Table 2

Bleeding and thromboembolic complications recorded during follow-up

DOACVKAP value
n=2170n=558
Total follow-up, days2295667
Follow-up, median (IQR), years0.81 (0.41–1.47)1.01 (0.48–1.64)0.001
Quality of laboratory control in VKA-treated patients (TTR), mean±SD%63%±20%
Lost to follow-up, n (%)23 (1.1)16 (2.9)0.0016
Duration of treatment, n (%)
 ≤90 days360 (16.6)85 (15.3)NS
 91–180 days351 (16.2)66 (11.8)0.01
 >180 days1459 (67.2)407 (72.9)0.01
Major bleeding and CRNMB, n (% patient-years)61 (2.7)21 (3.1)NS
Major bleeding, n (%)28 (1.3)8 (1.4)NS
 ICH63
 GIH112
 Other113
 Fatal3 (2 ICH, 1 GIH)2 (ICH)
Thrombotic events, n (% patient-years)67 (2.9)6 (0.9)0.003
 Standard-dose DOAC, n=1905 (FU: 2022 years)60 (3.0)
 Low-dose DOAC, n=265 (FU: 273 years)7 (2.6)
Venous events, n (%)52 (2.4)5 (0.90)0.027
 DVT±PE402
 Isolated PE41
 Superficial vein thrombosis82
Arterial events, n (%)15 (0.69)1 (0.18)NS
 TIA3
 Stroke/peripheral embolism51
 AMI7
 Fatal2 (AMI, stroke)1 (stroke)
Deaths during follow-up, n (%)56 (2.6)33 (5.9)<0.001
 Major bleeding32
 Stroke/ischaemic heart disease21
 Sudden death104
 Cancer123
 Not due to anticoagulation treatment23 (41.1)23 (69.7)0.01
 Other6
Patients who discontinued the treatment, n (%)747 (34.4)192 (34.4)NS
  • AMI, acute myocardial infarction; CRNMB, clinically relevant non-major bleeding; DOAC, direct oral anticoagulant; DVT, deep vein thrombosis; FU, follow-up; GIH, gastrointestinal haemorrhage; ICH, intracranial haemorrhage; NS, not statistically significant; PE, pulmonary embolism; TIA, transient cerebral ischaemic attack; TTR, Both expansion are correct: the first refers to general definition and correctly it was placed in method section; the second expansion at the bottom of the table refers to patients analysed in our study with a specific INR and for a wel defined period of time.0–3.0 INR) since the inclusion in the registry of vitamin K antagonists-treated patients; VKA, vitamin K antagonist.