Table 2. Prespecified Primary Quality of Life Measures by Intention-to-Treat Analysis in the CABANA Trial.
| Follow-up Point | Catheter Ablation | Drug Therapy | Mean Adjusted Difference (95% CI) | ||||
|---|---|---|---|---|---|---|---|
| Median (25th, 75th percentile) | Mean (SD) | No. | Median (25th, 75th percentile) | Mean (SD) | No. | ||
| AFEQT Summary Score a | |||||||
| Baseline | 63 (48, 79) | 62.9 (20.5) | 1084 | 63 (48, 80) | 63.1 (20.6) | 1078 | −0.2 (−1.9 to 1.5) |
| 3 mo | 85 (69, 95) | 79.8 (18.6) | 971 | 81 (63, 94) | 76.5 (20.4) | 983 | 3.0 (1.3 to 4.7) |
| 12 mo | 94 (80, 99) | 86.4 (16.5) | 915 | 86 (69, 96) | 80.9 (18.5) | 903 | 5.3 (3.7 to 6.9)b |
| 24 mo | 94 (78, 99) | 86.6 (16.2) | 856 | 88 (71, 98) | 81.8 (18.9) | 798 | 4.3 (2.7 to 6.0) |
| 36 mo | 93 (77, 99) | 86.1 (15.8) | 645 | 90 (76, 98) | 83.9 (17.3) | 605 | 2.5 (0.8 to 4.1) |
| 48 mo | 92 (78, 99) | 86.2 (15.9) | 476 | 89 (74, 98) | 83.5 (17.7) | 473 | 3.0 (1.1 to 4.9) |
| 60 mo | 93 (77, 100) | 86.2 (16.2) | 329 | 90 (75, 98) | 83.3 (18.6) | 320 | 2.6 (0.3 to 4.8) |
| All follow-up | 91 (76, 98) | 84.8 (17.0) | 4192 | 87 (70, 97) | 80.9 (19.0) | 4082 | 3.4 (2.1 to 4.8)b |
| MAFSI Frequency Score c | |||||||
| Baseline | 11 (7, 16) | 11.8 (6.2) | 1069 | 11 (7, 16) | 11.9 (6.4) | 1061 | −0.2 (−0.7 to 0.4) |
| 3 mo | 6 (2, 11) | 7.3 (5.9) | 897 | 8 (3, 13) | 8.9 (6.5) | 894 | −1.6 (−2.2 to −1.0) |
| 12 mo | 5 (1, 10) | 6.4 (6.0) | 828 | 7 (3, 12) | 8.1 (6.3) | 831 | −1.7 (−2.3 to −1.2)b |
| 24 mo | 5 (1, 10) | 6.2 (5.7) | 759 | 7 (3, 12) | 8.0 (6.5) | 724 | −1.7 (−2.3 to −1.1) |
| 36 mo | 5 (2, 10) | 6.4 (5.9) | 571 | 6 (2, 12) | 7.5 (6.4) | 559 | −1.2 (−1.9 to −0.6) |
| 48 mo | 5 (1, 10) | 6.5 (6.1) | 424 | 6 (2, 11) | 7.1 (6.2) | 419 | −0.8 (−1.6 to −0.1) |
| 60 mo | 4 (1, 9) | 5.8 (5.7) | 279 | 5 (2, 10) | 7.0 (6.3) | 295 | −1.3 (−2.1 to −0.5) |
| All follow-up | 5 (2, 10) | 6.5 (5.9) | 3758 | 7 (3, 12) | 8.0 (6.4) | 3722 | −1.4 (−1.9 to −0.9)b |
| MAFSI Severity Score d | |||||||
| Baseline | 9 (6, 13) | 9.3 (4.9) | 1066 | 9 (5, 13) | 9.3 (5.1) | 1056 | −0.1 (−0.5 to 0.4) |
| 3 mo | 5 (2, 9) | 5.8 (4.7) | 891 | 6 (3, 11) | 7.0 (5.2) | 892 | −1.3 (−1.8 to −0.9) |
| 12 mo | 4 (1, 8) | 5.0 (4.7) | 827 | 5 (2, 10) | 6.5 (5.1) | 830 | −1.5 (−2.0 to −1.1)b |
| 24 mo | 4 (1, 8) | 4.9 (4.5) | 757 | 5 (2, 9) | 6.2 (5.1) | 722 | −1.3 (−1.7 to −0.8) |
| 36 mo | 4 (1, 8) | 5.0 (4.5) | 569 | 5 (2, 9) | 5.8 (5.0) | 559 | −1.0 (−1.5 to −0.5) |
| 48 mo | 4 (1, 8) | 5.0 (4.7) | 423 | 5 (2, 9) | 5.5 (4.8) | 419 | −0.7 (−1.3 to −0.2) |
| 60 mo | 3 (1, 7) | 4.6 (4.7) | 279 | 4 (2, 8) | 5.6 (4.9) | 295 | −1.0 (−1.7 to −0.4) |
| All follow-up | 4 (1, 8) | 5.1 (4.7) | 3746 | 5 (2, 9) | 6.3 (5.1) | 3717 | −1.1 (−1.5 to −0.8)b |
Abbreviations: AFEQT, Atrial Fibrillation Effect on Quality of Life; MAFSI, Mayo AF-Specific Symptom Inventory.
a
Score range: 0-100; score <70 indicates severely symptomatic; 70-89, mildly to moderately symptomatic; ≥90, minimally symptomatic or asymptomatic.
b
P <.001; statistical significance testing results provided only for 12-mo interval and all follow-up.
c
Score range:0-40; score >9 indicates severely symptomatic; 4-9, mildly to moderately symptomatic; <4, minimally symptomatic or asymptomatic.
d
Score range: 0-40; higher scores indicate higher severity of symptoms.