Table 3.
Efficacy and safety outcomes by number of concomitant drug treatments used by ARISTOTLE trial participants
| Event | 0-5 drugs | 6-8 drugs | ≥9 drugs | P | |||||
|---|---|---|---|---|---|---|---|---|---|
| Rate per 100 patient years (no of patients) | Adjusted hazard ratio (95% CI) | Rate per 100 patient years (no of patients) | Adjusted hazard ratio (95% CI) | Rate per 100 patient years (no of patients) | Adjusted hazard ratio (95% CI) | ||||
| Efficacy outcomes | |||||||||
| Stroke/SE | 1.29 (166) | Reference | 1.48 (176) | 1.270 (1.022 to 1.577) | 1.57 (135) | 1.539 (1.190 to 1.991) | 0.004 | ||
| Ischaemic or uncertain type of stroke | 0.82 (106) | Reference | 1.11 (132) | 1.475 (1.136 to 1.915) | 1.15 (99) | 1.738 (1.275 to 2.369) | 0.001 | ||
| All cause death | 3.01 (396) | Reference | 3.80 (462) | 1.409 (1.229 to 1.616) | 4.70 (414) | 2.031 (1.735 to 2.377) | <0.001 | ||
| Safety outcomes | |||||||||
| Major bleeding | 1.91 (224) | Reference | 2.46 (267) | 1.243 (1.036 to 1.491) | 3.88 (298) | 1.721 (1.414 to 2.095) | <0.001 | ||
| Intracranial | 0.54 (64) | Reference | 0.55 (61) | 1.025 (0.722 to 1.456) | 0.62 (49) | 1.153 (0.795 to 1.673) | 0.73 | ||
| Gastrointestinal | 0.47 (56) | Reference | 0.71 (78) | 1.498 (1.062 to 2.111) | 1.15 (90) | 2.429 (1.740 to 3.391) | <0.001 | ||
| Clinically relevant non-major bleeding | 2.09 (243) | Reference | 2.47 (267) | 1.183 (0.994 to 1.408) | 3.30 (252) | 1.574 (1.319 to 1.877) | <0.001 | ||
| Any bleeding | 17.41 (1742) | Reference | 21.40 (1908) | 1.167 (1.092 to 1.247) | 29.63 (1766) | 1.452 (1.348 to 1.565) | <0.001 | ||
| Net benefit outcomes | |||||||||
| Stroke/SE/major bleeding/all cause death | 5.24 (665) | Reference | 6.59 (769) | 1.320 (1.187 to 1.468) | 8.92 (743) | 1.838 (1.631 to 2.071) | <0.001 | ||
| Other outcomes | |||||||||
| Permanent study drug discontinuation | 14.32 (1699) | Reference | 14.99 (1655) | 1.053 (0.982 to 1.129) | 17.44 (1372) | 1.218 (1.123 to 1.322) | <0.001 | ||
| Time in therapeutic range <66%* | 53.2 (1823) | Reference | 50.2 (1564) | 0.887 (0.805 to 0.977) | 44.9 (1044) | 0.716 (0.644 to 0.795) | <0.001 | ||
Hazard ratios and P values adjusted by country (strata), sex, and age (spline). SE=systemic embolism.
*Values reported are percentage (number of patients) and unadjusted odd ratios for patients randomised to warfarin.