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BP reductions with EnligHTN ablation system sustained at 1 year
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PARIS — New 6-month and 1-year data from the EnligHTN I first-in-man study demonstrate safety and efficacy of the multielectrode renal denervation system in patients with drug-resistant hypertension.
The prospective, multicenter, feasibility EngligHTN I trial enrolled 46 patients (mean age, 60 years; mean BMI, 32) who were taking at least three antihypertensive medications including a diuretic. Mean baseline BP was 176 mm Hg/96 mm Hg.
According to 1-year data presented at EuroPCR, patients treated with the EnligHTN Renal Denervation System (St. Jude Medical) experienced a mean systolic BP reduction of –27 mm Hg points when measured in an office setting. Further, 80% of patients responded to therapy, defined as BP reduction ≥10 mm Hg when measured during an office visit. The researchers reported no significant changes in kidney function, according to a company press release.
“The results of the EnligHTN I study confirm that the early significant reduction in BP is sustained through 12 months, but as important are the favorable renal effects as evidenced by an improvement in some kidney markers,” primary investigator Stephen G. Worthley, MBBS, PhD, of Royal Adelaide Hospital in Australia, stated in the release. Worthley reported the study’s 1-year findings during a presentation at EuroPCR in Paris.
At the American Society of Hypertension Annual Scientific Meeting in mid-May, Vasilios Papademetriou, MD, presented 6-month data from the EnligHTN I trial.
After renal denervation, average office BP was reduced by –28 mm Hg/10 mm Hg at 1 month, –27 mm Hg/10 mm Hg at 3 months and –26 mm Hg/10 mm Hg at 6 months (P<.001 for all). Mean reductions in 24-hour ambulatory BP monitoring (baseline, 150 mm Hg/83 mm Hg) were –10 mm Hg/5 mm Hg at 1 month, –10 mm Hg/5 mm Hg at 3 months and –10 mm Hg/6 mm Hg at 6 months (P<.001 for all). The percent of responders was 78% at 1 month, 80% at 3 months and 76% at 6 months, according to the study abstract.
Effective BP reduction was observed in all subgroups of patients, including those with type 2 diabetes, CAD, sleep apnea and elevated BMI. Pearson correlation analysis revealed a strong association between systolic BP response at 6 months and baseline BP (P<.0001) and baseline heart rate (P=.04), according to the abstract.
The researchers reported no clinically significant changes in serum creatinine or estimated glomerular filtration rate and no serious or life-threatening periprocedural complications.
“We concluded that data through 6 months demonstrate that the EnligHTN ablation system is safe and effective in the treatment of patients with drug-resistant hypertension,” Papademetriou and colleagues concluded.
In the EnligHTN I trial population, an average of 7.7 lesions were created in the right renal artery and 7.4 in the left renal artery. Median procedure time was 30 minutes, according to the study abstract.
Patients in this trial will be followed for 2 years after the procedure.
For more information:
Papademetriou V. LB-OR-03. Presented at: American Society of Hypertension Annual Scientific Meeting; May 15-18, 2013; San Francisco.
Worthley S. Renal denervation: Novel approaches and first-in-man results. Presented at: EuroPCR; May 21-24, 2013; Paris.
Disclosure: The EnligHTN I trial was sponsored by St. Jude Medical.
Perspective
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Krishna J. Rocha-Singh, MD, FACC, FAHA
If you compare the mean systolic BP reductions observed in the trials assessing the EnligHTN, Symplicity (Medtronic) and Vessix (Boston Scientific) renal denervation catheters in patients with severe treatment resistant hypertension on approximately 5 anti-hypertension medications, a similar trend begins to emerge; if you start at the same systolic BP (178-182 mm Hg), a successful renal denervation appears to result in a 6-month reduction in systolic BP between 25 to 28 mm Hg. This trend may relate to the pathophysiology and biology of ablating efferent and afferent renal nerves with radiofrequency energy. I anticipate that a discussion will evolve over the next year or so as more data emerges with radiofrequency energy as to whether we are witnessing the emergence of a "class effect" among these radiofrequency devices. In the coronary stent world, some cardiologists believe that technical evolution of drug-eluting stents has reached a plateau and they have become commodities. Obviously, we can’t say that about renal denervation as of yet because we don’t have the breadth and extent of effectiveness and safety follow-up data, but you do start to see the same systolic BP effect at 6 and 12 months. Perhaps longer-term (2-3 year) follow-up data may differentiate these radiofrequency devices based on durability of BP effect and safety. Other points of device differentiation will relate to ease-of-use, total ablation time, which relates to patient discomfort, and French size of the system. The EnligHTN catheter will likely be iterated because it is an 8F system and most US cardiologists are probably more comfortable with guidewire-based systems, particularly in difficult anatomies.
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