Renal sympathetic denervation for treatment of drug-resistant hypertension: One-year results from the symplicity htn-2 randomized, controlled trial

Murray D. Esler, Henry Krum, Markus Schlaich, Roland E. Schmieder, Michael Böhm, Paul A. Sobotka

Research output: Contribution to journalArticle

349 Citations (Scopus)

Abstract

BACKGROUND-: Renal sympathetic nerve activation contributes to the pathogenesis of hypertension. Symplicity HTN-2, a multicenter, randomized trial, demonstrated that catheter-based renal denervation produced significant blood pressure lowering in treatment-resistant patients at 6 months after the procedure compared with control, medication-only patients. Longer-term follow-up, including 6-month crossover results, is now presented. METHODS AND RESULTS-: Eligible patients were on ≥3 antihypertensive drugs and had a baseline systolic blood pressure ≥160 mm Hg (≥150 mm Hg for type 2 diabetics). After the 6-month primary end point was met, renal denervation in control patients was permitted. One-year results on patients randomized to immediate renal denervation (n=47) and 6-month postprocedure results for crossover patients are presented. At 12 months after the procedure, the mean fall in office systolic blood pressure in the initial renal denervation group (-28.1 mm Hg; 95% confidence interval,-35.4 to-20.7; P<0.001) was similar to the 6-month fall (-31.7 mm Hg; 95% confidence interval,-38.3 to-25.0; P=0.16 versus 6-month change). The mean systolic blood pressure of the crossover group 6 months after the procedure was significantly lowered (from 190.0±19.6 to 166.3±24.7 mm Hg; change,-23.7±27.5; P<0.001). In the crossover group, there was 1 renal artery dissection during guide catheter insertion, before denervation, corrected by renal artery stenting, and 1 hypotensive episode, which resolved with medication adjustment. CONCLUSIONS-: Control patients who crossed over to renal denervation with the Symplicity system had a significant drop in blood pressure similar to that observed in patients receiving immediate denervation. Renal denervation provides safe and sustained reduction of blood pressure to 1 year. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00888433.

Original languageEnglish
Pages (from-to)2976-2982
Number of pages7
JournalCirculation
Volume126
Issue number25
DOIs
Publication statusPublished - 18 Dec 2012
Externally publishedYes

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Sympathectomy
Denervation
Randomized Controlled Trials
Blood Pressure
Hypertension
Kidney
Pharmaceutical Preparations
Therapeutics
Renal Artery
Catheters
Confidence Intervals
Antihypertensive Agents
Multicenter Studies
Dissection
Clinical Trials

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Esler, Murray D. ; Krum, Henry ; Schlaich, Markus ; Schmieder, Roland E. ; Böhm, Michael ; Sobotka, Paul A. / Renal sympathetic denervation for treatment of drug-resistant hypertension : One-year results from the symplicity htn-2 randomized, controlled trial. In: Circulation. 2012 ; Vol. 126, No. 25. pp. 2976-2982.
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Renal sympathetic denervation for treatment of drug-resistant hypertension : One-year results from the symplicity htn-2 randomized, controlled trial. / Esler, Murray D.; Krum, Henry; Schlaich, Markus; Schmieder, Roland E.; Böhm, Michael; Sobotka, Paul A.

In: Circulation, Vol. 126, No. 25, 18.12.2012, p. 2976-2982.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Renal sympathetic denervation for treatment of drug-resistant hypertension

T2 - One-year results from the symplicity htn-2 randomized, controlled trial

AU - Esler, Murray D.

AU - Krum, Henry

AU - Schlaich, Markus

AU - Schmieder, Roland E.

AU - Böhm, Michael

AU - Sobotka, Paul A.

PY - 2012/12/18

Y1 - 2012/12/18

N2 - BACKGROUND-: Renal sympathetic nerve activation contributes to the pathogenesis of hypertension. Symplicity HTN-2, a multicenter, randomized trial, demonstrated that catheter-based renal denervation produced significant blood pressure lowering in treatment-resistant patients at 6 months after the procedure compared with control, medication-only patients. Longer-term follow-up, including 6-month crossover results, is now presented. METHODS AND RESULTS-: Eligible patients were on ≥3 antihypertensive drugs and had a baseline systolic blood pressure ≥160 mm Hg (≥150 mm Hg for type 2 diabetics). After the 6-month primary end point was met, renal denervation in control patients was permitted. One-year results on patients randomized to immediate renal denervation (n=47) and 6-month postprocedure results for crossover patients are presented. At 12 months after the procedure, the mean fall in office systolic blood pressure in the initial renal denervation group (-28.1 mm Hg; 95% confidence interval,-35.4 to-20.7; P<0.001) was similar to the 6-month fall (-31.7 mm Hg; 95% confidence interval,-38.3 to-25.0; P=0.16 versus 6-month change). The mean systolic blood pressure of the crossover group 6 months after the procedure was significantly lowered (from 190.0±19.6 to 166.3±24.7 mm Hg; change,-23.7±27.5; P<0.001). In the crossover group, there was 1 renal artery dissection during guide catheter insertion, before denervation, corrected by renal artery stenting, and 1 hypotensive episode, which resolved with medication adjustment. CONCLUSIONS-: Control patients who crossed over to renal denervation with the Symplicity system had a significant drop in blood pressure similar to that observed in patients receiving immediate denervation. Renal denervation provides safe and sustained reduction of blood pressure to 1 year. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00888433.

AB - BACKGROUND-: Renal sympathetic nerve activation contributes to the pathogenesis of hypertension. Symplicity HTN-2, a multicenter, randomized trial, demonstrated that catheter-based renal denervation produced significant blood pressure lowering in treatment-resistant patients at 6 months after the procedure compared with control, medication-only patients. Longer-term follow-up, including 6-month crossover results, is now presented. METHODS AND RESULTS-: Eligible patients were on ≥3 antihypertensive drugs and had a baseline systolic blood pressure ≥160 mm Hg (≥150 mm Hg for type 2 diabetics). After the 6-month primary end point was met, renal denervation in control patients was permitted. One-year results on patients randomized to immediate renal denervation (n=47) and 6-month postprocedure results for crossover patients are presented. At 12 months after the procedure, the mean fall in office systolic blood pressure in the initial renal denervation group (-28.1 mm Hg; 95% confidence interval,-35.4 to-20.7; P<0.001) was similar to the 6-month fall (-31.7 mm Hg; 95% confidence interval,-38.3 to-25.0; P=0.16 versus 6-month change). The mean systolic blood pressure of the crossover group 6 months after the procedure was significantly lowered (from 190.0±19.6 to 166.3±24.7 mm Hg; change,-23.7±27.5; P<0.001). In the crossover group, there was 1 renal artery dissection during guide catheter insertion, before denervation, corrected by renal artery stenting, and 1 hypotensive episode, which resolved with medication adjustment. CONCLUSIONS-: Control patients who crossed over to renal denervation with the Symplicity system had a significant drop in blood pressure similar to that observed in patients receiving immediate denervation. Renal denervation provides safe and sustained reduction of blood pressure to 1 year. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00888433.

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KW - hypertension

KW - nervous system, sympathetic

KW - renal denervation

KW - sympathetic nervous system

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