Table 2.
Primary Effectiveness Outcome, Key Secondary Effectiveness Outcomes, and Primary Safety Outcome.*
| Outcome | 81-mg Group | 325-mg Group | Hazard Ratio (95% CI) | P Value |
|---|---|---|---|---|
| events (estimated percentage) | ||||
| Primary effectiveness outcome: death from any cause, hospitalization for MI, or hospitalization for stroke | 590 (7.28) | 569 (7.51) | 1.02 (0.91–1.14) | 0.75 |
| Death from any cause | 315 (3.80) | 357 (4.43) | 0.87 (0.75–1.01) | |
| Hospitalization for Ml | 228 (2.99) | 213 (2.87) | 1.06 (0.88–1.27) | |
| Hospitalization for stroke | 102 (1.23) | 92 (1.27) | 1.09 (0.82–1.45) | |
| Occurrence of PCI or CABG | 471 (6.05) | 446 (5.96) | 1.04 (0.92–1.19) | |
| Hospitalization for transient ischemic attack | 20 (0.23) | 25 (0.35) | 0.79 (0.44–1.42) | |
| Primary safety outcome: hospitalization for major bleeding with associated blood-product transfusion | 53 (0.63) | 44 (0.60) | 1.18 (0.79–1.77) | 0.41 |
*
Events include data from electronic health record data, Centers for Medicare and Medicaid Services claims, private insurance claims, and confirmed patient-reported outcomes. Estimated percentages are calculated at median follow-up (26.2 months) with the use of the Kalbfleisch and Prentice cumulative incidence function estimator. CABG denotes coronary-artery bypass grafting, CI confidence interval, MI myocardial infarction, and PCI percutaneous coronary intervention.