1. PRAGUE-15: Renal Denervation Not Superior in True Resistant Hypertension
From ESH 2016 | POS 7D:
Jan Rosa, MD
General University Hospital, Charles University, Prague, Czech Republic

2. Overview
Renal denervation was not superior to intensified medical treatment in patients with validated true resistant hypertension, in the 12-month results from the PRAGUE-15 trial
Spironolactone, if tolerated and maintained, added to medical treatment was more effective in reducing blood pressure
PRAGUE-15 was a prospective, open, randomized, trial conducted at 3 centers in Prague to evaluate renal denervation with Symplicity catheters against intensified antihypertensive therapy including spironolactone 25 mg on 24-hour blood pressure
Crossover at 1 year was allowed

3. Overview
PRAGUE-15 terminated early, due to the Symplicity HTN-3 results
106 patients were randomized in PRAGUE-15, with 12-month follow-up data in 101 patients
The intention-to-treat (ITT) analysis of all randomized patients and the per-protocol (PP) analysis in a subgroup of patients with complete renal denervation, defined as ≥4 ablations, or had spironolactone added and maintained presented

4. Baseline Characteristics in PRAGUE-15
RDN
Medical p
Number of subjects 51 50 -
Age [years]
56±12
59±9
0.20
Male sex n (%)
40 (77%)
34 (63%)
0.14
Body mass index [kg/m2]
31.2±4.3
33.4±4.7
0.01
Plasma sodium [mmol/l]
141±3
0.76
Plasma potassium [mmol/l]
4.1±0.4
4.2±0.4
0.25
Creatinine clearance [ml/s/1.73m2]
87 (78-97)
84 (72-94)
0.96
1.5 ( )
1.6 ( )
0.98
Total plasma cholesterol [mmol/l]
4.4±1.0
4.7±1.0
0.12
Fasting plasma glucose [mmol/l]
5.9 ( )
6.1 ( )
0.79
RDN, renal denervation.

5. Baseline Characteristics in PRAGUE-15
RDN
Medical p
Office systolic BP [mmHg]
159±19
155±17
0.26
Office diastolic BP [mmHg]
92±14
89±14
0.21
Heart rate [bpm]
71±14
72±11
0.78
24h systolic BP [mmHg]
149±12
147±13
0.54
24h diastolic BP [mmHg]
86±10
84±10
0.20
24h heart rate [bpm]
69±10
70±10
0.72
Number of drugs used
5.1±1.2
5.4±1.2
0.40
RDN, renal denervation.

6. Reductions in 24-hour Systolic Blood Pressure
MEDICAL
RDN,
renal denervation.

7. Reductions in Office Systolic Blood Pressure
MEDICAL
RDN, renal denervation.

8. Conclusions
Office systolic blood pressure (SBP) was significantly reduced in both groups, no between-group difference, in the ITT and PP analyses
24-hour SBP measured with ABPM was significantly reduced in both groups, no between-group difference was found in the ITT, but significant between-group difference found in PP analysis
Similar change in the number of antihypertensive medications in the ITT analysis, but significantly higher number in the medical treatment group in PP analysis

9. PRAGUE-15: Renal Denervation Not Superior in True Resistant Hypertension
From ESH 2016 | POS 7D:
Jan Rosa, MD
General University Hospital, Charles University, Prague, Czech Republic