Paris, France, September 2nd, 2019 – Results from The Atrial Fibrillation Progression Trial (ATTEST), were presented on August 31st 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”.
For more information, please contact
Céline Fontaine, [email protected], +33 (0)6 28 60 45 41
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.
1. Kuck KH, Lebedev, D., Mikaylov, E., Romanov, A., Geller, L., Kalejs, O., Neumann, T., Davtyan, K., On, Y.K., Popov, S., Ouyang, F. (2019) Catheter ablation delays progression of atrial fibrillation from paroxysmal to persistent atrial fibrillation. ESC Late-breaking Science 2019. Paris, France. August 31, 2019.
2. Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N et al. (2017) Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol 28 (9): 1037-1047.
3. Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S et al. (2018) Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol 4 (1): 99-108.
4. Phlips T, Taghji P, El Haddad M, Wolf M, Knecht S et al. (2018) Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, ablation index, and contact force variability in the 'CLOSE'-protocol. Europace 20 (FI_3): f419-f427.
5. Solimene F, Schillaci V, Shopova G, Urraro F, Arestia A et al. (2019) Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. J Interv Card Electrophysiol 54 (1): 9-15.
6. Di Giovanni G, Wauters K, Chierchia GB, Sieira J, Levinstein M et al. (2014) One-year follow-up after single procedure Cryoballoon ablation: a comparison between the first and second generation balloon. J Cardiovasc Electrophysiol 25 (8): 834-839.
7. Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H et al. (2015) Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace 17 (2): 225-231.
8. Lemes C, Wissner E, Lin T, Mathew S, Deiss S et al. (2016) One-year clinical outcome after pulmonary vein isolation in persistent atrial fibrillation using the second-generation 28 mm cryoballoon: a retrospective analysis. Europace 18 (2): 201-205.
9. Guhl EN, Siddoway D, Adelstein E, Voigt A, Saba S et al. (2016) Efficacy of Cryoballoon Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol 27 (4): 423-427.
10. Irfan G, de Asmundis C, Mugnai G, Poelaert J, Verborgh C et al. (2016) One-year follow-up after second-generation cryoballoon ablation for atrial fibrillation in a large cohort of patients: a single-centre experience. Europace 18 (7): 987-993.
11. Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K et al. (2018) Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol 4 (11): 1440-1447.
12. Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD et al. (2019) Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA.
13. Noseworthy PA, Gersh BJ, Kent DM, Piccini JP, Packer DL et al. (2019) Atrial fibrillation ablation in practice: assessing CABANA generalizability. Eur Heart J 40 (16): 1257-1264.
14. Blomstrom-Lundqvist C, Gizurarson S, Schwieler J, Jensen SM, Bergfeldt L et al. (2019) Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial. JAMA 321 (11): 1059-1068.
15. Weerasooriya R, Jais P, Le Heuzey JY, Scavee C, Choi KJ et al. (2003) Cost analysis of catheter ablation for paroxysmal atrial fibrillation. Pacing Clin Electrophysiol 26 (1 Pt 2): 292-294.
16. Nieuwlaat R, Prins MH, Le Heuzey JY, Vardas PE, Aliot E et al. (2008) Prognosis, disease progression, and treatment of atrial fibrillation patients during 1 year: follow-up of the Euro Heart Survey on atrial fibrillation. Eur Heart J 29 (9): 1181-1189.
17. de Vos CB, Pisters R, Nieuwlaat R, Prins MH, Tieleman RG et al. (2010) Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol 55 (8): 725-731.
18. Schnabel R, Pecen L, Engler D, Lucerna M, Sellal JM et al. (2018) Atrial fibrillation patterns are associated with arrhythmia progression and clinical outcomes. Heart 2018 Oct;104(19):1608-1614.
19. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S (2014) Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 6 213-220.
20. McBride D, Mattenklotz AM, Willich SN, Bruggenjurgen B (2009) The costs of care in atrial fibrillation and the effect of treatment modalities in Germany. Value Health 12 (2): 293-301.
21. Ball J, Carrington MJ, McMurray JJ, Stewart S (2013) Atrial fibrillation: profile and burden of an evolving epidemic in the 21st century. Int J Cardiol 167 (5): 1807-1824.
22. Cotte FE, Chaize G, Gaudin AF, Samson A, Vainchtock A et al. (2016) Burden of stroke and other cardiovascular complications in patients with atrial fibrillation hospitalized in France. Europace 18 (4): 501-507.
23. Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ (2004) Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 90 (3): 286-292.
24. Global Burden of Disease Collaborative Network (2016) Global Burden of Disease Study 2016 (GBD 2016) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2019-08-13. Available from http://ghdx.healthdata.org/gbd-results-tool.
25. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017) Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390 (10100): 1211-1259.
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