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