Fridley, Minn.-based Medtronic said in a news release that trials showed the superiority of the Arctic Front advance cardiac cryoballoon and the Freezor max cardiac cryoablation catheter for the first-line treatment (before drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) when compared to antiarrhythmic drug (AAD) treatment.
The company presented the primary results from the randomized STOP-AF first trial at the 2020 European Society of Cardiology (ESC) Congress and noted that 12-month outcomes from the Cryo-First trial showed significant improvements in atrial fibrillation-related quality of life with the use of Medtronic’s cryoablation system compared to anti-arrhythmic drug therapy in patients who hadn’t previously received anti-arrhythmic drugs to treat their symptomatic PAF.
STOP-AF enrolled 225 patients across 24 U.S. sites, with 203 randomized to cryoablation (104 in treatment arm) or AAD therapy (99 in control arm). They received treatment and were followed for 12 months, after which results showed that cryoablation had treatment success in 75% of patients in the catheter ablation group compared to 45% in the AAD group.
Cryo-First enrolled 220 patients at 18 sites across nine countries in Europe, Australia and Latin America. Medtronic observed that its cryoablation solution resulted in a significant improvement in AF-specific, health-related quality of life at 12 months compared to AAD therapy.
Medtronic’s Arctic Front advance cryoablation system is approved in Europe for treating AF, while the FDA recently expanded the indication for it to include treating patients with symptomatic, recurrent persistent AF. Results of the STOP-AF first trial have not been reviewed by the FDA, Medtronic said.
“More than half of patients with symptomatic AF do not experience a reduction in AF with antiarrhythmic drugs, effectively delaying their therapy and leaving a critical need for an alternative first-line treatment,” Medtronic chief medical officer of the cardiac rhythm & heart failure & cardiac ablation solutions divisions Dr. Rob Kowal said in the release. “Not only do the STOP AF First findings show cryoablation is a potential first-line treatment for these patients, the Cryo-FIRST results show encouraging benefits of this treatment approach on these patients’ quality of life.”