Home > Journal Club > Journal Club 25 June 2014

Journal Club 25 June 2014

Paper

A Controlled Trial of Renal Denervation for Resistant Hypertension

Presenter

IM

Summary

Background

Prior unblinded studies have suggested that catheter-based renal-artery denervation
reduces blood pressure in patients with resistant hypertension.

Methods

We designed a prospective, single-blind, randomized, sham-controlled trial. Patients
with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo
renal denervation or a sham procedure. Before randomization, patients were receiving
a stable antihypertensive regimen involving maximally tolerated doses of at
least three drugs, including a diuretic. The primary efficacy end point was the
change in office systolic blood pressure at 6 months; a secondary efficacy end point
was the change in mean 24-hour ambulatory systolic blood pressure. The primary
safety end point was a composite of death, end-stage renal disease, embolic events
resulting in end-organ damage, renovascular complications, or hypertensive crisis
at 1 month or new renal-artery stenosis of more than 70% at 6 months.

Results

A total of 535 patients underwent randomization. The mean (±SD) change in systolic
blood pressure at 6 months was −14.13±23.93 mm Hg in the denervation
group as compared with −11.74±25.94 mm Hg in the sham-procedure group
(P<0.001 for both comparisons of the change from baseline), for a difference of
−2.39 mm Hg (95% confidence interval [CI], −6.89 to 2.12; P = 0.26 for superiority
with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure
was −6.75±15.11 mm Hg in the denervation group and −4.79±17.25 mm Hg in
the sham-procedure group, for a difference of −1.96 mm Hg (95% CI, −4.97 to 1.06;
P = 0.98 for superiority with a margin of 2 mm Hg). There were no significant differences
in safety between the two groups.

Conclusions

This blinded trial did not show a significant reduction of systolic blood pressure in
patients with resistant hypertension 6 months after renal-artery denervation as
compared with a sham control.

Supplementary Material

Supplementary material
Editorial
Schmieder commentary
Review

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