[OP.4C.04] SAFETY AND PERFORMANCE OF THE ENLIGHTN RENAL DENERVATION SYSTEM IN PATIENTS WITH DRUG-RESISTANT HYPERTENSION: POOLED ANALYSES FROM THE ENLIGHTN 1, 2 AND 3 TRIALS.

OBJECTIVE: Catheter-based renal denervation therapy is under evaluation in patients with resistant hypertension. To gain insights from a large dataset, we investigated safety and performance of the EnligHTN™ Renal Denervation System (St. Jude Medical) in patients with drug-resistant hypertension using pooled data from all trials performed to date. This is the first report of pooled data from the EnligHTN I-III trials through 24-months.

DESIGN AND METHOD: We analysed data from the EnligHTN trials with the following criteria: 18-80 years of age, office systolic BP >/=160 mmHg, >/=3 antihypertensive agents (including a diuretic), and renal artery diameter >/=4 mm, length >/=20 mm. All trials used the same renal artery ablation catheter.

RESULTS: 118 patients from these 3 studies (E1 n = 44, E2 n = 39, E3 n = 35), had 24-month follow up data available. Mean age was 61 yrs., mean office systolic BP (OSBP) at baseline of 177.1 mmHg and at 24 months of 151.3 mmHg. Therefore a 24-month reduction in OSBP of 25.8 mmHg was noted (p < 0.0001).103 patients from these 3 studies (E1 n = 43, E2 n = 27, E3 n = 33) had ABPM data available at 24-months. Mean 24-hr systolic ABP at baseline was 152.1 mmHg and at 24-months was 140.5 mmHg. This 11.7 mmHg drop was statistically significant (p < 0.0001).112 patients from these 3 studies (E1 n = 44, E2 n = 35, E3 n = 33) had eGFR data available at 24-months. Baseline was 79.8±19.9 mL/min/1.73 m; 24-month was 77.1 ± 20.8 mL/min/1.73 m. The change in eGFR at 24-months was not significant.

CONCLUSIONS: Pooled data from the complete EnligHTN clinical trial dataset meeting traditional study definitions of resistant hypertension confirm the efficacy and safety of multi-electrode systems for renal artery denervation. Future randomised controlled trials in the patient population with next generation multi-electrode renal denervation systems are warranted. Serious Renal Artery Adverse Events occurred in less than 2% of the population. In addition changes in medication and predictors of blood pressure response will be presented.