Abstract

JACC

Lots of interesting abstracts and cases were submitted for TCTAP 2022. Below are the accepted ones after a thorough review by our official reviewers. Don’t miss the opportunity to expand your knowledge and interact with authors as well as virtual participants by sharing your opinion in the comment section!

TCTAP A-048

Reduction of Clinical Events in High-Risk Hypertension Patients Treated With Renal Denervation: A Modeled Estimate From 36-Month Global SYMPLICTY Registry Data

By Markus Schlaich, Jan Benjamin Pietzsch, Felix Mahfoud, Bryan Wiliams, Giuseppe Mancia, Krzystzof Narkiewicz, Luis Ruilope, Doug Hettrick, Michael Böhm, Roland E. Schmieder

Presenter

Markus Schlaich

Authors

Markus Schlaich1, Jan Benjamin Pietzsch2, Felix Mahfoud3, Bryan Wiliams4, Giuseppe Mancia5, Krzystzof Narkiewicz6, Luis Ruilope7, Doug Hettrick8, Michael Böhm3, Roland E. Schmieder9

Affiliation

University of Western Australia Medical School, Australia1, Wing Tech, USA2, Saarland University Hospital, Germany3, UCL Institute of Cardiovascular Science, United Kingdom4, University of Milano-Bicocca and Policlinico di Monza, Italy5, Medical University of Gdansk, Poland6, University Hospital October 12/ CIBERCV, Spain7, Medtronic, USA8, University Hospital Erlangen, Germany9
View Study Report
TCTAP A-048
Hypertension Therapies and Renal Denervation

Reduction of Clinical Events in High-Risk Hypertension Patients Treated With Renal Denervation: A Modeled Estimate From 36-Month Global SYMPLICTY Registry Data

Markus Schlaich1, Jan Benjamin Pietzsch2, Felix Mahfoud3, Bryan Wiliams4, Giuseppe Mancia5, Krzystzof Narkiewicz6, Luis Ruilope7, Doug Hettrick8, Michael Böhm3, Roland E. Schmieder9

University of Western Australia Medical School, Australia1, Wing Tech, USA2, Saarland University Hospital, Germany3, UCL Institute of Cardiovascular Science, United Kingdom4, University of Milano-Bicocca and Policlinico di Monza, Italy5, Medical University of Gdansk, Poland6, University Hospital October 12/ CIBERCV, Spain7, Medtronic, USA8, University Hospital Erlangen, Germany9

Background

The Global SYMPLICTY Registry (GSR) is a prospective, all-comer registry designed to assess the long-term safety and efficacy of renal denervation (RDN) as an interventional procedure to control hypertension in a real world population. The lack of a direct comparative control group within GSR makes interpretation of the impact of RDN on long term events challenging. GSR data through 36-months is used to inform a mathematical model to estimate the reduction of clinical events following RDN.

Methods

Registry-reported changes in systolic blood pressure (SBP) were averaged from baseline to 6, 12, 24, and 36 month follow-up. The numbers needed to treat (NNT) and the relative risk (RR) for death, cardiovascular death, myocardial infarction, stroke, and new-onset end-stage renal disease were calculated for the full GSR cohort and certain high-risk subgroups including patients with resistant hypertension (RH) and type 2 diabetes (T2DM) using a previously published meta-regression analysis of hypertensive patient SBP changes from randomized trials. Estimates for number of clinical events assuming maintained baseline SBP were compared with the GSR-reported clinical outcomes to project the absolute reduction in clinical events over 36 months and the NNT for individual endpoints.

Results

The average baseline office SBP (OSBP) of the full GSR cohort (N=2,651) was 166±25 mmHg, with a reduction estimate of 14.8 mmHg. RH and T2DM patient subgroup OSBPs were 175.4±19.8 mmHg and 165.4±22.6 mmHg, respectively. The estimated OSBP reduction for RH and T2DM subgroups were 21.5mmHg and 14.7 mmHg, respectively. RRs ranged from 0.58 for stroke in the RH group to 0.92 for death in the T2DM group. RH and T2DM sub-groups were calculated to have an absolute reduction in major adverse cardiac events of 4.5% and 3.7%over three years, respectively, resulting in NNTs of 22 and 27 (Table).
  Resistant Hypertension (RH) Type-II Diabetes Mellitus (T2DM)
  Global Symplicity Registry Observed (36M) Calculated RR Calculated control (Baseline OSBP) Calculated NNT Global Symplicity Registry Observed (36 M) Calculated RR Calculated control (Baseline OSBP) Calculated NNT
Death 5.7% 0.91 6.3% 181 7.1% 0.92 7.7% 172
Cardiovascular 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 end-stage renal disease 1.9% 0.89 2.1% 426 2.8% 0.91 3.1% 363
Major adverse cardiac events (calculated) 8.7% 0.66 13.2% 22 10.4% 0.74 14.0% 27

Conclusion

Model-based projections using GSR data following RDN estimate the number of potential clinical events avoided and the range of NNTs through 3 years across the full cohort and a spectrum of subgroups with different baseline characteristics. 

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