Renal denervation (RDN) using ultrasound or radiofrequency energy has demonstrated reductions in blood pressure (BP) among individuals with uncontrolled hypertension. However, whether alcohol-mediated RDN can achieve similar effects was unclear. In the recent TARGET BP I phase 3 randomized clinical trial, Kandzari et al. showed that alcohol-mediated RDN was associated with a modest but significant reduction in 24-hour ambulatory systolic blood pressure with favorable safety in individuals with uncontrolled hypertension.
The international, blinded, sham-controlled phase 3 randomized clinical trial TARGET BP I included 301 patients with uncontrolled hypertension, who were treated with 2–5 prescribed antihypertensive medications. The patients (72–76% male for the two groups) were randomly assigned to receive either 0.6 ml dehydrated alcohol per renal artery with a maximum dose of 2.4 ml dehydrated alcohol per patient, or sham control with diagnostic renal angiography only. Follow-up assessments are planned at 1, 3 and 6 months, and then annually up to 3 years after the procedure. Analyzing the change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline to 3-month follow-up as a primary efficacy endpoint of the study, the researchers showed that the alcohol-mediated RDN in patients was associated with a significant reduction in 24-hour ambulatory SBP (−10.0 ± 14.2 mmHg in the RDN group versus −6.8 ± 12.1 mmHg in the control group), although differences in office systolic and diastolic BP measures did not statistically vary. Notably, nonadherence to prescribed medications was commonplace in both groups, exceeding 50% at both baseline and 3 months. Up to the 6-month follow-up, no significant differences in major adverse events or renal function were observed between groups. Vessel patency among RDN patients confirmed at 6-month follow-up imaging was 99.6%. These results suggest that alcohol-mediated RDN is safe and effective, and longer-term follow-up will provide further information about the effectiveness of this therapy in the treatment of uncontrolled hypertension.
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