Table 2. Rate of Ischemic Stroke and Association of Rivaroxaban vs Aspirin by Tertiles of HAVOC Score, Frequency of Premature Atrial Contractions, and Left Atrial Diameter.
| Subgroup | AF Reported, No. (%) | Rivaroxaban Group (n = 3563) | Aspirin Group (n = 3549) | Rivaroxaban vs Aspirin | ||||
|---|---|---|---|---|---|---|---|---|
| Randomized, No. | No. of Events (Events Ratea) | Randomized, No. | No. of Events (Events Ratea) | Hazard Ratio (95% CI)b | P Value for Interactionb | P Value for Trend | ||
| Overallc | 239 (3.4) | 3563 | 158 (4.8) | 3549 | 153 (4.6) | 1.03 (0.83-1.29) | .78 | NA |
| HAVOC score | ||||||||
| 0-4 | 199 (3.1) | 3218 | 141 (4.7) | 3158 | 129 (4.4) | 1.07 (0.84-1.36) | .68 | .41 |
| 5-9 | 40 (5.6) | 332 | 16 (5.4) | 376 | 22 (6.1) | 0.86 (0.45-1.64) | ||
| 10-14 | 0 (0.0) | 13 | 1 (7.0) | 15 | 2 (17.0) | 0.23 (0.02-2.92) | ||
| HAVOC score | ||||||||
| Tertile 1: 0-2 | 96 (2.3) | 2103 | 98 (5.1) | 2027 | 87 (4.7) | 1.08 (0.81-1.45) | .67 | .45 |
| Tertile 2: 3 | 34 (3.0) | 553 | 18 (3.4) | 562 | 15 (2.9) | 1.20 (0.61-2.39) | ||
| Tertile 3: >3 | 109 (5.8) | 907 | 42 (5.0) | 960 | 51 (5.5) | 0.89 (0.59-1.35) | ||
| Atrial premature beats per 24 hd | ||||||||
| Tertile 1: 0-20 | 10 (1.3) | 365 | 22 (6.8) | 404 | 17 (4.5) | 1.47 (0.78-2.77) | .96 | .77 |
| Tertile 2: 21-123 | 22 (2.9) | 384 | 21 (5.8) | 368 | 14 (4.2) | 1.40 (0.71-2.76) | ||
| Tertile 3: >123 | 52 (7.0) | 347 | 22 (6.7) | 401 | 20 (5.1) | 1.31 (0.72-2.41) | ||
| Atrial premature beats per 24 hd | ||||||||
| ≤720 | 60 (3.1) | 964 | 56 (6.3) | 1003 | 40 (4.3) | 1.47 (0.98-2.20) | .53 | NA |
| >720 | 24 (7.9) | 132 | 9 (7.4) | 170 | 11 (6.7) | 1.07 (0.45-2.59) | ||
| Longest episode of SVT, mind | ||||||||
| Tertile 1: 0-1 | 1 (1.7) | 33 | 0 (0.0) | 27 | 0 (0.0) | NA | NA | NA |
| Tertile 2: 2-5 | 2 (10.5) | 12 | 0 (0.0) | 7 | 0 (0.0) | NA | NA | NA |
| Tertile 3: >5 | 2 (5.9) | 12 | 0 (0.0) | 22 | 3 (14.4) | NA | NA | NA |
| No. of episodes of SVT per 24 hd | ||||||||
| Tertile 1: 0-2 | 9 (2.1) | 196 | 12 (6.9) | 225 | 6 (3.0) | 2.32 (0.87-6.20) | .23 | .19 |
| Tertile 2: 3-10 | 11 (4.1) | 140 | 6 (4.3) | 131 | 7 (6.4) | 0.66 (0.22-1.98) | ||
| Tertile 3: >10 | 16 (4.9) | 162 | 8 (4.7) | 165 | 8 (5.2) | 0.96 (0.36-2.56) | ||
| LA diameter, cm | ||||||||
| Tertile 1: 0-3.4 | 24 (1.8) | 683 | 43 (7.0) | 680 | 22 (3.5) | 1.97 (1.18-3.29) | .02 | .03 |
| Tertile 2: 3.5-4 | 50 (3.4) | 725 | 26 (3.9) | 758 | 38 (5.2) | 0.74 (0.45-1.21) | ||
| Tertile 3: >4 | 58 (4.9) | 587 | 25 (4.5) | 589 | 28 (5.0) | 0.90 (0.52-1.54) | ||
| LA diameter, cm | ||||||||
| ≤4.6 | 109 (3.0) | 1808 | 91 (5.5) | 1853 | 77 (4.4) | 1.23 (0.91-1.67) | .02 | NA |
| >4.6 | 23 (6.4) | 187 | 3 (1.7) | 174 | 11 (6.5) | 0.26 (0.07-0.94) | ||
| Combined atrial myopathy risk factorse | ||||||||
| No risk factor | 166 (2.9) | 2921 | 131 (4.9) | 2883 | 121 (4.6) | 1.07 (0.83-1.37) | .54 | NA |
| ≥1 Risk factors | 73 (5.6) | 642 | 27 (4.4) | 666 | 32 (4.9) | 0.89 (0.53-1.48) | ||
| Age, y | ||||||||
| Tertile 1: 0-62 | 32 (1.3) | 1190 | 50 (4.7) | 1186 | 41 (3.7) | 1.24 (0.82-1.87) | .52 | .25 |
| Tertile 2: 63-71 | 78 (3.3) | 1214 | 52 (4.6) | 1178 | 48 (4.5) | 1.03 (0.70-1.53) | ||
| Tertile 3: >71 | 129 (5.5) | 1159 | 56 (5.1) | 1185 | 64 (5.7) | 0.90 (0.63-1.29) | ||
| AF5F scoref | ||||||||
| Tertile 1: 0-56.88 | 38 (1.5) | 1256 | 52 (4.6) | 1233 | 41 (3.6) | 1.27 (0.84-1.91) | .47 | .23 |
| Tertile 2: 56.89-63.72 | 81 (3.4) | 1190 | 51 (4.6) | 1173 | 50 (4.6) | 0.99 (0.67-1.46) | ||
| Tertile 3: >63.72 | 120 (5.3) | 1117 | 55 (5.2) | 1143 | 62 (5.8) | 0.90 (0.63-1.30) | ||
Abbreviations: AF, atrial fibrillation; LA, left atrial; NA, not applicable; SVT, supraventricular tachycardia.
a
Event rates reported in 100 person-years.
b
Hazard ratio, 95% CI, and P for interaction not reported if hazard ratio is ≥10 or cannot be computed.
c
Randomized participants in NAVIGATE ESUS without AF/flutter reported at baseline.
d
Information available only if Holter electrocardiogram performed as a measure for cardiac rhythm monitoring.
e
One point: HAVOC score, >7; 1 point: >720 premature atrial contractions per 24 hours; 1 point: LA diameter, >41 mm.
f
AF5F score: (age at baseline × 0.76) + 9 (+ 12 points, if baseline National Institutes of Health Stroke Scale score >5).