Table 3.
Patient Background After Propensity Score Matching
| Variable | DOAC only | DOAC+antiplatelets | ||||
|---|---|---|---|---|---|---|
| Standard dose (n=212) |
Off-label reduced dose (n=212) |
P-value | Standard dose (n=62) |
Off-label reduced dose (n=62) |
P-value | |
| Age (years) | 69.94±8.32, 70.00 (64.00–76.00) |
68.51±11.25, 70.00 (62.75–76.00) |
0.138 | 72.44±7.04, 74.00 (68.00–77.00) |
72.23±9.19, 73.00 (67.25–79.00) |
0.887 |
| Body weight (kg) | 64.32±10.90, 65.00 (57.95–72.32) |
64.13±12.41, 64.15 (56.48–72.55) |
0.864 | 63.98±10.76, 63.85 (56.02–72.70) |
64.93±12.22, 65.00 (60.20–70.22) |
0.649 |
| Female | 50 (23.6) | 72 (34.0) | 0.024 | 12 (19.4) | 12 (19.4) | >0.999 |
| Hypertension | 143 (67.5) | 140 (66.0) | 0.837 | 54 (87.1) | 56 (90.3) | 0.778 |
| Diabetes mellitus | 51 (24.1) | 54 (25.5) | 0.822 | 25 (40.3) | 26 (41.9) | >0.999 |
| Dyslipidemia | 137 (64.6) | 128 (60.4) | 0.422 | 50 (80.6) | 51 (82.3) | >0.999 |
| Statin use | 69 (32.5) | 53 (25.0) | 0.107 | 37 (59.7) | 37 (59.7) | >0.999 |
| No. antiplatelets | ||||||
| None | 212 (100.0) | 212 (100.0) | >0.999 | |||
| Single | 51 (82.3) | 51 (82.3) | >0.999 | |||
| Dual | 11 (17.7) | 11 (17.7) | >0.999 | |||
| Type of antiplatelets | ||||||
| Aspirin | 46 (74.2) | 44 (71.0) | 0.841 | |||
| Cilostazol | 4 (6.5) | 6 (9.7) | 0.743 | |||
| Clopidogrel | 22 (35.5) | 22 (35.5) | >0.999 | |||
| Ticlopidine | 1 (1.6) | 1 (1.6) | >0.999 | |||
| Persistent or longstanding AF | 99 (46.7) | 89 (42.2) | 0.379 | 26 (42.6) | 19 (30.6) | 0.193 |
| History of HF | 48 (22.6) | 38 (17.9) | 0.277 | 19 (30.6) | 12 (19.4) | 0.213 |
| History of bleeding | 47 (22.2) | 45 (21.2) | 0.906 | 18 (29.0) | 20 (32.3) | 0.846 |
| CAD | 20 (9.4) | 11 (5.2) | 0.134 | 38 (61.3) | 39 (62.9) | >0.999 |
| History of PCI or CABG | 3 (1.4) | 3 (1.4) | >0.999 | 28 (45.2) | 27 (43.5) | >0.999 |
| History of stroke | 32 (15.1) | 31 (14.6) | >0.999 | 25 (40.3) | 22 (35.5) | 0.711 |
| Liver dysfunction | 90 (42.5) | 77 (36.3) | 0.233 | 20 (32.3) | 23 (37.1) | 0.706 |
| Creatinine (mg/dL) | 0.98±0.28, 0.97 (0.79–1.13) |
0.85±0.25, 0.82 (0.69–0.98) |
<0.001 | 1.04±0.37, 0.96 (0.86–1.18) |
0.95±0.29, 0.94 (0.74–1.10) |
0.120 |
| CrCl (mL/min) | 65.28±20.53, 59.98 (51.38–75.97) |
76.46±27.53, 72.05 (56.91–93.86) |
<0.001 | 59.24±15.81, 58.32 (51.57–65.51) |
68.33±26.96, 63.13 (51.31–76.36) |
0.024 |
| Hemoglobin (g/dL) | 13.55±2.00, 13.65 (12.20–15.00) |
13.55±1.85, 13.60 (12.30–15.03) |
0.990 | 13.21±1.90, 13.20 (12.10–14.28) |
13.28±1.68, 13.15 (11.93–14.47) |
0.829 |
| Modified HAS-BLED score†,‡ | 2.20±1.14, 2.00 (1.00–3.00) |
2.08±1.23, 2.00 (1.00–3.00) |
0.307 | 3.81±1.04, 4.00 (3.00–4.00) |
3.77±1.05, 4.00 (3.00–4.00) |
0.863 |
| ORBIT score† | 2.02±1.70, 2.00 (1.00–3.00) |
1.65±1.73, 1.00 (0.00–3.00) |
0.026 | 3.39±1.79, 3.00 (2.00–5.00) |
3.47±2.04, 3.00 (2.00–5.00) |
0.815 |
| CHADS2 score | 1.77±1.29, 2.00 (1.00–3.00) |
1.72±1.33, 1.00 (1.00–3.00) |
0.683 | 2.82±1.40, 3.00 (2.00–4.00) |
2.68±1.25, 2.00 (2.00–4.00) |
0.543 |
Data given as mean±SD, n (%) or median (IQR). †To calculate the ORBIT bleeding and HAS-BLED score,8,9 multiple imputation of missing values was performed taking into account the correlation between all potential predictors.10 A regression model was used for the imputation using the following variables as predictors: age, gender, body weight, diabetes mellitus, dyslipidemia, CAD, peripheral artery disease, creatinine, CrCl, and estimated glomerular filtration rate. ‡Modified HAS-BLED score: in the DIRECT registry, we did not evaluate PT-INR in daily clinical practice due to the use of DOAC. The criterion “labile INR” in HAS-BLED score was therefore set to zero in all patients. Abbreviations as in Table 2.