Abstract
Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (−6.6 mmHg) and sham control (−6.5 mmHg) groups (difference: −0.1, 95% confidence interval −5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: –1.8 mmHg [p = 0.488] and −2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial.Clinical trial registrationNCT02918305 (http://www.clinicaltrials.gov).
Highlights
A list of members and their affiliations appears in the Supplementary Information
Efficacy analyses for blood pressure (BP) values were conducted in the full analysis set, and safety was determined in the safety analysis set which included all randomized patients
The results presented here are interesting considering the findings of the SYMPLICITY HTN-3 [9] and RADIANCE-HTN TRIO [16] studies
Summary
There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia [5, 6]. Catheter-based renal denervation has emerged as a potential treatment option for patients with resistant hypertension. Proof-of-concept trials reported dramatic BP-lowering effects in patients treated with radiofrequency catheter-based renal denervation [7, 8]. The sham-controlled REnal denervation on Quality of 24-hr BP control by Ultrasound In REsistant hypertension (REQUIRE) trial was designed to assess the BPlowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea [26]. All physicians and study coordinators, including those who interacted with patients, were aware of treatment allocation, but BP assessments were performed by study personnel who were unaware of treatment allocation
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