Medtronic Cryoablation Superior to Drug Therapy for Symptomatic Paroxysmal Atrial Fibrillation

ESC Congress: New Research Highlights First-Line Use of Cryoablation as Highly Effective, and with Improved Quality of Life Scores

DUBLIN, Aug. 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced clinical trial results demonstrating superiority of the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) compared to antiarrhythmic drug (AAD) treatment. Primary results of the randomized STOP AF First trial were presented as a late breaking clinical trial at the European Society of Cardiology (ESC) Congress 2020 Digital Experience. Additionally, 12-month outcomes from the Cryo-FIRST trial showed a significant improvement in atrial fibrillation-related quality of life with the use of the Medtronic cryoablation system compared to anti-arrhythmic drug therapy in patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF.

Atrial fibrillation (AF) is a progressive condition that impacts more than 33 million people worldwide.¹ Without early intervention, progression of the condition 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 Antiarrhythmic drug therapy is currently the standard first-line treatment for patients with AF; however, AF recurs in approximately 50% of patients treated with AADs within a year of therapy onset. In addition, AAD therapy frequently causes side effects that can lead many patients to discontinue treatment.⁶ Cryoablation uses cold energy (freezing) delivered through an inflatable balloon to create scar tissue to interrupt unwanted electrical pathways in the heart.

STOP-AF First Primary Results
The STOP-AF First trial enrolled 225 patients at 24 sites in the United States and was designed to evaluate the safety and effectiveness of the Medtronic cryoablation system to treat recurrent symptomatic PAF in patients who had not previously received antiarrhythmic drugs for their AF. A total of 203 patients randomized to cryoablation (104 in treatment arm) or AAD therapy (99 in control arm) received treatment and were followed for 12 months.