[ad_1]
The results of three studies show
Medtronic cryoablation is superior to drug therapy for first-line treatment
DUBLIN – November 16, 2020 – Medtronic plc announced that key findings from the Medtronic-sponsored STOP AF First clinical trial were published in New England Journal of Medicine (NEJM). Study results reveal that cryoablation with Arctic Front ™ Advance Cardiac Cryoballoon and Freezor ™ MAX Cardiac Cryoablation Catheter is superior as a first-line treatment for preventing recurrence of atrial arrhythmia compared to using antiarrhythmic drug therapy (AAD) in patients with symptomatic paroxysmal atrial fibrillation (PAF). Similar results were reported from the Medtronic-sponsored Cryo-FIRST study and the EARLY AF study initiated by the investigator and presented at the American Heart Association Scientific Sessions 2020. Cryoablation uses cold energy delivered through an inflatable balloon to create scar tissue to interrupt unwanted electrical pathways in the heart.
Drug therapy is currently the standard first-line treatment for patients with atrial fibrillation (AF); however, AF recurs in about half of patients treated with AAD within a year of initial treatment. The use of AAD often 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 hospitalizations,2 hospitalization for heart failure,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 around the world.6 Medtronic cryoablation therapies are currently indicated only for the treatment of patients with recurrent, symptomatic persistent or paroxysmal drug-refractory AF.
“STOP AF First clinical results demonstrate the superiority of Medtronic cryoablation as a first-line treatment for patients with AF, before the disease progresses,” said Dr. Oussama Weight, principal investigator for the STOP AF First study e Section Chief of Electrophysiology at the Cleveland Clinic.
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) having achieved treatment success at 12 months. A low patient complication rate occurred when using catheter ablation as first-line treatment in patients with atrial fibrillation who had never received AAD therapy (12-month primary safety event rate: 1.9%) and percentage of patients with a serious adverse event was similar between treatment groups. These results were also presented in August as a cutting-edge clinical study at the 2020 Digital Experience European Society of Cardiology Congress. In addition to these results, NEJM also published quality of life results that demonstrated a significant (p <0.01) improvement in subjects' quality of life at 12 months for those treated with cryoablation.
The STOP AF First study is a randomized, multicenter, Food and Drug Administration (FDA) regulated study. It is designed to evaluate the safety and efficacy of the Medtronic Cryoablation System for the treatment of symptomatic recurrent PAF in patients who had not previously received AAD for atrial fibrillation. The study enrolled 225 patients at 24 sites across the United States. A total of 203 patients randomized to cryoablation (104 in the treatment arm) or AAD therapy (99 in the control arm) received treatment and were followed for 12 months.
Results of the EARLY-AF study Posted in New England Journal of Medicine and Featured at AHA 2020
Presented as a cutting-edge clinical study at the American Heart Association’s 2020 Scientific Sessions with a simultaneous publication in New England Journal of Medicine, the results of the EARLY AF study also demonstrated the superiority of Cryoballoon ablation of the arctic front versus AAD treatment to prevent recurrence of atrial arrhythmia in PAF-naive patients.
A total of 303 patients with Symptomatic AF who had not yet received treatment were randomized to first-line AAD therapy (149 in the treatment arm) or first-line pulmonary vein isolation based on cryoballoon (154 in the treatment arm). All patients underwent implantation of the Medtronic Reveal LINQ Insertable Cardiac Monitor for continuous arrhythmia monitoring. The the primary outcome was measured the amount of time after treatment that it takes patients to experience AF recurrence, atrial flutter, or atrial tachycardia.
Results from this investigator-initiated multicenter study 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 relapse of 24.9%; P <0.001) achieving treatment success at 12 months. Safety events were low in both groups with 4.0% of patients with AAD and 3.3% of patients with catheter ablation experiencing a serious adverse event. Additionally, patients treated with Medtronic cryoablation have demonstrated improvements in quality of life and arrhythmic symptoms (eg, fatigue, rapid heart rate, shortness of breath). The study was sponsored by Dr. Jason Andrade, director of electrophysiology and associate professor at the University of British Columbia.
“These randomized trials provide evidence to support cryoablation as an initial rhythm control strategy for patients with atrial fibrillation,” said Dr. Christopher Granger, professor of medicine, Duke University. “This is an important advance for our patients.”
Cryo-FIRST: the first results presented at AHA 2020
During the American Heart Association’s 2020 scientific sessions, the results of the Cryo-FIRST study were presented, demonstrating that patients with paroxysmal atrial fibrillation who received first-line treatment with Medtronic cryoablation experienced fewer symptom relapses, compared with to AAD.
Cryo-FIRST is a randomized multicenter study that enrolled 220 patients at 18 sites in nine countries in Europe, Australia and Latin America. Similar to STOP AF First, this study found that Medtronic cryoablation is superior to AAD therapy for the prevention of relapse of atrial arrhythmia in patients with PAF who have not previously been treated with drug therapy.
The Arctic Front Advance Cryoablation System is approved in Europe for the treatment of AF. The U.S. FDA recently expanded the indication for Medtronic cryablation therapy to include treatment of patients with symptomatic and drug-refractory recurrent atrial fibrillation (episode duration less than six months), as well as patients with symptomatic paroxysmal AF refractory to drugs. The results of the STOP AF First study have not been reviewed by the FDA.
“The results of these three studies demonstrate that Medtronic cryoablation is a viable and even preferable option for patients with paroxysmal atrial fibrillation even before the start of antiarrhythmic drug therapy,” said Rob Kowal, MD, Ph.D., chief medical officer of Cardiac Ablation Solutions at Medtronic. “It is wonderful for Medtronic cryoablation to achieve this level of consistent validation from multiple studies, and the new evidence will ultimately be useful to the patients and doctors who treat them.“
In collaboration with leading physicians, researchers and scientists from around the world, Medtronic offers the broadest range of innovative medical technologies for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company is committed to offering the highest quality products and services that provide clinical and economic value to consumers and healthcare providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the largest medical technology, services and solutions companies in the world, relieving pain, restoring health and extending the lives of millions of people around the world. Medtronic employs over 90,000 people worldwide, serving doctors, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare beyond, together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from expected results.
-end-
1 Valembois L et al. Antiarrhythmics to maintain sinus rhythm after cardioversion of atrial fibrillation. Cochrane database of systematic reviews 2019, Edition 9. Art. No.: CD005049. DOI: 10.1002 / 14651858.CD005049.pub5.
2 de Vos CB et al. clinical correlation and prognosis of paroxysmal to persistent atrial fibrillation regression. J Am Coll Cardiol. 2010; 55 (8): 725-731.
Source link
