DUBLIN, Nov. 16, 2020 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced that the primary results of the Medtronic-sponsored STOP
AF First clinical trial have been published in the New England
Journal of Medicine (NEJM). Results from the trial
reveal 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 use of antiarrhythmic drug (AAD) therapy in
patients with symptomatic paroxysmal atrial fibrillation (PAF).
Similar findings were reported from the Medtronic-sponsored
Cryo-FIRST trial and the investigator-initiated EARLY AF study
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
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
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) 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 European Society of Cardiology
Congress 2020 Digital Experience. In addition to these results,
NEJM also published quality of life findings that
demonstrated a significant improvement (p<0.01) in subjects'
quality of life at 12 months for those treated with
cryoablation.
The STOP AF First trial is a Food and Drug Administration
(FDA)-regulated, prospective, multi-center, randomized study. It is
designed to evaluate the safety and effectiveness of the Medtronic
cryoablation system to treat recurrent symptomatic PAF in patients
who had not previously received AADs for their atrial fibrillation.
The trial enrolled 225 patients at 24 sites in the United States. 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.
Results of EARLY-AF Study Published in the New England
Journal of Medicine and Presented at AHA 2020
Presented
as a late-breaking clinical trial at the American Heart Association
Scientific Sessions 2020 with a simultaneous publication in the
New England Journal of Medicine, the findings from the EARLY
AF study also demonstrated the superiority of Arctic Front
Cryoballoon ablation compared with AAD treatment for preventing
atrial arrhythmia recurrence in treatment-naive patients with
PAF.
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. Jason Andrade,
director of electrophysiology and associate professor at
University of British Columbia.
"These randomized trials provide evidence supporting
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: 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 Europe, Australia and Latin
America. Similar to STOP AF First, this trial found that
Medtronic cryoablation is superior to AAD therapy for the
prevention of atrial arrhythmia recurrence in PAF patients 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 United States FDA recently expanded the indication for
Medtronic cryoablation therapy to include treating patients with
drug-refractory recurrent, symptomatic persistent atrial
fibrillation (episode duration less than six months), in addition
to patients with drug-refractory, recurrent, symptomatic paroxysmal
AF. Results of the STOP AF First trial have not been reviewed by
the FDA.
"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 Rob
Kowal, M.D., Ph.D., chief medical officer of Cardiac
Ablation Solutions at Medtronic. "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."
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.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, 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 anticipated results.
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 Euro Heart
Survey, EP Europace, Volume 20, Issue 6, June 2018, Pages 929–934.
6 Chugh SS, et al. Circulation. 2014;129:837-847.
https://pubmed.ncbi.nlm.nih.gov/31955707//
Contacts:
|
|
Lauren
Mueller
|
Ryan
Weispfenning
|
Public
Relations
|
Investor
Relations
|
+1-763-285-9053
|
+1-763-505-4626
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/the-new-england-journal-of-medicine-medtronic-cryoablation-is-a-superior-treatment-option-for-symptomatic-paroxysmal-atrial-fibrillation-compared-to-drug-therapy-301173359.html
SOURCE Medtronic plc