Incidence and outcomes of major bleeding among first-time oral factor Xa inhibitor users: multinational observational cohort studies

Figures

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  Figure 1. Flow chart of patient populations. FXai, factor Xa inhibitor; GI, gastrointestinal; ICH, intracranial hemorrhage. aPatients may have experienced multiple bleed types, and assessments varied by country based on whether a hierarchy was applied.

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  Figure 2. Incidence rates of major bleeds and fatal major bleeds over time (initiator cohort).a PYR, person-years. aThe percentage of total variation across countries for major and fatal bleeds due to heterogeneity rather than chance, I2 (95% CI), was as follows: major bleeds at 3 months, 99.4% (99.2%-99.6%); 1 year, 99.6% (99.5%-99.7%); and 3 years, 99.7% (99.6%-99.7%); and fatal major bleeds at 3 months, 96.6% (94.3%-98.0%); 1 year, 97.7% (96.3%-98.5%); and 3 years, 98.3% (97.5%-98.9%).

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  Figure 3. Incidence rates of (A) major bleeds and (B) fatal major bleeds by FXai indication (initiator cohort).a,b,c AF, atrial fibrillation; CVR, cardiac valve replacement; FXai, factor Xa inhibitor; PYR, person-years; VTE, venous thromboembolism. aThe data presented are for 3 months, 1 year, and 3 years for all indications; however, the data points have been staggered to improve visibility. bThe percentage of total variation across countries for major bleeds due to heterogeneity rather than chance, I2 (95% CI), was as follows: AF major bleeds at 3 months, 99.3% (99.0%-99.5%); 1 year, 99.5% (99.3%-99.6%); and 3 years, 99.6% (99.5%-99.7%); nonmechanical CVR major bleeds at 3 months, 95.1% (91.2%-97.3%); 1 year, 94.8% (90.5%-97.1%); and 3 years, 94.7% (90.4%-97.1%); and VTE major bleeds at 3 months, 98.1% (97.0%-98.7%); 1 year, 98.5% (97.7%-99.0%); and 3 years, 98.7% (98.0%-99.1%). cThe percentage of total variation across countries for fatal major bleeds due to heterogeneity rather than chance, I2 (95% CI), was as follows: AF fatal major bleeds at 3 months, 96.4% (93.9%-97.9%); 1 year, 97.5% (96.0%-98.5%); and 3 years, 98.2% (97.2%-98.8%); nonmechanical CVR fatal major bleeds at 3 months,…

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  Figure 4. Incidence of (A) major bleeds by site and (B) fatal major bleeds by site (initiator cohort).a,b,c GI, gastrointestinal; ICH, intracranial hemorrhage; PYR, person-years. aThe data presented are for 3 months, 1 year, and 3 years for all bleed sites; however, the data points have been staggered to improve visibility. bThe percentage of total variation across countries for major bleeds due to heterogeneity rather than chance, I2 (95% CI), was as follows: ICH at 3 months, 67.6% (16.2%-87.5%); 1 year, 91.5% (83.2%-95.7%); and 3 years, 95.4% (91.9%-97.4%); GI major bleeds at 3 months, 98.8% (98.2%-99.2%); 1 year, 99.0% (98.6%-99.3%); and 3 years, 99.2% (98.9%-99.4%); traumatic major bleeds at 3 months, 98.4%; 1 year, 99.3%; and 3 years, 99.5%; and other major bleeds at 3 months, 99.4% (99.2%-99.6%); 1 year, 99.6% (99.5%-99.7%); and 3 years, 99.7% (99.6%-99.8%). cThe percentage of total variation across countries for fatal major bleeds due to heterogeneity rather than chance, I2 (95% CI), was as follows: fatal ICH at 3 months, 66.7% (13.4%-87.2%); 1 year, 64.1% (5.5%-86.4%); and 3 years, 82.2% (59.1%-92.3%); GI fatal major bleeds at 3 months, 91.8% (83.9%-95.8%); 1 year, 94.5%…

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  Figure 5. Clinical outcomes of major bleeding (major bleed cohort). AMI, acute myocardial infarction; CV, cardiovascular; PYR, person-years.

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  Supplementary Figure 1.