Symplicity HTN-2: Renal denervation therapy plus medication lowered BP vs. medication alone
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American Heart Association Scientific Sessions 2010
CHICAGO — Patients with high systolic BP treated with renal denervation therapy and medication had a significant drop in BP compared with patients treated with just medication alone.
Researchers of the multicenter, prospective, randomized, controlled trial of Endovascular Selective Renal Sympathetic Denervation for the Treatment of Hypertension (Symplicity HTN-2) compared 52 participants who received catheter treatment (Symplicity Catheter System, Ardian Inc.) plus medication to 54 controls who received medication only. Patients were aged 18 to 85 years and had systolic BP of 160 mm Hg or more.
At baseline, both groups had nearly identical mean BP (treatment, 178/98 mm HG vs. control, 178/97 mm HG). Six-month data showed that BP in the renal denervation group dropped by 32/12 mm HG (P<.0001), whereas there was no difference in the control group (systolic BP, P=.77; diastolic BP, P=.83). Eighty-four percent of patients undergoing renal denervation had reduced systolic BP of 10 mm Hg or more vs. 35% of controls (P<.0001).
“In patients with resistant, very difficult to control hypertension, renal denervation has a very material effect on BP. It could be achieved with almost complete safety and no significant side effects,” said Murray Esler, MD, associate director of the Baker IDI Heart and Diabetes Institute, Melbourne, Australia and principal investigator on the trial, said in a press conference. “This technique is to be trialed in the US starting early next year. For the future, I think this treatment will probably become part of more general care for very severe hypertension.”
Dr. Esler reported receiving research grant, travel and consultancy funding from Ardian. – by Brian Ellis
For more information:
- Esler M. LBCTIV, Abstract #21826. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
This is an extremely important study with a number of great strengths and the potential for really revolutionizing the way we deal with treatment-resistant hypertension. There is enormous clinical need for this type of approach. Resistant hypertension defined by AHA criteria as BP that cannot be controlled on three antihypertensive drugs given at full doses, one of which should be a diuretic, is very common now, about 15% of the total hypertension population. And, in fact, many patients are uncontrolled on four or five drugs. The expert statement says this condition may benefit from special therapeutic and diagnostic considerations and this [treatment] may in fact be one of them.
– Suzanne Oparil, MD
Director, Vascular
Biology and Hypertension Program, University of Alabama at Birmingham
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