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SYMPLICITY HTN-3: 1-year data support no further reduction in BP
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One-year follow-up data from the SYMPLICITY HTN-3 trial demonstrate that renal denervation was associated with further reductions in office BP, but failed to reduce 24-hour ambulatory BP more than levels recorded at 6 months.
“As a result of further detailed research into the renal denervation process itself and the evaluation of medication adherence, we conclude that renal denervation is safe but, by the method applied in SYMPLICITY HTN-3, does not clearly reduce BP to a greater extent than medication. Future randomized, blinded and sham-controlled studies will be necessary to determine if renal denervation performed differently will provide substantial BP reduction,” Cardiology Today Editorial Board member George L. Bakris, MD, from the ASH Comprehensive Hypertension Center, University of Chicago Medicine, and colleagues wrote.
George L. Bakris
The current study is an analysis of the 1-year SYMPLICITY HTN-3 results for three patient cohorts: the original denervation group; the sham patients who underwent denervation after the 6-month endpoint (crossover group); and the sham patients who did not undergo denervation after 6 months (n = 48). One-year follow-up data were available for 319 patients in the original denervation group and 48 patients in the non-crossover group, and 6-month follow-up data were available for 93 patients in the crossover group.
The primary endpoint was change in BP at 1 year after randomization to the Symplicity renal denervation system (Medtronic) or a sham procedure.
Patients who underwent renal denervation had an average change in office systolic BP –18.9 ± 25.4 mm Hg at 1 year compared with –15.5 ± 24.1 mm Hg at 6 months (P = .025). The researchers reported no significant difference in change in 24-hour systolic BP at 1 year. In the non-crossover group, office systolic BP was decreased by –32.9 ± 28.1 mm Hg at 6 months; however, the researchers reported a regression at 1 year (–21.4 ± 19.9 mm Hg; P = .01), with an increase to 11.5 ± 29.8 mm Hg.
Other results indicated that 6- and 12-month ambulatory BP did not change in the renal denervation groups.
All three groups demonstrated similar safety outcomes at 6 and 12 months. – by Rob Volansky
Disclosure: Bakris reports consulting for AstraZeneca, Bayer, Daiichi Sankyo, GlaxoSmithKline, Janssen, Medtronic, Novartis and Relypsa.
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