Renal Denervation Is Promising for Resistant Hypertension in a Sham Controlled Trial SPYRAL HTN-ON MED Study

Aditya Ganti, M.D.
By Aditya Ganti, M.D. on

A recent study published on The LANCET  demonstrated that renal denervation, targeting the sympathetic nervous system, significantly reduced systolic blood pressure among patients with uncontrolled hypertension who were taking antihypertensive medications.

This study aimed to demonstrate the efficacy and safety of catheter-based renal denervation for the treatment of moderate, uncontrolled hypertension in patients treated with commonly prescribed antihypertensive drugs.

David E Kandzari, MD ( the director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, Georgia) and colleagues report the 6-month efficacy and safety results from the randomized, single-blind, sham-controlled SPYRAL HTN-ON MED proof-of-concept trial. 467 patients screened, and only 80 got included, of which 38 patients randomized to renal denervation and 42 into sham control. Patients with uncontrolled hypertension with systolic blood pressure ≥ 150 to < 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher with one, two or three antihypertensive drugs, including a thiazide diuretic, were included in the trial. They underwent renal angiography and were randomly assigned to undergo renal denervation with radio-frequency ablation or sham control. The primary objective of this study is to monitor the blood pressure change from baseline, using ambulatory blood pressure measurements assessed at six months.

The authors stated that no significant difference was noticed between the groups at the end of 3 months. However, at the end of six months follow-up, patients randomized to the renal denervation procedure experienced an average 9 mm Hg drop in 24-hour mean systolic ambulatory blood pressure vs. a 1.6 mm Hg reduction in the sham procedure group resulting in a 7.4 mm Hg difference (p=0.005). Similarly, 24-hour mean diastolic ambulatory blood pressure also declined by 6 mm Hg with renal denervation vs. 1.9 mm Hg with the sham procedure which has 4.1 mm Hg  difference (p=0.029).

Furthermore, office systolic BP at six months follow-up was reduced by 9.4 mm Hg in the renal denervation group vs. 2.6 mm Hg in the sham procedure group (p = 0.215; difference, -6.8 mm Hg). Office diastolic BP was also reduced by 5.2 mm Hg with renal denervation vs. 1.7 mm Hg with the sham procedure (p= 0.188; difference, –3.5 mm Hg).

The investigators concluded a significant reduction in blood pressure following renal denervation over a six month period. Additionally, the short-term safety profile of the renal intervention was favorable with no major adverse events recorded. These findings showed great promise of this being a desirable intervention in the field of management of uncontrolled hypertension.

When asked about the clinical impact of this study Dr. Davdid Kandzari said “Data from the SPYRAL HTN-ON MED study is important for the clinical community and patients with hypertension as it represents a typical scenario of managing uncontrolled hypertension patients, prescribed up to three blood pressure medications.”


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