[OP.7D.09] THE ROLE OF ADDING SPIRONOLACTONE AND RENAL DENERVATION IN TRUE RESISTANT HYPERTENSION. ONE-YEAR OUTCOMES OF RANDOMIZED PRAGUE-15 STUDY

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Abstract

Objective:

This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension (TRH) and assessed the effect of spironolactone addition. We present the 12-month data.

Design and method:

The entry criteria included office systolic blood pressure (BP) over 140 mmHg, ambulatory 24-hour mean systolic BP over 130 mmHg, treatment with at least 3 antihypertensive drugs including a diuretic, exclusion of secondary hypertension and excluding drug non-compliance. Thus, only patients with TRH were included after thorough examination in three tertiary hypertension centers. After randomization, patients selected for RDN were maintained on baseline medical therapy for 1 year unless changes were considered clinically necessary. Patients selected for intensified medical treatment received baseline medical therapy plus spironolactone (25 mg daily, as generally recommended), if tolerated, and if no contraindications were present.

Results:

A total of 106 patients with TRH were randomized: 52 patients to RDN and 54 patients to the spironolactone addition, with baseline systolic BP of 159 ± 17 and 155 ± 17 mmHg 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 24-hour systolic BP decline of 6.4 mmHg, p = 0.001 in RDN versus 8.2 mmHg, p = 0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic BP decline between complete RDN (6.3 mmHg, p = 0.004) and the subgroup where spironolactone was added and this continued within the 12 months (15 mmHg, p = 0.003). See Figure. Renal artery CT angiograms before and after one year post-renal denervation did not reveal any relevant changes.

Conclusions:

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 TRH with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in BP reduction.

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