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
- Hypertension and CVD: New insights
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
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
CKD | No CKD | |||||||
GSR-observed (36M) | Calculated RR | Calculated control (BL oSBP) | Calculated NNT | GSR-observed (36M) | Calculated RR | Calculated control (BL oSBP) | Calculated NNT | |
Death | 10.0% | 0.93 | 10.8% | 135 | 4.0% | 0.92 | 4.3% | 298 |
CV death | 5.2% | 0.87 | 5.9% | 131 | 2.2% | 0.83 | 2.6% | 229 |
MI | 3.4% | 0.82 | 4.2% | 130 | 2.3% | 0.78 | 2.9% | 160 |
Stroke | 6.1% | 0.71 | 8.6% | 40 | 4.0% | 0.65 | 6.2% | 46 |
New-onset ESRD | 6.4% | 0.92 | 6.9% | 185 | 0.2% | 0.91 | 0.3% | 4,170 |
MACE | 14.7% | 0.79 | 18.8% | 25 | 8.4% | 0.72 | 11.7% | 31 |
BL: baseline; 36M: 36 months
Funding
- Commercial Support –