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The New England Journal of Medicine: Medtronic Cryoablation is a Superior Treatment Option for Symptomatic Paroxysmal Atrial Fibrillation Compared to Drug Therapy
Drug therapy is currently the standard first-line treatment for patients with atrial fibrillation (AF); however, AF recurs in approximately half of patients treated with AADs within a year of initial treatment. AAD usage frequently causes side effects that can lead many patients to discontinue treatment.1 Without early intervention, AF can progress, becoming more sustained over time. Progression of AF is associated with a higher rate of cardiovascular admissions,2 heart failure hospitalization,3 and mortality,4 along with a reduced quality of life.5 Atrial fibrillation (AF) is a progressive condition that affects more than 37 million people worldwide.6 Medtronic cryoablation therapies are currently indicated only to treat patients with drug-refractory recurrent, symptomatic persistent or paroxysmal AF.
"The clinical results of STOP AF First demonstrate the superiority of Medtronic cryoablation as a first-line treatment for AF patients, before the disease progresses," said Dr. Oussama Wazni, principal investigator for the STOP AF First trial and section head of electrophysiology at the
STOP AF First demonstrated that Medtronic cryoablation was superior in maintaining freedom from AF, atrial tachycardia and atrial flutter, with 75% of patients in the catheter ablation group versus 45% in the AAD group (P<0.001) achieving treatment success at 12 months. A low rate of patient complications occurred when using catheter ablation as a first-line treatment in AF patients who had never received AAD therapy (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. These findings also were presented in August as a late-breaking clinical trial at the
The STOP AF First trial is a
Results of EARLY-AF Study Published in the
Presented as a late-breaking clinical trial at the American Heart Association Scientific Sessions 2020 with a simultaneous publication in the
A total of 303 patients with symptomatic AF who had not yet received treatment were randomized to first-line AAD therapy (149 in treatment arm), or first-line cryoballoon-based pulmonary vein isolation (154 in treatment arm). All patients underwent implantation of the Medtronic Reveal LINQ insertable cardiac monitor for the purpose of continuous arrhythmia monitoring. The primary outcome was measured by the amount of time, after treatment, that it took for patients to experience a recurrence of AF, atrial flutter or atrial tachycardia.
Results from this multicenter investigator-initiated trial found that Medtronic cryoablation was superior in maintaining freedom from AF, atrial tachycardia and atrial flutter, with 57.1% of patients in the catheter ablation group versus 32.2% in the AAD group (absolute difference in recurrence of 24.9%; P<0.001) achieving treatment success at 12 months. Safety events were low in both groups with 4.0% of AAD patients and 3.3% of catheter ablation patients experiencing a serious adverse event. Additionally, patients treated with Medtronic cryoablation demonstrated improvements in quality of life and arrhythmic symptoms (e.g., fatigue, rapid heartbeat, shortness of breath). The trial was sponsored by Dr.
"These randomized trials provide evidence supporting cryoablation as an initial rhythm control strategy for patients with atrial fibrillation," said Dr.
Cryo-FIRST: Initial Results Presented at AHA 2020
At the American Heart Association Scientific Sessions 2020, results from the Cryo-FIRST trial were presented, demonstrating that patients with paroxysmal atrial fibrillation who received first-line treatment with Medtronic cryoablation experienced fewer recurrences of symptoms, compared to AAD.
Cryo-FIRST is a randomized, multicenter trial that enrolled 220 patients at 18 sites in nine countries across
The Arctic Front Advance Cryoablation System is approved in
"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," said
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
1 Valembois L et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD005049. DOI: 10.1002/14651858.CD005049.pub5.
2 de Vos CB et al. rogression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol. 2010;55(8):725-731.
3 Wong JA et al. Progression of Device-Detected Subclinical Atrial Fibrillation and the Risk of Heart Failure. J Am Coll Cardiol. 2018;71(23):2603-2611.
4Piccini JP et al. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019;21(3):404-413.
5Dudink E et al. The influence of progression of atrial fibrillation on quality of life: a report from the
6 Chugh SS, et al. Circulation. 2014;129:837-847. https://pubmed.ncbi.nlm.nih.gov/31955707//
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