice. 8This study seeks to evaluate the efficacy of RDN in a prospective multicenter randomized trial with the acronym PRAGUE-15 in patients with true RH. Twenty-four-hour ambulatory blood pressure monitoring, 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. The 6-month results of the PRAGUE-15 study were previously published. 6 To date, only 1 properly designed study has published 12-month results 9 where RDN was compared with a sham procedure. Here we present the 1-year data, including the evaluation of renal artery changes after RDN and hormonal and hemodynamic parameters. See Editorial Commentary, pp 278-280Abstract-This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension and assessed the effect of spironolactone addition. We present here the 12-month data. 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 systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable mean 24-hour systolic blood pressure decline of 6.4 mm Hg, P=0.001 in RDN versus 8.2 mm Hg, P=0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic blood pressure decline between complete RDN (6.3 mm Hg, P=0.004) and the subgroup where spironolactone was added, and this continued within the 12 months (15 mm Hg, P= 0.003). Renal artery computed tomography angiograms before and after 1 year post-RDN did not reveal any relevant changes. This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction.
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