REQUIRE: Renal denervation as effective as sham procedure for BP reduction

Catheter-based ultrasound renal denervation produces similar blood pressure (BP)-lowering effects as sham procedure in Asian patients with resistant hypertension receiving antihypertensive therapy, according to the results of the REQUIRE trial.

REQUIRE included 143 patients aged 20–75 years from Japan and South Korea who had seated office BP ≥150/90 mm Hg, 24-hour ambulatory systolic BP ≥140 mm Hg, and suitable renal artery anatomy. They were randomized to ultrasound renal denervation (n=72) or a sham procedure (n=71).

Compared with the sham group, the renal denervation group had higher procedure time (86.7 vs 40.6 min), x-ray fluoroscopy time (23.6 vs 5.2 min), and contrast volume (147.8 vs 54.1 mL). Except for one patient, all those (98.6 percent) who underwent renal denervation had at least two sonications in each renal artery.

The primary endpoint of change from baseline in 24-hour ambulatory systolic BP at 3 months was not significantly different between the two treatment groups, (−6.6 mm Hg with renal denervation vs −6.5 mm Hg with sham; difference, −0.1, 95 percent confidence interval, −5.5 to 5.3; p=0.971). The same was true for reductions from baseline in home and office systolic BP (differences, –1.8 mm Hg [p=0.488] and −2.0 mm Hg [p=0.511], respectively).

Medication load was also similar between the two groups.

In terms of safety, there were no reports of procedure-/device-related major adverse events.

The findings, according to researchers, likely reflect shortcomings in the design and conduct of REQUIRE.