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. 2021 Apr 28;6(6):1–9. doi: 10.1001/jamacardio.2021.0852

Table 1. Baseline Characteristics of Clinical Trials.

Variable RAAFT-1,17 2005 MANTRA-PAF,18 2012 RAAFT-2,19 2014 STOP AF,22 2020 EARLY AF,21 2020 CRYO-FIRST,23a
Funding source Acuson Danish Heart Foundation; Biosense Webster Biosense Webster; Population Health Research Institute Medtronic Cardiac Arrhythmia Network of Canada; Medtronic Medtronic
Mean (SD) age ablation vs AADs, y 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 (SD) CHA2DS2-VASc score (ablation vs AADs) NA NA 0.5 (0.7)b vs 0.7 (0.8)b NA 1.9 (1.0) vs 1.9 (1.1) NA
Patients randomized, No. 70 294 127 203 303 218
Randomization 1:1 1:1 1:1 1:1 1:1 1:1
Primary end point First recurrence of AF >15 s AF+ burden and cumulative burdenc First recurrence of AF/AFL/AT >30 s First recurrence of AF/AFL/AT ≥30 s First recurrence of AF/AFL/AT ≥30 s Free from any AF/AFL/AT >30 s
Total follow-up 1 y 2 y 2 y 1 y 1 y 1 y
Paroxysmal AF, %
Ablation 97 100 98.5 100 95.5 100
AAD 95 100 96.7 100 94 100
Withdrew/lost to follow-up, No.
Ablation 1 5 1 1 0 17
Drugs 2 7 1 6 1 13
First-line AADs, %
Class IC 77 99 94 69 81 92
Class III 23 1 3.3 21 19 8
Oral anticoagulant at baseline (ablation/AAD), % NR 47 vs 44 53 vs 31 69 vs 69 67 vs 64 35.5 vs 44.0
Time since AF diagnosis (ablation/AAD), mo 5 (2) vs 5 (2.5)d NR NR 1.3 (2.5) vs 1.3 (2.3) 1.3 (2.2) vs 1.7 (3.0) 0.7 (1.5) vs 0.8 (2.1)
Left atrial diameter (ablation/AAD), mm 41 (8) vs 42 (7) 40 (6) vs 40 (5) 40 (5) vs 43 (5) 39 (6) vs 38 (5) 39 (5) vs 38 (7) 37 (6) vs 38 (5)
LVEF (ablation/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)
Frequency of monitoring, mo 1 mo Event monitor at 1 and 3 mo, 24-h Holter recording before discharge, and at 3, 6, and 12 mo 7-d Holter monitor at 3, 6, 12, 18, and 24 mo Biweekly transtelephonic monitoring 12-Lead ECG at 1,3,6,12 mo Patient-activated telephone monitoring weekly. 24-h ambulatory. ECG monitoring at 6 and 12 mo Implantable loop recorder (Reveal LINQ, Medtronic) 7-d Holter monitor at 1, 3, 6, 9, 12 mo follow-up
Type of ablation Radiofrequency ablation Radiofrequency ablation Radiofrequency ablation Cryoablation Cryoablation Cryoablation
Ablation strategy Pulmonary vein isolation Pulmonary vein isolation, roof catheter, CTI catheter, mitral catheter Pulmonary vein isolation, CFAE ablation, roof catheter, SVC isolation, CTI catheter Pulmonary vein isolation Pulmonary vein isolation Pulmonary vein isolation
Acute isolation of pulmonary veins, % 100 NR 87 98 100 100
Blanking period 2 mo 3 mo 3 mo 3 mo 3 mo 3 mo
Additional ablation, (ablation/AAD), % 12.5 vs 51.4e 47 vs 36 15 vs 43 0 vs 34f 12 vs 24f 5.6 vs 17
Free from atrial arrhythmias in catheter ablation group on follow-up, % 87 64.4 45.5 79.9 57.8 82.2
Free from atrial arrhythmias in the drug therapy group on follow-up, % 37 44.6 27.9 64.7 32.2 67.6

Abbreviations: AADs, antiarrhythmic drugs; AF, atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia; CFAE, complex fractionated electrogram; CHA2DS2-VASc score, congestive heart failure, hypertension, age 75 years or older, diabetes, prior stroke/transient ischemic attack–vascular disease, age 65 to 74 years, sex category; CTI, cavotricuspid isthmus; ECG, electrocardiogram; LVEF, left ventricular ejection fraction; NA, not applicable; NR, not reported; SVC, superior vena cava.

a

Abstract published.

b

CHADS2 score, with CHA2DS2-VASC, 0 to 1 meaning low risk for stroke and CHA2DS2-VASc 2 or higher meaning high risk for stroke.

c

Only episodes of AF lasting longer than 1 minute.

d

Months.

e

Ablation outside the prespecified time period

f

Number of repeated ablations after meeting the primary end point.