Clin Res Cardiol (2021)
DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Clinical Event Reductions in High-Risk Hypertension Patients treated with Renal Denervation: A Model-based Estimate based on 36-Month Data from the Global Symplicity Registry
R. Schmieder1, J. Pietzsch2, F. Mahfoud3, B. Williams4, G. Mancia5, K. Narkiewicz6, L. Ruilope7, M. Schlaich8, M. Böhm3
1University Hospital Erlangen, Erlangen; 2Wing Tech, Inc., Menlo Park, CA, US; 3Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar; 4University College London, London, UK; 5University of Milano-Bicocca, Milano, IT; 6Medical University of Gdansk, Gdansk, PL; 7Universidad Europea de Madrid, Madrid, ES; 8The University of Western Australia, Perth, AU;

Background: 

Renal denervation (RDN) has been shown to lower systolic blood pressure (SBP) in multiple recent sham-controlled trials of patients with uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. We estimated potential clinical event reductions with RDN treatment based on recently reported 3-year follow-up from the Global Symplicity Registry (GSR). 

Methods:

Resistant hypertension (RH) and type 2 diabetes mellitus (T2DM) subcohorts of the GSR were comprised of n = 1,274 and n = 1,007 subjects at aged 61 ± 12 and 64 ± 10 years, respectively. Changes in SBP from baseline were averaged from the reductions reported at 6, 12, 24, and 36 months follow-up. First, relative risks (RR) for death, CV death, myocardial infarction (MI), stroke, and new-onset end-stage renal disease (ESRD) were obtained for these average blood pressure reductions from a meta-regression analysis of randomized trials investigating blood pressure lowering in hypertensive patients (Thomopoulos et al, J Hypertens. 2014 Dec; 32 (12): 2285-95).Second, clinical event estimates for maintained baseline SBP from the GSR-reported clinical endpoints at 36 months and the obtained relative risks were calculated,

Results: 

Average baseline SBP and SBP reduction estimates for the RH and T2DM subcohorts were 175.4 ± 19.8; -21.6 and 165.4 ± 22.6; -14.8 mmHg, respectively. Relative risks ranged from 0.58 for stroke in the RH cohort to 0.92 for death in the T2DM cohort. Over the three-year horizon, the calculated absolute reduction in MACE events was 5.2% and 3.8%, for the RH and T2DM cohorts, resulting in NNTs of 19 and 27, respectively (Table). 

 

 

RH

T2DM

GSR-observed (36M)

Calculated

RR

Calculated control (BL SBP)

Calculated NNT

GSR-observed (36M)

Calculated RR

Calculated control (BL SBP)

Calculated NNT

Death

5.7%

0.91

6.3%

181

7.1%

0.92

7.7%

172

CV death

2.8%

0.78

3.6%

128

4.0%

0.84

4.8%

130

MI

2.3%

0.74

3.1%

121

3.5%

0.79

4.5%

105

Stroke

4.8%

0.58

8.4%

28

4.0%

0.66

6.1%

49

New-onset ESRD

1.9%

0.89

2.1%

426

2.8%

0.91

3.1%

363

MACE (calculated)

9.9%

0.66

15.1%

19th

11.5%

0.75

15.3%

27

Analysis limitations include reliance on data from a single-arm registry with assumed maintained baseline SBP for untreated subjects, and reliance on relative risk estimates derived from a published meta-regression.

Conclusion

Model-based clinical event projections provide a directional estimate of the potential events avoided and the range of NNTs in the short-term through 3 years of follow-up. Such short-term data might provide useful orientation for clinicians and policymakers interested in extrapolating the potential clinical and economic implications of renal denervation treatment over longer-term horizons.
https://dgk.org/kongress_programme/jt2021/aP1069.html