Modest reduction in ambulatory SBP with renal denervation in the presence of antihypertensive drugs

16/04/2024

ACC.24 – In Target BP I, alcohol-mediated renal denervation was associated with a modest reduction in 24-h ambulatory SBP at month 3 in patients with uncontrolled hypertension despite antihypertensive medications compared with sham control. There was no difference in office BP between treatment groups.

This summary is based on the presentation of David Kandzari, MD (Atlanta, GA, US) at the ACC.24 Scientific Session - Effect Of Alcohol-mediated Renal Denervation On Blood Pressure In The Presence Of Antihypertensive Drugs: 3-month Primary Results From The Target Bp I Randomized Trial.

Introduction and methods

Alcohol-mediated renal denervation (RDN) is a novel method of RDN, where dehydrated alcohol is locally delivered in the perivascular region to ablate renal nerves in order to achieve blood pressure (BP) reductions. The goal of Target BP I trial was to evaluate the effectiveness and safety of alcohol-mediated RDN in patients with uncontrolled hypertension despite 2-5 antihypertensive medications.

Target BP I was an international, multicenter, sham-controlled, randomized trial, which enrolled patients with office systolic BP (SBP) between ≥150 and ≤ 180 mmHg, diastolic BP (DBP) ≥90 mmHg, and 24-h ambulatory SBP between ≥135 and ≤170 mmHg who were on stable regime of 2-5 antihypertensive medication including diuretic for at least 4 weeks prior to randomization. A total of 301 patients were randomized to alcohol-mediated RDN (n=148) or sham control (n=153). 

The primary endpoint was change in 24-h ambulatory SBP from baseline to month 3.

Main results

  • Alcohol-mediated RDN was associated with a greater reduction in 24-h ambulatory SBP at month 3 compared with sham control (-10.0 mmHg vs. -6.8 mmHg; difference: -3.2 mmHg; 95%CI: -6.3 to 0.0; P=0.049).
  • There was no difference in office SBP at month 3 between the alcohol-mediated RDN group and the sham control group (-12.7 mmHg vs. -9.7 mmHg; difference: -3.0 mmHg; 95%CI: -7.0 to 1.0; P=0.173).
  • There was also no difference in ambulatory DBP and office DBP at month 3 between treatment groups (difference: -1.4 mmHg; 95%CI: -3.1 to 0.3; P=0.12 for ambulatory DBP; and -0.78 mmHg; 95%CI: -2.95 to 1.38; P=0.31 for office DBP).
  • Adherence to antihypertensive medications did not differ between the RDN group and sham control group. The proportion of patients who were fully adherent to antihypertensive medications were 43% vs. 41% at baseline and 51% vs. 49% at month 3 in the RDN group and control group, respectively.
  • There was a higher incidence of major adverse events at 30 days in the RDN group compared with the sham control group (4.7% vs. 0.0%; P=0.007). Most of these events were hypotension requiring intervention or medication change.
  • Major adverse events occurred at a similar rate in both treatment groups at month 6 (5.3% with RDN vs. 4.0% with sham; P=0.22).

Conclusion

In Target BP I, alcohol-mediated RDN was associated with a modest decrease in 24-h ambulatory SBP at month 3 post-procedure in patients with uncontrolled hypertension despite antihypertensive medications compared with sham control. There was no difference in office SBP between groups. The procedural and intermediate-term safety profile of alcohol-mediated RDN appeared to be favorable. “An ongoing dedicated follow-up will be important to inform the effectiveness of this therapy for the treatment of uncontrolled hypertension” concluded David Kandzari.

- Our reporting is based on the information provided at the ACC.24 Scientific Session -

The findings of this study were simultaneously published in Circulation

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