Renal Denervation vs. Medical Treatment in Resistant Hypertension Study
The Prague-15 trial presented at the 26th European Meeting on Hypertension in Paris compared renal denervation with intensified medical treatment in true resistant hypertension patients. The study revealed that spironolactone added to medical therapy was more effective in reducing blood pressure over a 12-month period. The trial, conducted in Prague, concluded that renal denervation was not superior to intensified medical therapy for these patients.
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26thEuropean Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 Infomedica Conference Coverage* of 26thEuropean Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 * Infomedica is an independent medical education provider that produces medical information to healthcare professionals through conference coverage and online educational programs and activities. Powered by Infomedica
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 3 141 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 Creatinine clearance [ml/s/1.73m2] 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 RDN, renal denervation. Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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. Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 Reductions in 24-hour Systolic Blood Pressure MEDICAL RDN, renal denervation. Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 Reductions in Office Systolic Blood Pressure MEDICAL RDN, renal denervation. Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 Powered by Infomedica 26th European Meeting on Hypertension and Cardiovascular Protection
26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 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 Infomedica Conference Coverage* of 26th European Meeting on Hypertension and Cardiovascular Protection Paris (France), June 10-13, 2016 * Infomedica is an independent medical education provider that produces medical information to healthcare professionals through conference coverage and online educational programs and activities. Powered by Infomedica
