Biosense Webster, Inc. Announces Catheter Ablation May Be up to 10 Times More Effective Than Standard Drug Therapy Alone at Delaying Progression of Atrial Fibrillation

Results from The Atrial Fibrillation Progression Trial (ATTEST), were presented on August 31^st at the ESC^* Congress 2019 in Paris, France. ATTEST is the first randomised controlled trial to directly compare the effectiveness of ablation using radiofrequency (RF) catheters versus standard antiarrhythmic drugs (AAD) in delaying atrial fibrillation (AF) progression. The results show that patients treated with catheter ablation (aged 67.8 ± 4.8 years) were almost 10 times less likely to develop persistent AF than patients on AAD at three years after study initiation.¹

ATTEST was sponsored by Biosense Webster, Inc., a global leader in the science of diagnosing and treating heart rhythm disorders and part of Johnson & Johnson Medical Devices Companies^***. In the study, patients with intermittent AF were treated, according to current guidelines, with either AAD or underwent catheter ablation, an interventional procedure that creates small scars on targeted heart tissue to block abnormal electrical signals that cause arrhythmia. At the end of the study, 17.5% of patients from the AAD group developed persistent AF, while only 2.4% of patients from the catheter ablation group experienced disease progression.

“Progression from intermittent AF to a persistent form of the condition is very common, and with that progression we see an increased risk of stroke and death”, said Prof. Karl-Heinz Kuck^**, lead author for ATTEST. “These results are welcome as they suggest that early use of catheter ablation can significantly delay or prevent the progression of AF more effectively than drug therapy”.

Outcomes from ATTEST were similar to other key recent trials which demonstrated that up to 94% of patients with AF treated with catheter ablation are free from arrhythmia recurrence at one year,^2-11 with nearly half the chance of death, stroke, cardiac arrest and cardiovascular hospitalisation over seven years, compared to AAD.^12,13 These studies have also shown that catheter ablation could significantly improve patient quality of life over drug therapy¹⁴, as well as being a more cost effective option over the long term.¹⁵

AF is a serious and debilitating condition characterised by an irregular and often fast heart rhythm that results in uncoordinated contraction of the top two chambers of the heart. The irregular heart rhythm may cause blood clots that could lead to a particularly devastating form of stroke. AF is typically a progressive disease, with one in five patients progressing from paroxysmal (intermittent) AF to persistent (constant) AF in one year.^16-18

According to a report published by Biosense Webster in 2018, which highlighted the impact and burden of AF, the condition is fast becoming the ‘new millennium epidemic’ and one of the world’s most significant health issues. AF is responsible for disrupting the quality of life of 33 million people worldwide and rising by almost 70% by 2030.¹⁹ It also costs healthcare systems up to €3.286 billion annually in European countries alone.^20-25 A follow-up report focusing on the treatment of AF will be published in late 2019.

“We are dedicated to advancing the care of – and ultimately curing – AF through focusing on three main areas: innovating new technology solutions, investing in research and publications to advance clinical understanding – as demonstrated by ATTEST – and improving education and awareness of AF among clinicians and the general public,” said Uri Yaron, Worldwide President, Biosense Webster. “With approximately 150 electrophysiology (EP) centres involved in research with us globally and a heritage spanning 20 years of pioneering treatment in the field of EP, we are committed to driving progress and healing more hearts. We welcome the findings presented at this morning’s late breaking session, which reinforce the significant benefits of RF catheter ablation in the treatment of AF and should support clinicians in recommending its early use as the gold-standard in AF patient care”.

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NOTES TO EDITORS

About the ATTEST study
The Atrial Fibrillation Progression Trial (ATTEST) was a randomised controlled trial that evaluated progression to persistent Atrial Fibrillation (AF)/Atrial Tachycardia(AT) in subjects with recurrent, symptomatic paroxysmal (intermittent) AF. 128 subjects were randomised to pulmonary vein isolation using radiofrequency (RF) catheters, and 127 subjects to guideline-directed antiarrhythmic drug (AAD) therapy. The primary endpoint was the rate of persistent AF/AT at 3 years. Kaplan-Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF catheter ablation (2.4% [95% confidence interval (CI), 0.6-9.4%]) than with AAD (17.5% [95% CI, 10.7-27.8%]; 1-sided P=0.0009). The results remain consistent across most prespecified subgroups analysed. Patients ≥75 years were nearly 4 times more likely to progress to persistent AF than patients <75 years (p<0.05), suggesting RF catheter ablation at an early stage is superior to AAD at delaying or preventing disease progression (hazard ratio: 3.93, 95% CI: 1.28% 12.06%; p=0.0170).

About Biosense Webster
Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit www.biosensewebster.com
Follow us on Twitter @BiosenseWebster

About Johnson & Johnson Medical Devices Companies^***

At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

^* European Society of Cardiology
^** Prof. Kuck is a consultant to Biosense Webster
^*** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

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