Cryoballoon ablation may be better first-line treatment vs. drug therapy in paroxysmal AF
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In a study of patients with paroxysmal atrial fibrillation not previously treated with drug therapy, cryoballoon catheter ablation bested antiarrhythmic drugs in treatment success at 12 months.
The rate of freedom from primary efficacy failure at 12 months was 75% (95% CI, 65-82) in patients who underwent pulmonary vein isolation with the cryoballoon catheter (Arctic Front Advance, Medtronic) compared with 45% (95% CI, 35-55) in patients assigned class I or III antiarrhythmic drug therapy (P < .0001), Oussama Wazni, MD, section head of electrophysiology and pacing at Cleveland Clinic, said during a presentation of the STOP AF First study at the virtual European Society of Cardiology Congress.
Primary efficacy failure was defined as subsequent surgery or ablation treatment for AF; AF, atrial flutter or atrial tachycardia after the 90-day blanking period; cardioversion after the 90-day blanking period; and, in the treatment arm only, acute procedural failure or use of class I or III antiarrhythmic drugs after the 90-day blanking period.
The results were driven by more cases of AF, atrial flutter or atrial tachycardia and of ablation treatment for AF in the drug group compared with the cryoballoon ablation group, Wazni said.
“I was expecting, based on what we knew, that ablation was going to be more effective,” Wazni told Healio. “But I didn’t expect it to be by this much. One factor was that so many patients in the antiarrhythmic drug arm needed ablation anyway, and crossed over because of intolerance or recurrence of AF on the medications.”
The primary safety endpoint occurred in 1.9% of patients from the ablation group (95% CI, 0.5-7.5) at 12 months, beating the performance goal of 12% (P < .0001), according to the researchers.
Primary safety events were defined as stroke, transient ischemic attack, MI, major bleeding or vascular complications at 7 days; significant pericardial effusion at 30 days; and symptomatic pulmonary vein stenosis, an atrial-esophageal fistula or unresolved phrenic nerve injury at 12 months.
Safety events occurred in two patients in the cryoballoon arm: one who had MI within 7 days and one who had significant pericardial effusion at 30 days, Wazni said during the presentation. He also noted that one patient in the drug therapy arm had a major vascular complication after requiring an ablation.
“This tells us the procedure is very safe,” Wazni told Healio. “There was only one event in the ablation arm directly related to the procedure itself.”
The analysis included 104 patients from the cryoballoon arm (mean age, 60 years; 61% men) and 99 patients from the drug arm (mean age, 62 years; 58% men). The most common medication given to patients in the drug arm was flecainide (66%).
He said the results have the potential to change the labeling of the cryoballoon to allow its use before antiarrhythmic drugs, and noted that “the concept of ablation, regardless of technology, could get a boost. In our guidelines, ablation has a class IIa indication, and is only class I after the patient fails drug therapy. It’s possible that ablation without medications will be bumped up. It’s a big step forward for our patients, because these medications have a lot of side effects.”
As the authors highlight in their presentation, there have been several clinical trials focused on this important group of patients and the treatment decision they are faced with (antiarrhythmic drug or ablation) for first-line rhythm control. The results of these earlier trials suggest that AF ablation has advantages over drug therapy, but the STOP AF First results really highlight the superiority of ablation in terms of maintaining sinus rhythm, and with an excellent safety profile.
I think the American Heart Association/American College of Cardiology/Heart Rhythm Society and ESC guidelines have it right — it is a IIA indication and should be considered and discussed with patients when they require rhythm control for symptomatic AF. Not all patients should be treated with an antiarrhythmic drug. Shared decision-making with the patient is important. Many patients and physicians will conclude that first-line ablation is the better treatment for them.
There has been a growing emphasis on first-line ablation. Additional randomized evidence like STOP AF First will help the broader CV community see the advantages of first-line ablation and consider referral earlier for symptomatic AF.
Perspective
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Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS
As the authors highlight in their presentation, there have been several clinical trials focused on this important group of patients and the treatment decision they are faced with (antiarrhythmic drug or ablation) for first-line rhythm control. The results of these earlier trials suggest that AF ablation has advantages over drug therapy, but the STOP AF First results really highlight the superiority of ablation in terms of maintaining sinus rhythm, and with an excellent safety profile.
I think the American Heart Association/American College of Cardiology/Heart Rhythm Society and ESC guidelines have it right — it is a IIA indication and should be considered and discussed with patients when they require rhythm control for symptomatic AF. Not all patients should be treated with an antiarrhythmic drug. Shared decision-making with the patient is important. Many patients and physicians will conclude that first-line ablation is the better treatment for them.
There has been a growing emphasis on first-line ablation. Additional randomized evidence like STOP AF First will help the broader CV community see the advantages of first-line ablation and consider referral earlier for symptomatic AF.
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Wazni O, et al. Late-breaking science in atrial fibrillation 1. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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