A Controlled Trial of Renal Denervation in Patients with Resistant Hypertension

Bhatt et al published in the NEJM the findings of multicenter prospective trial of patients with severe resistant hypertension who were randomly assigned 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.

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 for a difference of −2.39 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.

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

The results of this landmark study that was designed to reduce clinical bias negate findings from prior reports that did not include sham treatment and reported that catheter renal artery denervation reduces blood pressure in patients with resistant hypertension.  The study reminds us of the importance of conducting blinded trials with sham controls before new treatments or devices are adopted.

Bhatt DL, Kandzari,DE, O'Neill WW et al:  A Controlled Trial of Renal Denervation for Resistant Hypertension.  N Engl J Med. 2014 Mar 29. [Epub ahead of print]

http://www.nejm.org/doi/full/10.1056/NEJMoa1402670?query=featured_home#t=article

DOI: 10.1056/NEJMoa1402670