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SearchAVANT GUARD is the first major study of PFA as first-line therapy for AF
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Oussama Wazni, M.D., MBA, performing a pulsed field ablation.
A new Cleveland Clinic-led trial has found that patients with persistent atrial fibrillation who received pulsed field ablation (PFA) as a first-line treatment experienced significantly less recurrence of irregular heart rhythms compared to those who received antiarrhythmic-drug therapy.
Findings were presented today during a late-breaking science session at the Heart Rhythm Society’s annual meeting in Chicago and simultaneously published in The New England Journal of Medicine.
Atrial fibrillation is the most common type of heart rhythm disorder, with at least 2.7 million Americans living with it. Persistent atrial fibrillation, defined as a continuous atrial fibrillation episode lasting more than seven days, affects up to 50% of those patients.
Compared to intermittent atrial fibrillation, persistent atrial fibrillation is associated with increased rates of adverse cardiovascular outcomes, such as premature death, blood clots, heart failure and increased rates of hospitalization.
The STOP AF FIRST trial, a previous Cleveland Clinic clinical trial published in 2020 and led by Oussama Wazni, M.D., section head of electrophysiology and pacing at Cleveland Clinic, was the first study to show that using catheter ablation as the first treatment for intermittent (paroxysmal) atrial fibrillation may be more effective than standard-of-care management using medications.
The AVANT GUARD trial reported today extends these findings to patients with persistent atrial fibrillation, showing that the success rate after one year is much higher with PFA compared to medical therapy.
“In the AVANT-GUARD trial, we found that an initial strategy of pulmonary vein isolation and posterior wall ablation using PFA for symptomatic, persistent atrial fibrillation resulted in a significantly lower rate of symptom recurrence compared to medical therapy,” said Dr. Wazni, principal investigator of the study.
“With continuous rhythm monitoring by an insertable device, the trial demonstrated that initial treatment with PFA resulted in a lower burden of detected atrial arrhythmia recurrence over one year follow-up compared to initial treatment with antiarrhythmic drugs.”
The trial enrolled 388 patients with previously untreated persistent atrial fibrillation; 310 patients were randomly assigned on a 2:1 basis to PFA (207 patients) or antiarrhythmic drug therapy (103 patients).
An additional 78 patients were assigned to receive PFA for the study's safety analysis. All patients received an insertable cardiac monitor.
Patients were followed for one year after treatment initiation and assessed at regular intervals throughout the year. For the PFA group, researchers looked at the initial success of the treatment and sustained lack of significant atrial fibrillation events throughout the year without additional treatment being needed. Researchers also compared how much time patients from both groups experienced an abnormal heart rhythm.
At 12 months, the primary effectiveness end point was met by 56.0% of patients in the PFA group versus 30.1% in the drug therapy group.
Device- or procedure-related serious adverse events occurred in 5.1% of PFA-treated patients, meeting the study’s prespecified safety goal. Serious adverse events overall occurred in 25.1% of the PFA group and 21.1% of the drug therapy group. No deaths were attributed to the PFA procedure or device.
The primary safety end point was the rate of device- or procedure-related serious adverse events in patients who received PFA. Six neurological events related to stroke occurred among the first 183 patients randomly assigned to PFA; all six showed clinical improvement or full recovery on follow-up.
After a temporary study pause and protocol modifications to improve safety, no strokes or transient ischemic attacks were observed among the subsequent 74 patients assigned to PFA.
“These latest results show that we are continuing to move the needle in terms of treatment since persistent atrial fibrillation patients are typically sicker and have more profound effects of the disease,” Dr. Wazni said. “We look forward to subsequent studies further down the line including a three-year follow-up as the next step.”
The AVANT GUARD study was funded by Boston Scientific.
Dr. Wazni is a paid speaker and consultant for Boston Scientific.
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