Table 4.

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

Variable	OR*	95% CI	P value	OR†	95% CI	P value	Score
Bleeding predisposition‡	4.10	2.54 to 6.60	<0.0001	3.87	2.32 to 6.47	<0.0001	4
Age ≥75 years	2.16	1.52 to 3.07	<0.0001	1.99	1.36 to 2.91	0.0004	2
Vascular disease§	1.92	1.35 to 2.73	0.0003	1.65	1.11 to 2.43	0.0125	1
Abnormal renal function¶	1.78	1.18 to 2.69	0.0062	1.50	1.01 to 2.23	0.0401	1
Abnormal liver function¶	3.48	1.65 to 7.35	0.0011	3.24	1.47 to 7.15	0.0035	2
Labile INR**	1.44	1.00 to 2.08	0.0492	1.31	0.91 to 1.89	0.0965	1
Excess alcohol	1.85	1.07 to 3.20	0.0134	1.94	1.02 to 3.69	0.0472	2
Drugs††	1.78	1.23 to 2.58	0.0023	1.35	0.89 to 2.05	0.1581	1

*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.