ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: PO1762

Clinical Event Reductions in Hypertension Patients with and Without CKD Treated with Renal Denervation: A Model-Based Estimate Based on Data from the Global SYMPLICITY Registry

Session Information

Category: Hypertension and CVD

  • 1401 Hypertension and CVD: Epidemiology, Risk Factors, and Prevention

Authors

  • Schmieder, Roland E., Universitatsklinikum Erlangen, Erlangen, Bayern, Germany
  • Mahfoud, Felix, Universitat des Saarlandes, Saarbrucken, Saarland, Germany
  • Williams, Bryan, University College London, London, London, United Kingdom
  • Mancia, Giuseppe, Universita degli Studi di Milano-Bicocca, Milano, Lombardia, Italy
  • Narkiewicz, Krzysztof, Gdanski Uniwersytet Medyczny, Gdansk, Poland
  • Ruilope, Luis M., Facultad de Ciencias Medicas 10 de Octubre, La Habana, La Habana, Cuba
  • Schlaich, Markus P., The University of Western Australia, Perth, Western Australia, Australia
  • Böhm, Michael, Universitat des Saarlandes, Saarbrucken, Saarland, Germany
  • Pietzsch, Jan B., Wing Tech, Inc., Menlo Park, California, United States
Background

Estimates of clinical event reductions following renal denervation (RDN) were modelled for patients with and without chronic kidney disease (CKD) based on 3-year follow-up data from the Global SYMPLICITY Registry (GSR).

Methods

CKD (eGFR<60 ml/min/1.73m2; n=630) and No CKD (eGFR ≥60 ml/min/1.73m2; n=1,860) cohorts of the GSR were analyzed. Reductions in office systolic blood pressure (oSBP) at 6, 12, 24, and 36 months follow-up were averaged and relative risks (RR) for death, cardiovascular (CV) death, myocardial infarction (MI), stroke, and new-onset end-stage renal disease (ESRD) were obtained from published meta-regression analysis of randomized trials of blood pressure lowering in hypertensive patients. Using the derived RRs, clinical event estimates for maintained baseline oSBP were calculated, facilitating estimation of 36-month absolute event reductions and resulting numbers needed to treat (NNT) for the individual endpoints.

Results

Baseline oSBP and oSBP reductions for the CKD and No CKD cohorts were 163.6 ± 25.7; -11.1 and 166.7 ± 24.6; -15.5 mmHg, respectively. RR ranged from 0.65 for stroke in the No CKD cohort to 0.93 for death in the CKD cohort. There was a numerically higher absolute reduction in major adverse cardiac events (MACE: composite of CV death, MI and stroke) within 3 years of RDN treatment in the CKD vs. No CKD patients (4.0% vs. 3.2%, p=0.12), in part due to higher overall 3-year MACE rates observed in CKD patients (18.8% vs. 11.7%, p<0.001) (Table).

Conclusion

Model-based projections provide a directional estimate of the potential clinical events avoided following RDN treatment and suggest clinically meaningful risk reduction in patients with and without CKD.

Observed and projected events for the CKD and No CKD cohorts
 CKDNo CKD
GSR-observed (36M)Calculated RRCalculated control (BL oSBP)Calculated NNTGSR-observed (36M)Calculated RRCalculated control (BL oSBP)Calculated NNT
Death10.0%0.9310.8%1354.0%0.924.3%298
CV death5.2%0.875.9%1312.2%0.832.6%229
MI3.4%0.824.2%1302.3%0.782.9%160
Stroke6.1%0.718.6%404.0%0.656.2%46
New-onset ESRD6.4%0.926.9%1850.2%0.910.3%4,170
MACE14.7%0.7918.8%258.4%0.7211.7%31

BL: baseline; 36M: 36 months

Funding

  • Commercial Support