Symplicity HTN-2: BP reductions sustained through 18 months

MUNICH — New 18-month data from the Symplicity HTN-2 trial demonstrate significant, sustained BP reductions in patients with treatment-resistant hypertension treated with renal denervation.

The international, multicenter, prospective, randomized, controlled study was designed to assess the safety and efficacy of renal denervation with a catheter-based renal denervation system (Symplicity, Medtronic) in patients with treatment-resistant hypertension.

At baseline, patients were randomly assigned renal denervation plus antihypertensive medications (n=49) and those assigned antihypertensive medications alone (n=52) had similar BP: 178/97 mm Hg and 178/98 mm Hg, respectively. Patients in the medication only group were offered renal denervation following BP assessment 6 months after randomization. Thirty-five patients from the control group with systolic BP >160 mm Hg received renal denervation at 6 months (crossover group), according to information in a press release. Researcher Michael Böhm, MD, chief investigator of the Symplicity HTN-2 trial and from Universität der Saarlandes, Homburg/Saar, Germany, said at a press conference that “reasons for changes were mostly unknown, but may be related to a variety of confounding factors.”

Murray D. Esler, MD, associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia, and study investigator, presented 18-month results on 43 patients following renal denervation and 31 crossover patients during a session here.

According to the findings, renal denervation was safe and effective in both treatment groups 18 months after the procedure. Compared with baseline, the post-renal denervation patients had an average BP reduction of –32/–12 mm Hg from baseline (P<.01) and the crossover patients had a BP reduction of –28/–11 mm Hg (P<.01).

“These 18-month BP reductions are consistent with the 12-month follow-up for both groups (–28/–10 mm Hg from baseline for the initial treatment group and –24/–10 mm Hg from baseline for the crossover group,” Esler stated in the release.

Further, safety results were sustained at 18 months and researchers noted no significant decline in kidney function, according to Böhm.

“We are encouraged to see that renal denervation shows substantial and sustained BP reduction in treatment-resistant patients,” Esler said. – by Katie Kalvaitis

For more information:

Esler MD. Renal denervation in hypertension. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.

Disclosure: Dr. Böhm reports receiving research grants, travel and consultancy funding from Ardian and Medtronic.