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. 2024 Apr 8;26(4):euae043. doi: 10.1093/europace/euae043

Table 5.

Randomized controlled clinical trials comparing catheter ablation vs. antiarrhythmic drugs as first-line treatment in patients with symptomatic AF

RAAFT-1248 MANTRA-PAF246 RAAFT-2247 STOP-AF243 EARLY-AF244 CRYO-FIRST245
Year of publication 2005 2012 2014 2021 2021 2021
Sample size (ablation vs. AADs) 32 vs. 35 146 vs. 148 66 vs. 61 104 vs. 99 154 vs. 149 107 vs. 111
Mean age (SD), years (ablation vs. AADs) 53 (8) vs. 54 (8) 56 (9) vs. 54 (10) 56 (9) vs. 54 (12) 60 (11) vs. 62 (11) 58 (12) vs. 60 (11) 51 (13) vs. 54 (13)
Mean LA diameter (SD), mm (ablation vs. AAD) 41 (8) vs. 42 (7) 40 (6) vs. 40 (5) 40 (5) vs. 43 (5) 39 (6) vs. 38 (5) 40 (5) vs. 38 (7) 37 (6) vs. 38 (5)
Mean LVEF (SD), % (ablation vs. AAD) 53 (5) vs. 54 (6) LVEF >60% in 80 vs. 82% 61 (5) vs. 61 (7) 61 (6) vs. 61 (6) 60 (7) vs. 60 (8) 63 (5.4) vs. 64 (5.4)
Paroxysmal AF (%) (ablation vs. AADs) 97 vs. 95 100 vs. 100 99 vs. 97 100 vs. 100 96 vs. 94 100 vs. 100
Ablation type Radiofrequency Radiofrequency Radiofrequency Cryoballoon Cryoballoon Cryoballoon
Ablation strategy PVI PV encirclement plus roof line, additional ablation lesions allowed PVI, additional ablation lesions allowed PVI PVI PVI
Acute PVI rate (%) 100 87 98 100 100
Rhythm monitoring protocol

  • 1 month event monitor at 1 and 3 months and thereafter in case of symptom recurrence AND

  • 24 h Holter recording before discharge and at 3, 6, and 12 months

  • 7 day Holter monitor at 3, 6, 12, 18, and 24 months

  • Biweekly TTM

  • 12-lead ECG at 1, 3, 6, and 12 months AND

  • Patient-activated TTM weekly and in case of symptoms AND

  • 24 h ambulatory ECG monitoring at 6 and 12 months

  • Implantable loop recorder

  • 12-lead ECG and 7 day Holter monitor at 1, 3, 6, 9, and 12 month follow-up
Primary endpoint—definition First recurrence of AF >15 s AF burden and cumulative burden First recurrence of AF/AFL/AT >30 s Initial failure of the procedure; subsequent AF surgery or LA ablation; AF/AFL/AT ≥30 s during ambulatory monitoring or ≥10 s on a 12-lead ECG; cardioversion or Class I or III AAD outside the 90 day blanking period (ablation group only) First recurrence of AF/AFL/AT ≥30 s or AAD initiation Free from any AF/AFL/AT >30 s
Follow-up (years) 1 2 2 1 1 1
Recurrence of any atrial tachyarrhythmia (%) (ablation vs. AADs) 13 vs. 63a 15 vs. 29b 54.5 vs. 72.1 20.2 vs. 35.4 42.9 vs. 67.8 17.8 vs. 32.4
Treatment effect 0.56 (0.35–0.90) 0.57 (0.36–0.91) 0.48 (0.35–0.66) 0.48 (0.26–0.86)
Serious AEs—no. of patients (%) (ablation vs. AADs) 13.7 vs. 10.8 (NS) 9.1 vs.4.9 14 vs. 14 (NS) 3.2 vs. 4.0 (N.S) 24.3 vs. 33.3 (NS)
Findings/comments RF ablation superior to AAD No significant difference between RF ablation and AADs in the cumulative AF burden over a period of 2 yearsc RF ablation superior to AAD Cryoballoon ablation superior to AADs Cryoballoon ablation superior to AADsd Cryoballoon ablation superior to AADs

AAD, antiarrhythmic drug; AE, adverse event; AF, atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia; LA, left atrium; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; NS, non-significant; PVI, pulmonary vein isolation; RF, radiofrequency; SD, standard deviation; TTM, transtelephonic monitoring.

aSymptomatic AF recurrence, P < 0.001.

bRecurrence of any AF, P = 0.004.

cNo PVI documentation.

dContinuous cardiac rhythm monitoring.