Medtronic (NYSE:MDT) today announced successful results from its STOP AF First clinical trial for cryoablation treatment.
Published in the New England Journal of Medicine, results showed that cryoablation with the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX cardiac cryoablation catheter is superior as a first-line treatment for preventing atrial arrhythmia recurrence compared to the use of antiarrhythmic drug (AAD) therapy in patients with symptomatic paroxysmal atrial fibrillation (PAF), according to a news release.
In September, Medtronic reported similar results at the 2020 European Society of Cardiology (ESC) Congress for the treatment which uses cold energy delivered through an inflatable balloon to create scar tissue and interrupt unwanted electrical pathways in the heart.
STOP AF First demonstrated that Medtronic’s cryoablation was superior in maintaining freedom from Afib, atrial tachycardia and atrial flutter, as 75% of patients in the catheter ablation group achieved treatment success at 12 months, compared to 45% in the AAD group.
The trial has enrolled 225 patients across 24 U.S. sites, with 203 randomized to cryoablation (104 in treatment arm) or AAD therapy (99 in control arm).
Medtronic’s EARLY-AF study performed similarly well, with 303 patients with symptomatic Afib undergoing implantation of the Medtronic Reveal LINQ insertable cardiac monitor to monitor arrhythmia, while 149 patients received AAD therapy and 154 received cryoballoon-based pulmonary vein isolation.
Results showed that Medtronic’s cryoablation was superior, with 57.1% of patients in the catheter group achieving 12-month treatment success, compared to 32.2% in the AAD group.
Cryo-FIRST, the third cryoablation trial for Medtronic, similarly found that the treatment is superior to AAD, in this case for preventing atrial arrhythmia recurrence in PAF patients for 220 patients across 18 sites in nine countries.
Medtronic’s Arctic Front Advance cryoablation system is approved in Europe for treating Afib, while the FDA recently expanded its indication to include patients with drug-refractory recurrent, symptomatic persistent Afib (episode duration less than six months), in addition to patients with drug-refractory, recurrent, symptomatic paroxysmal Afib.
“The results of these three trials show that Medtronic cryoablation is a viable and even preferable option for patients with paroxysmal atrial fibrillation even prior to initiation of antiarrhythmic drug therapy,” Medtronic chief medical officer of cardiac ablation solutions Dr. Rob Kowal said in the news release. “It’s wonderful for Medtronic cryoablation to attain this level of consistent validation from multiple studies, and the new evidence ultimately will be beneficial for patients and the physicians who treat them.”
