Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension

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 similar to 6.2 mm Hg (95% CI: similar to 9.0 to similar to 3.5 mm Hg) (P < 0.001) and for baseline office heart rate <70 beats/min it was similar to 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. (C) 2021 by the American College of Cardiology Foundation.