Long-term efficacy and safety of renal denervation: an update from registries and randomised trials

Figures & data

Table 1. Long-term BP reducing effects of RDN in registries, single centre series and RCTs.

Study	Device	Design	Follow-up Size (at 36 months)	Efficacy	Safety
Global SYMPLICITY Registry^5	Symplicity (RF)	Registry	1732	Baseline systolic OBP were 166 ± 25 mmHg Baseline systolic ABPM was 154 ± 18 mmHg SBP reduction after RDN was sustained over 3 years, including decreases: in systolic OBP (-16.5 ± 28.6 mmHg, p < 0.001) and in systolic ABPM (-8.0 ± 20.0 mmHg; p < 0.001)	eGFR declined: by 7.1 in patients without CKD by 3.7 in patients with CKD No long-term safety concerns were observed following the RDN procedure.
Sesa-Ashton et al^6	RF	Cohort	66 (at 8.8 ± 1.2 years post-procedure)	Systolic ABPM reduced by −12.1 ± 21.6 (from 145.2 to 133.1) mmHg (p < 0.0001)Diastolic ABPM reduce by −8.8 ± 12.8 (from 81.2 to 72.7) mmHg (p < 0.0001)Mean HR unchangedAt follow-up, participants were on one less AHM compared with baseline (P = 0.0052).	No short-term or long-term AEs associated with RDN
AFFORD^7	St. JudeEnligHTN™ system (RF)	Single-arm Pilot study (RDN in AF)	20	At baseline, mean ABPM was 129.5/77.3 ± 15.5/9.3 mmHgMean systolic ABPM decreased with − 2.2 (95% CI − 3.9, − 0.6; p = 0.01) mmHg/yearNumber of AHM remained stable over time Baseline daily AF burden was 1.4 [0.0-10.9] minutes/day and throughout a 3-year follow-up period, no significant change was observed	No short-term or long-term AEs associated with RDN
Al Ghorani et al^8	RDN (RF)	Single-armSingle-centre study	39 (10 years follow-up)	Systolic ABPM decreased by −16.2 mmHg (p< 0.001)Diastolic ABPM decreased by - −5.5 mmHg (p < 0.027) Mean number of AHM remained stable	No short-term or long-term AEs associated with RDN
SPYRAL HTN-ON MED^9	Symplicity Spyral (RF)	RCTRDN vs sham (1:1)	62RDN 30 sham 32	Systolic ABPM reduction was −18.7 mm Hg (SD 12.4) for the RDN group (n = 30) vs −8.6 mm Hg (14.6) for the sham control group (n = 32) Treatment differences between the RDN and sham were: −5·9 mm Hg (95% CI −10·1 to −1·8; p = 0·0055) for mean diastolic ABPM −11·0 mm Hg (-19·8 to −2·1; p = 0·016) for morning systolic ABPM −11·8 mm Hg (-19·0 to −4·7; p = 0·0017) for night-time systolic ABPM	No short-term or long-term AEs associated with RDN
RADIANCE-HTN SOLO^10	Paradise(US)	RCTRDN vs sham (1:1)	RDN 51 (out of 74 originally assigned)	OBP decreased by 18/11 ± 15/9 mmHgBP control improved significantly from 29.4% at screening to 45.1% (p = 0.059)No difference in the overall AHM between baseline and follow-up	No short-term or long-term AEs associated with RDN

ABPM: Ambulatory blood pressure monitoring, AF: Atrial fibrillation, AHM: Antihypertensive medication,CKD: Chronic kidney disease (defined as eGFR < 60 mL/min/1.73 m²) , eGFR: estimated glomerural filtration rate l OBP: Office blood pressure, HR: Heart rate, RDN: Renal denervation, RCT: Randomised controlled trial, RF: Radiofrequency, US: Ultrasound.

Figure 1. Long-term safety and efficacy of renal denervation.