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

Sep 16, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2014
Date Updated:
09/16/2014
Original Posted Date:
09/16/2014
References

Description:

The SYMPLICITY-HTN 3 trial failed to demonstrate a reduction in blood pressure from renal sympathetic denervation compared with sham among individuals with severe refractory hypertension (n = 535 patients). The goal of the current trial was to evaluate renal sympathetic denervation compared with sham among participants with mild resistant hypertension.

Hypothesis:

Renal sympathetic denervation will improve blood pressure.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Participants with mild resistant hypertension
  • Mean daytime ambulatory systolic blood pressure 135-149 mm Hg and/or mean diastolic blood pressure 90-94 mm Hg
  • ≥3 antihypertensive medications and stable dosage within the last 4 weeks
  • ≥18 years to ≤75 years

    Number of enrollees: 71
    Duration of follow-up: 6 months
    Mean patient age: 65 years
    Percentage female: 23%

Exclusions:

  • Unsuitable anatomy for renal sympathetic denervation
  • Estimated glomerular filtration rate <45 ml/min/1.73 m2

Primary Endpoints:

  • Change in 24-hour systolic blood pressure at 6 months

Drug/Procedures Used:

Participants with mild resistant hypertension were randomized to renal sympathetic denervation with the Symplicity Flex catheter (n = 35) versus sham procedure (n = 36).

Renal sympathetic denervation consisted of 4-6 circumferential ablation runs of 2 minutes. Sham procedure consisted of renal angiography and acoustic signals to mimic the denervation procedure, and saline infusion to mimic analgesic medications.

Principal Findings:

Overall, 71 patients were randomized. The mean age was 65 years, 23% were women, mean body mass index was 32 kg/m2, and 54% had diabetes. The mean number of antihypertensive medications was 4.4.

The mean change in 24-hour blood pressure (intention to treat) was -7.0 mm Hg in the renal denervation group versus -3.5 mm Hg in the sham group (p = 0.15). The mean change in 24-hour blood pressure (treatment received) was -8.3 mm Hg in the renal denervation group versus -3.5 mm Hg in the sham group (p = 0.042).

Interpretation:

Among patients with mild resistant hypertension on a mean of 4.4 antihypertensive medications, renal denervation failed to reduce the mean ambulatory blood pressure at 6 months. However, analysis according to actual treatment received suggested a benefit from renal denervation. The current study is limited by small sample size and no urine analysis to assess medication adherence.

References:

Presented by Dr. Steffen Desch at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 16, 2014.

Keywords: Medication Adherence, Denervation, Body Mass Index, Sympathectomy, Intention to Treat Analysis, Blood Pressure Determination, Hypertension, Diabetes Mellitus


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