ERADICATE-AF: Renal Artery Denervation Improves Results of Catheter Ablation in Atrial Fibrillation with Hypertension

May 14, 2019

SAN FRANCISCO--Study results reported at the 40th HRS Scientific Sessions showed at 1 year, more patients remained AF-free in the renal  denervation/catheter ablation group than in the group receiving catheter ablation alone (71.4% vs 57.8%). 

SAN FRANCISCO― Renal artery denervation, when used in conjunction with pulmonary vein isolation increased likelihood of freedom from atrial fibrillation (AF) at 12 months compared with pulmonary vein isolation alone, in patients with atrial fibrillation and hypertension.1 Jonathan S. Steinberg, MD, 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 presented this finding at the 40th Annual Heart Rhythm Scientific Sessions held in San Francisco last week.

Hypertension is a common comorbidity in patients with AF and contributes negatively to clinical outcomes and response to therapies, Dr Steinberg told the audience at the May 9th late breaking clinical trials session. Pulmonary vein isolation is a standard procedure used in these patients who have not achieved optimal response to previous antiarrhythmic pharmacotherapies, but it, too, often fails to produce durable results.

Early limited studies showed that renal artery denervation significantly reduced sympathetic tone in patients with AF and hypertension, but negative findings from the SYMPLICITY-HTN3 trial2 prompted questions about the efficacy of renal denervation. This outcome led Dr Steinberg and colleagues from multiple sites in Russia, Poland, and Germany, to test the hypothesis in a large, single-blind, longitudinal, randomized clinical trial. For the ERADICATE-AF (Evaluate renal artery denervation in addition to catheter ablation to eliminate atrial fibrillation) trial, they randomly assigned 302 patients with paroxysmal AF and hypertension to receive catheter ablation alone or catheter ablation plus renal denervation.

Hypertension was defined as systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg despite taking at least one antihypertensive medication (median = 2). The primary endpoint was freedom from AF recurrence at 12 months, free of antiarrhythmic therapy. Key secondary endpoints included procedure complications and blood pressure control at 6 and 12 months.

At the end of 12 months, more patients remained free of AF (off medication) in the renal artery denervation with catheter ablation group (71.4%) than in the group receiving catheter ablation alone (57.8%). Systolic and diastolic blood pressure control was also improved at both 6 and 12 months in the group that underwent both procedures.  Twice as many patients with catheter ablation alone were hospitalized (11.7% v 5.2%) for cardiovascular reasons.

Dr. Steinberg concluded that renal denervation is “reasonable to employ” as a method to enhance the success of catheter ablation in patients with AF and hypertension.

References

1. Steinberg JS, Shabanov V, Ivanickiy E, et al. Evaluate renal artery denervation in addition to catheter ablation to eliminate atrial fibrillation. In: Heart Rhythm Society Annual Scientific Sessions: Late Breaking Clinical Trials Session 1; May 8-11, 2019; San Francisco. S-LBCT01-03
2. Bakrus GL, Townsend RR, Liu M, et al. Impact of renal denervation on 24-hour ambulatory blood pressure: Results from SYMPLICITY HTN-3. JACC 2014;64:1071-1078. https://doi.org/10.1016/j.jacc.2014.05.012