Table 1. Efficacy and Safety Outcomes.
| Outcome | Patients, No. (%) | Model 1a | Model 2b | Model 3c | ||||
|---|---|---|---|---|---|---|---|---|
| Aspirin (n = 5035) | Clopidogrel-Aspirin (n = 5016) | Adjusted Hazard Ratio (95% CI) | P Value | Adjusted Hazard Ratio (95% CI) | P Value | Adjusted Hazard Ratio (95% CI) | P Value | |
| Efficacy Outcomes | ||||||||
| Composite of ischemic stroke, myocardial infarction, and death from ischemic vascular causes | 458 (9.1) | 328 (6.5) | 0.71 (0.61-0.81) | <.001 | 0.70 (0.61-0.81) | <.001 | 0.70 (0.60-0.82) | <.001 |
| Ischemic stroke | 450 (8.9) | 316 (6.3) | 0.69 (0.60-0.80) | <.001 | 0.69 (0.59-0.79) | <.001 | 0.69 (0.59-0.81) | <.001 |
| Myocardial infarction | 9 (0.2) | 13 (0.3) | 1.44 (0.62-3.38) | .40 | 1.40 (0.60-3.29) | .44 | 2.30 (0.60-8.93) | .23 |
| Death from ischemic vascular causes | 7 (0.1) | 9 (0.2) | 1.28 (0.48-3.42) | .63 | 1.22 (0.45-3.29) | .69 | 0.83 (0.20-3.44) | .80 |
| Ischemic or hemorrhagic stroke | 458 (9.1) | 328 (6.5) | 0.71 (0.61-0.81) | <.001 | 0.70 (0.61-0.80) | <.001 | 0.69 (0.59-0.81) | <.001 |
| Disabling or fatal stroked | 307 (6.1) | 232 (4.6) | 0.75 (0.63-0.89) | <.001 | 0.74 (0.62-0.87) | <.001 | 0.72 (0.60-0.87) | <.001 |
| Nondisabling strokee | 152 (3.0) | 96 (1.9) | 0.63 (0.48-0.81) | <.001 | 0.62 (0.48-0.80) | <.001 | 0.63 (0.47-0.84) | .002 |
| Composite of ischemic stroke, myocardial infarction, death from ischemic vascular causes, and major hemorrhage | 473 (9.4) | 354 (7.1) | 0.74 (0.64-0.85) | <.001 | 0.73 (0.64-0.84) | <.001 | 0.72 (0.62-0.84) | <.001 |
| Safety Outcomes | ||||||||
| Major hemorrhage | 18 (0.4) | 30 (0.6) | 1.67 (0.93-2.99) | .09 | 1.59 (0.88-2.86) | .12 | 1.20 (0.61-2.39) | .60 |
| Hemorrhagic stroke | 11 (0.2) | 13 (0.3) | 1.16 (0.52-2.60) | .71 | 1.06 (0.47-2.40) | .90 | 0.77 (0.30-1.95) | .58 |
| Minor hemorrhage | 46 (0.9) | 93 (1.9) | 2.02 (1.42-2.88) | <.001 | 2.01 (1.41-2.86) | <.001 | 1.87 (1.26-2.79) | .002 |
| Major or minor hemorrhage | 64 (1.3) | 123 (2.5) | 1.91 (1.41-2.58) | <.001 | 1.88 (1.39-2.54) | <.001 | 1.66 (1.18-2.35) | .004 |
| Death from any cause | 22 (0.4) | 28 (0.6) | 1.26 (0.72-2.21) | .42 | 1.17 (0.66-2.05) | .59 | 1.08 (0.54-2.16) | .82 |
Adjusted for trial, with study site as a random-effect variable in the model.
Adjusted for trial, sex, age, race, history of congestive heart failure, known atrial fibrillation or flutter, ischemic heart disease, hypertension, diabetes mellitus, current or previous smoking status, qualifying event, and time to randomization, with study site as a random-effect variable in the model.
Adjusted for trial, sex, age, race, history of congestive heart failure, known atrial fibrillation or flutter, ischemic heart disease, hypertension, diabetes mellitus, current or previous smoker, qualifying event, time to randomization, and lipid-lowering and antihypertensive treatments, with study site as a random-effect variable in the model; only 7663 patients (76.2%) were included in the model, because antihypertensive treatment was not collected in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke trial before 2014.
Defined by a modified Rankin Scale greater than 1.
Defined by a modified Rankin Scale of 0 or 1.