Table 3.
Efficacy and Safety End Points by SSRI Use (Matched Cohorts)
| Outcomes | SSRI Events/100 Patient‐years (Total Events) | No SSRI Events/100 Patient‐years (Total Events) | SSRI vs No SSRI | |
|---|---|---|---|---|
| HRa (95% CI) | P Value | |||
| Safety outcomes | ||||
| Major/NMCR bleeding | 18.57 (159) | 16.84 (242) | 1.16 (0.95, 1.43) | 0.15 |
| Major bleeding | 5.61 (48) | 4.11 (59) | 1.37 (0.94, 1.99) | 0.10 |
| Efficacy outcomes | ||||
| Stroke/non‐CNS embolism | 2.64 (27) | 2.31 (37) | 1.23 (0.76, 2.00) | 0.40 |
| Ischemic stroke | 2.15 (22) | 1.74 (28) | 1.20 (0.69, 2.09) | 0.51 |
CI indicates confidence interval; CNS, central nervous system; HR, hazard ratio; NMCR, nonmajor clinically relevant; SSRI, selective serotonin reuptake inhibitor.
The safety end point models used the safety population and were adjusted for age; sex; geographic region; prior stroke or transient ischemic attack; anemia; prior gastrointestinal bleed; chronic obstructive pulmonary disease; diastolic blood pressure; creatinine clearance (calculated using the Cockcroft‐Gault equation); platelets; albumin; prior acetylsalicylic acid, vitamin K antagonist, or thienopyridine; baseline nonsteroidal anti‐inflammatory drug; and randomized anticoagulant treatment. Efficacy end point models used the intention‐to‐treat population and were adjusted for age, sex, geographic region, body mass index, paroxysmal atrial fibrillation, diabetes mellitus, prior stroke or transient ischemic attack, vascular disease (myocardial infarction, peripheral artery disease, or carotid occlusive disease), congestive heart failure, hypertension, chronic obstructive pulmonary disease, diastolic blood pressure, creatinine clearance (calculated using the Cockcroft‐Gault equation), heart rate, abstinence from alcohol use, baseline nonsteroidal anti‐inflammatory drug, and randomized anticoagulant treatment.