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February 6, 2026European Heart Journal0 citations

Long-term outcomes after renal denervation in the two defined ESC guideline-recommended patient groups: an analysis from the Global SYMPLICITY Registry DEFINE

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FMF MahfoudMSM SchlaichRSR E Schmieder

Key Result

Radiofrequency renal denervation significantly reduced office systolic blood pressure at 3 years in both ESC guideline-recommended groups (-20.6 mmHg in group 1 and -18.8 mmHg in group 2, p<0.0001).

Key Points

  • The study aims to compare the 3-year outcomes of renal denervation in two patient groups with hypertension as defined by ESC guidelines.
  • Categorized patients into two groups based on ESC guidelines: resistant hypertension on ≥3 antihypertensive drugs (group 1) and hypertension on <3 antihypertensive drugs (group 2).
  • Evaluated office BP, 24-h ambulatory BP, medications, and adverse events over a 3-year follow-up.
  • Compared baseline characteristics and adverse events between the two patient groups.
  • Both groups showed significant reductions in office systolic BP after 3 years: -20.6±26.8 mmHg in group 1 and -18.8±29.1 mmHg in group 2 (p<0.0001).
  • Group 1 maintained a similar antihypertensive regimen, while group 2 saw an increase in antihypertensive medication use after 3 years (from 1.6±0.6 to 2.4±1.4).
  • Higher rates of all-cause death, stroke, and new end-stage renal disease were observed in group 2 compared to group 1.

Study Design

Type

Observational (n=2,884)

Multicenter

Yes

Structured PICO

Does radiofrequency renal denervation reduce blood pressure similarly in the two ESC guideline-recommended hypertensive patient groups?

P
Population
2,884 hypertensive patients undergoing radiofrequency renal denervation, categorized by ESC guideline recommendations (resistant HTN on ≥3 drugs vs HTN on <3 drugs with increased CVD risk), followed for 3 years.
E
Exposure
Radiofrequency (RF) renal denervation (RDN)
C
Comparator
Comparison between two ESC guideline-defined groups (Group 1: resistant HTN on ≥3 AH drugs vs Group 2: HTN on <3 AH drugs)
O
Outcome
Change in office systolic BP, 24-h ambulatory BP, medications, and adverse events at 3 yearssurrogate

Radiofrequency renal denervation provides significant and sustained 3-year blood pressure reductions in both ESC guideline-recommended patient groups.

Main Result

Absolute Event Rate: -20.6% vs -18.8%

p-value: p=<0.0001

Abstract

Abstract Background/Introduction Recent ESC guidelines recommend that renal denervation (RDN) should be considered in two groups of hypertensive (HTN) patients: 1) patients with an elevated office systolic or diastolic blood pressure (BP) ≥140/90 mmHg using 3 or more antihypertensive (AH) medications and any cardiovascular disease (CVD) risk or 2) patients with an elevated BP on 3 AH medications and increased CVD risk. The Global SYMPLICITY Registry (GSR) DEFINE is the largest study of its kind evaluating the safety and efficacy of radiofrequency (RF) RDN in a real-world setting. Purpose To compare the 3-year outcomes of RF RDN in the 2 ESC guideline-defined patient groups. Methods Patients were categorized into 2 groups based on the ESC guideline recommendations: 2703 with resistant HTN on ≥3 AH drugs and with any CVD risk (group 1) and 181 with HTN on 3 AH drugs and increase CVD risk (group 2). Office BP, 24-h ambulatory BP, medications, and adverse events were compared between groups at each follow-up. Results Differences in baseline characteristics and 3 year adverse events are shown below. There was no difference in CV death between groups, but rates of all-cause death, stroke and new end stage renal disease were higher in group 2. At 3 years, both groups had similar significant reductions in office systolic BP (p0.0001 for both): -20.6±26.8 mmHg in group 1 and -18.8±29.1 mmHg in group 2. Changes in 24h SBP were -9.6±20.9 and -5.6±18.1 mmHg in groups 1 and 2, respectively. AH medication use increased over time in group 2 (from 1.6±0.6 to 2.4±1.4 at 3y) but was similar in group 1 (from 4.9±1.3 to 4.7±1.6 at 3y). Conclusions RF RDN significantly reduced systolic BP in both ESC-guideline recommended patient groups. Further studies are warranted to understand the impact of RDN on CVD events in patient with uncontrolled HTN and increased CVD risk.Characteristics and 3 year AEs

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Cite This Study

Mahfoud et al. (2025) conducted an observational in Hypertension (n=2,884). Radiofrequency renal denervation in ESC group 1 (resistant HTN on ≥3 drugs) vs. ESC group 2 (HTN on <3 drugs) was evaluated on Change in office systolic blood pressure at 3 years (p=<0.0001). Radiofrequency renal denervation significantly reduced office systolic blood pressure at 3 years in both ESC guideline-recommended groups (-20.6 mmHg in group 1 and -18.8 mmHg in group 2, p<0.0001).

synapsesocial.com/papers/6985852f8f7c464f2300858dhttps://doi.org/10.1093/eurheartj/ehaf784.3406
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1THREE-YEAR OUTCOMES OF RADIOFREQUENCY RENAL DENERVATION IN PATIENTS WITH HYPERTENSION-MEDIATED ORGAN DAMAGE: INSIGHTS FROM THE GLOBAL SYMPLICITY REGISTRY DEFINE2026
  2. 2Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension2015 · 82 citations
  3. 3Long-term effects of renal denervation on hypertension management: insights from an ESH center of excellence and a meta-analysis of current evidence2025
  4. 4Long-term effects of renal denervation on hypertension management: insights from an ESH center of excellence and a meta-analysis of current evidence2025 · 3 citations
  5. 5Long-term safety and efficacy of renal sympathetic denervation in comparison to a population-based cohort: a propensity-matching approach2025