Initial cryoballoon ablation strategy bests drug therapy for long-term AF progression
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CHICAGO — Initial treatment of paroxysmal AF with cryoballoon ablation lowered the incidence of AF progression by 75% at 3 years compared with antiarrhythmic drugs, according to results of the PROGRESSIVE-AF study.
Researchers for PROGRESSIVE-AF, an extension of the EARLY-AF study, also reported that adults with AF assigned to a first-line strategy of cryoballoon ablation had improved quality of life metrics, lower health care utilization and fewer adverse events at 3 years compared with adults initially assigned antiarrhythmic drug therapy.
“All of the ablation research to date largely focuses on people who have failed [an antiarrhythmic] drug, and ablation is always going to look better in people who have failed a comparator,” Jason Andrade, FRCPC, MD, director of heart rhythm services at Vancouver General Hospital, Canada, told Healio. “The next step becomes: What if we take someone with AF who has never had any treatment, randomize them and see what the value would be? That is where the EARLY-AF study came from.”
Long-term data
As Healio previously reported, in the EARLY-AF study cryoballoon ablation was associated with significant improvement over antiarrhythmic drugs as a first-line intervention for preventing AF events. The initial findings were presented at the 2020 AHA Scientific Sessions.
For PROGRESSIVE-AF, Andrade and colleagues analyzed data from 303 adults with untreated paroxysmal who were enrolled in EARLY-AF. Participants were randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation (Arctic Front Family of Cryoablation Catheters, Medtronic; n = 154) or receive antiarrhythmic drug therapy (n = 149). All participants had implantable loop recorders placed at the time of trial entry; evaluation was conducted via downloaded daily recordings and in-person visits every 6 months. Researchers assessed data on the first episode of persistent AF, recurrent atrial tachyarrhythmia, AF burden, quality-of-life metrics, health care utilization and safety.
“We did not just want to assess arrythmia recurrences, because that is not going to tell us the whole story,” Andrade told Healio. “We assessed quality of life and health care utilization because we wanted to look at it from the perspective of the patient. We wanted the 1-year study to be the comprehensive answer to all of those pieces, recognizing also that we are taking people who are younger, healthier, who have a long life ahead of them. What is 1 year when you have perhaps 40 years ahead of you? This second phase asks, are we actually changing anything long-term?”
The PROGRESSIVE-AF findings were presented at the American Heart Association Scientific Sessions and simultaneously published in The New England Journal of Medicine.
Changing disease trajectory
During 36 months of follow-up, 1.9% of participants in the ablation group and 7.4% of participants in the drug therapy group had an episode of persistent AF (HR = 0.25; 95% CI, 0.09-0.7).
Recurrent atrial tachyarrhythmia occurred in 56.5% of participants in the ablation group and 77.2% of participants in the antiarrhythmic drug group (HR = 0.51; 95% CI, 0.38-0.67).
Median percentage of time in AF was 0% in the ablation group and 0.24% in the antiarrhythmic drug group.
At 3 years, 5.2% of participants in the ablation group and 16.8% of participants in the antiarrhythmic drug group had been hospitalized (RR = 0.31; 95% CI, 0.14-0.66).
“What this shows is there was a 75% reduction in the progression of disease,” Andrade told Healio. “Why is this important? We took patients who were healthy, who were at low risk for progression. The fact that we observed this finding in a population who should not really have progressed is the most significant finding.
Serious adverse events occurred in 4.5% of participants in the ablation group and in 10.1% of participants in the antiarrhythmic drug group.
“The final piece of the puzzle was adverse events were lower as well,” Andrade told Healio. “That means, if I am a patient with AF that is symptomatic enough that treatment needs to be initiated, and I look at ablation, I have something that may actually change that trajectory of disease. We know once patients get to persistent AF, they are at higher risk for stroke, HF and death.
Andrade said the findings are an “exciting milestone” in the treatment of AF.
“These data show that drugs treat the symptoms; ablation treats the disease,” Andrade said.
Reference:
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This is a terrific study that reaffirms our understanding of AF — that it is a progressive disorder and if left unchecked can progress from paroxysmal to persistent AF. Jason Andrade, FRCPC, MD, and colleagues followed a total of 303 patients over 3 years — half of which were randomized to cryoballoon ablation and the other half were assigned to an antiarrhythmic medication.
The early follow-up of this study presented a couple of years ago had shown that cryoablation in the initial treatment of symptomatic paroxysmal AF resulted in a significant lowered recurrence of atrial arrhythmias within the first year, as compared with antiarrhythmic drug therapy alone. The current extended follow-up study for 3 years shows that these early effects of an ablation translate into better longer-term outcomes, with reduced AF recurrences and a significantly lower incidence of the development of persistent AF. There is no conjecture here, as all the patients had implanted loop recorders, capable of continuous rhythm monitoring.
This study goes to show that early catheter ablation can be disease-modifying, reduce progression of AF and improve the quality of life of patients. The study also shows that ablation does not completely prevent AF recurrences, with over 56.5% of the patients in the ablation group showing recurrences of atrial tachyarrhythmias over the extended 3-year follow-up. With that being said, drug therapy, even though not as effective as ablation, can still serve as a useful adjunct in the management of patients with AF. Maybe the right long-term strategy is not an either-or, but a hybrid approach with early ablation, and if needed, antiarrhythmics added later on, especially if we want to prevent the continued progression of AF over a lifetime.
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Andrade JG, et al. LBS.08. Treating atrial and supraventricular arrhythmias Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
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