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      Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry

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          Abstract

          Aims

          Catheter-based renal artery denervation (RDN) has been shown to lower blood pressure (BP) in certain patients with uncontrolled hypertension. Isolated systolic hypertension (ISH) (systolic BP [SBP] ≥140 mmHg and diastolic BP <90 mmHg), characterized by increased vascular stiffness, is the predominant hypertensive phenotype in elderly patients. This study compared baseline characteristics and SBP change at 6 months between patients with ISH and combined systolic–diastolic hypertension (CH).

          Methods and results

          This study pooled data from 1103 patients from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. A total of 429 patients had ISH, and 674 had CH. Patients with ISH were significantly older than those with CH (66 vs. 55 years), had more type 2 diabetes mellitus (52.9 vs. 34.6%), and a lower estimated glomerular filtration rate (71.8 vs. 78.6 mL/min/1.73 m 2); all P < 0.001. At 6 months, the SBP drop for CH patients was −18.7 ± 23.7 mmHg compared with a reduction of −10.9 ± 21.7 mmHg for ISH patients −7.8 mmHg, 95% confidence interval, CI, −10.5, −5.1, P < 0.001). The change in 24-h SBP at 6 months was −8.8 ± 16.2 mmHg in patients with CH vs. −5.8 ± 15.4 mmHg in ISH (−3.0 mmHg, 95% CI −5.4, −0.6, P = 0.015). Presence of ISH at baseline but not age was associated with less pronounced BP changes following the procedure. The strongest predictor of office SBP reduction at 6 months was CH, followed by aldosterone antagonist use and non-use of vasodilators.

          Conclusion

          The reduction in BP among patients with ISH following RDN was less pronounced than the reduction in patients with CH.

          Clinical.Trials.gov identifiers

          NCT01534299 and NCT01418261.

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          Most cited references17

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          Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III.

          The purpose of the present study was to examine patterns of systolic and diastolic hypertension by age in the nationally representative National Health and Nutrition Examination Survey (NHANES) III and to determine when treatment and control efforts should be recommended. Percentage distribution of 3 blood pressure subtypes (isolated systolic hypertension, combined systolic/diastolic hypertension, and isolated diastolic hypertension) was categorized for uncontrolled hypertension (untreated and inadequately treated) in 2 age groups (ages /=50 years). Overall, isolated systolic hypertension was the most frequent subtype of uncontrolled hypertension (65%). Most subjects with hypertension (74%) were >/=50 years of age, and of this untreated older group, nearly all (94%) were accurately staged by systolic blood pressure alone, in contrast to subjects in the untreated younger group, who were best staged by diastolic blood pressure. Furthermore, most subjects (80%) in the older untreated and the inadequately treated groups had isolated systolic hypertension and required a greater reduction in systolic blood pressure than in the younger groups (-13.3 and -16.5 mm Hg versus -6.8 and -6.1 mm Hg, respectively; P:=0.0001) to attain a systolic blood pressure treatment goal of <140 mm Hg. Contrary to previous perceptions, isolated systolic hypertension was the majority subtype of uncontrolled hypertension in subjects of ages 50 to 59 years, comprised 87% frequency for subjects in the sixth decade of life, and required greater reduction in systolic blood pressure in these subjects to reach treatment goal compared with subjects in the younger group. Better awareness of this middle-aged and older high-risk group and more aggressive antihypertensive therapy are necessary to address this treatment gap.
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            Risks of untreated and treated isolated systolic hypertension in the elderly: meta-analysis of outcome trials.

            Previous meta-analysis of outcome trials in hypertension have not specifically focused on isolated systolic hypertension or they have explained treatment benefit mainly in function of the achieved diastolic blood pressure reduction. We therefore undertook a quantitative overview of the trials to further evaluate the risks associated with systolic blood pressure in treated and untreated older patients with isolated systolic hypertension Patients were 60 years old or more. Systolic blood pressure was 160 mm Hg or greater and diastolic blood pressure was less than 95 mm Hg. We used non-parametric methods and Cox regression to model the risks associated with blood pressure and to correct for regression dilution bias. We calculated pooled effects of treatment from stratified 2 x 2 contingency tables after application of Zelen's test of heterogeneity. In eight trials 15 693 patients with isolated systolic hypertension were followed up for 3.8 years (median). After correction for regression dilution bias, sex, age, and diastolic blood pressure, the relative hazard rates associated with a 10 mm Hg higher initial systolic blood pressure were 1.26 (p=0.0001) for total mortality, 1.22 (p=0.02) for stroke, but only 1.07 (p=0.37) for coronary events. Independent of systolic blood pressure, diastolic blood pressure was inversely correlated with total mortality, highlighting the role of pulse pressure as risk factor. Active treatment reduced total mortality by 13% (95% CI 2-22, p=0.02), cardiovascular mortality by 18%, all cardiovascular complications by 26%, stroke by 30%, and coronary events by 23%. The number of patients to treat for 5 years to prevent one major cardiovascular event was lower in men (18 vs 38), at or above age 70 (19 vs 39), and in patients with previous cardiovascular complications (16 vs 37). Drug treatment is justified in older patients with isolated systolic hypertension whose systolic blood pressure is 160 mm Hg or higher. Absolute benefit is larger in men, in patients aged 70 or more and in those with previous cardiovascular complications or wider pulse pressure. Treatment prevented stroke more effectively than coronary events. However, the absence of a relation between coronary events and systolic blood pressure in untreated patients suggests that the coronary protection may have been underestimated.
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              Elevated systolic blood pressure and risk of cardiovascular and renal disease: overview of evidence from observational epidemiologic studies and randomized controlled trials.

              The effect of elevated blood pressure on risk of cardiovascular and renal disease has been documented in both observational epidemiologic studies and clinical trials. However, these studies have traditionally concentrated on diastolic blood pressure to characterize the risk associated with hypertension. We reviewed evidence from prospective studies and randomized controlled trials to quantify the risk associated with systolic blood pressure. Prospective studies and randomized controlled clinical trials that were published in English-language journals were retrieved using MEDLINE, bibliographies, and the authors' reference files. All retrieved publications were reviewed and information on sample size, duration, study design, antihypertensive medication, participant characteristics, and outcomes was abstracted for randomized controlled trials that reported systolic blood pressure reduction during intervention. Several prospective studies indicate that the association between systolic blood pressure and risk of coronary heart disease, stroke, and end-stage renal disease is continuous, graded, and independent. Furthermore, they suggest that the association of systolic blood pressure with these outcomes is stronger than that of diastolic blood pressure. Pooling of the data available from randomized controlled trials indicates that an average reduction of 12 to 13 mm Hg in systolic blood pressure over 4 years of follow-up is associated with a 21% reduction in coronary heart disease, 37% reduction in stroke, 25% reduction in total cardiovascular mortality, and 13% reduction in all-cause mortality rates. These data indicate that systolic blood pressure is an independent and strong predictor for risk of cardiovascular and renal disease.
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                Author and article information

                Journal
                Eur Heart J
                Eur. Heart J
                eurheartj
                European Heart Journal
                Oxford University Press
                0195-668X
                1522-9645
                07 January 2017
                28 July 2016
                28 July 2016
                : 38
                : 2 , Focus Issue on Hypertension
                : 93-100
                Affiliations
                [1 ]Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Saarland University Hospital, Kirrberger Str., Geb. 40, Homburg/Saar 66421, Germany
                [2 ]University of Chicago Medicine, Chicago, IL, USA
                [3 ]Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA
                [4 ]Baker IDI Heart and Diabetes Institute, Melbourne, Australia
                [5 ]Medtronic, Santa Rosa, CA, USA
                [6 ]Piedmont Heart Institute, Atlanta, GA, USA
                [7 ]Jichi Medical University School of Medicine, Tochigi, Japan
                [8 ]University of Milano-Bicocca and Istituto Auxologico Italiano, Milan, Italy
                [9 ]SUNY Downstate Medical Center, Brooklyn, NY, USA
                Author notes
                [* ]Corresponding author. Tel: +49 6841 16 15911, Fax: +49 6841 16 15910, Email: felix.mahfoud@ 123456uniklinikum-saarland.de
                Article
                ehw325
                10.1093/eurheartj/ehw325
                5381589
                28158510
                edac9805-1a9e-4869-8d6a-73200c1f9c74
                © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 31 January 2016
                : 27 April 2016
                : 29 June 2016
                Page count
                Pages: 8
                Funding
                Funded by: Medtronic
                Categories
                Clinical Research
                Interventional Cardiology
                Editor's Choice

                Cardiovascular Medicine
                renal denervation,resistant hypertension,sympathetic nervous system,clinical trials

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