Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3

• Published in: Journal of the American College of Cardiology 2014-09, Vol.64 (11), p.1071-1078
• Main Authors: Bakris, George L, Townsend, Raymond R, Liu, Minglei, Cohen, Sidney A, D'Agostino, Ralph, Flack, John M, Kandzari, David E, Katzen, Barry T, Leon, Martin B, Mauri, Laura, Negoita, Manuela, O'Neill, William W, Oparil, Suzanne, Rocha-Singh, Krishna, Bhatt, Deepak L
• Format: Article
• Language: English
• Subjects: Blood Pressure; Blood Pressure Monitoring, Ambulatory; Double-Blind Method; Female; Humans; Hypertension - surgery; Male; Middle Aged; Prospective Studies; Renal Artery - innervation; Renal Artery - surgery; Sympathectomy; Time Factors
• ISSN: 1558-3597
• DOI: 10.1016/j.jacc.2014.05.012

Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure. SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization. Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months. The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94). This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).