Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial

Mahfoud, Felix; Kandzari, David E.; Kario, Kazuomi; Townsend, Raymond R.; Weber, Michael A.; Schmieder, Roland E.; Tsioufis, Κonstantinos; Pocock, Stuart J.; Dimitriadis, Kyriakos; Choi, James W.; East, Cara; D’Souza, Richard; Sharp, Andrew; Ewen, Sebastian; Walton, Antony; Hopper, Ingrid; Brar, Sandeep; McKenna, Pamela; Fahy, Martin; Böhm, Michael

doi:10.1016/s0140-6736(22)00455-x

“…The American College of Cardiology Annual Meeting (ACC2022) published the results of the 3-year long-term follow-up of the SPYRAL HTN-ON MED study [ 2 , 3 ]. The study analyzed blood pressure changes, antihypertensive medication use, and safety in patients in the denervation sympathectomy group compared with the sham-operated group.…”

Section: Introductionmentioning

confidence: 99%

Renal Denervation Reduces Blood Pressure and Improves Cardiac Function: Results from a 12-Month Study

Luo

¹

,

Lu

²

2022

BioMed Research International

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Background. Previous studies showed that a decline in BP can reverse pressure-overloaded left ventricular hypertrophy in the long term. Whether this structural remodeling and improved cardiac function were due to reduced BP levels or sympathetic tone is unclear. The aim of this study was to evaluate the efficacy of renal denervation (RDN) on cardiac function and left ventricular hypertrophy in patients diagnosed with resistant hypertension with systolic and diastolic dysfunction. Methods. Thirteen patients diagnosed with resistant hypertension underwent bilateral RDN (RDN group), and 13 patients were selected as the control group (drug group) who received regular antihypertensive drugs for the first time. Demographic analysis and hematologic tests were performed to determine renal function as well as BNP levels. Echocardiogram was performed at baseline and 12 months after RDN. Results. All the baseline characteristics are comparable in two groups. Both RDN and drug regiments resulted in significant reduction from baseline in SBP/DBP at 12-month follow-up (all P values < 0.01), and the decline due to two interventions showed no statistically significant difference ( F = 1.64 , P = 0.213 and F = 0.124 , P = 0.853 for SBP and DBP, respectively). RDN significantly reduced mean LV mass index (LVMI) from 151.43 ± 46.91 g/m2 to 136.02 ± 37.76 g/m2 ( P = 0.038 ) and ejection fraction (LVEF) increased from 57.15 ± 5.49 % at baseline to 59.54 ± 4.18 % at 12 months ( P = 0.039 ). No similar changes were detected in the drug group ( P values, 0.90 for EF and 0.38 for LVMI). Renal parameters including BUN, Cr, UA, and eGFR at baseline, 3 months, and 12 months showed no marked difference ( P = 0.497 , 0.223 , 0.862 , 0.075 , respectively). Conclusions. Our findings show that in addition to hypertension and its progression, elevated sympathetic hyperactivity is related to left ventricular hypertrophy and cardiac function.

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“…However, it should be recognized that our study has certain signifi cant limitations, which should be considered, when assessing the results. Firstly, based on the design, there was no sham intervention group (sham-control), as well as randomization procedure that was adopted in the recent published studies (11,12,15). Also, very important is the fact that the fi nal analysis refl ected the results of offi ce BP measurement only, the indicators of daily BP monitoring were not available at each stage of the analysis.…”

Section: Discussionmentioning

confidence: 99%

“…Also, very important is the fact that the fi nal analysis refl ected the results of offi ce BP measurement only, the indicators of daily BP monitoring were not available at each stage of the analysis. Although Korotkoff blood pressure measurement is the gold standard, in modern studies, the main endpoint of effectiveness was the mean daily BP (12,15).…”

Section: Discussionmentioning

confidence: 99%

Renal denervation in resistant hypertension treatment

OREKHOV¹,

SABITOV²,

KARAZHANOVA³

2022

BLL

1

0

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BACKGROUND AND OBJECTIVES: Purpose of the study is the assessment of the effectiveness of renal denervation with different types of catheters, as well as its long-term effects, in the patients with resistant hypertension. MATERIALS AND METHODS: This single-center prospective study included 81 patients who underwent a renal denervation procedure using 2 types of catheters: monopolar and helical (Medtronic Inc., Minneapolis, Minnesota, the USA) between 2015 and 2018. Baseline demographics, clinical, functional and laboratory characteristics of the patients were assessed. A comparative analysis of the dynamics of offi ce systolic and diastolic blood pressure during 5 years of follow-up was carried out. The Kaplan-Meier method was used to study the survival of the patients with resistant hypertension after renal denervation. RESULTS: A total of 81 patients with a mean age of 57.79 ± 9.87 years, of whom 37.04 % were men, were included in the 2-stage study (fi rst stage using monopolar catheters and second stage using spiral catheters). At the time of inclusion, study participants were receiving an average of 4.5 ± 1.4 antihypertensive medications. In 36 (or 44.4 %), the procedure was performed using a monopolar catheter; in 45 (or 55.6 %), a spiral catheter was used. There were no statistically signifi cant differences between the two groups of the patients. The analysis established statistically signifi cant changes in the dynamics of offi ce SBP and DBP (p < 0.001) assessed 1, 2, 3, 4, and 5 years after the renal denervation procedure. The analysis demonstrated a stability in the reduction of offi ce SBP and DBP during the 5-year follow-up. The results of the study showed that the median survival time was 1061 days from the beginning of follow-up (95% CI: 728.03 to 1 393.97 days); the median survival time in the monopolar catheter group was 777 days (95% CI: 692.314 to 861.686) and in the spiral catheter group 1 294 days (95% CI: 713.079 to 1 874.921). FINDINGS: Our results demonstrated the effi ciency and safety of renal denervation in both short-term and long-term follow-up using monopolar and spiral catheters in the treatment of uncontrolled hypertension with combined antihypertensive therapy. The most signifi cant is the demonstrated stability of the effect after the procedure. In addition, the survival rate of the patients with resistant hypertension after the intervention has been carried out (Tab. 2, Fig. 3, Ref. 22).

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“…A statistically significant 7.4 mmHg drop in 24-hour ABPM and a 6.8 mmHg drop in office systolic BP, in favour of RDN was seen [ 45 ]. Since then the long-term efficacy and safety of this proof-of-concept study results reported that the initial BP reductions seen at 6 months was even greater and sustained as at 36 months; the ambulatory systolic blood pressure reduction was—18·7 mmHg (SD 12·4) for the renal denervation group ( n = 30) and –8·6 mmHg (14·6) for the sham control group ( n = 32); adjusted treatment difference was –10·0 mmHg, 95% CI –16·6 to –3·3; ( p = 0·0039) and there were no short-term or long-term safety issues associated with renal denervation [ 16 ]…”

Section: Factors That May Influence Diagnosis Of Resistant Hypertensionmentioning

confidence: 99%

2022 Malaysian Working Group Consensus Statement on Renal Denervation for management of arterial hypertension

Chia

¹

,

Ahmad

²

,

Fong

³

et al. 2022

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Hypertension is highly prevalent and a major contributor to cardiovascular mortality and morbidity. In spite of the availability of efficacious, safe and affordable anti-hypertensive drugs, hypertension remains poorly controlled in the majority of hypertensive patients. Various reasons including non-adherence to the anti-hypertensive drugs, account for the poor control. Resistant hypertension is also one of the reasons for poor control of blood pressure (BP). The sympathetic nervous system (SNS) has long been recognized as one of the determinants in the pathophysiology of a raised BP. Overactivity of the SNS is a contributor to sustained arterial hypertension. Renal denervation (RDN) is increasingly recognized as a safe and effective adjunctive therapy to control BP with or without pharmacotherapy. Hence for patients who remain uncontrolled despite all efforts, renal denervation (RDN) is a novel treatment that can potentially improve BP control, hence reducing the major adverse cardiovascular events (MACE). More recent randomized, sham control trials of RDN have shown that RDN produces a sustained lowering of BP. To date, this lowering of BP through RDN is maintained for at least 3 years. Furthermore, this procedure has been found to be safe. Hence this consensus summarises the science behind RDN and the available clinical data to support the use of this therapy. It is hoped that this consensus will offer guidance on the importance of identifying patients who will benefit most from this therapy. A multidisciplinary team approach in the management of the patient undergoing RDN is recommended.

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Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial

Cited by 124 publications

References 37 publications

Renal Denervation Reduces Blood Pressure and Improves Cardiac Function: Results from a 12-Month Study

Renal Denervation Reduces Blood Pressure and Improves Cardiac Function: Results from a 12-Month Study

Renal denervation in resistant hypertension treatment

2022 Malaysian Working Group Consensus Statement on Renal Denervation for management of arterial hypertension

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