N ot Superior in True Resistant Hypertension From ESH 2016 POS 7D Jan Rosa MD General University Hospital Charles University Prague Czech Republic Overview Renal denervation was not superior to intensified medical treatment in patients with validated true resistant hypertension in ID: 916002
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Slide1
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
Slide2Overview
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
Slide3Overview
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
Slide4Baseline Characteristics in PRAGUE-15
RDN, renal denervation.
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/m
2
]
31.2±4.3
33.4±4.7
0.01
Plasma sodium [mmol/l]
141±3
141±3
0.76
Plasma potassium [mmol/l]
4.1±0.4
4.2±0.4
0.25
Creatinine clearance [ml/s/1.73m
2
]
87 (78-97)
84 (72-94)
0.96
Creatinine clearance [ml/s/1.73m
2
]
1.5 (1.3-1.9)
1.6 (1.2-2.1)
0.98
Total plasma cholesterol [mmol/l]
4.4±1.0
4.7±1.0
0.12
Fasting plasma glucose [mmol/l]
5.9 (5.1-7.2)
6.1 (5.1-7.8)
0.79
Slide5Baseline Characteristics in PRAGUE-15
RDN, renal denervation.
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
Slide6Reductions
in 24-hour Systolic Blood Pressure
RDN,
renal
denervation.
MEDICAL
Slide7Reductions
in Office Systolic Blood Pressure
RDN, renal denervation.
MEDICAL
Slide8Conclusions
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
Slide9PRAGUE-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