Sympathetic renal denervation treatment in resistant hypertension: one-year follow-up

Abstract

Aims A comparison influence of renal denervation versus pharmacological treatment with sympathetic nervous system blockers on blood pressure in patients with resistant hypertension. Methods 125 patients with resistant hypertension without comorbidities after a 3-week standardized treatment with Losartan 100 mg, Amlodipine 10 mg and Indapamid 1,5 mg and confirmation of their resistance were randomly assigned into three groups, depending on medication supplemented to previously administered: IM group – selective I1-imidazoline agonist Moxonidine, IIB group – cardioselective beta-blocker Bisoprolol and IIID group – renal artery denervation. Patients were assessed by ambulatory blood pressure monitoring at baseline, 3, 6 and 12 month follow-up. The compliance to drug treatment was confirmed by 8-item Morisky Medication Adherence Scale. Renal denervation was performed with a Symplicity Spyral catheter. Results The mean 24 hour systolic blood pressure (SBP m/24 h) at baseline were 179.0±2.02 mmHg in IM group versus 177.96±2.44 mmHg in IIB group and 176.92±1.97 mmHg in IIID group, p>0.05. Statistically significant dynamics was recorded starting with 3 months of evaluation in all three groups, the group of patients undergoing denervation of the renal arteries demonstrating a net superior effect compared with pharmacological treatment: −6.48±0.81 mmHg in I M group versus −6.2±0.88 mmHg in II B group and −23.28±1.9 mmHg in III D group, p<0.001. The beneficial effect was maintained until the end of the study, when in observational group supplemented with Moxonidine SBP m/24 h were 159.6±1.72 mmHg with a total reduction of −19.9±0.7 mmHg from baseline, in Bisoprolol group −164.08±1.93 mmHg with a reduction of −13.88±1.13 mmHg and 141.76±0.77 mmHg in renal denervation group with a total reduction of −35.16±2.23 mmHg, p<0.001. The mean 24 hour diastolic blood pressure (DBP m/24 h) increased at baseline in all three groups (105.52±1.28 mmHg in IM versus 108.6±1.6 mmHg in IIB and 107.24±0.92 mmHg in IIID, p>0.05) similar to SBP m/24 h noted a significantly reduction at 3 month follow-up: −4.8±0.96 mmHg in IM group versus −3.64±0.47 mmHg in IIB group and −12.08±0.63 mmHg in IIID group, p<0.001. The maximum reduction in DBP m/24 h were registered at 12 month follow-up, a comparative analyses of dynamics between groups showing a presence of statistical difference due to superiority of renal denervation treatment in amelioration of this parameter: −13.68±0.83 mmHg in IM group versus −10.72±0.64 mmHg in IIB group and −20.2±1.28 mmHg in IIID group, p<0.001. Conclusions The application of all three treatment regimens has been shown to be effective in reducing SBP and DBP values m/24 hours in patients with resistant hypertension, with a superior but comparable effect of Moxonidine to Bisoprolol and the absolute superiority of renal denervation treatment versus both pharmacological treatment regimens. Funding Acknowledgement Type of funding source: None

Renal denervation for uncontrolled hypertension: a systematic review and meta-analysis examining multiple subgroups

“…There were five RCTs that partially met the criteria for the ‘on-med’ group for the meta-analysis [ 39 , 41 , 50 , 52 , 53 ]. However, patients in these RCTs received different medication regimens in each arm.…”

“…Nine of the included RCTs were judged to have an overall low risk of methodological bias [15,16,[32][33][34][35][36][37][38], nine were judged to have 'some concerns' [39][40][41][42][43][44][45][46][47], and seven were judged to have a high risk of methodological bias according the Cochrane Risk of Bias tool [48][49][50][51][52][53][54]. A summary of the Risk of Bias Assessment is reported in Supplemental Digital Content 1 Appendix G, http://links.lww.com/HJH/C452.…”