Murray D Esler1, Michael Böhm2, Horst Sievert3, Christian L Rump4, Roland E Schmieder5, Henry Krum6, Felix Mahfoud2, Markus P Schlaich7. 1. Baker IDI Heart and Diabetes Institute, Monash University, 75 Commercial Road, Melbourne, Victoria 3004, Australia murray.esler@bakeridi.edu.au. 2. Universitätsklinium des Saarlandes, Homburg/Saar, Germany. 3. CardioVaskuläres Centrum, Frankfurt, Germany. 4. Department of Nephrology, Heinrich-Heine-University, Medical Faculty, Düsseldorf, Germany. 5. Department of Nephrology, Hypertension of the University Hospital, Clinical Research Competence Center of Hypertension and Vascular Medicine, Erlangen, Germany. 6. Monash Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. 7. Baker IDI Heart and Diabetes Institute, Monash University, 75 Commercial Road, Melbourne, Victoria 3004, Australia.
Abstract
AIM: The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study. METHODS: SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone. At 6 months, 37 control subjects crossed over to renal denervation. Office blood pressure measurements, antihypertensive medication use, and safety events were followed every 6 months through 3 years. RESULTS: Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months. Baseline blood pressure was 184 ± 19/99 ± 16 mmHg in all treated subjects. At 30-month post-procedure, systolic blood pressure decreased 34 mmHg (95% CI: -40, -27, P < 0.01) and diastolic blood pressure decreased 13 mmHg (95% CI: -16, -10, P < 0.01). The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg (95% CI: -40, -25, P < 0.01) and -14 mmHg (95% CI: -17, -10, P < 0.01), respectively. Procedural complications included one haematoma, and one renal artery dissection before energy delivery that was treated successfully. Later complications included two cases of acute renal failure, which fully resolved, 15 hypertensive events requiring hospitalization, and three deaths. CONCLUSION: Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns. CLINICAL TRIAL REGISTRATION: NCT00888433. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIM: The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study. METHODS: SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone. At 6 months, 37 control subjects crossed over to renal denervation. Office blood pressure measurements, antihypertensive medication use, and safety events were followed every 6 months through 3 years. RESULTS: Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months. Baseline blood pressure was 184 ± 19/99 ± 16 mmHg in all treated subjects. At 30-month post-procedure, systolic blood pressure decreased 34 mmHg (95% CI: -40, -27, P < 0.01) and diastolic blood pressure decreased 13 mmHg (95% CI: -16, -10, P < 0.01). The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg (95% CI: -40, -25, P < 0.01) and -14 mmHg (95% CI: -17, -10, P < 0.01), respectively. Procedural complications included one haematoma, and one renal artery dissection before energy delivery that was treated successfully. Later complications included two cases of acute renal failure, which fully resolved, 15 hypertensive events requiring hospitalization, and three deaths. CONCLUSION: Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns. CLINICAL TRIAL REGISTRATION: NCT00888433. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Patricia M Kearney; Megan Whelton; Kristi Reynolds; Paul Muntner; Paul K Whelton; Jiang He Journal: Lancet Date: 2005 Jan 15-21 Impact factor: 79.321
Authors: Henry Krum; Markus P Schlaich; Paul A Sobotka; Michael Böhm; Felix Mahfoud; Krishna Rocha-Singh; Richard Katholi; Murray D Esler Journal: Lancet Date: 2013-11-07 Impact factor: 79.321
Authors: Aram V Chobanian; George L Bakris; Henry R Black; William C Cushman; Lee A Green; Joseph L Izzo; Daniel W Jones; Barry J Materson; Suzanne Oparil; Jackson T Wright; Edward J Roccella Journal: Hypertension Date: 2003-12-01 Impact factor: 10.190
Authors: T A Bley; C J François; M L Schiebler; O Wieben; N Takei; J H Brittain; A Munoz Del Rio; T M Grist; S B Reeder Journal: Eur Radiol Date: 2015-05-28 Impact factor: 5.315
Authors: B-K Kim; M Böhm; F Mahfoud; G Mancia; S Park; M-K Hong; H-S Kim; S-J Park; C G Park; K B Seung; H-C Gwon; D-J Choi; T H Ahn; C J Kim; H M Kwon; M Esler; Y S Jang Journal: J Hum Hypertens Date: 2015-07-09 Impact factor: 3.012