Table 3. Components of the Composite Primary End Pointa.
| Warfarin Dosing, No. (%) | Absolute Difference (95% CI), % |
Relative Rate (95% CI) |
P Value | ||
|---|---|---|---|---|---|
| Genotype-Guided (n = 808) |
Clinically Guided (n = 789) |
||||
| Met ≥1 primary end point componentb | 87 (10.8) | 116 (14.7) | 3.9 (0.7 to 7.2) | 0.73 (0.56 to 0.95)c | .02 |
| Primary End Point Components | |||||
| Major bleeding on days 1-30 | 2 (0.2) | 8 (1.0) | 0.8 (–0.2 to 1.8) | 0.24 (0.05 to 1.15) | .06 |
| Plus INR <4 | 2 (0.2) | 6 (0.8) | 0.5 (–0.4 to 1.5) | ||
| Plus INR ≥4 | 0 | 2 (0.3) | 0.3 (–0.4 to 1.0) | ||
| INR ≥4 on days 1-30 | 56 (6.9) | 77 (9.8) | 2.8 (0.1 to 5.6) | 0.71 (0.51 to 0.99) | .04 |
| Venous thromboembolism on days 1-60 | 33 (4.1) | 38 (4.8) | 0.7 (–1.3 to 2.8) | 0.85 (0.54 to 1.34) | .48 |
| PE or symptomatic DVT | 10 (1.2) | 15 (1.9) | 0.7 (–0.7 to 2.1) | ||
| PE | 3 (0.4) | 8 (1.0) | 0.6 (–0.3 to 1.7) | ||
| Death on days 1-30 | 0 | 0 | |||
Abbreviations: DVT, deep vein thrombosis; INR, international normalized ratio; NA, not applicable; PE, pulmonary embolism.
a
There were 1597 patients who met criteria for a primary end point.
b
Patients who met multiple end points were counted only once in the total.
c
When using a mixed model with site as a random effect, the odds ratio was 0.70 (95% CI, 0.52-0.94), confirming a benefit with genotype-guided dosing of warfarin.