A Randomized Multicenter Comparison of Radiofrequency Ablation and Antiarrhythmic Drug Therapy as First Line Treatment in 294 Patients with Paroxysmal Atrial Fibrillation Jens Cosedis Nielsen, Professor, MD, DMSc, Aarhus, Denmark on behalf of the MANTRA-PAF investigators
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A Randomized Multicenter Comparison of Radiofrequency Ablation and Antiarrhythmic Drug Therapy as First Line Treatment in 294 Patients with Paroxysmal.
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A Randomized Multicenter Comparison of Radiofrequency Ablation and Antiarrhythmic Drug Therapy as First Line Treatment in 294
Patients with Paroxysmal Atrial Fibrillation
Jens Cosedis Nielsen, Professor, MD, DMSc,
Aarhus, Denmark
on behalf of the MANTRA-PAF investigators
MANTRA-PAF Investigators
• Arne Johannessen Gentofte University Hospital, CPH, Denmark• Pekka Raatikainen Oulu University Hospital, Finland• Gerhard Hindricks Leipzig University Hospital, Germany• Håkan Walfridsson University Hospital Linköping, Sweden• Ole Kongstad Lund University Hospital, Sweden• Steen Pehrson Rigshospitalet, Copenhagen, Denmark• Anders Englund University Hospital, Örebro, Sweden • Juha Hartikainen Kuipio University Hospital, Finland• Leif Spange Mortensen UNI-C, Denmark (Datamanagement and
statistics)• Peter Steen Hansen Aarhus University Hospital, Skejby, Denmark
Funding: The trial was supported by unrestricted grants from the Danish Heart Foundation and from Biosense Webster and Johnson&Johnson
Aim
• To compare radiofrequency ablation (RFA) with antiarrhythmic drug therapy (AAD) as first-line treatment in patients with paroxysmal atrial fibrillation (AF).
Methods
• Randomized controlled multicenter trial
• Antiarrhythmic drug therapy (Class IC or III) (AAD) versus pulmonary vein isolation (RFA)
• Power calculation: Assumed freedom from AF after 24 months in 75% (RFA) versus 60% (AAD) of the patients, α=0.05, 1-β=0.80, N=150 patients in each group
• Follow-up with 7-day Holter recordings after 3, 6, 12, 18 and 24 months
• Intention-to-treat analysis
Endpoints
• Primary endpoints:– Cumulative burden of AF– AF-burden at each 7-day Holter recording
• Secondary endpoints:– Freedom from any AF after 24 months– Freedom from symptomatic AF after 24 months– Burden of symptomatic AF after 3, 6, 12, 18, and 24 months – Atrial flutter– Quality of Life after 12 and 24 months– Serious adverse events
294 Patients Randomized
146 Assigned to RFA140 Underwent RFA (96%)
148 Assigned to AAD146 Started AAD (99%)
After 24 months
N=140; 223 RFA procedures (1.6±0.7)
On AAD: N=13/138 (9%) (IC: 10, III: 3)
Withdrawn N=5 Died N=3
666 7D Holter recordings
After 24 months
N=54; 87 RFA procedures (1.6±0.7)
On AAD: N=100 /137 (73%) (IC: 86, III:14)
Withdrawn N=7 Died N=4
665 7D Holter recordings
69 underwent repeated RFA
Treatment with1.24±0.48 AAD’s
Baseline Characteristics I RFA AADN 146 148
Age (years) 56±9 54±10
Male gender 100 (68%) 106 (72%)
Body Mass Index 27±4 27±4
Hypertension 43 (29%) 53 (36%)
Coronary artery disease 6 (4%) 2 (1%)
Valvular disease 7 (5%) 15 (10%)
Previous stroke or TIA 6 (4%) 5 (3%)
Diabetes 6 (4%) 10 (7%)
Chronic lung disease 8 (5%) 6 (4%)
Pacemaker 5 (3%) 6 (4%)
Thyroid disease 10 (7%) 10 (7%)
Previous Cardioversions
0 103 100
1 8 17
2 11 6
3 7 4
4 2 6
>4 15 15
Baseline Characteristics II RFA AADDuration of usual AF episodes
Retroperitoneal bleeding, coiling of small artery 1 0
Chest discomfort 1 0
Discomfort probably due to medication 0 2
Cancer 6 4
Other (Rotator cuff rupture, Arthroscopy, Gallbladder surgery) 1 2
Total 25 22
Conclusions
• At 24 months AF-burden and occurrence of any and symptomatic AF were significantly lower in the RFA group than in the AAD group.
• No significant difference was observed in the cumulative burden of AF between AAD and RFA.
• QOL (PCS) better in the RFA group after 12 and 24 months.
• These data support RFA as a first-line treatment in patients with paroxysmal AF.
Discussion
• Selected patient population.
• Not an argument for offering all patients with paroxysmal AF radiofrequency ablation!
• Both strategies should be discussed with the patients and considered by patients and physicians when rhythm control for symptomatic paroxysmal AF is indicated.
• The results of the MANTRA-PAF trial support the idea of early ablation for AF to avoid progression of AF on the long term.