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.
Abstract published.
CHADS2 score, with CHA2DS2-VASC, 0 to 1 meaning low risk for stroke and CHA2DS2-VASc 2 or higher meaning high risk for stroke.
Only episodes of AF lasting longer than 1 minute.
Months.
Ablation outside the prespecified time period
Number of repeated ablations after meeting the primary end point.