Table 6.
Randomized controlled clinical trials comparing catheter ablation vs. medical therapy in patients with atrial fibrillation and heart failure with reduced ejection fraction
| PABA-CHF301 | MacDonald et al.302 | ARC-HF303 | CAMTAF252 | AATAC255 | CAMERA-MRI250 | AMICA304 | CASTLE-AF256 | CABANA subanalysis257 | RAFT-AF253 | CASTLE HTx260 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Year of publication | 2008 | 2011 | 2013 | 2014 | 2016 | 2017 | 2019 | 2018 | 2021 | 2022 | 2023 |
| Sample size | 81 | 41 | 52 | 50 | 203 | 66 | 140 | 363 | 778 | 411 | 194 |
| Mean age (years) | 60.5 ± 8 | 63 ± 7 | 63 ± 9 | 57 ± 11 | 61 ± 11 | 61 ± 10 | 65 ± 8 | 64 ± 5 | 68 ± 8 | 67 ± 8 | 64 ± 11 |
| AF type | Parox: 52% Pers or LS-pers: 48% |
Pers: 100% | Pers: 100% | Pers: 100% | Pers: 100% | Pers: 100% | Pers: 76.4% LS-pers: 23.6% |
Parox: 32.5% Pers: 38.3% LS-pers: 29.2% |
Parox: 31.6% Pers: 55.3% LS-pers: 13.1% |
Parox: 7.3% Pers: 69.3% LS-pers: 23.4% |
Parox: 30% Pers: 56%, LS-pers: 14% |
| NYHA | NYHA II and III: 100% | NYHA II: 10% NYHA III: 90% |
NYHA II: 52% NYHA III: 48% |
NYHA II: 46% NYHA III: 54% |
NYHA II and III: 100% | Average NYHA: 2.5±0.6 | NYHA II: 39% NYHA III: 61% |
NYHA I: 11% NYHA II: 60% NYHA III: 28% NYHA IV: 1% |
NYHA II: 76.1% NYHA III: 23.7% NYHA IV: 0.3% |
NYHA II: 67% NYHA III: 33% |
NYHA II: 31% NYHA III: 55%, NYHA IV: 14% |
| Baseline LVEF | 28 ± 8% | 39 ± 11% | 24 ± 8% | 33 ± 10% | 29 ± 7% | 33 ± 9% | 26 ± 9% | 32 ± 9% | 55 ± 8% LVEF ≤35%: 8% |
41 ± 15% LVEF ≤45%: 58% |
27 ± 6% |
| Ischemic etiology | 71% | 49% | 33% | 26% | 64% | 0% | 50% | 46% | 21.9% | 31.4% | 39% |
| LA diameter (mm) | 48 ± 6 | 48 ± 7 | 51 ± 10 | 47 ± 5 | 48 ± 7 | 51 ± 6 | 49 ± 7 | – | 46 ± 6 | 49 ± 7 | |
| Follow-up (years) | 0.5 | 0.5 | 1 | 0.5 | 2 | 0.5 | 1 | 3.1 ± 1.6 | 5 | 3.2 ± 1.8 | 1.5 ± 0.5 |
| Control arm—therapy | AV node ablation plus BiV pacing | Rate control | Rate control | Rate control | Rate control Amiodarone |
Rate control | Best medical therapy (rate or rhythm control) | Medical therapy (rate or rhythm control) | Medical therapy (rate or rhythm control) | Rate control | Guideline-directed medical therapy |
| Primary outcome | Composite of LVEF, 6 min walk test distance, and MLWHF score | LVEF | Change in peak O2 consumption | LVEF | Freedom from AF/AFL/AT >30 s off AADs | Change in LVEF at 6 months | Absolute increase in LVEF | Composite of all-cause mortality and HF hospitalization | Composite of all-cause mortality, disabling stroke, serious bleeding, and cardiac arrest | Composite of all-cause mortality, and HF events | Composite of death from any cause, LVAD implantation, or urgent heart transplantation |
| Mean change in LVEF (ablation vs. control) | 8 ± 8 vs. 1 ± 4%, P < 0.001 |
4.5 ± 11.1 vs. 2.8 ± 6.7%, P = 0.6 | 10.9 ± 11.5 vs. 5.4 ± 8.5% P = 0.055 |
8.1 vs. −3.6%, P < 0.001 |
8.1 ± 4 vs. 6.2 ± 5, P = 0.02 | 18.3 vs. 4.4%, P < 0.0001 | 8.8 vs. 7.3% P = 0.36 |
8.0 vs. 0.2% P = 0.005 |
10.1 ± 1.2 vs. 3.8 ± 1.2% P = 0.017 (24 months) |
7.8 ± 7.6 vs. 1.4 ± 7.2 (12 months) |
|
| Rhythm outcome (ablation vs. control) | 12 vs. 100% in AF | 50 vs. 100% in AF | 88 vs. 8% in SR | 19 vs. 100% in AF (at 6 months) | 70 vs. 34% free from AF | 25 vs. 100% in AF (at 6 months) | 73.5 vs. 50% in SR (at 1 year) | 63.1 vs. 21.7% in SR (at 5 years) | 44 vs. 28% w/o AF recurrence (at 5 years) | 85.6 vs. 12.9% in SR (at 2 years) | 31.4 ± 33.3% vs 8.6 ± 26.3% AF burden reduction at 12 months |
| Main findings | Improved composite endpoint | No LVEF improvement | Significant increase in peak O2 consumption | LVEF improvement | Reduction in AF recurrence, unplanned hospitalizations, and mortality | LVEF improvement | No LVEF improvement | Reduction in all-cause death or HF hospitalization | Reduction in the primary composite, reduction in all-cause mortality, and improvement in QoL | Similar primary outcome (P = 0.066) Increase in LVEF |
Reduction in the primary composite endpoint |
AAD, antiarrhythmic drug; AF, atrial fibrillation; AFl, atrial flutter; AT, atrial tachycardia; AV, atrioventricular; BiV, biventricular; HF, heart failure; LA, left atrium; LS-pers, long-standing persistent; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; MLWHF, Minnesota Living with Heart Failure; NYHA, New York Heart Association; Parox, paroxysmal; Pers, persistent; QoL, quality of life; SR, sinus rhythm.