Two-year follow-up outcomes of renal denervation in polymorbid patients with true resistant hypertension, type 2 diabetes mellitus and coronary artery disease

Abstract

Aim: To study the clinical effects and long-term outcomes of radiofrequency renal denervation (RDN) in patients with true resistant arterial hypertension, type 2 diabetes mellitus, and coronary artery disease after completed myocardial revascularization.

Methods: 75 patients were randomized into RDN and control groups (1:1.5). RDN was performed via femoral access using a Spyral catheter (Medtronic, USA). The primary endpoint was the change in blood pressure (BP). Secondary endpoints were: the development of cardiovascular and cerebral complications, changes in laboratory and instrumental parameters, changes in antihypertensive medication, late lumen loss (LLL) in the stented segments [measured by computer-assisted quantitative coronary angiography analysis (QCA)], and the frequency of de novo stenosis.

Results: In the RDN group, there was a significant decrease in both office (o) and average daily (ad) systolic (S) and diastolic (D) BP (oSBP: -8 mmHg; oDBP: -6 mmHg; adSBP: -11 mmHg; adDBP: -8 mmHg - P < 0.05); decreased activity of plasma renin Δ-2.44 ng/mL/h; concentrations of angiotensin I Δ -1.27 ng/mL and aldosterone Δ -13 pg/mL - P < 0.05); decrease in fasting glycemia (Δ -2.73 mmol/l - P < 0.05), HbA1c (Δ -1% - P < 0.05) and the level of insulin resistance according to HOMA-IR index (Δ -1.78 - P < 0.05), as well as a decrease in the concentration of C-reactive peptide in the blood (Δ -1.84 mg/L - P < 0.05). No significant dynamics of these indicators were recorded in the control group. The effectiveness of RDN was highest in the cohorts of obese patients - OR 1.31 (95%CI: 1.17-1.44), patients with obstructive sleep apnea syndrome - OR 1.73 (95%CI: 1.23-2.26) and tachycardia - OR 2.02 (95%CI: 1.69-3.10); P < 0.001 in all cases. The incidence of major adverse cardiovascular events (26.7% in the RDN group; 24.4% in the control group), the average LLL (24.7% in the RDN group; 28.1% in the control group), and the incidence of de novo stenosis (23.3% in the RDN group; 22.2% in the control group) did not differ between the groups.

Conclusion: The use of RDN in the cohort of comorbid patients is safe and enables better control of modifiable risk factors of progression of resistant arterial hypertension and type 2 diabetes mellitus due to an improvement of BP, carbohydrate metabolism parameters, regulatory factors of the renin-angiotensin-aldosterone system (RAAS), and factors of the systemic inflammatory response.

Keywords

Comorbidity / diabetes / insulin resistance / hypertension / coronary artery disease / renal denervation / radiofrequency ablation

References

[1] Colussi G,Cavarape A.Hypertension and type 2 diabetes: lights and shadows about causality.J Hum Hypertens2020;34:91-3

[2] Mancia G,Brunström M.2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA).J Hypertens2023;41:1874-2071

[3] Kario K,Prejbisz A.Obstructive sleep apnea-induced neurogenic nocturnal hypertension: a potential role of renal denervation?.Hypertension2021;77:1047-60

[4] Fay KS.Resistant hypertension in people with CKD: a review.Am J Kidney Dis2021;77:110-21

[5] Massi-Benedetti M.The cost of diabetes Type II in Europe the CODE-2 study.Diabetologia2002;45:S1-4

[6] Standl E,Hansen TB.The global epidemics of diabetes in the 21st century: current situation and perspectives.Eur J Prev Cardiol2019;26:7-14

[7] Ruiz HH,Schmidt AM.Advanced glycation end products: building on the concept of the "common soil" in metabolic disease.Endocrinology2020;161:bqz006 PMCID:PMC7188081

[8] Paramasivam G,Jayaram A.In-stent restenosis of drug-eluting stents in patients with diabetes mellitus: Clinical presentation, angiographic features, and outcomes.Anatol J Cardiol2020;23:28-34 PMCID:PMC7141436

[9] Barbato E,Schmieder RE.Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).Eur Heart J2023;44:1313-30

[10] Bhatt DL,Kandzari DE.Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial.Lancet2022;400:1405-16

[11] Arablinsky NA,Shukurov FB,Drapkina OM.Promising areas of renal denervation application.Russ J Cardiol2024;29:5847

[12] Aripov M,Alimbayev S,Zhusupova G.Individualised renal artery denervation improves blood pressure control in Kazakhstani patients with resistant hypertension.Kardiol Pol2017;75:101-7

[13] Rosa J,Toušek P.Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study.Hypertension2015;65:407-13

[14] Mahfoud F,Kandzari DE.Changes in plasma renin activity after renal artery sympathetic denervation.J Am Coll Cardiol2021;77:2909-19

[15] Booth LC,Yao ST.Reinnervation of renal afferent and efferent nerves at 5.5 and 11 months after catheter-based radiofrequency renal denervation in sheep.Hypertension2015;65:393-400

[16] Panchavinnin P,Roubsanthisuk W.Long-term outcome of renal nerve denervation (RDN) for resistant hypertension.Hypertens Res2022;45:962-6 PMCID:PMC9106576

[17] Zeijen VJM,Nannan Panday R.Long-term follow-up of patients undergoing renal sympathetic denervation.Clin Res Cardiol2022;111:1256-68 PMCID:PMC9622524

[18] Sesa-Ashton G,Muente I.Catheter-based renal denervation: 9-year follow-up data on safety and blood pressure reduction in patients with resistant hypertension.Hypertension2023;80:811-9

[19] Falkovskaya AY,Pekarsky SY.Dynamics of glycemic control after renal denervation in patients with resistant hypertension and type 2 diabetes mellitus.Bull Sib Med2015;14:82-90

[20] Fink GD.Can we predict the blood pressure response to renal denervation?.Auton Neurosci2017;204:112-8 PMCID:PMC5280812

[21] Zhang Z,Ye R,Chen X.Patient preference for renal denervation therapy in hypertension: a cross-sectional survey in Chengdu, China.Hypertens Res2022;45:954-61

[22] Kario K,Hayashi S,Ozawa K.A Japan nationwide web-based survey of patient preference for renal denervation for hypertension treatment.Hypertens Res2022;45:232-40 PMCID:PMC8766287

[23] Bartus K,Sadowski J.Clinical factors predicting blood pressure reduction after catheter-based renal denervation.Postepy Kardiol Interwencyjnej2018;14:270-5

[24] Sanders MF.Chronic kidney disease as a potential indication for renal denervation.Front Physiol2016;7:220 PMCID:PMC4896963

[25] Warchol-Celinska E,Kadziela J.Renal denervation in resistant hypertension and obstructive sleep apnea: randomized proof-of-concept phase II trial.Hypertension2018;72:381-90