[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. (September 2016)

• Record Type: Journal Article
• Authors: Lobo, M.D.; Montarello, J.; Saxena, M.; Jain, A.; Walters, D.; Pincus, M.; Tsioufis, C.; Papademetriou, V.; Worthley, S.
• Is Part Of: Journal of hypertension. Volume 34:(2016) Supplement 2
• Publication Date: 2016-09
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000491460.20240.18
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : 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 2 ; 24-month was 77.1 ± 20.8 mL/min/1.73 m 2 . 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.