Renal Denervation—Ready for Prime Time!?
The Steep SPYRAL Stairs to RADIANCE in Hypertension Treatment
Two successive presentations at this year’s EuroPCR in Paris with simultaneous publication of the SPYRAL HTN-ON MED (Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial)1 and the RADIANCE-HTN SOLO (Endovascular ultrasound renal denervation to treat hypertension [RADIANCE-HTN SOLO]: a multicentre, international, single-blind, randomised, sham-controlled trial)2 trials in The Lancet may well go down as a turning point in the renal denervation saga. After much controversy around the efficacy of renal denervation as an interventional approach to lower blood pressure (BP), both studies, one performed with a multielectrode radiofrequency ablation device in hypertensive patients on concurrent medication (SPYRAL HTN-ON MED) and the other using a high-frequency ultrasound device in drug-naive hypertensive patients (RADIANCE-HTN SOLO), show a convincing and clinically relevant reduction of ambulatory BP compared with respective sham control groups. In concert with the recently published SPYRAL HTN-OFF MED3 study (Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications [SPYRAL HTN-OFF MED]: a randomised, sham-controlled, proof-of-concept trial), robust evidence is now available from 3 consecutive and adequately designed randomized, sham-controlled trials confirming the BP-lowering efficacy of catheter-based renal denervation approaches.
This represents an important milestone in the development of catheter-based ablation of renal sympathetic nerves and lays to rest the concerns that the experimentally well-established concept of therapeutically targeting these nerves4 may not apply in human hypertension.5 Similarly important in this context is the finding that various treatment modalities, that is, transluminal ablation achieved either by applying radiofrequency or ultrasound energy, seem to be safe and similarly effective in lowering BP in patients with hypertension.
Indeed, as observed in all renal denervation studies conducted thus far, the safety profile of each ablation approach …