EnligHTN-1: Renal Denervation Catheter Ablation System Appears Safe, Effective for Drug-Resistant Hypertension Patients

EnligHTN, a new multi-electrode renal denervation catheter ablation system that produces predictable stereotactic lesion patterns in the renal artery wall, may induce sustainable reductions in blood pressure in patients with drug-resistant hypertension, according to data from the EnligHTN-1 study released on Nov. 5 as part of AHA 2012.

The study looked at 46 patients with drug-resistant hypertension with a mean age of 60 years who were taking an average of four hypertension medications at the time of enrollment. At baseline, mean office blood pressure was 176/96 mm Hg. However, one month post-ablation there were statistically significant mean reductions in systolic and diastolic blood pressure of 28 and 10 mm Hg, respectively (p<0.001). Mean blood pressure was reduced to 148/87 mm Hg.

According to the study investigators, these reductions were maintained at three- and six-month follow-up. Reductions in 24-hour ambulatory blood pressure (ABP), a secondary endpoint, also achieved statistical significance. At baseline, mean 24-hour ABP was 150/83, which was reduced to a mean 140/78 mm Hg (p<0.0001). This reduction, too, was sustained at three- and six-month follow-up. Overall, 76 percent of patients had a greater than 10 mm Hg reduction in blood pressure from baseline. 

In addition to reductions in blood pressure, researchers noted there was no clinically significant changes in renal function were observed and there were no serious or life-threatening periprocedural complications. Several patients experienced minor complications during the ablation procedure.

Renal denervation is an emerging treatment for patients with drug-resistant hypertension. However, until the EnligHTN-1 clinical trial, no systems designed to produce predictable lesion patterns had been studied, said lead investigator Vasilios Papdemetriou, VA Medical Center, Washington, DC. In general, Papdemetriou and the other investigators said the EnligHTN-1 results suggest that the EnligHTN ablation system offers safe, rapidly achievable and sustainable blood pressure reductions in this patient population.

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