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Blood Pressure Reduction by Renal Denervation Maintained Over 24 Months in the EnligHTN I Trial


Presented by Costas Tsioufis, Greece

The EnligHTNTM renal denervation system reduced office blood pressure (BP) with no serious periprocedural adverse events over 24 months of follow-up. Costas Tsioufis, MD, PhD, University of Athens, Athens, Greece, presented long-term data from the Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients trial [EnligHTN I; NCT01438229].

The EnligHTN renal denervation system uses a multielectrode device to produce acute lesions with a predictable pattern. During the procedure, after being positioned proximal to the bifurcation of the renal artery, the basket is expanded and a diagnostic check is performed to ensure electrode contact. Ablation is performed for 90 seconds per electrode. The basket is collapsed, pulled back 1 cm then rotated and expanded, wherein the diagnostic check is performed, followed by ablation. The purpose of this study was to determine the long-term safety and efficacy of renal denervation with the EnligHTN renal denervation system.

In the open-label, interventional, first-in-human, EnligHTN I trial, 46 patients with resistant hypertension received renal denervation and were followed for 24 months. No control group was enrolled. Resistant hypertension was defined as office systolic BP of ≥160 mmHg that did not respond to ≥3 concurrent antihypertensive medications at maximally tolerated doses for a minimum of 14 days prior to enrollment. Patients aged 18 to 80 years were excluded if they had a history of prior renal artery intervention, renal artery stenosis >30%, multiple main renal arteries, main renal arteries <4 mm in diameter or <20 mm in length, a glomerular filtration rate of <45 mL/minute/1.73m2, type 1 diabetes, identified cause of secondary hypertension, or significant valvular heart disease.

The primary objective was to evaluate all adverse events and office BP. At baseline, the mean SBP and diastolic (DBP) were 176 mmHg and 96 mmHg, respectively, with a mean number of antihypertensives of 4.7. In addition, 33% of patients had diabetes, 30% had sleep apnea, 59% had hyperlipidemia, 20% had coronary artery disease, and the mean body mass index was 32 kg/m2. The mean left and right renal artery ablations that were performed were 7.4 and 7.7, respectively, with a mean of 15 total ablations performed per patient. The man procedure time was 34 minutes.

In the EnligHTN I trial, renal denervation resulted in a significant decrease in office SBP and DBP at 1 month that was maintained to 24 months (p<0.0001; Figure 1). Similarly, ambulatory BP was significantly decreased from baseline following renal artery denervation (p<0.0001). At 24 months, 77% of patients were considered to have responded to renal denervation, with a >10 mmHg reduction of office SBP from baseline. In addition, at 24 months, 39% of patients experienced an office SBP of <140 mmHg.

Through 24 months of follow-up, there were no serious periprocedural events in the EnligHTN I trial. Serious device or procedure-related events included 1 case of worsening pre-existing proteinuria, 1 case of symptomatic hypotension, and 2 events in 1 patient of worsening of pre-existing renal artery stenosis with a new stenotic lesion.

Prof. Tsioufis concluded that data from the EnligHTN I trial indicate that renal denervation with the EnligHTN system is effective in lowering office BP with an acceptable safety profile.



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