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ERADICATE-AF: Renal denervation may help eliminate AF in certain patients
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SAN FRANCISCO — In patients with atrial fibrillation and hypertension, performing renal artery denervation in addition to catheter ablation increased the odds of 12-month freedom from AF compared with catheter ablation alone, according to the results of the ERADICATE-AF study.
Jonathan S. Steinberg, MD, FHRS, adjunct professor of medicine at the University of Rochester School of Medicine and Dentistry and director of SMG Arrhythmia Services at Summit Medical Group of New Jersey, and colleagues randomly assigned 302 patients with paroxysmal AF planned for catheter ablation and hypertension, defined as systolic BP 130 mm Hg or more and/or diastolic BP 80 mm Hg or more despite taking at least one antihypertensive medication (median = 2), to receive catheter ablation alone or catheter ablation plus renal denervation.
“The autonomic nervous system plays an important role in the development of atrial fibrillation,” Steinberg said during a presentation at the at the Heart Rhythm Society Annual Scientific Sessions. “Renal artery denervation can reduce systemic sympathetic tone. Hypertension is common in patients with AF, and contributes importantly to clinical outcomes and response to therapies. Pulmonary vein isolation is used in many patients who have unsatisfactory results with drug therapy for AF, and although effective, can have suboptimal results, both short- and long-term. The ERADICATE-AF trial was designed to test the hypothesis that renal denervation in addition to PVI enhances long-term antiarrhythmic efficacy in comparison to PVI alone for patients with AF and hypertension.”
All patients (mean age, 60 years; 40% women; mean baseline BP, 150.2 mm Hg/89.8 mm Hg) underwent complete pulmonary vein isolation with a cryoballoon catheter (Arctic Front Advance, Medtronic), and the renal denervation group underwent the procedure via radiofrequency ablation delivery within each radial artery by approved catheters, Steinberg said during the presentation.
The primary endpoint was, after a 3-month blanking period, freedom from AF recurrence and antiarrhythmic drugs at 12 months.
Periprocedural complications occurred in 4.4% of patients, but there were no differences in them between the groups, Steinberg said, noting that all complications were resolved prior to discharge.
At the end of the study period, more patients from the renal denervation group were free from AF recurrence compared with the control group (72.1% vs. 56.5%; HR = 0.57; 95% CI, 0.38-0.85), according to the researchers.
Systolic and diastolic BP control was better in the renal denervation group at 6 months and 12 months (P < .001 for all), Steinberg said.
There were two deaths in each group, one stroke in the control group and one MI in the renal denervation group, and there were more CV hospitalizations in the control group (5.2% vs. 11.7%), he said.
“Renal denervation is reasonable to employ to increase the success rate of AF ablation in patients with hypertension,” Steinberg said. – by Erik Swain
Reference:
Steinberg JS, et al. LBCT01-03. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 8-11, 2019; San Francisco.
Disclosure: Steinberg reports he consults for Allergan, Atricure, Biosense Webster, Corfigo, G Medical, Medtronic, National Cardiac and Omron, holds equity in AliveCor, G Medical and National Cardiac and received research grants from AliveCor, Biosense Webster and Medtronic.
Perspective
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Patrick T. Ellinor, MD, PhD
There has been lack of clarity about the potential role for renal denervation in the concomitant treatment of AF at the time of ablation. Lowering BP and disrupting renal enervation is an appealing hypothesis, but prior smaller trials were negative. The compelling parts of this study were that it was moderately sized, multicenter, well-designed and with an AF outcome as the primary endpoint. It is also critical that the procedure was safe, and the length of the procedure was only modestly longer than AF ablation without renal denervation. It was also encouraging that the study met its primary endpoint.
It would be nice to see these results replicated, which is always the case when there have been prior failures in an area. When there have been prior failures, I’m not sure having one positive study will or should lead to widespread clinical application of this approach.
A number of questions were raised that are important to consider. Obviously, BP was better controlled in the renal denervation arm. But the BP control was suboptimal in the pulmonary vein isolation-only group. The question is whether the better outcome is due to lower BP, as we know hypertension is a major driver for AF. Would the same success rates have been achieved if BP was lowered to goal by other means? Also, I was surprised that the success rate for the primary endpoint in the control group was only 56.5%, which seems like a lower-than-anticipated success rate compared to other contemporaneous ablation trials.
These results give the strategy of renal denervation a new life. If this study had been negative, that would likely have been the final nail in the coffin for renal denervation in this population. The fact that it is positive should spur additional studies that address the questions raised by this one, such as better BP control in the control arm and higher AF ablation success rates in both arms. That said, this was a nicely done study and the investigators should be congratulated.
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