PP.26.05

Abstract

Objective: In order to gain insights from a large patient dataset, we investigated the safety and performance of the EnligHTN™ Renal Denervation System (St. Jude Medical) in patients with drug-resistant hypertension using poled data from all trials performed to date. This is the first report of pooled data from the EnligHTN I, II and III trials. Design and method: The EnligHTN renal artery ablation catheter has 4 electrodes attached on a basket mounted at the tip of the catheter. We analysed data from the EnligHTN I, III and III trials which met the following criteria: 18–80 years of age, an office systolic BP > 160 mmHg, on three or more antihypertensive agents (including a diuretic), and renal artery diameter > 4 mm and length > 20 mm. All trials used the same catheter, but in the later phase of the EnligHTN II trial and the EnligHTN III trial the next generation simultaneous delivery of radiofrequency was performed. Results: To date 187 patients met this criteria from these 3 studies, with 6 month follow up data available (EI n = 46, EII n = 104, EIII n = 37). Mean age for the dataset was 61 yr.s with mean office systolic BP at baseline of 179mmHg and at 6 months of 158mmHg. A 6 month reduction in office systolic BP of 21mmHg was noted (p < 0.05). Mean 24 hr systolic ABP at baseline was 155mmHg and at 6 months was 147mmHg. This 8mmHg drop was statistically significant (p < 0.05). With regards BP reduction within this dataset, baseline systolic office and 24 hour ambulatory BP value, and the use of ACEI/ARB and aldosterone antagonists at baseline were predictors of the level of BP reduction. Enrolment within the first in human trials (EI&III) had larger observed reductions in BP. Complete safety analysis including renal function will be included in the presentation. Conclusions: Pooled data from the complete EnligHTN clinical trial dataset meeting traditional study definitions of resistant hypertension confirm the efficacy and safety of the EnligHTN multi-electrode system for renal artery denervation. Future randomised controlled trials in the patient population with next generation multi-electrode renal denervation systems are warranted.