Table 2.
Outcomes by treatment arm in patients with atrial fibrillation
| Endpoints | ICD (n = 54) |
CRT-D (n = 77) |
Measure of effect | Unadjusted hazard or odds ratio or difference (95% CI) |
P-value | Adjusted hazard or odds ratio or difference (95% CI)a |
P-value |
|---|---|---|---|---|---|---|---|
| Primary outcome | |||||||
| Composite endpoint of all-cause death or heart failure hospitalization or <15% end-systolic volume decrease, no./total no. (%) | 41/47 (87) | 24/65 (37) | OR | 0.09 (0.03–0.23) | <0.0001 | 0.06 (0.02–0.17) | <0.0001 |
| Secondary outcomes | |||||||
| Composite endpoint of all-cause death or HF hospitalizations, no./total no. (%) | 20/54 (37) |
13/77 (17) |
HR | 0.39 (0.20–0.79) | 0.009 | 0.33 (0.16–0.70) | 0.003 |
| Death from any cause, no./total no. (%) | 7/54 (13) |
6/77 (8) |
HR | 0.59 (0.20–1.76) | 0.345 | 0.57 (0.18–1.80) | 0.337 |
| HF hospitalizationb, no./total no. (%) | 16/54 (30) |
11/77 (14) |
HR | 0.44 (0.20–0.94) | 0.034 | 0.38 (0.17–0.85) | 0.019 |
| Changes in left ventricular end-diastolic volume from baseline to 12 months, mL ± SD | 2.08 ± 39.9 | −46.9 ± 52.3 | Difference | −48.95 (−68.52 to −29.38) | <0.0001 | −49.21 (−69.10 to −29.32) | <0.0001 |
| Changes in left ventricular ejection fraction from baseline to 12 months, % ± SD | −0.23 ± 7.15 | 9.75 ± 8.8 | Difference | 9.99 (6.64–13.34) | <0.0001 | 10.28 (6.92–13.65) | <0.0001 |
| Tertiary outcomes | |||||||
| Changes in 6-MWT at 12 months (m), mean ± SD | −2.93 ± 136.3 | 23.5 ± 123.7 | Difference | 26.43 (−34.41 to 87.27) | 0.389 | 22.54 (−41.84 to 86.91) | 0.487 |
| Changes EQ-5D-3L from baseline to 12 months, score ± SD | 0.005 ± 0.35 | 0.06 ± 0.37 | Difference | 0.06 (−0.08 to 0.20) | 0.401 | 0.07 (−0.07 to 0.20) | 0.322 |
| Changes in NT-proBNP (pg/mL), from baseline to 12 months, median (25th–75th percentile) | −245 (−1073–809) | −431 (−1705–73) | Difference | −1006 (−2505 to 492) | 0.185 | −1645 (−3204 to −85) | 0.039 |
| Changes in NYHA class from baseline to 12 months, NYHA class | Difference | 0.47 (0.23–0.99) | 0.047 | 0.38 (0.18–0.83) | 0.015 | ||
| Unchanged, no./total no. (%) | 21/41 (51) | 33/64 (51) | |||||
| Improved, no./total no. (%) | 15/41 (37) | 28/64 (44) | |||||
| Worsened, no./total no. (%) | 5/41 (12) | 3/64 (5) | |||||
6-MWT, 6-min walk test; CRT-D, cardiac resynchronization therapy with defibrillator; HF, heart failure; HR, hazard ratio; ICD, implantable cardioverter defibrillator; NT-proBNP, N-terminal pro b-type natriuretic peptide; NYHA, New York Heart Association; OR, odds ratio; SD, standard deviation.
aAdjusted for pre-specified variables considered as strong predictors of the outcome: age, sex, ischaemic aetiology, diabetes, and secondary prevention.
b Post hoc analysis.