What question did this study set out to answer?

To evaluate the efficacy of catheter-based renal sympathetic denervation compared with an invasive sham control in patients with mild resistant hypertension.

April 1, 2015HypertensionOpen Access

Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension

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Why the study?

Does renal sympathetic denervation reduce 24-hour systolic BP in patients with mild resistant hypertension?

Population

71 patients with resistant hypertension and slightly elevated BP

Comparison

Renal sympathetic denervation with the… vs Invasive sham procedure

Design

RCT, 1:1 ratio, sham-controlled

Follow-up

6 months

Authors

SDSteffen DeschInterventional Cardiology TOThomas OkonUniversity Hospital Leipzig DHDiana HeinemannLeipzig Heart Institute

Discussion

Member takes

Implication

Renal denervation is not superior to sham for 24-hour SBP reduction in mild resistant hypertension; challenges prior non-sham evidence and leaves efficacy open in severe cases.

Key Points

To evaluate the efficacy of catheter-based renal sympathetic denervation compared with an invasive sham control in patients with mild resistant hypertension.
Randomized, sham-controlled trial (N=71; NCT01656096) assigning patients 1:1 to renal sympathetic denervation with the Symplicity Flex Catheter or an invasive sham procedure.
Included participants had resistant hypertension with mild daytime elevations (systolic 135–149 mm Hg and diastolic 90–94 mm Hg on 24-hour ambulatory measurement).
The primary endpoint was the change in 24-hour ambulatory systolic blood pressure at 6 months analyzed in the intention-to-treat population.
In the primary intention-to-treat analysis, 24-hour systolic blood pressure changed by -7.0 mm Hg (95% CI, -10.8 to -3.2) with denervation versus -3.5 mm Hg (95% CI, -6.7 to -0.2) with sham (P=0.15).
In the per-protocol population, 24-hour systolic blood pressure changed by -8.3 mm Hg (95% CI, -11.7 to -5.0) in the denervation group compared to -3.5 mm Hg (95% CI, -6.8 to -0.2) in the sham group (P=0.042).

Structured PICO

Does renal sympathetic denervation reduce 24-hour systolic BP in patients with mild resistant hypertension?

Population

71 patients with resistant hypertension and slightly elevated BP (day-time systolic pressure 135-149 and diastolic pressure 90-94 mm Hg on 24-hour ambulatory measurement)

Intervention

Renal sympathetic denervation with the Symplicity Flex Catheter

Comparator

Invasive sham procedure

Outcome

Change in 24-hour systolic BP at 6 months between groups in the intention to treat populationsurrogate

In patients with mild resistant hypertension, renal sympathetic denervation did not significantly reduce 24-hour systolic BP at 6 months compared to a sham procedure in the intention-to-treat analysis.

Cite This Study

Desch et al. (2015) studied this question.

synapsesocial.com/papers/6a71a8dda528af2d65c42a75 https://doi.org/10.1161/hypertensionaha.115.05283

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Implication

Renal denervation is not superior to sham for 24-hour SBP reduction in mild resistant hypertension; challenges prior non-sham evidence and leaves efficacy open in severe cases.

Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider