One year results from The Peregrine Study of alcohol-mediated renal denervation in refractory hypertension

The Peregrine Study isa prospective, multicenter, open-label,safety and performance study to treatpatients with refractory hypertension via alcohol-mediated renal denervation. Inclusion required a systolic OBP of ≥ 160 mmHg and daytime mean ABPM of ≥ 135 mmHg, while on a stable regimen of 3 medications including a diuretic (monitored for 28 days). Secondary hypertension was ruled out. Dehydrated alcohol was infused via the Peregrine Catheter at a volume of 0.3 mL per renal artery. The majority of procedures (15 total in 10 subjects) were performed without the need for sedation. No serious procedural events or device complications were recorded. There were no vascular or cardiovascular complications.The mean procedure time and fluoroscopy time per renal artery were 8±5and 6±5 minutes respectively. Mean total contrast used per renal artery was 40±18 mL. CTA analysis showed no new stenosis from baseline to the 6-month exam. Study endpoints at 6-months were met: no major adverse events at 30 days, and mean systolic OBP was reduced by ≥ 10%. At 1 year, mean systolic and diastolic OBPand 24-hour systolic ABPM were reduced from baseline by21/2mmHg and 7/3 mmHg, respectively.At 1-year mean eGFR was unchanged from baseline, consistent with the 6-month results. Noserious adverse events were reported between the 6-month and the 1-year visits. Reduction in blood pressure at 1 year continue to demonstrate the effect of alcohol-mediated renal denervation on blood pressure. Further studies evaluating an alcohol volume of 0.6 mL per renal artery are on-going.