Acute VTE was defined as either distal or proximal DVT, PE or both. Cancer was defined as being active if patients were receiving ongoing treatment, whereas a history of cancer was applicable to all patients with a cancer diagnosis. Cardiovascular disease was defined as one of the following: documented coronary artery disease or vascular disease (e. g. peripheral artery disease or aortic plaque), transient ischaemic attack (TIA); stroke; congestive heart failure or left ventricular systolic dysfunction. Hypertension was defined as a blood pressure >130/80 mmHg in patients with diabetes, and a SBP >140 mmHg or diastolic blood pressure (DBP) >90 mmHg in those without diabetes. Liver disease was considered present in patients with chronic hepatic disease or biochemical evidence of significant hepatic derangement. Renal insufficiency was classed into mild (reduction of the glomerular filtration rate [GFR] to 60–89 ml/min with kidney damage), moderate (reduction in GFR to 30–59 ml/min), severe (reduction in GFR to 15–29 ml/min) or end-stage renal disease.
Bleeding risk was assessed using the HAS-BLED score. In this score, one point is awarded for each of the following, up to a maximum of 9 points: hypertension (systolic blood pressure [SBP] >160 mmHg); abnormal renal function (transplantation, chronic dialysis, or serum creatinine ≥200 µmol/L); abnormal liver function (chronic hepatic disease or biochemical evidence of significant hepatic derangement); stroke (history of stroke); bleeding history or predisposition (anaemia); labile INR (time in therapeutic range <60 %); advanced age (>65 years); concomitant drugs/alcohol (one point for use of antiplatelet agents and/or non-steroidal anti-inflammatory drugs, plus one point for excessive alcohol consumption) (
6 (link)
). To assess bleeding outcomes, the International Society of Thrombosis and Haemostasis (ISTH) definitions of major, clinically relevant non-major (CRNM) and nuisance bleeding were used (
7 (link)
).
Bleeding risk was assessed using the HAS-BLED score. In this score, one point is awarded for each of the following, up to a maximum of 9 points: hypertension (systolic blood pressure [SBP] >160 mmHg); abnormal renal function (transplantation, chronic dialysis, or serum creatinine ≥200 µmol/L); abnormal liver function (chronic hepatic disease or biochemical evidence of significant hepatic derangement); stroke (history of stroke); bleeding history or predisposition (anaemia); labile INR (time in therapeutic range <60 %); advanced age (>65 years); concomitant drugs/alcohol (one point for use of antiplatelet agents and/or non-steroidal anti-inflammatory drugs, plus one point for excessive alcohol consumption) (
6 (link)
). To assess bleeding outcomes, the International Society of Thrombosis and Haemostasis (ISTH) definitions of major, clinically relevant non-major (CRNM) and nuisance bleeding were used (
7 (link)
).
