STOP AF First(opens new window)6, a Medtronic-sponsored, prospective, multicenter, randomized trial, included 225 patients at 24 sites in the U.S. Patients who had never received AAD therapy were randomized to cryoablation or AAD treatment and followed for 12 months. Results, published in the New England Journal of Medicine (NEJM) in Nov. 2020, reported 74.6% of patients in the cryoballoon versus 45.0% in the AAD group (P<0.001) achieved treatment success at 12 months. The quality of life (QoL) data published in NEJM demonstrate that cryoballoon ablation resulted in significant improvements in quality of life as assessed using the Atrial Fibrillation Effect on Quality-of-Life [AFEQT] and European Quality of Life–5 Dimensions [EQ-5D] questionnaires. A low rate of patient complications occurred when using catheter ablation as a first-line treatment (12-month rate of primary safety events: 1.9%), and the percentage of patients with a serious adverse event was similar between the treatment groups.
EARLY-AF(opens new window)8, an investigator-initiated, multicenter trial, randomized 303 patients with AF who had never received AAD to cryoballoon-based pulmonary vein isolation or first-line AAD therapy. Results from EARLY-AF, published in the New England Journal of Medicine (NEJM) in Nov. 2020 and presented at American Heart Association Scientific Sessions 2020, found 57.1% of patients in the cryoballoon versus 32.2% in the AAD group achieved freedom from atrial tachyarrhythmia recurrence at 12 months. Mean AF burden was lower in the cryoballoon (0.6±3.3%) vs. AAD group (3.9±12.4%). Patients treated with cryoablation demonstrated larger improvements in quality of life and more frequently had resolution of arrhythmic symptoms (e.g., fatigue, rapid heartbeat, shortness of breath) than patients receiving AAD therapy. Safety events were low in both groups with 3.2% of catheter ablation and 4.0% of AAD-treated patients experiencing a serious adverse event related to the trial regimen.
Cryo-FIRST(opens new window)7, a Medtronic-sponsored, randomized, multicenter trial, enrolled 220 patients at 18 sites in nine countries across Europe, Australia and Latin America. At 12 months, freedom from atrial arrhythmia recurrence was achieved in 82.2% of the cryoballoon and 67.6% of the AAD group. Cryo-FIRST demonstrated that more patients with PAF who received first-line treatment with Medtronic cryoablation vs. AAD therapy were asymptomatic at 12 months. Cryoablation resulted in significant improvement in in AF-specific health-related quality of life at 12 months compared to AAD therapy. The cryoablation and AAD arms had comparable safety profiles in terms of the rate of serious adverse events.

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