Böhm M, Kario K, Kandzari DE, et al. - Given catheter-based renal denervation has significantly decreased blood pressure in earlier investigations, researchers planned the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial, following a positive pilot trial, to determine the efficacy of renal denervation in the absence of antihypertensive medications. They undertook this international, prospective, single-blinded, sham-controlled trial at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA. The participants were hypertensive patients exhibiting office systolic blood pressure of 150 mm Hg to less than 180 mm Hg. The patients were randomly allocated 1:1 to either a renal denervation or sham procedure. In SPYRAL Pivotal, catheter-based renal denervation was shown to be superior to a sham procedure to safely reduce blood pressure in the absence of antihypertensive medications.