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SYMPLICITY HTN-3: Renal denervation did not affect ambulatory BP
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NEW YORK — Consistent with results of the primary endpoint of reduction of office BP, new data from the SYMPLICITY HTN-3 trial demonstrate no difference between renal denervation and a sham procedure in reduction of ambulatory BP.
SYMPLICITY HTN-3 was “the first trial of renal denervation to include a requirement of [ambulatory] BP [monitoring] for all patients as a prespecified secondary endpoint and an entry endpoint,” George Bakris, MD, from the University of Chicago School of Medicine, said during a presentation at the American Society of Hypertension Annual Scientific Meeting.
George Bakris
The researchers randomly assigned 535 patients in a 2:1 fashion to renal denervation with the Symplicity catheter (Medtronic) or a sham procedure. According to a previous report, the study revealed no difference between the treatment groups in the primary endpoint of reduction of office systolic BP at 6 months (denervation group, –14.13 mm Hg; sham group, –11.74 mm Hg; difference, –2.39 mm Hg; 95% CI, –6.89 to 2.12).
According to new results presented at the meeting, the mean 24-hour ambulatory systolic BP change was –6.75 mm Hg in the denervation group and –4.79 mm Hg in the sham group (difference, –1.96 mm Hg; 95% CI, –4.97 to 1.06), said Bakris, a member of the Cardiology Today Editorial Board.
“The [ambulatory] diastolic pressures … trend similarly to the systolic pressures,” Bakris said during the presentation. “Both groups had nice reductions, and ultimately it was a millimeter difference between the groups, certainly not significant.”
There was no difference in mean daytime ambulatory systolic BP (difference, –1.08 mm Hg; 95% CI, –4.33 to 2.18), but data suggest a trend toward greater reduction of mean nighttime ambulatory systolic BP in the denervation group (difference, –3.27 mm Hg; 95% CI, –6.66 to 0.12), Bakris said. “The diastolic [BP] had a similar trend, but was even less significant.”
In addition, the researchers found no difference in percentage of non-dippers converted to dippers (denervation group, 21.2%; sham group, 15%; P=.3) and no difference between the groups in BP variability or heart rate variability, he said.
“These results underscore the importance of blinding and sham controls in the evaluation of new devices, and further study is of course needed,” Bakris said. Such research includes the ability “to get at what renal denervation is actually doing and how to properly assess whether you have done it correctly with validated methods.” – by Erik Swain
For more information:
Bakris G. Abstract LB-OR-01. Presented at: American Society of Hypertension 2014 Annual Scientific Meeting; May 16-20, 2014; New York.
Disclosure: The study was funded by Medtronic. Bakris reports financial ties with AbbVie, Bayer, Daiichi Sankyo, Janssen, Medtronic, Novartis, Relypsa and Takeda.