A-33 | Clinical Event Reductions in Younger Vs. OLDER Hypertension Patients treated with Radiofrequency Renal Denervation: 10-Year Projections based on 3-Year Follow-up from the Global SYMPLICITY Registry

TLDR: In this paper , a Markov model was used to compare projected 10-year clinical events for radiofrequency renal denervation (RDN) patients vs. a hypothetical control for age <65 (n=1,551; 53±9 years) and age ≥65 years (n =1,101; 72±5 years) subgroups.

Abstract: BackgroundClinical event rates through 3 years have been published for patients with uncontrolled hypertension treated with radiofrequency renal denervation (RDN) in the Global SYMPLICITY Registry (GSR). We estimated 10-year clinical event reductions by age.MethodsA Markov model was used to compare projected 10-year clinical events for RDN patients vs. a hypothetical control for age <65 (n=1,551; 53±9 years) and age ≥65 years (n=1,101; 72±5 years) subgroups. The simulated control assumed maintenance of baseline office systolic blood pressure (oSBP) over time and maintained RDN effect over the analysis horizon. The model was calibrated to 3-year stroke and MI events reported in the GSR and used published meta-regression data to calculate risk reduction based on cohort-specific changes in oSBP from baseline. Relative risks (RRs), events avoided, and numbers needed to treat (NNTs) were calculated at 3 and 10 years, along with the ratio of 10- vs. 3-year projected events avoided.ResultsProjected 10-year MACE events were 33.4% vs. 44.9% (-11.6%, RR=0.74) for RDN vs. control for age <65, and 39.8% vs. 54.2% (-14.4%, RR=0.73) for age ≥65. 10-year events avoided were highest for stroke and lowest for MI, and 10-year NNTs for MACE were below 10 in both age cohorts. The ratio of model-projected MACE at 10- vs. 3-years was 4.35 and 4.61, respectively. See Table 1.ConclusionsDisclosuresD. E. Kandzari: Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Ablative Solutions: Consulting and Principal Investigator for a Research Study; Boston Scientific Corp.: Principal Investigator for a Research Study; Cardiovascular Systems, Inc.: Consulting and Principal Investigator for a Research Study; Teleflex: Principal Investigator for a Research Study; Orbus Neich: Principal Investigator for a Research Study; K. Cao: Medtronic: Consulting; M. Esler: Medtronic: Advisory Board/Board Member; SyMap: Advisory Board/Board Member; R. Schmieder: Medtronic: Consulting; Recor: Consulting; Ablative Solutions: Consulting; M. Lobo: Medtronic: Consulting and educational grant funding; ReCor Medical: Consulting and educational grant funding; Ablative Solutions: Consulting; Vascular Dynamics: Consulting; Aktiia: Consulting; A. Sharp: Medtronic: Consulting; Recor Medical: Consulting; Boston Scientific Corp.: Consulting; Philips: Consulting; G. Mancia: Böhringer Ingelheim: Speaker Bureau; Medtronic: Speaker Bureau; Ferrer: Speaker Bureau; Gedeon Richter: Speaker Bureau; Menarini Int.: Speaker Bureau; Merck Healthcare KGaA: Speaker Bureau; Neopharmed-Gentili: Speaker Bureau; Novartis Pharma: Speaker Bureau; Recordati: Speaker Bureau; Sanofi: Speaker Bureau; Servier: Speaker Bureau; M. Böhm: Abbott: Consulting; Bayer AG: Consulting; Amgen: Consulting; AstraZeneca: Consulting; Servier: Consulting; Medtronic: Consulting; Vifor: Consulting; is supported by Deutsche Forschungsgemeinschaft (SFB TRR219): Principal Investigator for a Research Study; J. B. Pietzsch: Medtronic: Consulting; Aktiia SA: Consulting. BackgroundClinical event rates through 3 years have been published for patients with uncontrolled hypertension treated with radiofrequency renal denervation (RDN) in the Global SYMPLICITY Registry (GSR). We estimated 10-year clinical event reductions by age. Clinical event rates through 3 years have been published for patients with uncontrolled hypertension treated with radiofrequency renal denervation (RDN) in the Global SYMPLICITY Registry (GSR). We estimated 10-year clinical event reductions by age. MethodsA Markov model was used to compare projected 10-year clinical events for RDN patients vs. a hypothetical control for age <65 (n=1,551; 53±9 years) and age ≥65 years (n=1,101; 72±5 years) subgroups. The simulated control assumed maintenance of baseline office systolic blood pressure (oSBP) over time and maintained RDN effect over the analysis horizon. The model was calibrated to 3-year stroke and MI events reported in the GSR and used published meta-regression data to calculate risk reduction based on cohort-specific changes in oSBP from baseline. Relative risks (RRs), events avoided, and numbers needed to treat (NNTs) were calculated at 3 and 10 years, along with the ratio of 10- vs. 3-year projected events avoided. A Markov model was used to compare projected 10-year clinical events for RDN patients vs. a hypothetical control for age <65 (n=1,551; 53±9 years) and age ≥65 years (n=1,101; 72±5 years) subgroups. The simulated control assumed maintenance of baseline office systolic blood pressure (oSBP) over time and maintained RDN effect over the analysis horizon. The model was calibrated to 3-year stroke and MI events reported in the GSR and used published meta-regression data to calculate risk reduction based on cohort-specific changes in oSBP from baseline. Relative risks (RRs), events avoided, and numbers needed to treat (NNTs) were calculated at 3 and 10 years, along with the ratio of 10- vs. 3-year projected events avoided. ResultsProjected 10-year MACE events were 33.4% vs. 44.9% (-11.6%, RR=0.74) for RDN vs. control for age <65, and 39.8% vs. 54.2% (-14.4%, RR=0.73) for age ≥65. 10-year events avoided were highest for stroke and lowest for MI, and 10-year NNTs for MACE were below 10 in both age cohorts. The ratio of model-projected MACE at 10- vs. 3-years was 4.35 and 4.61, respectively. See Table 1. Projected 10-year MACE events were 33.4% vs. 44.9% (-11.6%, RR=0.74) for RDN vs. control for age <65, and 39.8% vs. 54.2% (-14.4%, RR=0.73) for age ≥65. 10-year events avoided were highest for stroke and lowest for MI, and 10-year NNTs for MACE were below 10 in both age cohorts. The ratio of model-projected MACE at 10- vs. 3-years was 4.35 and 4.61, respectively. See Table 1. Conclusions DisclosuresD. E. Kandzari: Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Ablative Solutions: Consulting and Principal Investigator for a Research Study; Boston Scientific Corp.: Principal Investigator for a Research Study; Cardiovascular Systems, Inc.: Consulting and Principal Investigator for a Research Study; Teleflex: Principal Investigator for a Research Study; Orbus Neich: Principal Investigator for a Research Study; K. Cao: Medtronic: Consulting; M. Esler: Medtronic: Advisory Board/Board Member; SyMap: Advisory Board/Board Member; R. Schmieder: Medtronic: Consulting; Recor: Consulting; Ablative Solutions: Consulting; M. Lobo: Medtronic: Consulting and educational grant funding; ReCor Medical: Consulting and educational grant funding; Ablative Solutions: Consulting; Vascular Dynamics: Consulting; Aktiia: Consulting; A. Sharp: Medtronic: Consulting; Recor Medical: Consulting; Boston Scientific Corp.: Consulting; Philips: Consulting; G. Mancia: Böhringer Ingelheim: Speaker Bureau; Medtronic: Speaker Bureau; Ferrer: Speaker Bureau; Gedeon Richter: Speaker Bureau; Menarini Int.: Speaker Bureau; Merck Healthcare KGaA: Speaker Bureau; Neopharmed-Gentili: Speaker Bureau; Novartis Pharma: Speaker Bureau; Recordati: Speaker Bureau; Sanofi: Speaker Bureau; Servier: Speaker Bureau; M. Böhm: Abbott: Consulting; Bayer AG: Consulting; Amgen: Consulting; AstraZeneca: Consulting; Servier: Consulting; Medtronic: Consulting; Vifor: Consulting; is supported by Deutsche Forschungsgemeinschaft (SFB TRR219): Principal Investigator for a Research Study; J. B. Pietzsch: Medtronic: Consulting; Aktiia SA: Consulting. D. E. Kandzari: Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Ablative Solutions: Consulting and Principal Investigator for a Research Study; Boston Scientific Corp.: Principal Investigator for a Research Study; Cardiovascular Systems, Inc.: Consulting and Principal Investigator for a Research Study; Teleflex: Principal Investigator for a Research Study; Orbus Neich: Principal Investigator for a Research Study; K. Cao: Medtronic: Consulting; M. Esler: Medtronic: Advisory Board/Board Member; SyMap: Advisory Board/Board Member; R. Schmieder: Medtronic: Consulting; Recor: Consulting; Ablative Solutions: Consulting; M. Lobo: Medtronic: Consulting and educational grant funding; ReCor Medical: Consulting and educational grant funding; Ablative Solutions: Consulting; Vascular Dynamics: Consulting; Aktiia: Consulting; A. Sharp: Medtronic: Consulting; Recor Medical: Consulting; Boston Scientific Corp.: Consulting; Philips: Consulting; G. Mancia: Böhringer Ingelheim: Speaker Bureau; Medtronic: Speaker Bureau; Ferrer: Speaker Bureau; Gedeon Richter: Speaker Bureau; Menarini Int.: Speaker Bureau; Merck Healthcare KGaA: Speaker Bureau; Neopharmed-Gentili: Speaker Bureau; Novartis Pharma: Speaker Bureau; Recordati: Speaker Bureau; Sanofi: Speaker Bureau; Servier: Speaker Bureau; M. Böhm: Abbott: Consulting; Bayer AG: Consulting; Amgen: Consulting; AstraZeneca: Consulting; Servier: Consulting; Medtronic: Consulting; Vifor: Consulting; is supported by Deutsche Forschungsgemeinschaft (SFB TRR219): Principal Investigator for a Research Study; J. B. Pietzsch: Medtronic: Consulting; Aktiia SA: Consulting.