Physicians' Academy for Cardiovascular Education

Renal denervation associated with SBP reduction in meta-analysis of sham-controlled trials

Sham-Controlled Randomized Trials of Catheter-Based Renal Denervation in Patients With Hypertension

Literature - Sardar P, Bhatt DL, Kirtane AJ et al., - J Am Coll Cardiol. 2019; 73. DOI: 10.1016/j.jacc.2018.12.082

Introduction and methods

Conflicting results have been found in randomized trials evaluating the effectiveness of renal sympathetic denervation (RSD) to lower blood pressure (BP) in uncontrolled hypertension [1-4].

While initial trials showed significant BP reductions, three later, randomized, blinded, sham-controlled trials did not show a significant difference between treatment arms [3-5].

The lack of an observed treatment effect was postulated to arise from differences in patient selection criteria, procedural technique, concomitant medical regimens and primary outcomes. In response, smaller sham-controlled trials have been conducted that addressed some of these questions.

This meta-analysis of all available sham-controlled randomized trials (n≥50) evaluated the effect of RSD on BP in patients with uncontrolled hypertension. Patients with hypertension despite optimal and stable antihypertensive treatment regimens were included, as well as those with hypertension but not taking antihypertensive therapy. Primary efficacy outcome was change in 24-hour ambulatory systolic BP (ASBP).

Six trials met inclusion criteria, totaling of 977 participants (582 randomized to RSD and 395 to sham). Four trials permitted continuation of stable optimal medical therapy in both groups, and two trials enrolled patients who did not take antihypertensive medication for at least 3 to 4 weeks before randomization. SYMPLICITY HTN-3 accounted for 54.7% of patients in this meta-analysis.

Main results


This meta-analysis of six sham-controlled randomized trials demonstrates that patients treated with RSD show significantly greater reduction in 24-h ambulatory, daytime ambulatory, and office systolic and diastolic BP, than those who underwent the sham-procedure. This meta-analysis reinforces the importance of incorporating modifications in trial design as in the latest trials. A larger, pivotal trial should be conducted, consistent with the design of second-generation trials included in this analysis, to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension.


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