26-A-9790-ACC PREDICTORS OF GASTROINTESTINAL BLEEDING IN ATRIAL FIBRILLATION: A PATIENT-LEVEL POOLED ANALYSIS OF LARGE-SCALE RANDOMIZED TRIALS FROM COMBINE AF

Gastrointestinal bleeding (GIB) is the most common type of bleeding in pts with AF on oral anticoagulation (OAC). Reliably characterizing independent predictors of GIB may help identify higher risk pts.

Methods

We pooled individual pt data from the 4 pivotal phase 3 randomized trials comparing DOACs with warfarin for stroke prevention in AF. We specified covariates with established bleeding associations and employed backwards selection to identify further covariates associated with GIB. A multivariable Cox model was fitted to identify predictors of major or clinically relevant non-major (CRNM) GIB and major GIB alone. The contribution of predictors to model fit was assessed with the chi-square statistic.

Results

In 71,442 randomized pts, 2,510 had major or CRNM GIB (2.01 per 100 person-yrs, 95% CI 1.93-2.09) over median 23.3 months. Lower baseline hemoglobin was the strongest predictor, with each 1-g/dL decrease conferring 23% increased GIB hazard (HR 1.23, 95% CI 1.20-1.27, P<0.001). Concomitant antiplatelet therapy, reduced creatinine clearance, higher bodyweight, smoking, older age, male sex, Hx of heart failure and higher AST were also independent predictors of GIB (all P<0.001). 1,538 pts had major GIB (1.22 per 100 person-yrs, 95% CI 1.16-1.29) and predictors were similar to those for major or CRNM GIB, with the addition of diabetes Hx (P<0.001).

Conclusion

Modifiable (including antiplatelet therapy) and non-modifiable risk factors predict increased GIB in pts with AF on OAC.