Abstract
Aim: The aim of this studywas 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 thatwas 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.
| Original language | English |
|---|---|
| Pages (from-to) | 1752-1759 |
| Number of pages | 8 |
| Journal | European Heart Journal |
| Volume | 35 |
| Issue number | 26 |
| DOIs | |
| Publication status | Published - 7 Jul 2014 |
| Externally published | Yes |
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Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension : 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. / Esler, Murray D.; Böhm, Michael; Sievert, Horst; Rump, Christian L.; Schmieder, Roland E.; Krum, Henry; Mahfoud, Felix; Schlaich, Markus P.
In: European Heart Journal, Vol. 35, No. 26, 07.07.2014, p. 1752-1759.Research output: Contribution to journal › Article
TY - JOUR
T1 - Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension
T2 - 36 month results from the SYMPLICITY HTN-2 randomized clinical trial
AU - Esler, Murray D.
AU - Böhm, Michael
AU - Sievert, Horst
AU - Rump, Christian L.
AU - Schmieder, Roland E.
AU - Krum, Henry
AU - Mahfoud, Felix
AU - Schlaich, Markus P.
PY - 2014/7/7
Y1 - 2014/7/7
N2 - Aim: The aim of this studywas 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 thatwas 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.
AB - Aim: The aim of this studywas 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 thatwas 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.
KW - Renal denervation
KW - Resistant hypertension
KW - Symplicity
UR - http://www.scopus.com/inward/record.url?scp=84907549838&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehu209
DO - 10.1093/eurheartj/ehu209
M3 - Article
VL - 35
SP - 1752
EP - 1759
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 26
ER -