Table 4

Risk factors associated with major bleeding (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation derivation cohort)

VariableOR*95% CIP valueOR†95% CIP valueScore
Bleeding predisposition‡4.102.54 to 6.60<0.00013.872.32 to 6.47<0.00014
Age ≥75 years2.161.52 to 3.07<0.00011.991.36 to 2.910.00042
Vascular disease§1.921.35 to 2.730.00031.651.11 to 2.430.01251
Abnormal renal function¶1.781.18 to 2.690.00621.501.01 to 2.230.04011
Abnormal liver function¶3.481.65 to 7.350.00113.241.47 to 7.150.00352
Labile INR**1.441.00 to 2.080.04921.310.91 to 1.890.09651
Excess alcohol1.851.07 to 3.200.01341.941.02 to 3.690.04722
Drugs††1.781.23 to 2.580.00231.350.89 to 2.050.15811
  • *Univariate analysis.

  • †Multivariable analysis.

  • ‡History of bleeding/anaemia (HAS-BLED).

  • §Peripheral artery disease, prior myocardial infarction, aortic plaque (CHA2DS2-VASc).

  • ¶Abnormal renal function (HAS-BLED): serum creatinine >2.3 mg/dL (200 μmol/L), renal transplantation or chronic dialysis. Abnormal liver function (HAS-BLED): cirrhosis, elevated liver transaminases or alkaline phosphatase >3 times above the upper limit of normal (ULN), or bilirubin >2 times above the ULN.

  • **<60% time in therapeutic range.

  • ††Antiplatelet agents or non-steroidal anti-inflammatory drugs.

  • INR, international normalised ratio.