Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Böhm, Michael; Mahfoud, Felix; Townsend, Raymond R.; Weber, Michael A.; Pocock, Stuart J.; Tsioufis, Κonstantinos; Tousoulis, Dimitrios; Choi, James W.; East, Cara; Brar, Sandeep; Cohen, Sidney A.; Fahy, Martin; Pilcher, Garrett; Kario, Kazuomi; Aoki, Jiro; Batson, Bryan; Cohen, Debbie L.; Dangas, George; David, Shukri; Davies, Justin E.; Devireddy, Chandan; Kandzari, David E.; Lee, David P.; Lurz, Philipp; Papademetriou, Vasilios; Patel, Manesh R.; Patel, Kiritkumar; Schmieder, Roland E.; Sharp, Andrew; Singh, Jasvindar; Walton, Antony; Weber, Thomas; Weil, Joachim; Zeller, Thomas; Ziada, Khaled M.; Tanabe, Kengo; Wilkins, Robert B.; Wilensky, Robert L.; Contreras, Johanna; Steigerwalt, Susan; Chapman, Neil; Lea, Janice P.; Reedus, Denise; Hoshide, Satoshi; Ma, Adrian; Fengler, Karl; Li, Ping; Svetkey, Laura P.; Rao, Anjani; Schmid, Axel; Watkinson, Anthony; Brown, Angela L.; Hopper, Ingrid; Suppan, Markus; Agdirlioglu, Tolga; Noory, Elias; Chasen, Craig

doi:10.1016/s0140-6736(18)30951-6

Cited by 638 publications

(551 citation statements)

References 38 publications

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“…The average number of ablations per patient varied from 14 to 45.9 among clinical studies which investigated the effect of branch treatment . Even considering the variation in clinical studies, the number of ablations seems to be smaller in the present study (14.5–17.5) compared with the clinical studies.…”

Section: Discussioncontrasting

confidence: 57%

“…Importantly, a recent anatomical study showed that the renal sympathetic nerve fibers are distributed closer to the lumen in branch renal arteries (RAs) compared with the main RA, suggesting that RDN that includes the branch RA may ablate more sympathetic nerves than RDN on the main RA alone . This hypothesis was supported in recent animal and clinical studies including the blinded, randomized, sham‐controlled SPYRAL HTN‐OFF MED and ON MED trials . Direct comparison studies in animals and humans clearly confirmed greater efficacy in RDN on both branch and main RA compared with RDN on main RA alone .…”

Section: Introductionmentioning

confidence: 74%

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Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Sakaoka

Rousselle²,

Hagiwara

et al. 2018

Cathet Cardio Intervent

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Objectives We aimed to investigate the safety of radiofrequency (RF)‐renal denervation (RDN) on branch renal arteries (RAs) in a porcine model. Background The efficacy of RF‐RDN was enhanced by treatment of the branch RA, in addition to the main RA. However, there are concerns regarding the safety of RF‐RDN on branch RA because of their smaller diameter and proximity to the kidney. Methods RF was delivered to 24 RA from 12 swine. A total of 8 RA from 4 swine were untreated. Treated RA were examined by angiography and histopathology at 7, 30, and 90 days. Serum creatinine concentration, biophysical parameters during RF delivery, and renal norepinephrine concentration were also assessed. Results Angiography revealed minimal late lumen loss and diameter stenosis in the main and branch RA at any time point. There was no change in serum creatinine after RF‐RDN. Histopathologically, no augmentation of medial damage or neointimal formation was found in branch RA compared with main RA. No or minimal damage to surrounding tissues including the kidneys, ureters, lymph nodes, and muscles was observed at any time point in both the main and branch RA. Equivalent electrode temperature in the main and branch RA was achieved by automatic adjustment of output power by the generator. The renal norepinephrine concentration was significantly lower in the treated group compared with the untreated group. Conclusions RF‐RDN on branch RA was safe in a porcine model, with stenosis‐free healing of treated arteries and negligible kidney damage at 7, 30, and 90 days.

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Section: Discussioncontrasting

confidence: 57%

Section: Introductionmentioning

confidence: 74%

Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Sakaoka

Rousselle²,

Hagiwara

et al. 2018

Cathet Cardio Intervent

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“…Since the first description of the novel technique, numerous studies including randomized and observational trials have demonstrated that catheter‐based RDN resulted in substantial reduction in BP in patients with resistant hypertension . Most recently, three multicenter, randomized, sham‐controlled studies using new generation of RDN device continue to show cogent evidence of significant BP reduction in patients with uncontrolled hypertension …”

Section: Discussionmentioning

confidence: 99%

Synergy of pulmonary vein isolation and catheter renal denervation in atrial fibrillation complicated with uncontrolled hypertension: Mapping the renal sympathetic nerve and pulmonary vein (the pulmonary vein isolation plus renal denervation strategy)?

Chen

Kiuchi

Yin

et al. 2019

Cardiovasc electrophysiol

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Introduction Disturbance of sympathetic and vagal nervous system participates in the pathogenesis of hypertension and atrial fibrillation (AF). Renal denervation (RDN) can modulate autonomic nervous activity and reduce blood pressure (BP) in hypertensive patients. We aimed to evaluate the effect of RDN combined with pulmonary vein isolation (PVI) in patients with AF and hypertension. Methods Clinical trials including randomized data comparing PVI plus RDN vs PVI alone were enrolled. Primary outcome was incidence of AF recurrence after procedure. Results A total of 387 patients, of them 252 were randomized and were enrolled. Mean age was 57 ± 10 years, 71% were male, and mean left ventricular ejection fraction was 57.4% ± 6.9%. Follow‐up for randomized data was 12 months. Overall comparison for primary outcome showed that PVI + RDN was associated with significantly lower AF recurrence as compared with PVI alone (35.8% vs 55.4%, P < 0.0001). This advantageous effect was consistently maintained among randomized patients (37.3% vs 61.9%, odds ratio = 0.37, P = 0.0001), and among patients with implanted devices for detection of AF recurrence (38.9% vs 61.6%, P = 0.007). Post‐hoc sensitivity and regression analysis demonstrated very good stability of this primary result. Pooled Kaplan‐Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log‐rank test, P = 0.001). Besides, RDN resulted in significant BP reduction without additionally increasing the risk of adverse events. Conclusions RDN may provide synergetic effects with PVI to reduce the burden of AF and improve BP control in patients with AF and uncontrolled hypertension.

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“…However, the two groups were matched in all baseline characteristics. In addition, the sham effect was absent in recently published sham‐controlled trials including the SPYRAL HTN and RADIANCE‐HTN SOLO . Second, no assessment of ambulatory BP at baseline and at follow‐ups was carried out, which could lead to inclusion of patients with pseudoresistance and whitecoat syndrome.…”

Section: Limitationmentioning

confidence: 99%

Comparison of two different radiofrequency ablation systems for renal artery denervation: Evaluation of short‐term and long‐term follow up

Raisi

Pouliopoulos

Qian

et al. 2018

Cathet Cardio Intervent

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Objectives To assess the clinical efficacy of renal artery denervation (RAD) in our center and to compare the efficacy of two different radiofrequency (RF) systems. Background Several systems are available for RF renal denervation. Whether there is a difference in clinical efficacy among various systems remains unknown. Methods Renal artery denervation was performed on 43 patients with resistant hypertension using either the single electrode Symplicity Flex (n = 20) or the multi‐electrode EnligHTN system (n = 23). Median post‐procedural follow‐up was 32.93 months. The primary outcome was post‐procedural change in office blood pressure (BP) within 1 year (short‐term follow‐up). Secondary outcomes were change in office BP between 1 and 4 years (long‐term follow‐up) and the difference in office BP reduction between the two systems at each follow‐up period. Results For the total cohort, mean baseline office BP (systolic/diastolic) was 174/94 mmHg. At follow‐up, mean changes in office BP from baseline were −19.70/−11.86 mmHg ( P < 0.001) and −21.90/−13.94 mmHg ( P < 0.001) for short‐term and long‐term follow‐up, respectively. The differences in office BP reduction between Symplicity and EnligHTN groups were 8.96/1.23 mmHg ( P = 0.42 for systolic BP, P = 0.83 for diastolic BP) and 9.56/7.68 mmHg ( P = 0.14 for systolic BP, P = 0.07 for diastolic BP) for short‐term and long‐term follow‐up, respectively. Conclusions In our cohort, there was a clinically significant office BP reduction after RAD, which persisted up to 4 years. No significant difference in office BP reduction between the two systems was found.

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Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Abstract: Medtronic.

Cited by 638 publications

References 38 publications

Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Synergy of pulmonary vein isolation and catheter renal denervation in atrial fibrillation complicated with uncontrolled hypertension: Mapping the renal sympathetic nerve and pulmonary vein (the pulmonary vein isolation plus renal denervation strategy)?

Comparison of two different radiofrequency ablation systems for renal artery denervation: Evaluation of short‐term and long‐term follow up

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