Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban

Figure 1. Flow chart of patients in this analysis (STROBE format). *Patients can have missing data in more than 1 candidate risk factor. †Patients who died (treatment‐emergent) with bleeding as cause of death based on model population. ‡Patients who died (treatment‐emergent) excluding bleeding as cause of death based on model population. CrCl indicates creatinine clearance.

Figure 2. Risk factors associated with major bleeding events in XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation). Forest plot showing all factors associated with major bleeding events in the XANTUS population after parameter‐wise shrinkage. Alcohol consumption was defined as: abstinent (0 g alcohol/d); mild (<40 g alcohol/d); moderate (40–80 g alcohol/d); or heavy (>80 g alcohol/d). AP indicates antiplatelet; NSAID, nonsteroidal anti‐inflammatory drug.

Figure 3. Patient risk profiles. Donut chart showing study population (outer ring) and patients who experienced a major bleeding event (inner ring) according to the presence of bleeding risk factors, split into modifiable and nonmodifiable risk factors. Age ≥75 years was used as a cut‐off point for age to qualify as a nonmodifiable risk factor.

Figure 4. Analysis of bleeding risk in patients with 0 or ≥1 modifiable bleeding risk factors. A, Kaplan–Meier curve of bleeding events in patients with 0 or ≥1 modifiable risk factors for bleeding. Patients with ≥1 modifiable risk factor (heavy alcohol use, uncontrolled hypertension, and concomitant therapy with antiplatelet agents, NSAIDs, or paracetamol) were twice as likely to experience a bleeding event compared with patients without modifiable risk factors. B, Model‐predicted probabilities of bleeding events in patients with an average profile with respect to all risk factors (yellow), average with respect to all nonmodifiable risk factors and no (purple), 1 (green), 2 (red), or all 3 (blue) modifiable risk factors. Predicted probabilities shown at the end of each projection are for day 360. NSAID indicates nonsteroidal anti‐inflammatory drug.