Table 3. Number of Outcome Events and Rates per 100 Patient-Years of Follow-up Prior to Matching by Comorbidity Level.
| Comorbidity Measure | No. (%) | ||
|---|---|---|---|
| Dabigatran, 150 mg (n = 21 979) | Rivaroxaban, 20 mg (n = 23 177) | Warfarin (n = 101 715) | |
| No. of ischemic strokes | |||
| All patients | 216 (1.46) | 183 (1.39) | 1328 (2.09) |
| CHA2DS2-VASc scorea | |||
| Low | 34 (0.68) | 31 (0.71) | 122 (0.88) |
| Moderate | 95 (1.45) | 78 (1.33) | 448 (1.58) |
| High | 87 (2.67) | 74 (2.53) | 758 (3.52) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 84 (1.06) | 73 (1.03) | 379 (1.36) |
| Moderate | 77 (1.53) | 63 (1.43) | 523 (2.27) |
| High | 55 (2.91) | 47 (2.84) | 426 (3.35) |
| Gagne comorbidity scorec | |||
| Low | 91 (1.14) | 77 (1.07) | 387 (1.60) |
| Moderate | 56 (1.32) | 58 (1.57) | 390 (2.19) |
| High | 69 (2.64) | 48 (2.06) | 551 (2.55) |
| No. of MH | |||
| All patients | 502 (3.40) | 615 (4.69) | 1358 (5.31) |
| CHA2DS2-VASc scorea | |||
| Low | 80 (1.60) | 95 (2.17) | 395 (2.88) |
| Moderate | 233 (3.56) | 290 (4.96) | 1385 (4.92) |
| High | 189 (5.83) | 230 (7.94) | 1578 (7.38) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 205 (2.60) | 242 (3.41) | 1012 (3.65) |
| Moderate | 183 (3.65) | 228 (5.19) | 1267 (5.53) |
| High | 114 (6.09) | 145 (8.88) | 1079 (8.58) |
| Gagne comorbidity scorec | |||
| Low | 166 (2.09) | 207 (2.89) | 738 (3.06) |
| Moderate | 154 (3.65) | 190 (5.18) | 878 (4.96) |
| High | 182 (7.02) | 218 (9.52) | 1742 (8.14) |
| No. of GIH | |||
| All patients | 453 (3.07) | 533 (4.06) | 2597 (4.09) |
| CHA2DS2-VASc scorea | |||
| Low | 70 (1.40) | 78 (1.78) | 286 (2.08) |
| Moderate | 207 (3.16) | 256 (4.38) | 1075 (3.81) |
| High | 176 (5.42) | 199 (6.85) | 1236 (5.76) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 187 (2.37) | 206 (2.90) | 757 (2.72) |
| Moderate | 163 (3.25) | 199 (4.53) | 1003 (4.36) |
| High | 103 (5.49) | 128 (7.82) | 837 (6.62) |
| Gagne comorbidity scorec | |||
| Low | 146 (1.83) | 172 (2.40) | 528 (2.18) |
| Moderate | 140 (3.32) | 169 (4.60) | 659 (3.71) |
| High | 167 (6.44) | 192 (8.36) | 1410 (6.57) |
| No. of other (nongastrointestinal) major hemorrhage | |||
| All patients | 54 (0.36) | 85 (0.64) | 801 (1.26) |
| CHA2DS2-VASc scorea | |||
| Low | 11 (0.22) | 17 (0.39) | 115 (0.83) |
| Moderate | 28 (0.42) | 36 (0.61) | 325 (1.14) |
| High | 15 (0.46) | 32 (1.09) | 361 (1.66) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 19 (0.24) | 37 (0.52) | 260 (0.93) |
| Moderate | 22 (0.44) | 30 (0.68) | 284 (1.22) |
| High | 13 (0.68) | 18 (1.08) | 257 (2.01) |
| Gagne comorbidity scorec | |||
| Low | 20 (0.25) | 35 (0.49) | 218 (0.90) |
| Moderate | 16 (0.38) | 23 (0.62) | 225 (1.26) |
| High | 18 (0.68) | 27 (1.16) | 358 (1.65) |
| No. of AMI | |||
| All patients | 125 (0.84) | 108 (0.82) | 849 (1.33) |
| CHA2DS2-VASc scorea | |||
| Low | 22 (0.44) | 19 (0.43) | 84 (0.61) |
| Moderate | 46 (0.70) | 45 (0.76) | 334 (1.18) |
| High | 57 (1.74) | 44 (1.50) | 431 (1.99) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 47 (0.59) | 43 (0.60) | 250 (0.89) |
| Moderate | 47 (0.93) | 40 (0.90) | 316 (1.37) |
| High | 31 (1.63) | 25 (1.50) | 283 (2.22) |
| Gagne comorbidity scorec | |||
| Low | 46 (0.58) | 40 (0.56) | 179 (0.74) |
| Moderate | 35 (0.82) | 32 (0.86) | 221 (1.24) |
| High | 44 (1.67) | 36 (1.54) | 449 (2.07) |
| No. of deaths | |||
| All patients | 393 (2.64) | 417 (3.15) | 4282 (6.67) |
| CHA2DS2-VASc scorea | |||
| Low | 64 (1.28) | 86 (1.96) | 506 (3.65) |
| Moderate | 180 (2.73) | 190 (3.22) | 1603 (5.62) |
| High | 149 (4.53) | 141 (4.78) | 2173 (9.96) |
| HAS-BLED bleeding risk scoreb | |||
| Low | 159 (2.00) | 178 (2.49) | 1304 (4.65) |
| Moderate | 166 (3.29) | 157 (3.54) | 1673 (7.19) |
| High | 68 (3.57) | 82 (4.91) | 1305 (10.15) |
| Gagne comorbidity scorec | |||
| Low | 92 (1.15) | 88 (1.22) | 511 (2.10) |
| Moderate | 104 (2.44) | 112 (3.02) | 824 (4.59) |
| High | 197 (7.48) | 217 (9.28) | 2947 (13.50) |
Abbreviations: AMI, acute myocardial infarction; GIH, gastrointestinal hemorrhage; MH, major hemorrhage.
a
CHA2DS2-VASc score ranges from 0 to 9; higher scores indicate higher risk of stroke, transient ischemic attack, or embolism. Category ranges are low (0-3), moderate (4-5), and high (≥6).
b
HAS-BLED score ranges from 0 to 9; higher scores indicate higher bleeding risk. Category ranges are low (0-1), moderate (2), or high (≥3).
c
Gagne multicomorbidity score ranges from 0 to 24; higher scores indicate higher risk of death. Category ranges are low (0-2), moderate (3-4), or high (≥5).