SYMPLICITY HTN-3 Results Suggest No Benefit of Renal Artery Denervation on Ambulatory Blood Pressure

There was no demonstrated benefit of renal artery denervation on reduction in ambulatory blood pressure over 24-hours or over day and night periods compared with sham, according to results from the SYMPLICITY HTN-3 trial published on May 20 in the Journal of the American College of Cardiology.

The trial randomized 535 patients with resistant hypertension to renal denervation or sham control. According to the study authors, patients were on a stable antihypertensive regimen including maximally-tolerated doses of at least three drugs including a diuretic before randomization. Overall results showed that 24-hour ambulatory systolic blood pressure changed -6.8±15.1 mmHg in the renal denervation group and -4.8 ±17.3 mmHg in the sham group, while the daytime ambulatory systolic blood pressure change difference between groups was -1.1 (95% CI, -4.3 to 2.2; p = 0.52) and the nighttime ambulatory systolic blood pressure change difference between groups was -3.3 (95 CI, -6.7 to 0.1; p = 0.06). Change in 24-hour 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 randomized, sham-controlled, blinded trial failed to show a benefit of renal artery denervation on the powered secondary endpoint of 24-hour ambulatory [systolic blood pressure]. Daytime and nighttime [ambulatory blood pressure monitoring] and heart rate change were also not different between the denervation and sham control groups," the investigators said. Given previous unblended trials showing significant reductions in ambulatory blood pressure monitoring measurements six months post-denervation, they recommend further clinical research to truly understand if renal denervation has any role in the treatment of resistant hypertension.

Keywords: Renal Artery, Denervation, Diuretics, Blood Pressure Monitoring, Ambulatory, Hypertension

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