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Meta-Analysis of Sham-Controlled Renal Denervation Trials
Study Questions:
What is the effect of renal sympathetic denervation (RSD) on blood pressure (BP) in previously published sham-controlled randomized trials?
Methods:
Randomized controlled trials with >50 patients comparing catheter-based RSD with sham-control were included in this random-effects meta-analysis. The authors compared weighted mean differences (WMDs) in BP between the two groups.
Results:
Six trials with 977 patients were included in the analysis. The reduction in 24-hour ambulatory systolic BP (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD -3.65 mm Hg, 95% confidence interval, -5.33 to -1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP, office SBP, 24-hour ambulatory diastolic BP (DBP), daytime ambulatory DBP, and office DBP. Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p for interaction = 0.04).
Conclusions:
RSD significantly reduced BP compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.
Perspective:
This analysis highlights the safety of catheter-based RSD and attempts to show efficacy with respect to greater BP reduction with RSD compared to sham-controlled procedure. The analysis included six trials, of which the majority enrolled <100 patients and were not powered for efficacy. In addition, the follow-up period was short-term. The authors were able to show meager but clinically relevant improvements in SBP in favor of renal denervation. The results of this analysis mainly provide guidance for designing a large randomized clinical trial to compare the effect of sham-control versus newer catheter-based denervation techniques on BP in patients with resistant hypertension.
Clinical Topics: Prevention, Hypertension
Keywords: Blood Pressure, Blood Pressure Monitoring, Ambulatory, Catheters, Denervation, Hypertension, Secondary Prevention, Sympathectomy, Vascular Diseases
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