Key result
Renal denervation lowers 24-hour SBP by ~6 mmHg in patients with baseline HR ≥70 bpm.
Why the study?
Although sham-controlled trials demonstrated the safety and efficacy of renal denervation to lower blood pressure, the association between baseline heart rate and blood pressure reduction after renal denervation in the absence of antihypertensive medications remained incompletely understood.
Does renal denervation reduce 24-hour and office systolic blood pressure at 3 months differently based on baseline heart rate (<70 vs ≥70 beats/min) in unmedicated patients with uncontrolled hypertension?
RCT
Sham-controlled
1:1
Yes
Does renal denervation reduce 24-hour and office systolic blood pressure at 3 months differently based on baseline heart rate (<70 vs ≥70 beats/min) in unmedicated patients with uncontrolled hypertension?
In unmedicated patients with uncontrolled hypertension, renal denervation produces significantly greater 3-month blood pressure reductions in those with a baseline office heart rate ≥70 beats/min compared to <70 beats/min.
Background Sham-controlled trials demonstrated safety and efficacy of renal denervation (RDN) to lower blood pressure (BP). Association of baseline heart rate with BP reduction after RDN is incompletely understood. Objectives The purpose of this analysis was to evaluate the impact of baseline heart rate on BP reduction without antihypertensive medications in the SPYRAL HTN-OFF MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications) Pivotal trial. Methods Patients removed from any antihypertensive medications were enrolled with office systolic blood pressure (SBP) ≥150 and <180 mm Hg and randomized 1:1 to RDN or sham control. Patients were separated according to baseline office heart rate <70 or ≥70 beats/min. BP changes from baseline to 3 months between treatment arms were adjusted for baseline SBP using analysis of covariance. Results Scatter plots of 3-month changes in 24-hour and office SBP illustrate a wide range of changes in SBP for different baseline heart rates. Treatment difference at 3 months between RDN and sham control with baseline office heart rate ≥70 beats/min for 24-hour SBP was -6.2 mm Hg (95% CI: -9.0 to -3.5 mm Hg) (P < 0.001) and for baseline office heart rate <70 beats/min it was -0.1 mm Hg (-3.8 to 3.6 mm Hg) (P = 0.97) with an interaction P value of 0.008. Results were similar for changes in office, daytime, and nighttime SBP at 3 months, with a greater reduction in SBP with baseline office heart rate ≥70 beats/min. Conclusions Reduction in mean office, 24-hour, daytime, and nighttime SBP for RDN at 3 months was greater with baseline office heart rate ≥70 than <70 beats/min, suggesting an association between baseline heart rate and BP reduction after RDN. (SPYRAL PIVOTAL-SPYRAL HTN-OFF MED Study; NCT02439749).
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Böhm et al. (2021) conducted an RCT in Uncontrolled hypertension. Renal denervation (Symplicity Spyral multi-electrode system) vs. Sham control was evaluated on Treatment difference in 24-hour systolic blood pressure change from baseline to 3 months (in patients with baseline office heart rate ≥70 beats/min) (MD -6.2 mm Hg, 95% CI -9.0 to -3.5, p=<0.001). Renal denervation reduced 3-month 24-h SBP more in patients with baseline HR ≥70 bpm (-6.2 mm Hg; 95% CI -9.0 to -3.5; P<0.001) than <70 bpm (-0.1 mm Hg; P_interaction=0.008).
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