Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Drugs - TARGET BP I

Apr 08, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Ablative Solutions, Inc.
Date Presented:
04/08/2024
Date Published:
04/08/2024
Original Posted Date:
04/08/2024
References

Contribution To Literature:

The TARGET BP I trial showed that renal denervation was associated with a modest reduction in 3-month ambulatory systolic BP compared with sham control.

Description:

The goal of the trial was to evaluate alcohol-mediated renal denervation compared with sham control among patients with resistant hypertension.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Sham

Patients with resistant hypertension were randomized to alcohol-mediated renal denervation (n = 148) vs. sham control (n = 153).

  • Total number of enrollees: 301
  • Duration of follow-up: 6 months
  • Mean patient age: 57 years
  • Percentage female: 23%
  • Percentage with diabetes: 20%

Inclusion criteria:

  • Stable regimen of 2-5 antihypertensive medications, including diuretic
  • Renal artery diameter 3-7 mm
  • Office systolic blood pressure (BP) 150-180 mm Hg
  • Office diastolic BP ≥90 mm Hg
  • Ambulatory systolic BP 135-170 mm Hg

Exclusion criteria:

  • Secondary hypertension
  • Type 1 or uncontrolled diabetes
  • Estimated glomerular filtration rate <45 cc/min/1.73 m2
  • Acute coronary syndrome or stroke/transient ischemic attack within the last 6 months
  • New York Heart Association class II-III symptoms or left ventricular ejection fraction <30%
  • Chronic atrial fibrillation

Other salient features/characteristics:

  • Mean office systolic BP: 164 mm Hg
  • Mean office diastolic BP: 98 mm Hg

Principal Findings:

The primary outcome (24-hour ambulatory systolic BP) was -10.0 mm Hg in the renal denervation group vs. -6.8 mm Hg in the sham control group (p = 0.049).

Secondary outcomes:

  • 24-hour ambulatory diastolic BP: -5.4 mm Hg in the renal denervation group vs. -4.1 mm Hg in the sham control group (p = 0.12)
  • Office systolic BP: -12.7 mm Hg in the renal denervation group vs. -9.7 mm Hg in the sham control group (p = 0.17)
  • Major adverse events: 5.3% in the renal denervation group vs. 4.0% in the sham control group (p = 0.22)

Interpretation:

Among patients with resistant hypertension, renal denervation was associated with a modest improvement in BP control. Renal denervation was associated with a reduction in 24-hour ambulatory systolic BP at 3 months; however, there was no significant difference in office systolic BP compared with control. Further evaluation of this treatment strategy is warranted.

References:

Kandzari DE, Weber MA, Pathak A, et al. Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial. Circulation 2024;Apr 8:[Epub ahead of print].

Presented by Dr. David E. Kandzari at the American College of Cardiology Annual Scientific Session (ACC.24), Atlanta, GA, April 8, 2024.

Clinical Topics: Prevention, Hypertension, Vascular Medicine

Keywords: ACC24, ACC Annual Scientific Session, Hypertension, Renal Artery


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