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Symplicity-HTN2: Renal denervation lowers BP out to 1 year
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Renal denervation provided safe and sustained reduction of BP for 1 year in patients allowed to crossover from the control group to the treatment group, according to results of the Symplicity-HTN2 trial published today in Circulation.
The multicenter, randomized trial had previously shown that catheter-based renal denervation with the Symplicity system (Medtronic) produced significant BP lowering in patients with treatment-resistant hypertension for 6 months compared with a control group of patients treated only with medication.
Control patients in the trial who met the 6-month primary endpoint of change in office-based systolic BP were allowed to undergo and were randomly assigned to renal denervation.
The mean decrease in systolic BP in the initial renal denervation group (–28.1 mm Hg; 95% CI, –35.4 to –20.7) was similar to the 6-month reduction (–31.7 mm Hg; 95% CI –38.3 to –25).
The mean systolic BP of the crossover group 6 months after the procedure fell significantly (190 ± 19.6 mm Hg to 166.3 ± 24.7 mm Hg; change –23.7 ± 27.5; P<.001).
Control patients who crossed over to renal denervation had a similar significant drop in BP to that observed in patients receiving immediate denervation, Murray D. Esler, MBBS, PhD, FRACP, trial investigator with Baker IDI Heart and Diabetes Institute, Melbourne, and fellow researchers noted.
Murray D. Esler
“These data further substantiate the safety of renal sympathetic denervation via delivery of controlled radiofrequency energy bursts,” Esler and colleagues wrote. “Measures of renal function were unchanged 6 and 12 months after renal denervation, suggesting no adverse consequences of the renal denervation on kidney function.”
Disclosure: Esler received research support from Medtronic Ardian, LLC for conducting this trial. The trial was funded by Medtronic Ardian, LLC.
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